PROSPECTUS
Filed pursuant to Rule 424b4(2)
Registration No. 333-275989
ACLARION, INC.
5,175,000 UNITS, EACH UNIT CONSISTING OF
ONE SHARE OF COMMON STOCK,
OR ONE PRE-FUNDED WARRANT TO PURCHASE ONE SHARE
OF COMMON STOCK, AND
TWO COMMON WARRANTS EACH
TO PURCHASE ONE SHARE OF COMMON STOCK
We are offering on a best efforts basis 5,175,000
Units, each consisting of one share of our common stock, par value $0.00001 per share, and two warrants each to purchase one share of
common stock (“Common Warrants”), at an offering price of $0.58 per Unit for gross proceeds of approximately $3.0 million.
Each Common Warrant will have an exercise price of $0.58 per share of common stock (equal to 100% of the public offering price of each
Unit sold in this offering), will be exercisable immediately, and will expire five years from the date of issuance.
We are also offering to each purchaser of Units
that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding shares of common stock immediately
following the consummation of this offering the opportunity to purchase Units consisting of one Pre-Funded Warrant, or Pre-Funded Warrant
(in lieu of one share of common stock). A holder of Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded
Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such
limit may be increased to up to 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise.
Each Pre-Funded Warrant will be exercisable for one share of common stock. The purchase price of each Unit including a Pre-Funded Warrant
will be equal to the price per Unit including one share of common stock, minus $0.00001, and the remaining exercise price of each Pre-Funded
Warrant will equal $0.00001 per share. The Pre-Funded Warrants will be immediately exercisable (subject to the beneficial ownership cap)
and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. For each Unit including a Pre-Funded Warrant
we sell (without regard to any limitation on exercise set forth therein), the number of Units including a share of common stock we are
offering will be decreased on a one-for-one basis. The shares of common stock and Pre-Funded Warrants, if any, can each be purchased in
this offering only with the accompanying Common Warrants as part of a Unit, but the components of the Units will immediately separate
upon issuance. See “Description of Securities Included in this Offering” in this prospectus for more information.
We are also registering the shares of common stock
issuable from time to time upon the exercise of the Common Warrants and Pre-Funded Warrants included in the Units offered hereby.
The shares of our common stock and Pre-Funded
Warrants, if any, and the accompanying Common Warrants can only be purchased together in this offering but will be issued separately and
will be immediately separable upon issuance. We are also registering the shares of common stock issuable from time to time upon exercise
of the Common Warrants and Pre-Funded Warrants included in the Units offered hereby.
Our common stock is listed on the Nasdaq Capital
Market under the symbol “ACON.” On February 26, 2024, the closing price for our common stock, as reported on the Nasdaq Capital
Market, was $0.3576 per share. Our IPO Warrants offered in connection with our April 2022 initial public offering are quoted on the Nasdaq
Capital Market under the symbol “ACONW.” The last reported sale price of our IPO Warrants on the Nasdaq Capital Market on
February 26, 2024 was $0.03 per IPO Warrant.
On March 3, 2023, we received a notice (the
“Stockholder Equity Notice”) from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5550(b)(1), which
requires companies listed on The Nasdaq Stock Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued
listing. On April 20, 2023, we received a notice (the “Extension Notice”) from Nasdaq notifying us that the Company had been
granted an additional 180-day period, or until August 30, 2023, to regain compliance with Nasdaq Listing Rule 5550(b)(1). On August 31,
2023, the Nasdaq staff notified us that the Company had not met the terms of the Extension Notice. Accordingly, the Nasdaq staff had
determined to delist the Company’s common stock from Nasdaq, unless the Company timely requested an appeal of the staff’s
determination to a hearings panel (the “Panel”). The Company requested a hearing before the Panel to appeal the delisting
notice from the staff. The Company's hearing with the Panel occurred on October 19, 2023.
On November 7, 2023, we were notified by the
Panel that the Company’s request for continued listing on Nasdaq was granted, subject to the Company demonstrating compliance with
the stockholders’ equity requirement and bid price requirement on or before January 31, 2024. The Panel subsequently extended this
compliance date to February 27, 2024. The Panel has the right to reconsider the terms of this exception based on any event, condition
or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities
on Nasdaq inadvisable or unwarranted. There can be no assurances that the Company will regain compliance with the Stockholders' Equity
Requirement, or that the Company will maintain its listing on the Nasdaq Capital Market. See “Risk Factors -- Risks related to
our Nasdaq listing.”
There is
no established public trading market for the Common Warrants or the Pre-Funded Warrants. We do not intend to apply for listing of the
Common Warrants or Pre-Funded Warrants on any securities exchange or recognized trading system.
Except as
otherwise indicated, all share and per share information in this prospectus gives effect to the reverse stock split of the Company’s
outstanding common stock, which was effective at a ratio of 1-for-16 shares as of 5:00 pm Eastern Time on January 3, 2024, trading for
which began as of 9:30 am Eastern Time on January 4, 2024. In particular, our financial statements included in this prospectus and beginning
on page F-1 have not been restated to reflect the reverse stock split.
The public offering price per Unit will be determined
at the time of pricing and may be at a discount to the then current market price. The recent market price used throughout this prospectus
may not be indicative of the final offering price. The final public offering price will be determined through negotiation between us
and investors based upon a number of factors, including our history and our prospects, the industry in which we operate, our past
and present operating results, the previous experience of our executive officers and the general condition of the securities markets
at the time of this offering.
The Units will be offered at a fixed price and are
expected to be issued in a single closing. We expect this offering to be completed not later than two business days following the commencement
of this offering and we will deliver all securities to be issued in connection with this offering delivery versus payment/receipt versus
payment upon receipt of investor funds received by us. Accordingly, neither we nor the placement agent have made any arrangements to
place investor funds in an escrow account or trust account since the placement agent will not receive investor funds in connection with
the sale of the securities offered hereunder.
We have engaged Maxim Group LLC as our exclusive
placement agent (“Maxim” or the “placement agent”) to use its reasonable best efforts to solicit offers to purchase
our securities in this offering. The placement agent is not purchasing or selling any of the securities we are offering and is not required
to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount
required as a condition to closing in this offering the actual public offering amount, placement agent’s fee, and proceeds to us,
if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above and throughout
this prospectus. We have agreed to pay the placement agent the placement agent fees set forth in the table below. See “Plan of Distribution” in this prospectus for more information.
| | |
Per Unit(1) | | |
Total(2) | |
| Public offering price | |
$ | 0.5800 | | |
$ | 3,001,500 | |
| Placement Agent Fees (1) | |
$ | 0.0406 | | |
$ | 210,105 | |
| Proceeds, before expenses, to us | |
$ | 0.5394 | | |
$ | 2,791.395 | |
| (1) |
In connection with this Offering, we have
agreed to pay to Maxim as placement agent a cash fee equal to 7% of the gross proceeds received
by us in the Offering. We have also agreed to provide Maxim up to $100,000 for reimbursement of accountable expenses in
connection with its engagement as placement agent. See “Plan of Distribution.” |
| (2) |
Assumes no Pre-Funded Warrants
are issued and all Units issued in the offering include common stock. |
The above summary of offering proceeds to us does
not give effect to any exercise of the Common Warrants being issued in this offering.
We are an “emerging growth company” and
a “smaller reporting company” as defined under the federal securities laws and, as such, have elected to be subject to reduced
public company reporting requirements.
Investing in our securities involves a high
degree of risk. Before buying any shares, you should carefully read the discussion of material risks of investing in our securities in
“Risk Factors” beginning on page 20 of this prospectus.
Neither the Securities
and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed on the adequacy
or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
Maxim Group LLC
The date of this prospectus is February
26, 2024
TABLE OF CONTENTS
Neither we nor the placement agents have authorized
anyone to provide any information or to make any representations other than those contained in or incorporated by reference in this prospectus
or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and the placement agents take no
responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus
is an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so.
The information contained in or incorporated by reference in this prospectus or in any applicable free writing prospectus is current only
as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results
of operations and prospects may have changed since that date.
To the extent there is
a conflict between the information contained in this prospectus, on the one hand, and the information contained in any document incorporated
by reference filed with the Securities and Exchange Commission, or the SEC, before the date of this prospectus, on the other hand, you
should rely on the information in this prospectus. If any statement in a document incorporated by reference is inconsistent with a statement
in another document incorporated by reference having a later date, the statement in the document having the late date modifies or supersedes
the earlier statement.
No action is being taken
in any jurisdiction outside the United States to permit a public offering of our common stock or possession or distribution of this prospectus
in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to
inform themselves about and to observe any restrictions as to this public offering and the distribution of this prospectus applicable
to that jurisdiction.
Unless otherwise indicated,
information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations
and market position, market opportunity and market share, is based on information from our own management estimates and research, as
well as from industry and general publications and research, surveys and studies conducted by third-parties. Management estimates are
derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which
we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have not independently
verified any third-party information. In addition, assumptions and estimates of our and our industry’s future performance are necessarily
subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.”
These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Risk Factors”
and “Information Regarding Forward-Looking Statements.”
We further note that the
representations, warranties and covenants made by us in any agreement that is filed as an exhibit to the registration statement of which
this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose
of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you.
Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations,
warranties and covenants should not be relied on as accurately representing the current state of our affairs.
We may also provide a prospectus
supplement or post-effective amendment to the registration statement to add information to, or update or change information contained
in, this prospectus. You should read both this prospectus and any applicable prospectus supplement or post-effective amendment to the
registration statement together with the additional information to which we refer you in the sections of this prospectus entitled “Where You Can Find More Information.”
Our company name was changed
from “Nocimed, Inc.”, to “Aclarion, Inc.” on December 3, 2021. NOCIMED™ -, NOCISCAN® -, NOCIGRAM™
, NOCISCORE™ -, NOCICALC™ - MRS NOCI+™ - NOCI-™ -, NOCImild™ -NOCIWEB™ - SI-SCORE™, VIRTUAL
DISCOGRAM™ - and the Nocimed logo are our trademarks. All other service marks, trademarks and trade names appearing in this prospectus
are the property of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks or
service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies. Solely for convenience, trademarks
and tradenames referred to in this prospectus may appear without the ® or™ symbols, but such references are not intended to
indicate in any way that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will
not assert its rights, to these trademarks and tradenames.
GLOSSARY
Unless otherwise indicated or the context otherwise requires, references
in this prospectus to the term:
“AI” means Artificial Intelligence
“Category I Codes” means numeric
codes that identify a procedure or service that is approved by the Food and Drug Administration (FDA), performed by healthcare professionals
nationwide, and is proven and documented.
“Category III Codes” are CPT Category III codes that
are a set of temporary codes assigned to emerging technologies, services, and procedures.
“CE mark” is an administrative
marking with which a manufacturer or importer affirms its products are in conformity with European health, safety, and environmental
protection standards for products sold within the European Economic Area (EEA).
"Covered Entity” is a health care
provider or other person or entity who acquires and transmits private health information of patients, as covered under HIPAA and GDPR
regulations (see e.g. 45 CFR §160.103).
“CPT” means “Current Procedural
Terminology”, and refers to a medical code set created and maintained by the American Medical Association (“AMA”) and
used by providers of healthcare services to bill insurance companies for their work. All new medical devices and services are required
to secure CPT codes to receive payment from government and private commercial payers.
“CT-Scan” means a computerized
tomography (CT) scan combines a series of X-ray images taken from different angles around the body and uses computer processing to create
cross-sectional images (slices) of the bones, blood vessels and soft tissues inside the body. CT scan images provide more-detailed information
than plain X-rays do.
“Cures Act” means the 21st Century Cures
Act, signed into law on December 13, 2016, as Public Law No: 114-255.
“DICOM” means an acronym for digital image communication,
typically referring to standardized data architecture formats for managing, storing, and communicating or transferring MRI images and
other associated data.
“Disc” means an intervertebral disc
which is made of a gel-like material (nucleus pulposus) surrounded by a thick fibrous ring (annulus fibrosus) is situated between
the vertebral bodies of the spine.
“DLBP” means Discogenic Low Back Pain
“DOC” means “Declaration
of Conformity,” a document signed by us that declares that we have self-complied with applicable regulations for self-certifying
our CE Marking for our products.
“Fusion” means “Spinal Fusion”
which is surgery to permanently connect two or more vertebrae in the spine, eliminating motion between them.
“GDPR” means the General Data Protection
Regulation in the EU, originally effective May 25, 2018 and implemented in all local privacy laws across the EU and EEA region, to protect
a patient’s personally identifiable information (PII) and regulate how it must be collected, stored, and used by others, and in
certain situations applies concurrently with HIPAA requirements with respect to PII that is PHI for persons located in the EU and received
by companies or other persons or entities in the US.
“IRB” means Institutional Review
Board, which is typically an appointed board for reviewing and approving investigational clinical trials.
“Indications for Use” means the
limited scope of the intended uses and related medical indications for appropriately using our products.
“LBP” means Lower Back Pain.
“Labeling” means the scope of
intended “Indications for Use” that is identified with the commercial sale and use of our products.
“Lumbar Spine” means the five
(5) lower vertebrae, L-1 to L-5.
“MR” means Magnetic Resonance.
“MRI” means Magnetic Resonance Imaging.
“MRS” means Magnetic Resonance
Spectroscopy and is a type of pulse sequence used by MR scanners that, unlike MRI pulse sequences which generate images of tissue structures,
generates a ‘spectrum’ with various peaks that represent different chemicals in the body tissue being examined, and which
allows for the quantitative measurement of the relative amounts of those chemicals in the examined tissues.
“Notified Body” means an organization
designated by an EU country to assess the conformity of certain products before being placed on the market, as is required for certain
medical products.
“NIH” means the United States
National Institutes of Health.
“PD TEST” means a Provocation
Discogram test which is a diagnostic test meant to confirm or exclude the intervertebral disc(s) as a source of back pain. This technique
involves puncture of the disc with a fine-gauge needle under fluoroscopic guidance and pressurization of the disc via the injection of
contrast media.
“PMA” means Premarket Approval by the FDA.
"QMS” means Quality Management
System, which is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives,
in particular to meet customer and regulatory requirements.
“DICOM” means an acronym
for digital image communication, typically referring to standardized data architecture formats for managing, storing, and communicating
or transferring MRI images and other associated data.
“Disc” means intervertebral
disc that is located between two vertebral body bones of the spine, where it is bordered by superior and inferior disc end-plate structures,
and comprises an inner disc nucleus between the two end-plates and that is a circumferentially surrounded by, and normally contained
by, and outer disc annulus that is normally a fibrous collagen-based connective tissue structure.
“Spectroscopy” means the science
of deriving and evaluating a multi-peak spectrum for a material and in which different molecular bonds representing different components
of the material are represented by unique respective peaks at particular locations along the spectra, and with the different peaks typically
reflecting different resonant frequencies of the different components when subjected to a pulsed magnetic field; and in our current product,
relates to producing and evaluating spectra for the different chemical constituents of disc tissue as derived from MR pulse sequences
applied to those tissues for that chemical analysis.
PROSPECTUS SUMMARY
The following summary
highlights information contained elsewhere in this prospectus and in documents incorporated by reference. This summary is not complete
and may not contain all the information you should consider before investing in our common stock. You should read this entire prospectus
and the documents incorporated by reference in this prospectus carefully, especially the risks of investing in our common stock discussed
under the heading “Risk Factors,” and our financial statements and related notes incorporated by reference in this prospectus
before making an investment decision. This prospectus includes forward-looking statements that involve risks and uncertainties. See “Information Regarding Forward-Looking Statements.”
The Company was originally
formed in Delaware as Nocimed, LLC in January 2008. Nocimed, LLC was converted to Nocimed, Inc., a Delaware corporation in February 2015.
The name of the Company was changed from “Nocimed, Inc.” to “Aclarion, Inc.” on December 3, 2021. In this prospectus,
unless the context otherwise requires, the terms “Aclarion, Inc.,” “Aclarion”, “Nocimed, Inc.” the
“Company,” “we,” “us” and “our” refer, prior to the name change discussed herein, to
Nocimed, Inc., and after the name change, to Aclarion, Inc.
This prospectus includes
trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this
prospectus are the property of their respective owners.
Except as otherwise noted,
all information in this prospectus reflects and assumes (i) no sale of Pre-Funded Warrants in this offering, which, if sold, would reduce
the number of shares of common stock that we are offering on a one-for-one basis and (ii) no exercise of the Common Warrants issued in
this offering.
Except as otherwise
indicated, all share and per share information in this prospectus gives effect to the reverse stock split of the Company’s outstanding
common stock, which was effective at a ratio of 1-for-16 shares as of 5:00 pm Eastern Time on January 3, 2024, trading for which began
as of 9:30 am Eastern Time on January 4, 2024. Our financial statements included in this prospectus and beginning on page F-1 have been
restated to reflect the reverse stock split.
Overview
Aclarion is a healthcare
technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), and a proprietary biomarker to optimize clinical
treatments. Aclarion’s technology addresses the $134.5B U.S. low back and neck pain market, which according to a 2020 JAMA (Journal
of the American Medical Association) article is now the most costly healthcare condition in the United States. The Company is currently
utilizing Artificial Intelligence (“AI”) to assist in quality control processes that flag spectroscopy data indicative of
a poor MRS study. The use of AI in this application is early in its development cycle and is expected to evolve with further research
and development. The Company is also researching the application of AI and machine learning platforms to analyze both the raw spectroscopy
data and the post-processed signal to evaluate whether AI platforms can more efficiently and more effectively associate MRS data with
clinical outcomes. The use of AI in this application is aspirational and we intend this type of AI research and development to be an
ongoing process applied not only to the various treatment paths associated with back pain, such as conservative therapies, regenerative
and cell therapies and surgical intervention, but also to potentially expand into other clinical explorations involving the diagnosis
of brain, breast and prostate tumors.
The Company, which has
limited sales to date, is addressing this market by initially focusing on improving the outcomes of surgical interventions to treat low
back pain. In this initial application, Aclarion technology is intended to assist surgeons in determining the optimal surgical procedure
for a patient undergoing surgery for pain isolated to their lumbar spine (the “lumbar spine” is comprised of the five (5)
lower vertebrae, L-1 to L-5). We then intend to add additional applications of our technology targeting the management of large segments
of low back pain patients from the point of initial Magnetic Resonance Imaging (“MRI”) through to episode resolution. We believe
this will expand the use of our technology to low back pain patients undergoing conservative therapies such as physical therapy or biologic
and cell therapies aimed at regenerating the lumbar discs. We plan to expand the application of our technology beyond the lumbar spine
to address neck pain populations in addition to low back pain populations. To expand the application of our technology for use in neck
pain populations, we will need to overcome technical changes associated with securing adequate MRS data from the cervical disc, which
is significantly smaller than the lumbar disc, and there can be no assurance the Company will be able to overcome these challenges.
The core technology Aclarion
employs is MRS. The patient experience when undergoing an MRS exam is exactly like that of a standard MRI, with the exception of an additional
3-5 minutes for each disc undergoing a spectroscopy exam. Whereas a standard MRI produces a signal that is converted into anatomical images,
an MRS produces a signal that is converted into a waveform that identifies the chemical composition of tissues. Just like with standard
MRI’s, the data from spectroscopy is useless without technologies that can process the data. Aclarion has developed proprietary
signal processing software that transforms spectroscopy data into clear biomarkers. These biomarkers, which are exclusively licensed from
the Regents of University of California, San Francisco (“UCSF”), are the key data inputs for our proprietary algorithms that,
when applied, determine if an intervertebral disc is consistent with pain. Our patent portfolio includes 22 U.S. Patents, 17 Foreign Patents,
6 pending U.S. patent applications, and 7 pending Foreign patent applications, including patents and patent applications exclusively licensed
from Regents of the University of California.
We believe one of the biggest
issues driving the cost of treating low back and neck pain patients to the top of the list for healthcare spending is that there is no
objective, cost effective and noninvasive diagnostics to reliably identify the source of a patient’s pain. We believe the poor
surgical outcomes for Discogenic Low Back Pain (“DLBP”) are largely due to difficulties in reliably and accurately diagnosing
the specific spinal discs that are causing pain. The current primary diagnostic standard is the MRI, which is useful for showing abnormal
structures and tissue dehydration, but, we believe, cannot reliably identify specific discs that are causing pain. To diagnose specific
discs that are causing pain, a needle-based Provocation Discogram test (“PD Test”) has been developed. PD Tests have been
shown to be highly accurate when performed properly. However, a PD Test is invasive, subjective and unpleasant for the patient as the
patient needs to be awake in order to tell the physician if the pain the physician is purposefully causing in the disc is the same as
the pain the patient feels when they are experiencing a back pain episode. In addition, recent evidence has shown that the action of
inserting a needle into a normal disc during a discogram procedure leads to an increased rate of degeneration in these previously normal
discs. Based on the limitations and concerns of the PD Test, we believe there is a significant need for an objective, accurate, personalized
and noninvasive diagnostic test that can reliably determine if an individual disc is a pain generator. By providing physicians information
about whether a disc has the chemical and structural makeup consistent with pain or not, we believe the treatment plan for each patient
will lead to more efficient and targeted care that, will in turn, result in lower costs and healthier patient outcomes.
Aclarion has taken the
first steps to demonstrate the potential use of our technology in helping to improve the outcome of surgical intervention for DLBP patients
by publishing a clinical study (Gornet et al) in the European Spine Journal in April 2019. The study illustrated that when all discs identified
as consistent with pain by our technology were included in a surgical treatment, 97% of the patients met the criteria for “clinical
improvement”. This compared to only 54% of patients meeting the criteria for clinical improvement if a disc that our technology
identified as consistent with pain, was not included in the surgical treatment.
The results of this clinical
study led the CPT committee to approve four Category III codes for our technology in January 2021. The NIH also included our technology
as one of the handful of technologies selected to participate in their $150 million Back Pain Consortium (BACPAC) Research Program, an
NIH translational, patient-centered effort to address the need for effective and personalized therapies for chronic low back pain.
In April 2023, Aclarion
advanced the evidence of our technology with a peer-reviewed journal article detailing the Gornet 2-year outcomes, published in the European
Spine Journal. The 2-year outcomes were durable with 1-year outcomes previously published in 2019. At 2-years follow-up, 85% of patients
improved when disc(s) identified as consistent with pain by our technology were included in a surgical treatment, compared to only 63%
of patients when disc(s) identified as consistent with pain were not treated or disc(s) identified as consistent without pain were treated.
Aclarion Solution
Evolving science coupled
with the understanding of degenerative painful discs has suggested that lumbar discs may become painful due to certain chemical changes,
which changes cannot be identified using standard lumbar MRI imaging. However, an application of MRI scanners Magnetic Resonance Spectroscopy
has been developed by manufacturers of MRI equipment. MRSs are different than MRIs. An MRI generates images of body structures, while
an MRS analyzes the relative amounts of various chemicals in body tissues.
Aclarion has developed a
software application called NOCISCAN-LS® which uses the existing MRS capabilities of many commercially available scanners to non-invasively
analyze the chemical makeup of intervertebral discs in the spine. The software post-processes the MRS exam data and detects the presence
of chemical biomarkers that we, in conjunction with spine researchers at UCSF, have demonstrated to be associated with degenerative pain
and structural integrity of the lumbar discs. After processing the MRS exam data, we send the ordering clinician a report that details
how to interpret the results of the MRS exam. We believe these results help clinicians make quicker and more informed decisions about
which lumbar discs are painful, and which are not. We believe the ordering clinician can use this information to determine the optimal
treatment plan for an individual patient.
NOCISCAN is entirely
non-invasive and only briefly extends an otherwise standard MRI exam. The MRI scan is the most frequently used type of pulse sequence
for operating Nuclear Magnetic Resonance (NMR) scanners. It uses a powerful magnet to apply a pulsed magnetic field to a patient, sensors
to detect radio waves that emanate from the resonant vibrations of different chemicals in the body in response to that pulsed magnetic
field and a computer to create detailed images of tissue structures in the patient based on those detected chemical signals. Because water
and fat are the most prevalent chemicals in the body, standard MRI images are typically based on the different levels of water and fat
between different tissues. MRS, however, is another type of pulse sequence that uses NMR scanners in a similar way as an MRI, but instead
of using the chemical resonances to create an image, MRS creates a spectrum for a tissue with different peaks that represent many different
chemicals, in addition to water and fat, in that tissue. The relative amounts of those chemicals can be calculated by measuring their
respective spectral peaks. While MRS has been used previously for diagnosing certain cancers (e.g. brain, breast, prostate) by measuring
unique chemical biomarkers for tumors, NOCISCAN uses MRS for measuring the relative levels of degenerative pain and structural integrity
biomarkers in discs. The relative levels of degenerative pain and structural integrity biomarkers are derived through the use of proprietary
post processing technologies.
The platform used to
conduct a NOCISCAN involves: (i) an MRS exam of an intervertebral disc performed according to a proprietary protocol, (ii) a data transfer
portal to securely transfer data from the MRS exam to Aclarion’s cloud based post-processer technology, (iii) post-processor technology
that identifies biomarker peaks and leverages calculation tables that evaluate a number of ratios of biomarker peaks, where pain biomarkers
are in the numerator and structural biomarkers are in the denominator, and (iv) a final diagnostic report called a Nocigram that identifies
discs as painful or not.
NOCISCAN MRS Exam
Protocol.
We have developed a custom
software protocol and technique for using commercially available MRS pulse sequences in scanning intervertebral discs which extends the
time of a standard lumbar MRI exam by an average of about 30 minutes for 5 lumbar discs. The custom protocol is a proprietary series of
settings and instructions for MRS to conduct the NOCISCAN exam to obtain optimal and reliable MRS data. This protocol is not a product
sold by the Company. The software protocol was created by Aclarion for insertion within a pre-existing software file format and is downloaded
onto the MRS by the MRS owner, for use within the MRS’s operating system environment. Currently, our software protocol is compatible
with only certain MRS models and operating systems available from SIEMENS, as those SIEMENS models specifically provide for user-defined
customizations available for running our custom pulse sequences on SIEMENS MRS equipment.
Data Transfer.
Data is routinely transferred
from MR scanners to externally hosted cloud post-processors in many settings and applications, with an existing market of products and
protocols for doing so. Aclarion provides MR imaging providers two options for data transfer: (1) a licensed proprietary imaging data
transfer platform provided by AMBRA® Health, and (2) NOCIWEB®, a custom developed web-interface developed and offered by Aclarion.
NOCISCAN-LS Post-Processor
Suite.
The NOCISCAN-LS Post Processor
Suite is comprised of the products that Aclarion currently markets and sells. The post-processor technology requires MRS exam data acquired
only according to Aclarion’s proprietary MRS exam protocols. The Suite is comprised of two software products that interact with
each other:
| |
· |
NOCICALC-LS® receives
the raw un-processed NOCISCAN-LS MRS exam data and post-processes that raw data into final spectra, and performs various degenerative
pain biomarker calculations from those spectra, for each disc examined. NOCICALC-LS is Registered as a Class I Medical Device with
the FDA. |
| |
|
|
| |
· |
NOCIGRAM® further processes
the NOCICALC-LS results into individual NOCISCORES, on a 0-10 scale, that represent the different relative levels of degenerative
pain biomarkers the various discs examined in the patient. High/low NOCISCORE ranges are also correlated to painful (indicated as
“NOCI+” result) versus non-painful (indicated as a “NOCI-“ result). The NOCISCORE scale was developed according
to a reference PD TEST that was used as a standard control in a peer reviewed clinical development trial for our technology. The
post-processed MRS results are shown in an intuitive NOCIGRAM-LS report with reference to certain MRI images of the related patient’s
lumbar spine. The NOCIGRAM-LS report is provided to the physician to aid in the physician’s diagnosis and treatment planning.
NOCIGRAM is commercially available in the United States as “Clinical Decision Support Software” under the 21st Century
Cures Act, and as such is not considered a medical device nor regulated by the FDA. |
Clinical Evidence
We have pursued a clinical
study (the “Gornet Study”) to demonstrate the benefits of our technology to surgeons, imaging centers, third party payers,
and patients. Without strong clinical data in support of our technology to improve clinical outcomes, the opportunity to secure new reimbursement
codes and change existing treatment pathways would be limited.
In a clinical study sponsored
by us, and authored by, among others, a spine surgeon who has a financial interest in the Company. and published in the European Spine
Journal in April 2019, it was shown that 97% of the treated patients met the criteria for significant clinical improvement, where all
discs identified as painful by NOCISCAN-LS were included in the surgical treatment. This compared to 54% of surgical patients achieving
clinically significant improvement when discs identified as painful by NOCISCAN-LS were omitted from the surgical treatment, or discs
identified as not painful by NOCISCAN-LS were included in the treatment. Some authors of this study had a financial relationship with
Aclarion, who sponsored the study.
This clinical study included
139 chronic low back pain patients who collectively underwent a NOCISCAN-LS exam across 623 lumbar discs. Seventy-three patients underwent
surgical intervention, consisting of fusion or disc replacement, and reached six months follow up. Clinical improvement post surgically
was evaluated using the industry standard Oswestry Disability Index (“ODI”), and the Visual Analog Scale (“VAS”).
ODI evaluates patient disability on a scale of 1-100 with a higher score indicating less impairment. VAS evaluates subjective pain on
a scale of 1-10 with a lower score indicating less pain. Significant clinical improvement in the study was defined as a 15-point improvement
in ODI and a 2-point improvement in VAS. NOCISCAN-LS data was not used in surgical decision making.
Post-operatively, patients
were separated into various groups for analysis. One group consisted of patients where the surgical intervention included every disc
that was identified by NOCISCAN-LS as painful. This group consisted of 36 patients with 26 undergoing a one-level surgical procedure
and 10 undergoing a two-level surgical procedure. 97% (35 of 36) of the patients in this category met the criteria for significant clinical
improvement. The one failure in this group did meet the VAS requirement and missed the ODI cutoff of 15 by only one point.
In another group consisting
of 13 patients, a disc identified as painful by NOCISCAN-LS was not included in the surgical intervention. In this group only 54% (7
of 13) of patients met the criteria for clinically significant improvement.
In April 2023, Aclarion
advanced the evidence of our technology with a peer-reviewed journal article detailing the Gornet 2-year outcomes, published in the European
Spine Journal. The 2-year outcomes were durable with 1-year outcomes previously published in 2019. At 2-years follow-up, 85% of patients
improved when disc(s) identified as consistent with pain by our technology were included in a surgical treatment, compared to only 63%
of patients when disc(s) identified as consistent with pain were not treated or disc(s) identified as consistent without pain were treated.
We believe the results of
this study indicate that using NOCISCAN-LS data to help determine the appropriate level for surgical intervention will significantly
improve the outcomes for patients undergoing spine surgery for back pain. However, the Gornet Study was a single, relatively small, clinical
study at a single clinical center sponsored by us, and authored by, among others, a spine surgeon who has a financial interest in the
Company, and there can be no assurance that the results of such study accurately support our conclusions related to the market opportunity
of our products.
Competitive Landscape
We believe our main competition
for diagnosing disc pain are the PD Test and SPECT – CT.
Since MRIs are considered
the current standard for lumbar imaging, “SPECT – CT” requires an MRI, a CT-Scan, and an injection of a radioactive
dye followed by a period of time for circulation of the dye. We believe the radioactive dye that is injected is aimed at binding to inflammatory
markers that make the inflammation markers visible to the CT-Scan. However, we believe the inflammation markers have not been shown to
specifically correlate with pain. Because of the extra cost, time and radiation exposure when compared to MRS and our belief that SPECT
– CT does not bind to specific known pain biomarkers, we do not believe that SPECT – CT will play a major role in diagnosing
DLBP.
As set forth above, a PD
Test has many issues. We believe the most significant issue impacting the future use of the PD Test is the growing evidence that the
PD Test causes long term harm to the patient by accelerating degeneration of the normal control discs that are a required component of
the PD Test. We believe this issue will create significant hesitation for spine surgeons to use a PD Test which will leave them, and
other clinicians, with a void in information about whether a disc is painful.
We believe the advantages
NOCISCAN-LS delivers against this competitive landscape to address the needs of the marketplace are significant and include the following:
| |
· |
Published clinical trial
indicating improved surgical outcomes when surgically treated discs were identified as consistent with pain by our technology; |
| |
|
|
| |
· |
Noninvasive study that
is delivered with minimal risk and no pain; |
| |
|
|
| |
· |
Objective results that
are quantifiable; |
| |
|
|
| |
· |
Core technology that identifies
biomarkers shown to be linked to pain and structural integrity of intervertebral discs; |
| |
|
|
| |
· |
Software product that leverages
the ubiquitous install base of compatible MRI scanners so that no new hardware is required; and |
| |
|
|
| |
· |
Potential diagnostic to
evaluate the efficacy of regenerative therapies to treat degenerative discs with conservative measures such as PT, chiropractic interventions,
steroid injections, etc., to impact outcomes. |
Because of the advantages
of Aclarion’s solution as well as the issues associated with the limited availability of alternatives for patients and clinicians,
we believe NOCISCAN-LS can become the standard of care in diagnosing DLBP prior to a surgical intervention. We will continue to expand
clinical registries and data in support of the efficacy of our product.
Intellectual Property
Patents
Aclarion has an intellectual
property portfolio consisting of 22 U.S. Patents, 17 Foreign Patents, 6 pending U.S. patent applications, and 7 pending Foreign patent
applications. This portfolio includes patents assigned to Aclarion and patents exclusively licensed from the Regents of the University
of California. Many of the patents in our patent portfolio relate to aspects of our NOCISCAN-LS product suite and the related disc MRS
exam itself, as well as to broader applications of our technologies to other applications for MRS. We may expand our portfolio into alternative
approaches for pain diagnosis, in particular DLBP diagnosis, such as including using labeled molecular antibodies for imaging localized
pain. The Company is not aware of any third-party intellectual property rights that might threaten or prevent our ability to market products
or services without infringing such third-party intellectual property rights.
Trademarks
The Company holds multiple trademarks for its
previous corporate brand name as well as for its key products and brands (“®” designates registered trademark, “™”
designates unregistered trademark under common law protection). With respect to involved meanings, the recurrent prefix term “NOCI”
is derived from Latin origins for “pain” e.g. nerves that report pain are called “nociceptors. These marks include:
NOCIMED®, NOCISCAN®, NOCIGRAM®, NOCISCORE®, NOCICALC™, NOCI+™, NOCI-™, NOCImild™, NOCIWEB™,
SI-SCORE™, VIRTUAL DISCOGRAM™.
Market Opportunity
The current NOCISCAN-LS product
addresses the $10 billion that is spent in the U.S. on spine fusion procedures annually. Our early clinical evidence points to a marked
improvement in surgical outcomes when discs identified as consistent with pain by our technology are included in the surgical treatment.
We believe this market is actionable now, and a significant portion of the proceeds of this offering will be directed towards commercializing
this market opportunity. However, our early clinical evidence is supported by a single (relatively small) clinical study at a single clinical
center sponsored by us, and authored by, among others, a spine surgeon who has a financial interest in the Company, and there can be no
assurance that the results of such study accurately support our conclusions related to the market opportunity of our products (See “Clinical
Evidence” above.)
As the commercialization
process progresses, Aclarion plans to track patients through clinical registries in order to build on our early clinical evidence. We
expect to use these registries to track NOCISCAN-LS patients regardless of what treatment path they may follow. Presently, NOCISCAN-LS
has only been evaluated in formal clinical studies for patients primarily undergoing surgical interventions for fusion or disc replacement.
The Company plans on expanding clinical registries to capture patients undergoing surgical interventions for back pain that includes
all surgical interventions, not just fusion and disc replacement procedures. We believe that if we are able to correlate specific MRS
findings to improved surgical outcomes for all spine surgeries, this will expand the size of the market opportunity in the U.S. from
$10 billion to roughly $40 billion, inclusive of pre-surgical conservative therapy costs. However, there can be no assurance that we
will be able to correlate specific MRS findings on all spine surgeries, or even if we do, that we would be successful in expanding our
market to all spine surgeries.
Our objective for NOCISCAN-LS
is to address the entire low back and neck pain market which at $134.5 billion annually, represents the largest amount of healthcare
dollars spent to treat any disease. To address this market, our current algorithms will need to expand to include advanced machine learning
techniques that incorporate multiple data inputs in addition to the chemical composition of discs. These additional inputs will need
to be correlated to clinical outcomes for treatments ranging from physical therapy to regenerative therapies to surgical interventions.
This process is already underway as we have been selected as a participant in a $150 million, NIH funded study (the “Study”),
which is focused on evaluating the most promising data inputs for predicting the optimal treatment path for back pain patients. The Study
will cover a number of protocols for the treatment of LBP, including NOCISCAN-LS. We will derive no revenue from the Study, but all results
will be available to us.
In addition to participation
in major external studies such as the NIH BACPAC initiative, we expect to create our own internal data by adding patients undergoing
conservative and regenerative treatment plans to our clinical registries, and then correlating NOCISCAN-LS results to outcomes in order
to leverage AI to associate spectroscopy signals with the optimal treatment pathway. If our internal data demonstrates what we believe
to be clinical effectiveness of our technology, we intend to expand our marketing opportunity to the management of all low back and neck
pain patients, thereby increasing our potential market to $134.5 billion in the United States. However, there can be no assurance that
our internal data will demonstrate the clinical effectiveness of our technology on all back and neck pain patients, or even if we do,
that we will be successful in marketing our technology to such patients.
Current Market Limitation
Because we believe that
spectroscopy is not widely used for any clinical purposes today, there are practical limitations to the market opportunity that must
be addressed. We believe the two biggest limitations may be the lack of deployment of spectroscopy software across the installed base
of existing MRIs worldwide, and the fact that only certain MR scanner models are compatible with our technology. For compatible MRI sites
that do not currently have spectroscopy software installed, the onetime cost of the software ranges from $25,000 to $50,000. Currently,
our NOCISCAN-LS platform is only compatible with certain MRI scanner models provided by SIEMENS, of which there are an estimated 1,500
in the United States, and 4,320 worldwide. We plan to collaborate with other MRI scanner vendors, as well as SIEMENS, to establish compatibility
with their respective scanners and MRS capabilities for use with our products. That allows us to include discounted pricing on spectroscopy
software for MRI sites interested in providing DLBP patients with the Nociscan-LS offering.
Reimbursement by Third
Party Payers
“Current Procedural
Terminology”, more commonly known as CPT® (“CPT”), refers to a medical code set created and maintained by the American
Medical Association (“AMA”) and used by providers of healthcare services to bill insurance companies for their work. All
new medical devices and services are required to secure CPT codes to receive payment from government and private commercial payers.
Based on the strength of
the improvement in surgical outcomes from the Gornet study (see “Overview”, “Clinical Evidence” above), we applied
to the CPT committee for Category III codes to cover Nociscan reimbursement. On January 1, 2021, Category III CPT Codes became effective.
CPT code 609T was established to cover payment to the imaging center and CPT code 611T was established to cover payment to us for the
use of NOCISCAN-LS.
Category III codes represent
the first step in the reimbursement process. It also starts a five-year period in which we are required to demonstrate that the medical
community needs (“Clinical Needs”) the NOCISCAN-LS product. Clinical Needs would be demonstrated to the CPT Committee based
on the volume at which our codes are billed by imaging centers and physicians. In addition to demonstrating that there is a Clinical
Need, we also are required to show that NOCISCAN-LS is clinically effective as indicated by patients having better outcomes when NOCISCAN-LS
reports are used to help guide surgical treatments. We expect to show clinical effectiveness through a combination of clinical registries
and clinical studies that build upon our published clinical study the CPT committee used to create our Category III CPT codes. There
can be no assurance that we will be able to demonstrate Clinical Needs, and if we do not, our business would be adversely affected.
In addition to the core
CPT codes that provide payment to the imaging center and to us, the AMA has approved two additional Category III codes. The first is
CPT code 610T which covers the process of transmitting the raw spectroscopy biomarker data from the MRI scanner to our software for analysis.
This code is for payment to the imaging center and is bundled with CPT code 609T, which means the code can be billed but no additional
payments beyond 609T will be made by government payers. Although additional payment by commercial payers is possible, we believe it is
unlikely. The second is CPT code 612T, which is billed by the ordering physician and paid to the ordering physician for interpreting
the report.
The 611T Code is the sole
Code under which we will derive revenue.
Regulatory Filings
The NOCISCAN-LS Post-Processor
Suite consists of two software products that interact with each other, NOCICALC-LS® and NOCIGRAM-LS®.
NOCICALC-LS receives and
processes the acquired disc MRS data to calculate levels of degenerative pain biomarkers. In conjunction with our regulatory consultants,
we determined NOCICALC-LS to be a “Class I 510(k)-exempt” medical device subject only to registration listing requirements
with no pre-market review required by the FDA for clearance or approval. As such, in accordance with FDA regulations, NOCICALC-LS is
registered with the FDA as an exempt Class I device.
The process to determine
whether a product can be considered a Class I “exempt” medical device consists of self-determining whether the product is
adequately described by one of the existing categories classified by the FDA. In consultation with our regulatory consultants, we determined
that the product Classification “Calculator/Data Processing Module, for Clinical Use,” adequately described our NOCICALC-LS
product. Our registration filing is available for review at this link; Establishment Registration and Device Listing (fda.gov).
We believe NOCIGRAM is not
considered a medical device as it meets the exclusion criteria of the 21st Century Cures Act for Clinical Support Software. Under the
Cures Act provision, a software product is not considered a device if it meets the following four elements:
| |
· |
Not intended to acquire,
process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition
system; |
| |
|
|
| |
· |
Intended for the purpose
of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical
studies and clinical practice guidelines); |
| |
|
|
| |
· |
Intended for the purpose
of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or
condition; and |
| |
|
|
| |
· |
Intended for the purpose
of enabling such health care professional to independently review the basis for such recommendations that such software presents
so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical
diagnosis or treatment decision regarding an individual patient. |
Management has evaluated
NOCIGRAM-LS against these four elements and believes NOCIGRAM meets each of the four criteria.
However, although we believe
our analysis is reasonable, whenever a company self classifies, there is a risk that FDA could disagree with the classification. Accordingly,
in that context, it is possible that FDA could potentially disagree that the NOCIGRAM-LS falls under the CDS software exemption to the
definition of a device and there can be no assurance that the FDA will agree with our conclusion and in the event the FDA does not agree,
our business would be severely negatively impacted.
For commercialization
outside the United States, in particular the EU and UK, the Company, in conjunction with our regulatory consultants, determined NOCISCAN-LS
to be a Class I medical device, for which we secured a CE mark via self-certification. Since self-certification, the EU adopted Regulation
(EU) 2019/1020 that went into effect on July 16, 2021. Under these new regulations, we believe NOCISCAN-LS to be considered a Class II(a)
device that requires re-certification for CE mark by a Notified Body prior to May 2024. The EU Parliament has voted to extend the Medical
Device Regulation (MDR 2017/745) transition period. The extension will see the May 2024 deadline postponed until 2027 for higher-risk
Class III and implantable IIb devices, and May 2028 for lower-risk Class I, IIa and other IIb devices. A “Notified Body” is
an organization designated by an EU country to assess the conformity of certain products before being placed on the market, as is required
for certain medical products. The Company is in the process of re-certifying our CE mark.
In conjunction with Brexit,
medical devices in the UK are no longer governed by CE regulations. The UK has introduced the UKCA marking system, which largely follows
the CE marking regulations to include permitting use of the same submissions for approval. The major difference post-Brexit is that CE
marking is regulated by the EU and UKCA marking is regulated by the UK. The only practical implication to the Company is requiring a
Notifying Body within both the EU and the UK. The Company expects to meet all requirements for UKCA marking.
Commercialization
The issuance of Category
III codes and satisfaction of regulatory requirements for marketing starts the commercialization phase which will be the primary use
of proceeds from this offering. The commercialization process in support of moving temporary Category III codes to permanent Category
I codes consists of the following key activities:
| |
· |
Identifying and supporting
Key Opinion Leader (“KOL”) spine surgeons and radiologists to help secure local payer coverage decisions and surgical
society support for our technology; |
| |
· |
Expanding the network of
imaging centers and surgeons using NOCISCAN-LS in each market such that the technology is widely available to patients covered by
payers; |
| |
· |
Supporting surgeons, radiologists,
Physical Medicine and Rehabilitation physicians, physical therapists, regenerative therapy physicians and medical device companies
that address low back pain to initiate studies and report results; |
| |
· |
Building and expanding
clinical registries to provide real world evidence of better outcomes when using Nociscan to help determine which discs to treat;
and |
| |
· |
Pursuing value-based care
contracts to share in the profits that result from the improved surgical outcomes we believe our technology enables in DLBP patients. |
Our primary near-term growth
strategy is to secure payer contracts (including insurance companies, self- insured employers, Medicare, Medicaid, workmen’s compensation
boards et. al.) to cover our Category III CPT codes. We believe that with favorable payer coverage, the Company has the opportunity to
more efficiently engage spine surgeons and imaging centers that will adopt our technology.
The Company currently
generates the vast majority of its revenue directly from patients paying out of pocket.
In order to effectively
commercialize our technology, the Company has completed its initial plan to gain the support of up to ten leading spine surgeons as Key
Opinion Leaders (KOL) who believe Nociscan technology will help them with surgical decisions in their practices. These KOL surgeons are
leaders in their field and will be assisting the Company in generating important clinical data in support of Nociscan, and using that
data to help the Company in discussions with payers to secure positive payment decisions for our Category III CPT codes.
Based primarily on our
KOL surgeons and the strength of physician engagement in markets, the Company is prioritizing the following markets:
| |
1. |
NYC Metropolitan Area |
| |
2. |
San Francisco, CA |
| |
3. |
Chicago, IL |
| |
4. |
Phoenix, AZ |
| |
5. |
Miami, FL |
| |
6. |
Denver and Colorado Springs, CO |
| |
7. |
Detroit, MI |
| |
8. |
Indianapolis |
Once a positive local
payment decision is secured in a geographical area, we intend to place a market manager and a team of business development professionals
into each market to focus on expanding physician support and securing favorable coverage decisions from additional payers in the market.
The objective in each market is to expand the provider network to include additional imaging centers and surgeons so there is increasing
geographical coverage. We believe increasing our footprint in each market will grow volume and revenue through increased pressure on payers
to expand positive coverage decisions across all of the varied plans associated with each payer.
Recent Developments
Publication of
Gornet Study
As discussed above, in
April 2019, the initial results of the clinical Gornet Study were published in the European Spine journal. We have pursued the Gornet
Study to demonstrate the benefits of our technology to surgeons, imaging centers, third party payers, and patients.
On April 24, 2023, the
Company announced the publication in the European Spine Journal of two-year durability data as a follow up to the initial Gornet Study.
The multi-year, single
site clinical trial comprised 78 patients who received surgery for DLBP following standard clinical work-up including MRI and provocative
discography. Nociscan was performed on all patients but was not available in the surgical decision-making process. The patient outcomes
were evaluated using the Oswestry Disability Index (ODI) scoring scale (100 points), a common clinical outcomes measure for low back pain,
where surgical success was defined using an industry-standard improvement of 15 points or more between surgeries that were concordant
versus discordant with Nociscan results. Surgical success rates at 2 years illustrates a 22 percentage point improvement between the two
groups. The results suggest that Nociscan provides valuable new information that can help physicians successfully treat DLBP.
Both clinical studies
were study sponsored by us. The principal author of these studies is a spine surgeon who has a financial interest in the Company. Other
authors of these studies also have a financial relationship with Aclarion.
White Lion Equity
Line Agreement
On October 9, 2023, the Company entered into
an equity line common stock purchase agreement (the “Equity Line Purchase Agreement”) and a related registration rights agreement
with White Lion Capital, LLC (“White Lion”). Pursuant to the Equity Line Agreement, the Company has the right, but not the
obligation to require White Lion to purchase, from time to time, up to $10,000,000 in aggregate gross purchase price of newly issued
shares of the Company’s common stock, subject to certain limitations and conditions set forth in the Equity Line Purchase Agreement.
It is anticipated that the Company may sell shares
of common stock to White Lion from time-to-time over a sales period that expires December 31, 2024. The number of shares ultimately offered
for sale to White Lion under the Equity Line Purchase Agreement is dependent upon the number of shares we elect to sell to White Lion
under the Equity Line Purchase Agreement. The actual number of shares of common stock that are sold to White Lion may depend based on
a number of factors, including the market price of our common stock during the time that the Equity Line Purchase Agreement in is effect.
The actual gross proceeds the Company may derive from the Equity Line Purchase Agreement may be less than $10.0 million, which may
impact our future liquidity. Because the price per share of each share sold to White Lion will fluctuate during the sales period, it
is not currently possible to predict the number of shares that will be sold or the actual gross proceeds to be raised in connection with
those sales, if any.
The
Company currently has an effective registration statement to register for resale by White Lion 2,500,000 shares of common
stock. White Lion may ultimately purchase all or some of these shares. After White Lion has acquired shares under the Equity Line Purchase
Agreement, it may sell all, some or none of those shares. Sales to the Selling Securityholder by us pursuant to the Equity Line Purchase
Agreement may result in substantial dilution to the interests of other holders of our common stock.
The sale of a substantial number of shares to
White Lion, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future
at a time and at a price that we might otherwise desire. The number of shares of our common stock ultimately offered for resale by White
Lion is dependent upon the number of shares of common stock issued to White Lion pursuant to the Equity Line Purchase Agreement. Depending
on a variety of factors, including market liquidity of our common stock, the issuance of shares to White Lion may cause the trading price
of our common stock to decline.
In consideration for the commitments of White Lion, as described above,
the Company issued to White Lion 187,500 pre-split shares (11,719 post-split) of Common Stock (the “Commitment Shares”),
having a value of $75,000 based upon the closing sale price of Common Stock on October 6, 2023.
Alphatec Strategic Partnership
On January 8, 2024, we announced that we had
executed a strategic partnership agreement solidifying our previously signed non-binding letter of intent with ATEC Spine, Inc., the
wholly owned operating subsidiary of Alphatec Holdings, Inc. (“ATEC”). ATEC is a medical device company dedicated to revolutionizing
the approach to spine surgery through clinical distinction.
The agreement contemplates a multi-step
strategic partnership. Under the agreement, ATEC and Aclarion will work together to identify Key Opinion Leader (KOL) surgeons
to evaluate our Nociscan technology. Feedback from these surgeons will inform clinical evaluations designed to assess the utility of
Nociscan in conjunction with EOS imaging, the foundation of ATEC’s AlphaInformatiX platform. Assuming positive synergies, ATEC
and Aclarion will co-market Nociscan in targeted markets. In exchange for select access to ATEC’s surgeon network for the evaluation
and advancement of Nociscan, Aclarion will provide ATEC with certain exclusive distribution rights to include Nociscan as part of an
integrated procedural solution.
Nasdaq Bid Price Notice
On August 4, 2023, we received a written notice
(the “Bid Price Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) indicating
that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued
listing on The Nasdaq Capital Market (the “Bid Price Requirement”).
Following our recently implemented reverse
stock split of the Company’s outstanding common stock, which was effective at a ratio of 1-for-16 shares, on January 23, 2024 the
Nasdaq staff informed us that we had regained compliance with the Nasdaq Bid Price Requirement.
Nasdaq Stockholder
Equity Notice
On March 3, 2023, the
Company received a written notice (the “Stockholder Equity Notice”) from Nasdaq indicating that it is not in compliance with
Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Stock Market to maintain a minimum of $2,500,000 in stockholders’
equity for continued listing. In its annual report on Form 10-K filed on February 27, 2023 for the period ended December 31, 2022, the
Company reported stockholders’ equity of $1,787,751, and, as a result, does not currently satisfy Listing Rule 5550(b)(1).
The Stockholder Equity
Notice also indicated that the Company had a period of 45 calendar days from the date of the Stockholder Equity Notice, or until April
17, 2023, to submit a plan to regain compliance with the stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1).
The Company submitted such a plan to Nasdaq on April 12, 2023.
On April 20, 2023, the
Company received a letter (the “Extension Notice”) from Nasdaq notifying the Company that it has been granted an additional
180-day period, or until August 30, 2023, to regain compliance with Nasdaq Listing Rule 5550(b)(1).
On August 31, 2023, the Nasdaq staff notified
the Company that it had not met the terms of the Extension Notice. Accordingly, the Nasdaq staff had determined to delist the Company’s
common stock from Nasdaq, unless the Company timely requests an appeal of the staff’s determination to a hearings panel (the “Panel”),
pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series.
The Company requested a hearing
before a hearings panel (the “Panel”) to appeal the delisting notice from the staff. The Company's hearing with the Panel
occurred on October 19, 2023.
On November 7, 2023, the Company was notified
by the Panel that the Company’s request for continued listing on Nasdaq was granted, subject to the Company demonstrating compliance
with the stockholders’ equity requirement and bid price requirement on or before January 31, 2024. The Panel subsequently extended
this compliance date to February 27, 2024. The Panel has the right to reconsider the terms of this exception based on any event, condition
or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities
on Nasdaq inadvisable or unwarranted. There can be no assurances that the Company will regain compliance with the Stockholders' Equity
Requirement, or that the Company will maintain its listing on the Nasdaq Capital Market.
The Company intends to take all reasonable measures
available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq.
Going Concern Opinion
Our working capital deficiency,
stockholders’ deficit, and recurring losses from operations raise substantial doubt about our ability to continue as a going concern.
As a result, our independent registered public accounting firm included an explanatory paragraph in its report dated June 12, 2023 on
our financial statements for the year ended December 31, 2022 with respect to this uncertainty. Our ability to continue as a going concern
will require us to obtain additional funding.
As of December 31, 2023, we had cash of approximately
$1.0 million. Subsequent to December 31, 2023, the Company raised capital using an equity line (refer to Note 17 – Subsequent Events
to our financial statements), and as of February 1, 2024, the Company had approximately $1.5 million of cash, which we believe will fund
our operating expenses and capital expenditure requirements into the second quarter of 2024, up to our first maturity repayment on our
unsecured non-convertible note repayment which is due in April 2024. The Company has based these estimates, however, on assumptions that
may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need to raise
additional funds to continue funding our technology development and commercialization efforts over the following twelve months. Management
has plans to secure such additional funding.
As a result of the Company’s recurring
losses from operations, and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding
the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to
the Company’s ability to continue as a going concern.
Following the receipt of the proceeds of this
offering, we believe our cash resources will be sufficient to repay our first maturity repayment of our unsecured non-convertible notes
which is due in April 2024, and fund our current operating plans into the third quarter of 2024, prior to the final maturity repayment
of our unsecured non-convertible notes which is due in September 2024 . We have based these estimates, however, on assumptions that may
prove to be wrong, and we could spend our available financial resources much faster than we currently expect and need to raise additional
funds sooner than we anticipate. If we are unable to raise additional capital when needed or on acceptable terms, we would be forced to
delay, reduce, or eliminate our technology development and commercialization efforts.
Reverse Stock Split
As previously announced, in March 2023 the
Company’s stockholders approved a reverse stock split proposal at a ratio in the range of one-for-five to one-for-fifty, with the
final ratio to be determined by the Company's board in its discretion without further approval from the Company's stockholders. In January
2024, the Company's board subsequently approved the final reverse stock split ratio of one-for-sixteen, which resulted in a reduction
in the number of outstanding shares of common stock and a proportionate increase in the value of each share. The common stock began trading
on a reverse split-adjusted basis on the NASDAQ on January 4, 2024.
The following table presents selected share
information reflecting on a retroactive basis the reverse stock splits for the years ended December 31, 2023 and 2022:
| | |
December 31 | |
| | |
2023 | | |
2022 | |
| Common shares issued and outstanding - pre-2024 split, 13,206,229 and 7,861,515 shares | |
$ | 132 | | |
$ | 79 | |
| Common shares issued and outstanding - post-2024 split, 825,459 and 491,345 shares | |
$ | 8 | | |
$ | 5 | |
| Additional paid-in capital - pre-2024 split | |
$ | 43,553,399 | | |
$ | 41,596,032 | |
| Additional paid-in capital - post-2024 split | |
$ | 43,553,523 | | |
$ | 41,596,106 | |
| | |
Year ended December 31 | |
| | |
2023 | | |
2022 | |
| Weighted average shares outstanding, basic and diluted - pre-2024 split | |
| 8,908,934 | | |
| 6,105,569 | |
| Weighted average shares outstanding, basic and diluted - post-2024 split | |
| 556,808 | | |
| 381,598 | |
| Basic and diluted net loss per shares attributable to common stockholders - pre-2024 split | |
$ | (0.55 | ) | |
$ | (1.23 | ) |
| Basic and diluted net loss per shares attributable to common stockholders - post-2024 split | |
$ | (8.82 | ) | |
$ | (19.61 | ) |
Exchange Agreements
In May, September and November 2023 the Company issued $2,550,000
aggregate principal amount of unsecured non-convertible notes to certain accredited investors.
Between January 22
and January 29, 2024, the Company entered into a series of exchange agreements (the “Exchange Agreements”) with the accredited
investors to exchange principal and accrued interest on these notes for shares of common stock. Pursuant to the Exchange Agreements,
the Company issued an aggregate of 644,142 shares of common stock in exchange for $1,519,779 principal and accrued interest on the notes.
Following these exchanges, the remaining outstanding balance of principal and interest on the notes is $1,145,037.
The Company and the
accredited investors may elect in the future to effect additional exchanges of the notes for common stock. Any such future exchanges
would be negotiated and agreed to among the parties.
Notwithstanding that
the Company desires to consummate one or more additional exchanges in the future, at this time the Company has no such additional oral
or written agreements to consummate any such exchanges, and, as such, we cannot guarantee that any such exchanges will occur in the future.
The occurrence of any such exchange is contingent on reaching mutual agreement with the institutional investor on the terms and conditions
and the execution and delivery of one or more additional definitive agreements with respect thereto.
Summary of Risk Factors
Investing in our
securities involves a high degree of risk. You should carefully consider the risks described in “Risk
Factors” beginning on page 20 before making a decision to invest in our common stock. If any of these risks actually
occurs, our business, financial condition, results of operations and prospects would likely be materially, adversely affected. In
that event, the trading price of our common stock could decline, and you could lose part or all of your investment. Below is a
summary of some of the principal risks we face:
| |
· |
We are not currently in compliance with the minimum stockholders’ equity rule of the Nasdaq Capital Market and a delisting could limit the liquidity of our stock, increase
its volatility and hinder our ability to raise capital. |
| |
|
|
| |
· |
We have a history of net
losses, and we expect to continue to incur losses for the foreseeable future. If we do achieve profitability, we may not be able
to sustain it. |
| |
|
|
| · | We, as well as the auditors of our financial statements, have previously
expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing;
have previously expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further
financing. |
| |
|
|
| |
· |
Following the receipt of
the net proceeds from this offering, we believe our cash resources would be sufficient to fund our current operating plans into the
first quarter
of 2025.
We have based these estimates, however, on assumptions that may prove to be wrong, and we could spend our available financial resources
much faster than we currently expect and need to raise additional funds sooner than we anticipate. If we are unable to raise additional
capital when needed or on acceptable terms, we would be forced to delay, reduce, or eliminate our technology development and commercialization
efforts. |
| |
|
|
| |
· |
We have identified material
weaknesses in our internal control over financial reporting. Failure to maintain effective internal controls could cause our investors
to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we
may not be able to accurately report our financial results or prevent fraud. |
| |
|
|
| |
· |
The COVID-19 pandemic or
other epidemic disease may have a material adverse effect on our business, financial condition and operating results, as well as on
the operations and financial performance of our customers and suppliers. We are unable to predict the extent to which the pandemic
and related restrictions will impact our business, operations, financial performance and the achievement of our strategic
objectives. |
| |
|
|
| |
· |
We currently rely on our
technology for use in assisting doctors to diagnose chemically painful discs causing discogenic low back pain, as well for supporting
other diagnoses, treatments, and research related to lumbar disc chemistry. If we are not successful in marketing and enhancing awareness
of our technology, driving adoption across our current target population, increasing referrals, and expanding the population of eligible
patients, our sales, business, financial condition and results of operations will be negatively affected. |
| |
|
|
| |
· |
Currently, we can only
market our product in the United States and certain countries observing CE mark regulations. Regulatory approvals that currently
apply to our products include assessments where we determine the appropriate regulatory pathway for our products. Although we use
regulatory consultants to assist in the self-registration processes and determinations, it is possible a regulator could disagree
with our analysis. It is also possible that regulations relating to how we market our products may change. In addition, to maintain
our ability to market our products under the approved regulations, we are required to adhere to multiple protocols in order to maintain
regulatory approvals. The Company has failed to adequately follow protocols in the past and it is possible this may happen again
in the future. If there is a change in our ability to market our products it may harm our sales, business, financial condition and
results of operations. |
| |
|
|
| |
· |
Our commercial success
will depend on attaining significant market acceptance of our technology among patients, clinicians (primarily spine surgeons and
pain management physicians) and imaging facilities, as well as increasing the number of patients who are prescribed for use of our
diagnostic technology. If we are unable to successfully achieve substantial market acceptance and adoption of our technology, our
sales, business, financial condition and results of operations would be harmed. |
| |
|
|
| |
· |
Our commercial software
products currently depend on compatible use with a limited number of MR scanners that are provided by one MR scanner vendor, SIEMENS,
which limits our ability to address the total potential patient population that our products could otherwise address in commercial
sales. There are risks related to the on-going compatibility, shortages, price fluctuations, and ability to grow the number of compatible
MR scanner platforms that, if realized, could harm our sales, business, financial condition, and results of operations. |
| |
· |
If we are unable to obtain,
maintain, protect, enforce and defend patent or other intellectual property protection for our technology, or if the scope of our
patents and other intellectual property protections is not sufficiently broad, or as a result of our existing or any future out-licenses
of our intellectual property, our competitors could develop and commercialize products similar to or competitive with our products
and services, our ability to continue to commercialize our technology, or our other products and services, may be harmed. |
| |
|
|
| |
· |
We may be unable to compete
successfully with other available alternatives for diagnosing low back pain, including, in particular, identifying painful discs
causing discogenic low back pain, which could harm our sales, business, financial condition and results of operations. |
| |
|
|
| |
· |
If adequate reimbursement
becomes unavailable for the procedures that use, or could use, our diagnostic technology, or becomes unavailable for providing other
ongoing care for patients diagnosed with the assistance of our technology, it could diminish our sales, affect our ability to sell
our technology profitably, or could otherwise harm our business, financial condition, and results of operations. |
| |
|
|
| |
· |
Our collection, use, storage,
disclosure, transfer and other processing of sensitive and personal information could give rise to significant costs, liabilities
and other risks, including, as a result of investigations, inquiries, litigation, fines, legislative and regulatory action and negative
press about our privacy and data protection practices, which may harm our business, financial conditions, results of operations. |
| |
|
|
| |
· |
Our current product is
supported by a single clinical study at a single clinical center involving one spine surgeon who has a financial interest in the
Company. If we are unable to replicate the success of our initial clinical trial, the efficacy of our product may be in question
and our sales, business, financial condition and results of operations will be harmed. |
| |
|
|
| |
· |
To reach the full market
potential of our product, we will need to leverage advanced machine learning and artificial intelligence technologies (“AI”)
to a larger degree than we do today. Introducing new technologies into our products require that we secure new regulatory approvals
and demonstrate additional clinical success. If we are unable to secure regulatory approvals for our new products, or if they prove
incapable of demonstrating clinical success, our market opportunity will be reduced and our sales, business, financial condition
and results of operations may be harmed. |
| |
|
|
| |
· |
Our current product is
dependent on certain processes that are not optimized to support the scaling of our technology. If we are not able to efficiently
automate these processes, the Company will not be able to grow and our sales, business, financial condition and results of operations
will be harmed. |
| |
|
|
| · | We may fail to continue to meet the listing standards of The Nasdaq
Capital Market whether or not this offering occurs. Even if this offering occurs, this offering could cause our stock price to fall,
which could result in us being delisted from The Nasdaq Capital Market. Failure to maintain the listing of our common stock with a U.S.
national securities exchange could adversely effect the liquidity of our common stock. |
Implications of Being
an Emerging Growth Company and a Smaller Reporting Company
We qualify as an “emerging growth company”
as defined in the Jumpstart our Business Startups Act of 2012 (the “JOBS Act”). An emerging growth company may take advantage
of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:
| |
· |
inclusion
of only two years, as compared to three years, of audited financial statements in addition to any required unaudited interim financial
statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
disclosure; |
| |
|
|
| |
· |
an
exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to
the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); |
| |
|
|
| |
· |
an
exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”)
requiring mandatory audit firm rotation; |
| |
|
|
| |
· |
reduced
disclosure about executive compensation arrangements; and |
| |
|
|
| |
· |
an
exemption from the requirement to seek non-binding advisory votes on executive compensation or golden parachute arrangements. |
We may take advantage of
these provisions until we are no longer an emerging growth company. We will remain an emerging growth company until the earliest of (1)
the last day of the fiscal year (a) following the fifth anniversary of the completion of our April 2022 IPO, (b) in which we have total
annual gross revenue of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market
value of our common stock that is held by non-affiliates exceeds $700 million as of the prior December 31st, and (2) the date on which
we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We have taken advantage
of the reduced reporting requirements in this prospectus and in the documents incorporated by reference into this prospectus. Accordingly,
the information contained herein may be different from the information you receive from other public companies that are not emerging
growth companies.
The JOBS Act permits an
emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards
applicable to public companies until those standards would otherwise apply to private companies.
We are also a “smaller reporting company”
meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100
million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value
of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently
completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting
company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements
that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two
most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies,
smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Our Corporate Information
We were formed under the
name Nocimed, LLC, a limited liability company in January 2008, under the laws of the State of Delaware. In February 2015, Nocimed, LLC
was converted into Nocimed, Inc. a Delaware corporation. On December 3, 2021, we changed our name to Aclarion, Inc. Our principal executive
offices are located at 8181 Arista Place, Suite 100, Broomfield, Colorado 80021. Our main telephone number is (833) 275-2266. Our internet
website is www.aclarion.com. The information contained in, or that can be accessed through, our website is not incorporated by reference
and is not a part of this prospectus.
INFORMATION REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus and the
documents incorporated by reference in this prospectus include forward-looking statements, which involve risks and uncertainties. These
forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believe,” “estimate,”
“project,” “anticipate,” “expect,” “seek,” “predict,” “continue,”
“possible,” “intend,” “may,” “might,” “will,” “could,” would”
or “should” or, in each case, their negative, or other variations or comparable terminology. These forward-looking statements
include all matters that are not historical facts. They appear in a number of places throughout this prospectus and the documents incorporated
by reference in this prospectus, and include statements regarding our intentions, beliefs or current expectations concerning, among other
things, our product candidates, research and development, commercialization objectives, prospects, strategies, the industry in which
we operate and potential collaborations. We derive many of our forward-looking statements from our operating budgets and forecasts, which
are based upon many detailed assumptions. While we believe that our assumptions are reasonable, we caution that it is very difficult
to predict the impact of known factors, and, of course, it is impossible for us to anticipate all factors that could affect our actual
results. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications
of when such performance or results will be achieved. In light of these risks and uncertainties, the forward-looking events and circumstances
discussed in this prospectus may not occur and actual results could differ materially from those anticipated or implied in the forward-looking
statements.
Forward-looking statements
speak only as of the date of this prospectus. You should not put undue reliance on any forward-looking statements. We assume no obligation
to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking
information, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should
be drawn that we will make additional updates with respect to those or other forward-looking statements.
You should read this prospectus,
the documents incorporated by reference in this prospectus, and the documents that we reference in this prospectus and have filed with
the SEC as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results,
levels of activity, performance and events and circumstances may be materially different from what we expect. All forward-looking statements
are based upon information available to us on the date of this prospectus.
By their nature, forward-looking
statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the
future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations,
financial condition, business and prospects may differ materially from those made in or suggested by the forward-looking statements contained
in this prospectus. In addition, even if our results of operations, financial condition, business and prospects are consistent with the
forward-looking statements contained (or incorporated by reference) in this prospectus, those results may not be indicative of results
in subsequent periods.
Forward-looking statements
necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward-looking
statements due to a number of factors, including those set forth below under “Risk Factors” and elsewhere in this prospectus.
The factors set forth below under “Risk Factors” and other cautionary statements made in this prospectus should be read and
understood as being applicable to all related forward-looking statements wherever they appear in this prospectus. The forward-looking
statements contained in this prospectus represent our judgment as of the date of this prospectus. We caution readers not to place undue
reliance on such statements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements
for any reason, even if new information becomes available or other events occur in the future. All subsequent written and oral forward-looking
statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements
contained above and throughout this prospectus.
You should read this prospectus,
the documents incorporated by reference in this prospectus, and the documents that we reference in this prospectus and have filed as
exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future
results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
THE OFFERING
| Securities Offered |
5,175,000 Units on a best-efforts basis at a public offering price
of $0.58 per Unit. Each Unit consists of one share of common stock and two Common Warrants each to purchase one share of common stock.
We are also offering to each purchaser, with respect to the purchase
of Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding shares of common
stock immediately following the consummation of this offering, the opportunity to purchase one Pre-Funded Warrant in lieu of one share
of common stock. A holder of Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrant if the holder,
together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may be increased
to up to 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. Each Pre-Funded
Warrant will be exercisable for one share of common stock. The purchase price per Pre-Funded Warrant will be equal to the price per share
of common stock, minus $0.00001, and the exercise price of each Pre-Funded Warrant will equal $0.00001 per share. The Pre-Funded Warrants
will be immediately exercisable (subject to the beneficial ownership cap) and may be exercised at any time in perpetuity until all of
the Pre-Funded Warrants are exercised in full. The Units will not be certificated or issued in stand-alone form. The shares of common
stock, and/or Pre-Funded Warrants, and the Common Warrants comprising the Units are immediately separable upon issuance and will be issued
separately in this offering |
| |
|
| Common stock to be outstanding prior to this offering |
1,975,585 |
| |
|
| Common stock to be outstanding after this offering |
7,150,585 shares |
| |
|
| Public offering price per Unit |
$0.58
per Unit |
| |
|
Description of Common Warrants:
|
The Common Warrants will
be immediately exercisable on the date of issuance and expire on the five-year anniversary of the date of issuance at an initial
exercise price per share equal to $0.58 (equal to 100% of the public offering price of each Unit sold in this offering), subject to
appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations,
reclassifications, reorganizations or similar events affecting our common stock. The terms of the Common Warrants will be governed
by a Warrant Agency Agreement, dated as of the closing date of this offering, that we expect to be entered into between us and
VStock Transfer LLC or its affiliate (the “Warrant Agent”). This prospectus also relates to the offering of the shares
of common stock issuable upon exercise of the Common Warrants. For more information regarding the Common Warrants, you should
carefully read the section titled “Description of Securities We Are Offering” in this
prospectus. |
| |
|
| Use of Proceeds |
We expect to receive net proceeds from this offering
of approximately $2.54 million, after deducting the placement agent discounts and commissions and estimated offering expenses payable
by us.
We intend to use the net proceeds from this offering, together with
our existing cash, to repay outstanding debt, build out the product platforms, expand our sales and marketing efforts, and for general
and administration expenses and other general corporate purposes.
See “Use of Proceeds.” |
| |
|
| Nasdaq Capital Market Symbols |
Common Stock “ACON”.
IPO Warrants “ACONW”. |
| |
|
| Risk Factors |
Investing in our
securities involves a high degree of risk. See “Risk Factors” beginning on page 20 of this
prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities. |
| |
|
| Best Efforts Offering |
We have agreed to offer
and sell the securities offered hereby to the purchasers through the placement agent. The placement agent is not required to buy or
sell any specific number or dollar amount of the securities offered hereby, but it will use its reasonable best efforts to solicit
offers to purchase the securities offered by this prospectus. See “Plan of Distribution” on page
131 of this prospectus. |
| |
|
| Lock-up |
We, and each of our officers
and directors have agreed, subject to certain exceptions, not to sell, offer, agree to sell, contract to sell, hypothecate, pledge, grant
any option to purchase, make any short sale of, or otherwise dispose of or hedge, directly or indirectly, any shares of our capital stock
or any securities convertible into or exercisable or exchangeable for shares of capital stock, for a period of ninety (90) days after
the date of this prospectus, without the prior written consent of Maxim Group LLC. See “Shares Eligible for Future
Sale” and “Plan of Distribution” for additional information. |
The
number of shares outstanding after this offering is based on 1,975,585 shares of our common
stock outstanding as of February 26, 2024, and excludes:
| |
· |
136,124
shares of our common stock issuable upon the
exercise of outstanding stock options granted under our 2015 Stock Plan, |
| |
· |
33,334
shares of our common stock issuable upon the exercise of outstanding stock options granted under our 2022 Stock Plan, |
| |
· |
24,211 shares of our common
stock issuable upon the settlement of outstanding restricted stock units (“RSUs) options granted under our 2022 Stock Plan, |
| |
· |
122,108
shares of our common stock reserved for future grant under our 2022 Stock Plan, |
| |
· |
155,610
shares of common stock issuable upon the exercise of our outstanding Nasdaq-listed IPO Warrants, |
| |
· |
154,730
shares of common stock issuable upon the exercise of outstanding privately placed warrants, |
| |
· |
10,825
shares of common stock reserved for issuance upon the exercise of an outstanding IPO underwriter representative common stock warrants,
and, |
|
· |
up to $7,087,517 worth
of common stock that may be sold in the future by the Company to White Lion from time to time pursuant to the Equity Line
Purchase Agreement. |
RISK FACTORS
Risk Factors.
Investing in our securities involves a high
degree of risk. You should carefully consider the risks and uncertainties described below, together with the other information contained
in this prospectus, before making a decision to invest in our securities. If any of the following events occur, our business, financial
condition and operating results may be materially adversely affected. In that event, the trading price of our securities could decline,
and you could lose all or part of your investment. The risks included here are not exhaustive or exclusive. Other sections of this prospectus
may include additional factors which could adversely affect our business, results of operations and financial performance. We operate
in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management
to predict all such risk factors, nor can it assess the impact of all such risk factors on our business or the extent to which any factor,
or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Risks related to our Nasdaq listing
We are not currently in compliance with the minimum stockholders’ equity rule of the Nasdaq Capital Market and a delisting could limit the liquidity
of our stock, increase its volatility and hinder our ability to raise capital.
On March 3, 2023, the Company received a written
notice (the “Stockholder Equity Notice”) from Nasdaq indicating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1),
which requires companies listed on The Nasdaq Stock Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued
listing. In its annual report on Form 10-K for the period ended December 31, 2022, the Company reported stockholders’ equity of
$1,787,751, and, as a result, did not satisfy Listing Rule 5550(b)(1).
The Stockholder Equity Notice also indicated that
the Company had a period of 45 calendar days from the date of the Stockholder Equity Notice, or until April 17, 2023, to submit a plan
to regain compliance with the stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1). The Company submitted such
a plan to Nasdaq on April 12, 2023.
On April 20, 2023, the Company received a letter
(the “Extension Notice”) from Nasdaq notifying the Company that it had been granted an additional 180-day period, or until
August 30, 2023, to regain compliance with Nasdaq Listing Rule 5550(b)(1).
On August 31, 2023, the Nasdaq staff notified the
Company that it had not met the terms of the Extension Notice. Accordingly, the Nasdaq staff had determined to delist the Company’s
common stock from Nasdaq, unless the Company timely requests an appeal of the staff’s determination to a hearings panel (the “Panel”),
pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. The Company requested a hearing before the Panel to appeal
the delisting notice from the staff. The Company's hearing with the Panel occurred on October 19, 2023.
On November 7, 2023, the Company was notified
by the Panel that the Company’s request for continued listing on Nasdaq was granted, subject to the Company demonstrating compliance
with the stockholders’ equity requirement and bid price requirement on or before January 31, 2024. The Panel subsequently extended
this compliance date to February 27, 2024. The Panel has the right to reconsider the terms of this exception based on any event,
condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s
securities on Nasdaq inadvisable or unwarranted.
If our common stock is
delisted by Nasdaq, our common stock may be eligible for quotation on an over-the-counter quotation system or on the pink sheets. Upon
any such delisting, our common stock would become subject to the regulations of the SEC relating to the market for penny stocks. A penny
stock is any equity security not traded on a national securities exchange that has a market price of less than $5.00 per share. The regulations
applicable to penny stocks may severely affect the market liquidity for our common stock and could limit the ability of shareholders to
sell securities in the secondary market. In such a case, an investor may find it more difficult to dispose of or obtain accurate quotations
as to the market value of our common stock, and there can be no assurance that our common stock will be eligible for trading or quotation
on any alternative exchanges or markets.
Delisting from Nasdaq
could adversely affect our ability to raise additional financing through public or private sales of equity securities, would significantly
affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock. Delisting
could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest
and fewer business development opportunities.
Risks related to financial, operational, commercial and manufacturing
matters
The auditors of our
December 31, 2023 and 2022 financial statements have expressed substantial doubt about our ability to continue as a going concern,
which may hinder our ability to obtain further financing.
Our past working capital deficiency, stockholders’
deficit and recurring losses from operations raised substantial doubt about our ability to continue as a going concern. As a result,
our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the
year ended December 31, 2023, with respect to this uncertainty. Our existing cash will only be sufficient to fund our current
operating plans into the second quarter of 2024, up to our first maturity repayment on our unsecured non-convertible note repayment which
is due in April 2024. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce, or eliminate
our technology development and commercialization efforts.
We have incurred significant
net losses since inception and anticipate that we will continue to incur net losses for the foreseeable future and may never achieve or
maintain profitability.
Since our inception, we have incurred significant
net losses. Our net losses were $4,911,374 and $7,068,593 for the years ended December 31, 2023, and 2022, respectively.
As of December 31, 2023, we had an accumulated deficit of $44,281,526. To date, we have devoted our efforts toward securing
financing, building and evolving our technology platform, and complying with regulatory requirements as well as initiating marketing
efforts for our products. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate
that our expenses will increase substantially if, and as, we:
| |
· |
hire and retain additional sales, accounting and finance, marketing and engineering personnel; |
| |
|
|
| |
· |
build out our product pipeline; |
| |
|
|
| |
· |
add operational, financial and management information systems and personnel; and |
| |
|
|
| |
· |
maintain, expand, protect and enforce our intellectual property portfolio. |
To become and remain profitable, we must enhance
the marketing and commercial acceptance of our products. This will require us to be successful in a range of challenging activities, and
our expenses will increase substantially as we bring these products to market. We may never succeed in any or all of these activities
and, even if we do, we may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability,
we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would
decrease the value of our company and could impair our ability to raise capital, develop new products, expand our business or continue
our operations. A decline in the value of our company also could cause stockholders to lose all or part of their investment.
We
have identified a material weakness in our internal control over financial reporting. Failure to maintain effective internal controls
could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls
are not effective, we may not be able to accurately report our financial results or prevent fraud.
Section 404 of the Sarbanes-Oxley Act of 2002,
or Section 404, requires that we maintain internal control over financial reporting that meets applicable standards. We may err in the
design or operation of our controls, and all internal control systems, no matter how well designed and operated, can provide only reasonable
assurance that the objectives of the control system are met. Because there are inherent limitations in all control systems, there can
be no assurance that all control issues have been or will be detected. If we are unable, or are perceived as unable, to produce reliable
financial reports due to internal control deficiencies, investors could lose confidence in our reported financial information and operating
results, which could result in a negative market reaction and a decrease in our stock price.
The Company will be required, pursuant to Section
404, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. Such
report will not be required until our second annual report filed on Form 10-K. We will need to disclose any material weaknesses identified
by our management in our internal control over financial reporting. As an “emerging growth company,” we will avail ourselves
of the exemption from the requirement that our independent registered public accounting firm attest to the effectiveness of our internal
control over financial reporting under Section 404. However, we may no longer avail ourselves of this exemption when we cease to be an
“emerging growth company.” When our independent registered public accounting firm is required to undertake an assessment
of our internal control over financial reporting, the cost of our compliance with Section 404 will correspondingly increase. Our compliance
with applicable provisions of Section 404 will require that we incur substantial accounting expense and expend significant management
time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. Moreover,
if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or our independent registered
public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses,
the market price of our stock could decline and we could be subject to sanctions or investigations by the U.S. Securities and Exchange
Commission, or SEC, or other regulatory authorities, which would require additional financial and management resources.
If we continue to have material weaknesses in
our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 in a timely manner, if
we are unable to assert that our internal control over financial reporting is effective, or if our independent registered public accounting
firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, we may be late with the
filing of our periodic reports, investors may lose confidence in the accuracy and completeness of our financial reports and the market
price of our common stock could be negatively affected.
We will need additional
funding, which may not be available on acceptable terms, or at all. Failure to obtain this capital when needed may force us to delay,
limit or terminate our product development efforts or other operations.
We believe our current cash resources will be
sufficient to fund our current operating plans into the second quarter of 2024, up to our first maturity repayment on our unsecured
non-convertible note repayment which is due in April 2024. We expect our expenses to increase in connection with our ongoing activities,
particularly as we continue to invest in sales, marketing and engineering resources and bring our products to market. Furthermore, since
the closing of our IPO, we have incurred additional costs associated with operating as a public company. We will need additional funding
to complete the development of our full product line and scale products with a demonstrated market fit.
Building and scaling
technology products is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary
user experience required to obtain market acceptance and achieve meaningful product sales. In addition, our product candidates, once developed,
may not achieve commercial success. The majority of revenue will be derived from or based on sales of software products that may not be
commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our
business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.
Raising additional
capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies
and product candidates.
We may seek additional
capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing
arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership
interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
The incurrence of indebtedness would result in increased fixed payment obligations and could involve restrictive covenants, such as limitations
on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating
restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships
and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, or our other
product candidates, or grant licenses on terms unfavorable to us.
We are highly dependent on our senior management
team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
We are highly dependent on our senior management
and key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in
the future, including sales and marketing professionals, engineers, scientists, clinical trial specialists and other highly skilled personnel
and to integrate current and additional personnel in all departments. The loss of members of our senior management, marketing professionals,
engineers, scientists and clinical trial specialists could result in delays in product development and harm our business.
Competition for skilled personnel in our market
is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, or at all. To induce valuable
employees to remain at our company, in addition to salary and cash incentives, we have issued stock options that vest over time. The value
to employees of stock options that vest over time may be significantly affected by fluctuations in our stock price that are beyond our
control, and may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable
employees, members of our management and other key personnel may terminate their employment with us on short notice. Our employment arrangements
with our employees provide for at-will employment, which means that any of our employees could leave our employment at any time, with
or without notice. We also do not maintain “key man” insurance policies on the lives of these individuals or the lives of
any of our other employees.
Our MR data post-processing products currently
depend on compatible use with only a limited number of MR scanners that are provided only by one manufacturer of MR devices.
Our MR data post-processing software products
are only compatible for post-processing disc MRS data acquired via certain scanner models and operating configurations provided only by
one, third-party scanner vendor - SIEMENS. There are risks associated with our reliance on SIEMENS, and/or the MR service providers who
own and operate the SIEMENS scanners, to maintain those scanners and their operating configurations in a manner that continues to support
compatibility with our products. There are also risks that current compatible scanner platforms may become incompatible as a result of
changes made to those scanners by SIEMENS, or by the scanner owner or related service provider, which would frustrate our ability to continue
supporting that MR provider customer with our products. There are also risks that these SIEMENS scanners do not perform reliably as intended
or expected in performing data acquisition exams as required by our post-processing products, which would also frustrate the ability for
our products to perform as intended. There is also a risk that SIEMENS loses its install base of compatible MR Scanners due to cannibalization
by other non-compatible replacement scanner sales or fails to grow its install base of those compatible scanners, which could adversely
affect the number and locations of compatible scanners for our own market share and penetration. Manifestations of these risks becoming
actually realized in the marketplace could harm our business, financial condition, and results of operations. We are not subject to any
exclusivity agreement or obligations with SIEMENS, nor do we have any fee sharing, royalty, or other exchange of moneys or payments between
us and Siemens. The nexus for our focused relationship with Siemens resulted from our determination that SIEMENS scanner models were optimally
positioned to support our product. We have had a collaborative relationship with Siemens since 2011 and have been party to a Collaborative
Agreement with Siemens since October of 2017, The Collaborative Agreement is terminable.at any time by either party if such party is of
the opinion that the goals of the Collaborative Agreement cannot be achieved for technical, economic and/or clinical reasons. If Siemens
were to terminate its relationship with the Company, it would have a material adverse effect on our business.
If we are not successful in enhancing awareness
of our technology, driving adoption across our current target population, increasing referrals from surgeons and clinicians, and expanding
the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected.
Our business depends on our ability to successfully
market our technology, which includes increasing the number of patients scanned with our technology, increasing adoption of our technology
and driving utilization of our technology by surgeons and clinicians. Additionally, our technology is primarily recommended and implemented
to provide advanced diagnosis and management of spine and back pain, in particular, for diagnosing painful discs causing discogenic low
back pain. Therefore, we are dependent on widespread market adoption of our technology. While we intend to expand the population of patients
we can provide with our diagnostic technology as well as increase the number of physicians, surgeons and clinicians that can prescribe
technology, there can be no assurance that we will succeed.
The commercial success of
our technology will continue to depend on a number of factors, including the following:
| |
· |
the actual and perceived effectiveness, safety and reliability, and clinical
benefit, of our technology, especially relative to alternative diagnostic systems and devices; |
| |
· |
the prevalence and severity of any adverse patient events involving the use
of our technology; |
| |
· |
the degree to which physicians, surgeons and clinicians, patients and imaging
centers adopt our technology; |
| |
· |
the availability, relative cost and perceived advantages and disadvantages of
alternative technologies, or other diagnostic or treatment methods, for spine and back pain; |
| |
· |
the results of additional clinical and other studies relating to the health,
safety, economic or other benefits of our technology; |
| |
· |
whether key thought leaders in the medical community accept that our clinical
efficacy and safety results are sufficiently meaningful to influence their decision to adopt our technology over other spine and back
pain diagnostics; |
| |
· |
the extent to which we are successful in educating physicians, surgeons, clinicians,
patients, and imaging facilities about the appropriate (and inappropriate) uses and benefits of our technology; |
| |
· |
the strength of our marketing and distribution infrastructure, including our
ability to drive adoption and utilization of our technology, as well as our ability to develop and maintain relationships with MRI manufacturers
and imaging centers; |
| |
· |
our ability to obtain, maintain, protect, enforce and defend our intellectual
property rights, in and to our technology; |
| |
· |
our ability to maintain compliance with all legal and regulatory requirements,
including those applicable to our technology; |
| |
· |
our ability to maintain our contractual relationships with our vendors and component
suppliers, including single-source vendors and suppliers through which we obtain critical components for (or compatible use with) our
technology; |
| |
· |
the establishment and continued reimbursement coverage of and adequate payment
for the use of our technology and |
| |
· |
our ability to continue to attract and retain key personnel. |
If we fail to successfully market and sell our
technology cost-effectively and maintain and expand our market share, our sales, business, financial condition and results of operations
will be negatively affected.
Our commercial success will continue to depend
on attaining significant market acceptance of our technology among physicians, surgeons, patients, clinicians and imaging facilities,
and increasing the number of patients diagnosed by our technology.
Our commercial success will depend, in large part,
on the further acceptance by surgeons, physicians, clinicians, patients and imaging facilities of our technology as safe, useful, cost-effective,
and that it can increase the number of patients that are diagnosed. We cannot predict how quickly, or if at all, additional surgeons,
physicians, clinicians, patients and imaging facilities will adopt our technology over competing diagnostic platforms for support in on-going
care and treatment options that are expected to be supported by the intended diagnostic uses of our technology. For example, surgeons,
other physicians, clinicians, patients, and imaging facilities may be reluctant to use our technology due to familiarity with pre-existing
diagnostic systems that are more established or an otherwise resistance to adopt new technologies or change current practices. Our ability
to grow sales of our technology and drive market acceptance will depend on successfully educating surgeons, physicians, clinicians, patients
and MR imaging facilities on the relative benefits of our Technology.
We may be unable to compete successfully with
other diagnostic options for low back pain, or may be unable to continue providing value for supporting new treatments that may not need
the diagnostic information our products provide.
The medical device industry is intensely competitive,
subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.
Our current competition primarily resides with the diagnostic standards over which our products are intended to improve – in particular,
X-ray, lumbar MRI, and PD. Our products are positioned for synergistic use with lumbar MRI, and to enhance the diagnostic value of lumbar
MR exams. However, the existing reliance on lumbar MRI as a standard of care for our DLBP indication, and on PD in some medical practices,
and the potential for other enhancements to those platforms and techniques, nonetheless also represents a competitive threat. To the extent
that these other platforms represent our primary competitors, they are mainly provided by large, well-capitalized companies with significant
market share and resources. Most of our competitors have more established sales and marketing programs than us and have greater name recognition.
These competitors also have long operating histories and may have more established relationships with potential customers. Also, there
can be no assurance that other companies or institutions will not succeed in developing or marketing devices and products that are more
accurate, useful, effective or safer than our technology or that would render our technology obsolete or noncompetitive.
Adoption of our technology depends on positive
clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians
would harm our sales, business, financial condition, and results of operations.
The rate of adoption and sales of our products
are heavily influenced by clinical data. We have published positive clinical data from an Institutional Review Board (“IRB”),
approved more than 100 patient single center trial in a major peer-reviewed spine journal which showed both: (a) high diagnostic accuracy
against provocation discography controls, and (b) much higher patient success outcomes for surgeries that treated discs identified as
painful using our products, versus much lower success rates when discs diagnosed as painful with our products were left untreated. However,
there can be no assurance that our clinical data will continue to be positive for our ongoing or future clinical studies. Additionally,
there can be no assurance that future clinical studies, including those to continue demonstrating the diagnostic accuracy and value of
our products in currently approved patient populations and those to support label retention and expansion for our products, will demonstrate
diagnostic acuity or value. Unfavorable or inconsistent clinical data from ongoing or future clinical studies conducted by us, our competitors,
or third parties, or the potential for negative interpretation of our clinical data by customers, competitors, patients, and regulators,
or the potential for finding new or more frequent adverse events related to the use of our products could harm our sales, business, financial
condition, and results of operations.
If adequate reimbursement is not available
for the procedures implementing our technology, or for clinicians to provide ongoing care for patients diagnosed with our technology,
it could diminish our sales or affect our ability to sell our technology.
Our ability to increase sales of our technology
depends, in significant part, on the availability of adequate financial coverage and reimbursement from third-party payors, which include:
(i) governmental payors such as the Medicare and Medicaid programs in the United States; (ii) private managed care organizations; and
(iii) private health insurers. Third-party payers determine which services and treatments they will cover and establish reimbursement
rates for those treatments. While we have secured certain reimbursement codes against which the use of our products can potentially be
billed, we do not yet currently bill any third-party payers directly for our technology. The cost of our customers using our technology
is currently being paid for by either: (i) billing patients to pay directly (ii) allocation at least in part against payments received
by healthcare providers for other procedures conducted in association with the use of our technology, or (c) third-party payer reimbursement
payments to a several of our customers for less than 10 patients through the date of this prospectus. A failure to obtain wide coverage
and adequate reimbursement for using our technology in conducting our new diagnostic procedures, or for clinicians providing ongoing patient
care based on or related to our diagnostic results could diminish our sales and affect our ability to sell our technology.
If adequate reimbursement for our temporary
Category III CMS Code designation for our products cannot be obtained or we are not successful in obtaining conversion to permanent Category
I codes at an adequate reimbursement level, it would diminish our sales and would affect our ability to market our technology.
On January 1, 2021, our Category III CPT Codes
became effective. Category III codes represent the first step in the reimbursement process. The effectiveness of our Category III codes
commenced a five-year period in which, in order to maintain our Category III status, we are required to demonstrate that the medical community
needs (“Clinical Needs”) the NOCISCAN product. Clinical Needs would be demonstrated to the CPT Committee based on the volume
at which our Category III codes are billed by imaging centers and physicians. In addition to demonstrating that there is Clinical Needs,
we also are required to show that NOCISCAN is clinically effective as indicated by patients having better outcomes when NOCISCAN reports
are used to help guide surgical treatments. We expect to show clinical effectiveness through a combination of clinical registries and
clinical studies that build upon our published clinical study the CPT committee used to create our Category III CPT codes. However, if
we are not able to demonstrate Clinical Needs, nor that NOCISCAN is clinically effective, our revenue would be limited to a direct patient
payment model, which will severely limit our ability to market our products and generate sufficient revenue to continue market our technology.
Further, for us to obtain a conversion from of
our CPT codes from Category III to Category I, we will need to attract a significant larger number of surgeons and imaging centers to
adopt our technology and thereby increase the volume of reimbursement claims data needed for the CPT committee to determine that our product
is needed in the healthcare marketplace. In addition to generating clinical use volume, we will also need to demonstrate the ongoing clinical
efficacy of our products to secure adequate reimbursement from payers. A failure to convert Category III codes to Category I codes will
ultimately make us more dependent on a patient pay model which will significantly diminish our sales and affect our ability to market
our technology.
Use of our technology requires appropriate
training for proper use of our products, and inadequate training may lead to negative patient outcomes, which could harm our business,
financial condition, and results of operations.
The successful use of our technology depends,
in part, on the training and skill of referring doctors and other healthcare providers for appropriately prescribing our diagnostic exam
for the correctly indicated patients and anatomy, and properly interpreting the results from using our product as indicated under our
related IFUs. It also depends upon MR technicians and operators appropriately implementing and using our technology as indicated under
our related IFUs. MR technicians and operators could also experience difficulty with the steps and techniques necessary to successfully
implement and use our technology protocols. We cannot guarantee that all medical and MR technician professionals will have the necessary
skills and training, according to our instructions for use, or will sufficiently comply with that training and instructions for use in
order to properly prescribe and interpret the results of our diagnostic imaging platform. We cannot be certain that surgeons, other physicians,
MRI technicians or operators, or other healthcare providers that use our technology will have received sufficient training or will continue
to comply with that training in their on-going practice in using our technology. If physicians and surgeons utilize our technology incorrectly
or, without adhering to or completing all relevant training according to our instructions, the utility and value of our diagnostic products
and their related patient outcomes from on-going care following that diagnostic work-up may not be consistent with the outcomes achieved
in our clinical studies or otherwise expected or desired by such care providers or the patients themselves. Adverse treatment outcomes
that could potentially arise from improper or incorrect use of our technology may negatively impact the perception of patient benefit
and safety of our technology, notwithstanding results from our clinical studies. These results could limit adoption of our technology,
which would harm our sales, business, financial condition, and results of operations.
We expect to increase the size of our organization
in the future, and we may experience difficulties in managing this growth. If we are unable to manage the anticipated growth of our business,
our future revenue and operating results may be harmed.
As
of February 26, 2024 we had 4 full-time employees, 2 part-time employees, 1 full-time
consultant, and 3 part-time consultants. As our sales and marketing strategies develop, and
as we transition into operating as a public company, we expect to need additional managerial,
operational, sales, marketing, financial and other personnel. Future growth would impose
significant added responsibilities on members of management, including:
| |
· |
identifying, recruiting, integrating, maintaining and motivating additional
employees; |
| |
· |
managing our internal development efforts effectively, while complying with
our contractual obligations to contractors and other third parties; and |
| |
· |
improving our operational, financial and management controls, reporting systems
and procedures. |
Our future financial performance and our ability
to successfully market and sell our technology will depend, in part, on our ability to effectively manage any future growth, and our management
may also have to divert a disproportionate amount of attention away from day-to-day activities in order to devote a substantial amount
of time to managing these growth activities.
We may not be able to achieve or maintain satisfactory
pricing and margins for our NOCISCAN disc MRS diagnostic software products and related services, which could harm our business and
results of operations.
Software products classified as medical devices
have a history of price competition and we can give no assurance that we will be able to maintain satisfactory prices for our technology.
The pricing of our technology could be impacted by several factors, including pressure to reduce prices by our customers due to a decline
in the amount that third-party payers reimburse for diagnostic procedures using our technology or for clinicians providing ongoing patient
care related to the diagnostic information we provide. A decline in the amount that third-party payers reimburse our customers for ongoing
patient care could also make it difficult for us to maintain procedural volume without a corresponding reduction in prices for our products.
If we are forced to lower the price we charge for our technology, our gross margins will decrease, which, will harm our ability to invest
in and grow our business. If we are unable to maintain our prices or if our costs increase and we are unable to offset such increase with
an increase in our prices, our margins would erode and could harm our business, financial condition, and results of operations.
Our results of operations may be harmed if
we are unable to accurately forecast customer demand for our technology
Our ability to accurately forecast demand for
our products could be negatively affected by many factors, including (i) our potential failure to accurately manage or execute our expansion
strategy, (ii) new product introductions by competitors, (iii) an increase or decrease in customer demand for our products or for other
competing products, (iv) our failure to accurately forecast customer adoption of new products, (v) unanticipated changes in general market
conditions or regulatory matters and (vi) weakening of economic conditions or consumer confidence in future economic conditions. Software
processing capacity, data storage, and related computer hosting resources in excess of customer demand may result in financial write-downs
or write-offs, which would cause our gross margin to be adversely affected and could impair the strength of our brand. Conversely, if
we underestimate customer demand for our products, our technical and IT resource support team, software processing and storage resources,
and computing architectures may not be able to support sufficient processing requirements to meet the demand for our products; and, this
could result in lost sales and damage to our reputation and customer relationships. In addition, if we experience a significant increase
in demand, additional computing and storage capacity and resources, and additional technical support personnel required to support the
increased demand may not be available when required or on terms that are acceptable to us, or at all, which may negatively affect our
sales, business, financial condition, and results of operations.
Risks related to government regulation and
our industry
Our operations and technology are subject to
pervasive and continuing FDA regulatory requirements, and failure to comply with these requirements could harm our business, financial
condition and results of operations.
Before a regulated new medical device or service,
or a new intended use for an existing device or service, can be marketed in the United States, a company must first receive either 510(k)
clearance, or a PMA from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA
must determine that: (i) a proposed device is substantially equivalent to a legally-marketed predicate device, which includes a legal
marketed device that has been previously cleared through the 510(k) process, (ii) was legally marketed prior to May 28, 1976 (pre-amendments
device), (iii) was legally marketed pursuant to an approved PMA and later down-classified, or (iv) is covered by a classification regulation
created through the de novo review process.
In the process of obtaining PMA approval, which
the FDA could potentially require in the future for our products, the FDA must determine that a proposed device is safe and effective
for its intended use based, in part, on extensive data, including, but not limited to, technical, preclinical, clinical study, manufacturing
and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining,
life-supporting or implantable devices.
We believe that one of our products under the
NOCISCAN Suite, NOCICALC, is a Class I 510(k)-exempt medical device, which only requires registration and no pre-market review with
the FDA, and which we registered as such with the FDA. We also believe the other of our products in the suite, NOCIGRAM, is “Clinical
Decision Support Software” under the 21st Century Cures Act and as such, is not considered a medical device, and thus
is not regulated by the FDA. Accordingly, we believe that our current products do not require FDA clearance or approval under either 510(k)
or PMA approval pathways. However, there can be no assurance that in the future, the FDA will not determine that PMA approval, de novo
classification, or 510(k) clearance is required for our products. If the FDA were to make such a determination, we would not be able to
sell or market our products without or until securing such approval or clearance and may be subject to potential fines and other penalties
or remedial actions for illegally marketing or selling an unapproved medical device, which would affect our sales, business, financial
condition, and results of operation.
If we are unable to expand the labeling claims
for using our technology to include additional indications, our growth potential could be harmed.
We intend to seek expanded labeling claims for
our technology in the future, including for example: (i) extending the intended indications for use to include disc MRS along the thoracic
or cervical spine, (ii) incorporating certain MRI image post-processing along with MRS data post-processing, and (iii) real-time post-processing
of MRS exam data during the exam itself via our software installed and operated within the MR scanner software environment (vs. our current
products which are for cloud-hosted post-processing of MRS data that is transferred to us, following the MRS exams, via our own remote
computing resources). If regulatory clearance or approval is required to expand the use of our technology, and which clearance and approval
may require clinical trial results, we could incur substantial costs and the attention of management could be diverted throughout this
process. However, there can be no assurance we will be able to obtain and maintain necessary clearance or approvals for additional uses
of our technology, or even if obtained, that the broadened use of our technology would be accepted or adopted by intended users, thus
limiting the growth potential of our business.
Our medical device products may be subject
to recalls, which could divert managerial and financial resources, harm our reputation and our business.
The FDA has the authority to require the recall
of medical device products in certain circumstances. A government mandated or voluntary product recall by us could occur because of device
malfunctions or other adverse events, such as quality-related issues resulting from product operating malfunctions or defects. Any future
recalls of our products could divert managerial and financial resources, harm our reputation and negatively impact our business.
If we initiate a correction or removal of certain
of our products from the market to reduce a risk to health posed by the device, we would be required to submit a Correction and Removal
report to the FDA and, in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a device
recall which could lead to increased scrutiny by the FDA and our customers regarding the quality and safety of our products. Furthermore,
the submission of these reports could be used by competitors against us and could harm our reputation, which could cause customers to
delay purchase decisions, cancel orders or decide not to purchase our products and could cause patients to lose trust in our technology.
We may experience difficulties outside the
US in obtaining or maintaining regulatory clearance or approval, or exemptions therefrom, or in successfully gaining third-party reimbursement
or marketing our technology, even if approved or otherwise legally marketed.
Our NOCISCAN product suite was initially commercialized
as a Class I medical device under European Commission regulations. The process did not require pre-market submission, review, or certification
by a Notified Body in order to be CE marked. A “Notified Body” is an organization designated by an EU country to assess the
conformity of certain products before being placed on the market.
For commercialization outside the United States,
in particular the European Union (“EU”) and United Kingdom (“UK”), the Company, in conjunction with our regulatory
consultants, determined NOCISCAN to be a Class I medical device, for which we secured a CE mark via self-certification. As such, we self-certified
our product for the CE mark under a Declaration of Continuity (“DOC”) filed by us as part of a dossier with a qualified EU
Representative. Since self-certification was completed by the Company, the EU adopted Medical Device Regulation (EU) 2019/1020, known
as MDR, that went into effect on July 16, 2021. Under these new regulations, we believe NOCISCAN to be considered a Class II(a) device
that requires re-certification for CE mark by a Notified Body prior to May 2024. Notified Bodies carry out tasks related to conformity
assessment procedures set out in the applicable legislation, when a third party is required. Class II(a) device certification is subject
to additional requirements for approval beyond our existing submissions, including requiring pre-market review and CE mark approval by
a Notified Body, and which may require submission and approval of supportive clinical data. We are currently seeking to identify, but
have not yet engaged, a Notified Body for this purpose. The available number of Notified Bodies, and those engaging new company applicants,
has been significantly reduced in recent years and the ability for conducting a Notified Body review and CE mark approval can typically
take more than a year. Certain aspects of the new MDR also place new requirements on Class I medical devices that are not subject to the
extended 2024 grace period and became effective as of May 2021. This applies to new required policies and practices for post-market surveillance
of our products. While we are not currently compliant with these new requirements, we are in the process of updating our policies and
practices and taking the corrective actions to achieve and maintain ongoing compliance. We believe the actions we are taking are sufficient
to support the continuance of our commercial activities in the EU under our CE mark without adverse penalties or other consequences. However,
there is a risk that one or more regulatory body or agency in the EU may determine otherwise, either with respect to our prior non-compliance
that has since been corrected or with respect to the sufficiency of our corrective actions, and which could result in us incurring certain
penalties or other consequences.
If we are unable to engage or receive CE mark
approval from a Notified Body under the MDR by the May 2024 grace period deadline, or are determined to be non-compliant with MDR regulations
not subject to the grace period and therefore applicable to us as of May 2021, we could lose our CE mark, and may become unable to continue
promoting or selling our products for commercial use in the EU, UK, or other countries that relate their medical device regulations to
a CE mark.
In conjunction with Brexit, medical devices in
the UK are no longer governed by CE regulations. As such, the UK has introduced the UKCA marking system which largely follows the CE marking
regulations to include permitting use of the same submissions for approval. The major difference post-Brexit is that CE marking is regulated
by the EU and UKCA marking is regulated by the UK. The only practical implication to the Company is the requirement of a Notifying Body
within both the EU and the UK. If the Company is successful in meeting all requirements of the CE mark under MDR set forth above, the
company believes it will meet all requirements for UKCA marking. While we are not currently compliant with new requirements in the UK,
we are in the process of updating our policies and practices and taking what we believe are corrective actions to achieve and maintain
ongoing compliance in the UK. We believe our activities are sufficient to support the continuance of our commercial activities in the
UK under our CE mark without adverse penalties or other consequences. However, there is a risk that one or more regulatory body or agency
in the UK may determine otherwise, either with respect to our prior non-compliance that we believe has been corrected or with respect
to the sufficiency of those corrective actions and which could result in us incurring certain penalties or other adverse consequences
to our business. There can be no assurance that we can obtain a UKCA mark and if we are not able to secure a UKCA mark, we will lose our
ability to conduct business in the UK.
Sales of our technology outside of the United
States will be subject to foreign regulatory requirements governing clinical studies and marketing approval, as well as additional post-market
requirements. We would incur substantial expenses in connection with any international expansion. Additional risks related to operating
in foreign countries include:
| |
· |
differing, and potential changes in, regulatory requirements in foreign countries,
including with respect to data privacy and security; |
| |
· |
differing, and potential changes in, reimbursement regimes in foreign countries,
including price controls; |
| |
· |
unexpected changes in tariffs, trade barriers, price and exchange controls and
other regulatory requirements; |
| |
· |
economic weakness, including inflation, or political instability in particular
foreign economies and markets; |
| |
· |
compliance with tax, employment, immigration and labor laws for employees living
or traveling abroad; |
| |
· |
foreign taxes, including withholding of payroll taxes; |
| |
· |
foreign currency fluctuations, which could result in increased operating expenses
or reduced revenue; |
| |
· |
difficulties staffing and managing foreign operations; |
| |
· |
workforce uncertainty in countries where labor unrest is more common than in
the United States; |
| |
· |
potential liability under the U.S. Foreign Corrupt Practices Act of 1977, as
amended, or the FCPA, or comparable foreign regulations; |
| |
· |
challenges enforcing our contractual and intellectual property rights as well
as intellectual property theft or compulsory licensing, especially in those foreign countries that do not respect and protect intellectual
property rights to the same extent as the United States; and |
| |
· |
business interruptions resulting from geopolitical actions, including war and
terrorism. |
These and other risks associated with international
operations that may harm our ability to attain or maintain profitable operations internationally, which would harm our growth potential.
Furthermore, there are foreign privacy laws and
regulations that impose restrictions on the collection, use, storage, disclosure, transfer and other processing of personal data, including
health information. For example, the European Union General Data Protection Regulation (“GDPR”), imposes stringent data protection
requirements, including, for example, more robust disclosures to individuals, a strengthened individual data rights regime, shortened
timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories
of data, such as health data, and additional obligations regarding third-party processors in connection with the processing of the personal
data. Our failure to comply with the GDPR or other applicable foreign privacy laws or regulations or significant changes in the laws and
regulations restricting our ability to obtain or use required patient information could significantly impact our business and our future
business plans.
If we fail to comply with fraud and abuse and
other healthcare laws and regulations in the U.S. and internationally including those relating to kickbacks and false claims for reimbursement,
we could face substantial penalties and our business, financial condition and results of operations could be harmed.
Healthcare providers play a primary role in the
distribution, recommendation, ordering and purchasing of any of our products. Through our arrangements with healthcare professionals and
hospital facilities, we are exposed to broadly applicable anti-fraud and abuse, anti-kickback, false claims and other healthcare laws
and regulations that may constrain our business, our arrangements and relationships with customers, and how we market, sell and distribute
our marketed medical devices. We have a compliance program, code of conduct and associated policies and procedures, but it is not always
possible to identify and deter misconduct by our employees, contractors, and other third parties, including our customers, and the precautions
we take to detect and prevent noncompliance may not be effective in protecting us from governmental investigations for failure to comply
with applicable fraud and abuse or other healthcare laws and regulations.
In the United States, we are subject to various
state and federal anti-fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal civil False
Claims Act, or the FCA. Our relationships with physicians, other health care professionals and hospitals are subject to scrutiny under
these laws. There are also similar laws in other countries that we may become subject to if we expand internationally.
The laws that may affect our ability to operate
include, among others:
| |
· |
The Anti-Kickback Statute, which prohibits, among other things, knowingly and
willingly soliciting, offering, receiving or paying remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to
induce or reward either the referral of an individual, or the purchase, order or recommendation of, items or services for which payment
may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs; |
| |
|
|
| |
· |
The federal civil and criminal false claims laws, including the FCA, and civil
monetary penalties laws, which prohibits, among other things, persons or entities from knowingly presenting, or causing to be presented,
a false or fraudulent claim for payment of government funds and knowingly making, using or causing to be made or used, a false record
or statement to get a false claim paid or to avoid, decrease or conceal an obligation to pay money to the federal government; |
| |
|
|
| |
· |
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, which
applies to our customers and some of their downstream vendors and contractors, imposes criminal and civil liability for, among other actions,
knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party
payers, or knowingly and willfully falsifying, concealing or covering up a material fact or making a materially false, fictitious or fraudulent
statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious
or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services; |
| |
|
|
| |
· |
Various state laws governing the privacy and security of personal information,
including the California Consumer Privacy Act (“CCPA"), which became effective on January 1, 2020, which regulates the processing
of personal information of California residents and increases the privacy and security obligations of covered companies handling such
personal information. The CCPA requires covered companies to, amongst other things, provide new and additional disclosures to California
residents, and affords such residents new abilities to access their personal information and opt out of certain sales of personal information;
and |
| |
|
|
| |
· |
The federal Physician Payments Sunshine Act, also known as Open Payments, requires
manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s
Health Insurance Program to report annually, with certain exceptions to the Centers for Medicare and Medicaid Services, or CMS, information
related to payments or other “transfers of value” made to certain physicians or other healthcare providers, as defined by
such law, and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to CMS ownership
and investment interests held by physicians and their immediate family members. |
State and federal regulatory and enforcement agencies
continue to actively investigate violations of healthcare laws and regulations, and the U.S. Congress continues to strengthen the arsenal
of enforcement tools. Enforcement agencies also continue to pursue novel theories of liability under these laws. In particular, government
agencies have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and
patient care programs, including bringing criminal charges or civil enforcement actions under the Anti-Kickback Statute, the FCA and HIPAA’s
healthcare fraud and privacy provisions.
Achieving and sustaining compliance with applicable
federal and state anti-fraud and abuse laws may prove costly. If we, or our employees, are found to have violated any of the above laws
we may be subjected to substantial criminal, civil and administrative penalties, including imprisonment, exclusion from participation
in federal healthcare programs, such as Medicare and Medicaid, and significant fines, monetary penalties, forfeiture, disgorgement and
damages, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings and the curtailment or
restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any
action or investigation against us for the violation of these healthcare fraud and abuse laws, even if successfully defended, could result
in significant legal expenses and could divert our management’s attention from the operation of our business. Companies settling
FCA, Anti-Kickback Statute or civil monetary penalties law cases also may be required to enter into a Corporate Integrity Agreement with
the OIG, in order to avoid exclusion from participation (which results in a loss of coverage for their products) in federal healthcare
programs such as Medicare and Medicaid. Corporate Integrity Agreements typically impose substantial costs and operational burdens on companies
to ensure compliance. Defending against any such actions can be detrimental to our reputation and brand and can otherwise be costly, time-consuming
and may require significant personnel resources, and may harm our business, financial condition and results of operations.
We have financial relationships with certain
physicians and health care providers, research investigators, and authors for our clinical or scientific publications that may be deemed
a conflict of interest and may be subject to certain statutory or regulatory requirements, under which a failure to comply could lead
to enforcement actions against us and other negative consequences for our business.
We have certain financial relationships with medical
doctors and other healthcare providers who are investors and shareholders in our Company and/or paid consultants, clinical investigators,
or speakers promoting our products and clinical results, some of whom are also our customers who pay us for patients receiving a NOCISCAN
exam, or otherwise prescribe and get paid for interpreting a NOCISCAN exam. There are risks that one or more of these relationships
may be determined to be a conflict of interest and be in violation of applicable laws, regulations, or guidelines, which could potentially
subject us to significant fines or curtailment of our active commercial operations, and which could also potentially harm our reputation
in the marketplace. If we are deemed to not comply with requirements governing the industry’s relationships with physicians or there
is an investigation into our compliance by the Office of the Inspector General, the Department of Justice, states’ attorney generals
or other government agencies, it could harm our sales, business, financial condition, and results of operations.
Regulatory compliance is expensive, complex
and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
The FDA, EU, and other foreign regulatory agencies
or governing bodies, regulate certain of our products as medical devices. Complying with these regulations is costly, time-consuming,
complex and uncertain. For instance, before a new medical device, or a new intended use for an existing device, can be marketed in the
United States, a company must first submit and receive either 510(k) clearance, de novo approval, or approval of a PMA from the FDA, unless
an exemption applies. FDA regulations and regulations of similar agencies are wide-ranging and include, among other things, oversight
of:
| |
· |
product design, development, manufacturing (including suppliers) and testing; |
| |
· |
laboratory, preclinical and clinical studies; |
| |
· |
product safety and effectiveness; |
| |
· |
product labeling; |
| |
· |
product storage and shipping; |
| |
· |
quality assurance policies, practices, and record keeping; |
| |
· |
pre-market clearance or approval; |
| |
· |
marketing, advertising and promotion; |
| |
· |
product sales and distribution; |
| |
· |
product changes; |
| |
· |
product recalls; and |
| |
· |
post-market surveillance and reporting of deaths, serious injuries, certain
malfunctions, and related corrective actions. |
Further, improvements of our existing technology,
any potential new technology, and new indications for use of our current technology may be subject to extensive regulation, and we may
require permission from regulatory agencies and ethics boards to conduct clinical studies, as well as clearance or approval from the FDA,
or other such foreign regulatory agencies or governing bodies, prior to commercial sale. In order to commercialize and distribute our
products in markets outside of the United States, it will require approval from, or otherwise meeting the requirements of, non-U.S. regulatory
agencies.
The FDA and foreign regulatory bodies can delay,
limit or deny clearance or approval (or otherwise a related “exemption”) for a device for many reasons, including:
| |
· |
our inability to demonstrate to the satisfaction of the FDA or the applicable
regulatory entity or notified body that our products are safe or effective for their intended uses; |
| |
· |
disagreement of the FDA or the applicable foreign regulatory body with the design
or implementation of our clinical studies or the interpretation of data from clinical studies, or with the regulatory classification or
related pre-market regulatory pathway pursued by the Company for our products; |
| |
· |
adverse device effects experienced by participants in our clinical studies; |
| |
· |
the insufficiency of data from our preclinical studies and clinical studies
to support clearance or approval, where required; |
| |
· |
our inability to demonstrate that the clinical and other benefits of our products
outweigh the risks; |
| |
· |
failure of our manufacturing process or facilities to meet applicable requirements;
and |
| |
· |
significant changes to the policies or regulations of the FDA or applicable
foreign regulatory bodies that render our clinical data or regulatory classifications, pre-market review pathways, or related filings
insufficient for approval or that otherwise prevent us from legally marketing our products. |
Future clinical studies may be delayed, suspended
or terminated for many reasons, including to support reimbursement coverage and certain potential label expansions for additional indications,
which will increase our expenses and delay the time it takes to secure reimbursement coverage or support label expansion for additional
indications.
We plan to continue to develop and execute clinical
studies to support reimbursement coverage for using our products, label retention for our products, label expansion for our products into
additional claims for diagnosing painful discs and improving patient outcomes and additional thoracic and cervical discogenic back pain
patient populations. We may also develop and execute clinical studies for new products or for label expansion for our current products
into patient populations suffering from other pain or tissue chemistry-mediated conditions. We may also develop modifications to our products,
and conduct related clinical studies, related to expanding indications for post-processing data from other MRS applications in the body.
We do not know whether future clinical studies will begin on time, will need to be redesigned, have an adequate number of patients enrolled
or be completed on schedule, if at all. The commencement and completion of clinical studies to support label retention and expansion for
additional indications or for new products may be delayed, suspended or terminated as a result of many factors, including:
| |
· |
the delay or refusal of regulators or Institutional Review Boards, or IRBs,
to authorize us to commence a clinical study at a prospective trial site; |
| |
· |
changes in regulatory requirements, policies and guidelines; |
| |
· |
delays or failure to reach agreement on acceptable terms with prospective clinical
research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly
among different CROs and trial sites; |
| |
· |
delays in patient enrollment and variability in the number and types of patients
available for clinical studies, including due to COVID-19 or other disease outbreak, and delays in or the inability to monitor enrolled
patients, including due to COVID-19 or other disease outbreak; |
| |
· |
the inability to recruit, enroll, or retain a sufficient number of patients; |
| |
· |
deviations by our CROs or clinical sites from the trial protocol or study discontinuation
by participants, investigators, or study sites; |
| |
· |
safety or tolerability concerns that could cause us to suspend or terminate
a trial if we find that the participants are being exposed to unacceptable health risks; |
| |
· |
regulators, Institutional Review Boards (“IRBs”), Ethics Committees
or Data Safety Monitoring Boards requiring that we or our investigators or study sites suspend or terminate clinical studies for various
reasons, including noncompliance with GCP or other regulatory requirements or safety concerns; |
| |
· |
lower than anticipated retention rates of patients and volunteers in clinical
studies; |
| |
· |
failure of our CROs or clinical studies sites to comply with regulatory requirements
or meet their contractual obligations to us in a timely manner, or at all; |
| |
· |
delays relating to identifying and engaging with and adding new clinical study
site that have access to compatible MR scanners for using our products; and |
| |
· |
exceeding budgeted costs. |
In addition, if the FDA concludes that we have
not adequately disclosed financial interests of our investigators or if our disclosed financial relationships with investigators result
in a perceived or actual conflict of interest that may have affected the interpretation of a study, the integrity of the data generated
at the applicable clinical study site or the utility of the clinical study itself, FDA may refuse to consider data from the study. This
could result in the delay or rejection by the FDA. Any such delay or rejection could prevent us from supporting label retention and expansion
for our products.
A failure to comply with governmental regulatory
requirements would have a negative impact upon our business.
Failure to comply with applicable U.S. requirements
regarding promoting, manufacturing, labeling, and establishing and complying with appropriate quality assurance policies, systems, and
practices for our products may subject us to a variety of administrative or judicial actions and sanctions. We currently offer the NOCISCAN
product suite via two interactive products, NOCICALC, which is listed with the FDA as a Class I, 510(k)-exempt product, and NOCIGRAM,
a type of medical software that we have concluded is exempt from medical device regulation by the FDA pursuant to the 21st
Century Cures Act. This product suite is also self-certified and CE Marked as a Class I medical device under MDD requirements, while we
believe it is considered a Class II medical device and requiring Notified Body review and certification under newer MDR regulations (subject
to a grace period until May 2024). These products are marketed and sold with certain labeling and related instructions for use and are
promoted by various marketing and sales materials and related human interactions via our personnel and our target customers. We have also
established, and operate under, certain quality assurance systems, policies, and procedures under our QMS intended to be compliant with
applicable requirements for all relevant territories and jurisdictions related to our commercial activities. In the event that our establishment,
maintenance, marketing, promotion, labeling, or execution of these products, or these systems, policies, practices, or procedures, are
determined to be inadequate or non-compliant with applicable regulatory requirements, such defect could result in certain potential enforcement
actions or other adverse consequences, and our business would be negatively affected.
If we become subject to enforcement action
by governmental regulatory agencies, our business would be negatively affected.
Our failure to comply with applicable regulatory
requirements could result in enforcement action by the FDA or other governmental regulatory agencies, which enforcement actions may include
the following:
| |
· |
untitled letters, warning letters, fines, injunctions, consent decrees and civil
penalties; |
| |
· |
unanticipated expenditures to address or defend such actions; |
| |
· |
issuance of form 483s, or other compliance or enforcement notices, communications
or correspondence from regulatory bodies; |
| |
· |
recall, detention or seizure of our products; |
| |
· |
operating restrictions or partial suspension or total shutdown of marketing,
sales and production or offering of product-related services; |
| |
· |
refusing or delaying our requests for 510(k) clearance or de novo classification
or PMA approval of new products or modified products; |
| |
· |
requiring products that we determined to be classified and listed with the FDA
as a Class I, 510(k)-exempt medical device, or that we determined not to be a medical device and thus unregulated by the FDA, instead
to be submitted for marketing authorization (510(k) clearance, de novo classification, or PMA approval); |
| |
· |
operating restrictions; |
| |
· |
withdrawing market authorizations that have already been granted; |
| |
· |
refusal to grant any export approval that might be required for our NOCISCAN
product suite; or |
| |
· |
criminal prosecution |
If any of these events were to occur, it would
have a negative impact on our business, financial condition and results of operations.
If certain of our medical device products cause
or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device
reporting regulations, or MDRs, which can result in voluntary corrective actions or agency enforcement actions and harm our reputation,
business, financial condition and results of operations.
FDA’s Medical Device Reporting (“MDR”)
regulation requires, medical device manufacturers to report to the FDA information of which the manufacturer becomes aware that a device
has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute
to death or serious injury if the malfunction of the device or a similar device marketed by the manufacturer were to recur. If we fail
to report events required to be reported to the FDA within the required timeframes, or at all, the FDA could take enforcement action and
impose sanctions against us. Any such adverse event involving our products also could result in the need to take corrective and preventative
actions, such as changes to design or manufacturing processes, corrections, removals, or recalls or customer notifications, or agency
action, such as inspection or enforcement action. Risk of harm to patients, including without limitation serious injury or death, associated
with using our products could also result in product liability actions against us. Any corrective action, whether voluntary or involuntary,
as well as defending ourselves in a lawsuit, would be costly, distract management from operating our business, could be used by competitors
against us, and may harm our reputation, business, financial condition and results of operations.
From time to time, we engage outside parties
to perform services related to certain of our clinical studies. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to complete our clinical studies on our planned timelines, or at all, and may incur
significant additional costs.
The FDA’s investigational device exemption
(“IDE”) regulations impose requirements on the conduct of certain clinical investigations conducted with medical devices.
The requirements depend on whether the study is considered to be exempt, a nonsignificant risk or a significant risk. In general, clinical
investigations with medical devices, including those that are IDE exempt, must comply with requirements for the protection of human subjects,
which include review and approval by an institutional review board (“IRB”) and informed consent of subject participants. Significant
risk device studies also must submit an IDE to FDA for approval. The IDE regulations specify the responsibilities of sponsors and investigators
to ensure compliance with IDE requirements, including compliance with Good Clinical Practice (“GCP”) requirements. Failure
to comply may result in FDA placing a temporary or permanent clinical hold on the study, issuance of warning letters, or other regulatory
actions.
From time to time, we engage consultants to help
design, monitor and analyze the results of certain clinical studies and trials that we sponsor. The consultants we engage may interact
with clinical investigators to enroll patients in our clinical studies. We depend on these consultants and clinical investigators to conduct
clinical studies and trials and monitor and analyze data from these studies and trials under the investigational plan and protocol for
the study or trial and in compliance with applicable regulations and standards. We may face delays in, or be prevented from, completing
our clinical studies if these parties do not perform their obligations in a timely, compliant or competent manner. Such roles, functions,
and related risks, also apply to certain employees of the Company. If these third parties or employees do not successfully carry out their
duties, comply with Good Clinical Practice (GCP) guidelines and other applicable requirements, or meet expected deadlines, or if the quality,
completeness or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical study protocols or for other
reasons, our clinical studies or trials may need to be extended, delayed or terminated by us or be placed on clinical hold by FDA, or
may otherwise prove to be unsuccessful, and we may have to conduct additional studies, which would significantly increase our costs.
Healthcare reform initiatives and other administrative
and legislative proposals may harm our business, financial condition, results of operations and cash flows in our key markets.
There have been, and continue to be, proposals
by the federal government, state governments, regulators and third-party payers to control or manage the increased costs of healthcare
and, more generally, to reform the U.S. healthcare system. Certain of these proposals could limit the prices we are able to charge for
our products or the coverage and reimbursement available for our products and could limit the acceptance and availability of our products.
The adoption of proposals to control costs could harm our business, financial condition and results of operations.
There likely will continue to be legislative and
regulatory proposals at the federal and state levels directed at containing or lowering the cost of healthcare. We cannot predict the
initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed
care organizations and other payers of healthcare services to contain or reduce costs of healthcare may harm:
| |
· |
our ability to set a price that we believe is fair for our products; |
| |
· |
our ability to generate revenue and achieve or maintain profitability; and |
| |
· |
the availability of capital. |
Recently there has been heightened governmental
scrutiny over the manner in which companies set prices for their marketed products, which has resulted in several U.S. Congressional inquiries
and proposed and enacted federal legislation designed to bring transparency to product pricing and reduce the cost of products and services
under government healthcare programs. Additionally, individual states in the United States have also increasingly passed legislation and
implemented regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions
on certain product access and marketing cost disclosure and transparency measures. Moreover, regional healthcare authorities and individual
hospitals are increasingly using bidding procedures to determine what products to purchase and which suppliers will be included in their
healthcare programs. Adoption of price controls and other cost-containment measures, and adoption of more restrictive policies in jurisdictions
with existing controls and measures may prevent or limit our ability to generate revenue and attain profitability.
Various new healthcare reform proposals are emerging
at the federal and state level. Any new federal and state healthcare initiatives that may be adopted could limit the amounts that federal and state governments will pay
for healthcare products and services, and could harm our business, financial condition and results of operations.
Our collection, use, storage, disclosure, transfer
and other processing of sensitive and personal information could give rise to significant costs, liabilities and other risks, including
as a result of investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and
data protection practices, which may harm our business, financial conditions, results of operations and prospects.
In the course of our operations, we collect, use,
store, disclose, transfer and otherwise process an increasing volume of sensitive, and personal information including detailed recordings
of MRI and MRS results from patients as well as information from our employees and third parties with whom we conduct business. The collection,
use, storage, disclosure, transfer and other processing of personal information is increasingly subject to a wide array of federal, state
and foreign laws, rules, regulations, and standards regarding data privacy and security including comprehensive laws of broad application,
such as the CCPA and the GDPR, that are intended to protect the privacy of personal information that is collected, used, stored, disclosed,
transferred or otherwise processed in or from the governing jurisdiction. As we seek to expand our business, we are, and may increasingly
become, subject to various laws, rules, regulations and standards, as well as contractual obligations, relating to data privacy and security
in the jurisdictions in which we operate or in the jurisdictions where our patients may be. When conducting clinical studies, we face
risks associated with collecting trial participants’ data, especially health data, in a manner consistent with applicable laws and
regulations, such as GCP guidelines or FDA human subject protection regulations.
In many cases, these laws, rules, regulations
and standards apply not only to third-party transactions, but also to transfers of information between or among us, any of our affiliates
and other parties with whom we conduct business. These laws, rules, regulations and standards may be interpreted and applied differently
over time and from jurisdiction to jurisdiction, and it is possible that they will be interpreted and applied in ways that may harm our
business, financial condition and results of operations. The regulatory framework for data privacy and security worldwide is continuously
evolving and developing and, as a result, interpretation and implementation standards and enforcement practices are likely to remain uncertain
for the foreseeable future.
We are subject to many diverse laws and regulations
relating to data privacy and security. In the United States, various federal and state regulators have adopted, or are considering adopting,
laws and regulations concerning personal information and data security. Additionally, our customers may be subject to additional federal
and state privacy and security laws, rules, regulations and standards, including HIPAA, that they may require us to comply with through
contractual obligations. This patchwork of legislation and regulation may give rise to conflicts or differing views of personal privacy
rights. For example, certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to
personal information than federal, foreign or other state laws, and such laws may differ from each other, all of which may complicate
compliance efforts. Additionally, new privacy rules are being enacted in the United States and globally, and existing ones are being updated
and strengthened. The CCPA regulates the processing of personal information of California residents and increases the privacy and security
obligations of covered companies handling such personal information. The CCPA requires covered companies to, amongst other things, provide
new and additional disclosures to California consumers and provide such consumers new data protection and privacy rights, including the
ability to access their personal information and opt out of certain sales of personal information. The CCPA provides for civil penalties
for violations, as well as a private right of action for certain data breaches that result in the loss of personal information. This private
right of action may increase the likelihood of, and risks associated with, data breach litigation. The CCPA was amended in September 2018
and November 2019, and it is possible that further amendments will be enacted, but even in its current form it remains unclear how various
provisions of the CCPA will be interpreted and enforced. Moreover, a new privacy law, the California Privacy Rights Act, (“CPRA”)
a consumer privacy ballot initiative that amends and expands the CCPA, was recently passed. The CPRA affords California residents significantly
more control over their personal information, imposes heightened compliance obligations on covered companies, and establishes a new enforcement
agency dedicated to consumer privacy. The CPRA’s substantive provisions become effective January 1, 2023, and new regulations are
expected to be introduced by July 1, 2022. While aspects of the CPRA and its interpretation remain to be determined in practice, they
create further uncertainty and may result in additional costs and expenses in an effort to comply. Further, all 50 states have passed
laws regulating the actions that a business must take if it experiences a data breach, such as prompt disclosure to affected customers.
In addition to data breach notification laws, some states have enacted statutes and rules requiring businesses to reasonably protect certain
types of personal information they hold or to otherwise comply with certain specified data security requirements for personal information.
We are also subject to the supervisory and enforcement authority of the Federal Trade Commission with regard to the collection, use, sharing,
and disclosure of certain data collected from or about individuals. State laws are changing rapidly and there is discussion in Congress
of a new federal data protection and privacy law to which we would become subject if it is enacted. All of these evolving compliance and
operational requirements impose significant costs that are likely to increase over time, may require us to modify our data processing
practices and policies, divert resources from other initiatives and projects, and could restrict the way products and services involving
data are offered, all of which may harm our business, financial condition and results of operations.
In the event we expand our operations internationally,
we may become subject to additional foreign data privacy and security laws, rules, regulations, requirements, and standards, which in
the European Union, for instance, have been significantly reformed. On May 25, 2018, the General Data Protection Regulation (“GDPR”)
entered into force and became directly applicable in all European Union member states. The GDPR implements more stringent operational
requirements than its predecessor legislation. For example, the GDPR requires companies to make more detailed disclosures to data subjects,
requires disclosure of the legal basis on which companies can process personal data, makes it harder for companies to obtain valid consent
for processing, requires the appointment of data protection officers when sensitive personal data, such as health data, is processed on
a large scale, provides more robust rights for data subjects, introduces mandatory data breach notification through the European Union,
imposes additional obligations on companies when contracting with service providers and requires companies to adopt appropriate privacy
governance including policies, procedures, training and data audits. The GDPR permits data protection authorities to impose large penalties
for violations of the GDPR, including potential fines of up to €20 million or four percent of annual global revenues, whichever
is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory
authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. If we become subject to
the GDPR and do not comply with our obligations under the GDPR, we could be exposed to significant fines. Compliance with the GDPR will
be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices,
and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection
with our European activities. In addition, we may be the subject of litigation or adverse publicity, which could negatively affect our
business, financial condition and results of operations.
We expect that there will continue to be new proposed
laws and regulations concerning data privacy and security, and we cannot yet determine the impact such future laws, rules, regulations
and standards may have on our business. New laws, amendments to or re-interpretations of existing laws, regulations, standards and other
obligations may require us to incur additional costs and restrict our business operations. Because the interpretation, scope, and application
of laws, regulations, standards and other obligations relating to data privacy and security are still uncertain, it is possible that these
laws, regulations, standards and other obligations may be interpreted and applied in a manner that is inconsistent with our data processing
practices and policies or the features of our products and services. If so, in addition to the possibility of fines, lawsuits, regulatory
investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could
be materially and adversely affected if legislation or regulations are expanded to require changes in our data processing practices and
policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business,
financial condition and results of operations. We may be unable to make such changes and modifications in a commercially reasonable manner,
or at all. In addition to government regulation, privacy advocates and industry groups have and may in the future propose self-regulatory
standards from time to time. These and other industry standards may legally or contractually apply to us, or we may elect to comply with
such standards. Any inability to adequately address data privacy or security-related concerns, even if unfounded, or to comply with applicable
laws, regulations, standards and other obligations relating to data privacy and security, could result in additional cost and liability
to us, harm our reputation and brand, damage our relationships with consumers and harm our business, financial condition and results of
operations.
We make public statements about our use and disclosure
of personal information through our privacy policies, information provided on our website and press statements. Although we endeavor to
comply with our public statements and documentation, we may at times fail to do so or be alleged to have failed to do so. The publication
of our privacy policies and other statements that provide promises and assurances about data privacy and security can subject us to potential
government or legal action if they are found to be deceptive, unfair or misrepresentative of our actual practices. Any concerns about
our data privacy and security practices, even if unfounded, could damage the reputation of our business and harm our business, financial
condition and results of operations.
Complying with these numerous, complex and often
changing laws, rules, regulations, and standards is expensive and difficult. Any failure or perceived failure by us or our service providers
to comply with our posted privacy policies or with any applicable or potentially applicable federal or state laws, rules, regulations,
standards, certifications or orders relating to data privacy, security or consumer protection, or any compromise of security that results
in the theft, unauthorized access, acquisition, use, disclosure, or misappropriation of personal information or other user data, could
result in significant fines or penalties, negative publicity or proceedings or litigation by governmental agencies or consumers, including
class action privacy litigation in certain jurisdictions, which would subject us to significant awards, penalties or judgments, one or
all of which could require us to change our business practices or increase our costs and could materially and adversely affect our business,
financial condition and results of operations. In addition, if our practices are not consistent, or viewed as not consistent, with applicable
legal and regulatory requirements, including changes in laws, regulations and standards or new interpretations or applications of existing
laws, regulations and standards, we may also become subject to audits, inquiries, whistleblower complaints, adverse media coverage, investigations,
criminal or civil sanctions, all of which may harm our business, financial condition and results of operations.
Our employees, independent contractors, consultants,
commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards
and requirements, which could harm our business, financial condition and results of operations.
We are exposed to the risk that our employees,
independent contractors, consultants, commercial partners and vendors may engage in fraudulent or illegal activity. Misconduct by these
parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the
laws of the FDA and other similar state or foreign regulatory bodies, including those laws requiring the reporting of true, complete and
accurate information to such regulators, (ii) manufacturing standards, (iii) healthcare fraud and abuse laws in the United States and
similar foreign fraudulent misconduct laws, (iv) laws related to discrimination, harassment, or other conduct relating to a hostile work
environment, or (v) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact,
among other things, future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items
and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud,
kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing arrangements,
discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements
generally. These laws also address the improper use of information obtained in the course of patient recruitment for clinical studies.
We have adopted a code of conduct, employee handbook,
and compliance policies, but it is not always possible to identify and deter misconduct by our employees and other third parties, and
the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses
or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such
laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights,
those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and
administrative penalties, damages, monetary fines, disgorgement, imprisonment, reporting and oversight obligations, possible exclusion
from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, diminished profits and future earnings
and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations.
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions
could result in integrity issues, or a negative impact to our reputation or brand. Whether or not we are successful in defending against
any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in
defending ourselves against any of these claims or investigations, which could harm our business, financial condition and results of operations.
Significant disruptions in our information
technology systems, whether through breaches or failures of our technology, unauthorized access or otherwise, may result in both an adverse
impact to our products, as well as the unauthorized use, disclosure, modification or misappropriation of patient personal information,
the occurrence of fraudulent activity, or other data security-related incidents, all of which could have a material and adverse impact
on our business, financial condition and results of operations.
We are increasingly dependent on complex information
technology systems for the efficient functioning of our business, including the manufacture, distribution and maintenance of our products,
as well as for accounting, data storage, compliance, purchasing and inventory management purposes. Further, our products collect, use,
store, disclose, transfer, and otherwise process sensitive patient data, such as detailed recordings of MRIs to help clinicians make more
informed treatment decisions and optimize their patients’ care. These data are recorded by our technology and can be viewed by the
physician during regular patient visits using the Physician Tablet or on demand through a secure website. We also collect, use, store,
disclose, transfer, and otherwise process a growing volume of other personal information and confidential, proprietary and sensitive data,
which may include procedure-based information and sensitive healthcare data, credit card, and other financial information, insurance information,
and other potentially personally identifiable information. Our information technology systems or those of our service providers may be
subject to computer viruses, phishing, social engineering, denial or degradation of service attacks, ransomware, malware attacks or other
threats, cyberattacks, or dishonest acts by computer hackers or terrorists, failures during the process of upgrading or replacing software,
databases or components thereof, power outages, damage or interruption from fires or other natural disasters, hardware failures, telecommunication
failures and user errors, among other malfunctions. Technological interruptions or threats would disrupt our operations, including the
ability of our clinicians to use our products as intended to treat patients, the ability of patients to safely and securely upload their
data using and into our products, as well as our ability to adequately manufacture our products, timely ship and track product orders,
project inventory requirements, manage our supply chain and otherwise adequately service our customers. Additionally, any of these incidents
could result in the theft, unauthorized access, acquisition, use, disclosure, modification, or misappropriation of personal information
of patients that use our products, trial participants, employees, third parties with whom we conduct business, as well as other confidential,
proprietary, and sensitive data, and can also result in fraudulent activity, system disruptions or shutdowns.
The occurrence of any actual or attempted breach,
failure of security or fraudulent activity, the reporting of such an incident, whether accurate or not, or our failure to make adequate
or timely disclosures to the public or law enforcement agencies following any such event, whether due to delayed discovery or a failure
to follow existing protocols, could result in claims made against us or our service providers, which could result in state and/or federal
litigation and related financial liabilities, as well as criminal penalties or civil liabilities, regulatory actions from state and/or
federal governmental authorities, and significant fines, orders, sanctions, litigation and claims against us by consumers or third parties
and related indemnification obligations. Actual or perceived security breaches or failures could also cause financial losses, increased
costs, interruptions in the operations of our businesses, misappropriation of assets, significant damage to our brand and reputation with
customers, patients, employees, and third parties with whom we do business, and result in adverse publicity, loss of consumer confidence,
distraction to our management, and reduced sales and profits, any or all of which could harm our business, financial condition and results
of operations.
Our technology is also subject to compromise from
internal threats, such as theft, misuse, unauthorized access or other improper actions by employees, service providers and other third
parties with otherwise legitimate access to our systems and website. Data security-related incidents and fraudulent activity are increasing
in frequency and evolving in nature. We rely on a framework of security processes, procedures, tools, and controls designed to protect
our information and assets but, given the unpredictability of the timing, nature and scope of data security-related incidents and fraudulent
activity, there can be no assurance that any security procedures and controls that we or our service providers have implemented will be
sufficient to prevent data security-related incidents or other fraudulent activity from occurring. Furthermore, because the methods of
attack and deception change frequently, are increasingly complex and sophisticated, and can originate from a wide variety of sources,
including third parties such as service providers and even nation-state actors, despite our reasonable efforts to ensure the integrity
of our systems and website, it is possible that we may not be able to anticipate, detect, appropriately react and respond to, or implement
effective preventative measures against, all security breaches and failures and fraudulent activity. In the event we experience significant
disruptions, we may be unable to repair our systems in an efficient and timely manner.
We also face risks associated with security breaches
affecting third parties with whom we are affiliated or otherwise conduct business. Due to applicable laws and regulations or contractual
obligations, we may be held responsible for any breach, failure or fraudulent activity attributed to our service providers as they relate
to the information we share with them. In addition, while we take precautions in selecting service providers, because we do not control
our service providers and our ability to monitor their data security is limited, we cannot ensure the security measures they take will
be sufficient to protect our information. Any of the foregoing could harm our business, financial condition and results of operations.
As data security-related threats continue to evolve,
we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate
and remediate any information security vulnerabilities, or to protect against, respond to and recover from any potential, attempted, or
existing security breaches. In addition, our remediation efforts may not be successful. The inability to implement, maintain and upgrade
adequate safeguards could have a material and adverse impact on our business, financial condition and results of operations. Moreover,
there could be public announcements regarding any data security-related incidents and any steps we take to respond to or remediate such
incidents, and if securities analysts or investors perceive these announcements to be negative, it could, among other things, have a substantial
adverse effect on the price of our common stock. Any of the foregoing could harm our business, financial condition and results of operations.
We currently maintain a cybersecurity insurance
policy and business interruption coverage in order to mitigate certain potential losses but this insurance is limited in amount, and we
cannot be certain that such potential losses will not exceed our policy limits, or will cover all potential claims to which we are exposed
and may not be adequate to indemnify us for all liability that may be imposed. Therefore, failure to maintain or protect our information
systems and data integrity effectively could harm our business, financial condition, and results of operations.
We face potential liability related to the
privacy of health information we obtain.
We may maintain, use, and share sensitive health
information that we receive directly from patients that use our technology, throughout the clinical study process, in the course of our
research collaborations, and from healthcare providers in the course of using our products and systems. Most healthcare providers, including
hospitals from which we obtain patient health information, are subject to privacy and security regulations promulgated under HIPAA, as
amended by the HITECH, and also under GDPR. We believe that we are not currently classified or regulated under HIPAA or GDPR as a Covered
Entity, but we believe we are considered and regulated as a Business Associate. Accordingly, we are subject to HIPAA and GDPR requirements
or penalties as applied to Business Associates. However, in certain situations, any person may be prosecuted under HIPAA’s criminal
provisions either directly or under aiding-and-abetting or conspiracy principles. Consequently, depending on the facts and circumstances,
we could face substantial criminal penalties if we knowingly receive, maintain, use, or transfer individually identifiable health information
from a Covered Entity, as defined under HIPAA, that has not satisfied HIPAA’s requirements for disclosure of individually identifiable
health information. Furthermore, certain health privacy laws, data breach notification laws, consumer protection laws and genetic testing
laws may apply directly to our operations or those of our collaborators and may impose restrictions on our collection, use and dissemination
of individuals’ health information As such, we may be subject to state laws requiring notification of affected individuals and state
regulators in the event of a breach of personal information, including certain health information, which is a broader class of information
than the health information protected by HIPAA. To the extent we engage in clinical studies and commercial uses of our products outside
the United States, we may implicate foreign data privacy and security laws and regulations, including the GDPR and legislation of the
European Union member states implementing it.
To the extent we do business in international
markets now, and in the future, any failure by us or our third-party contractors to comply with the strict rules on the transfer of personal
data from outside of the European Union, the United Kingdom, or other foreign country or territory into the United States in accordance
with such laws and regulations may result in the imposition of criminal and administrative sanctions on such contractors, which could
adversely affect our sales, business, financial condition, and results of operations.
Moreover, patients about whom we or our contractors
or collaborators obtain or share health information, as well as the providers who share this information with us or whom we share this
data with, may have statutory or contractual rights that limit our ability to use and disclose the information. We may be required to
expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws. Potential
claims alleging that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found
liable, could be expensive and time consuming to defend and could result in adverse publicity that could negatively affect our business,
financial condition and results of operations. If we or third-party contractors or consultants fail to comply with applicable federal,
state or local regulatory requirements, we could be subject to a range of regulatory actions that could affect our or our contractors’
ability to develop and commercialize our products and could harm or prevent sales of our technology, or could substantially increase the
costs and expenses of developing, commercializing and marketing our products. Any threatened or actual government enforcement action could
also generate adverse publicity and require that we devote substantial resources that could otherwise be used in other aspects of our
business.
Additionally, data collection, privacy and security
have become the subject of increasing public concern and changing preferences towards data collection, privacy and security could adversely
affect patient willingness to consent to our collection of their health information. Patients may be reluctant or unwilling to consent
to the collecting of their health information, and patients that have opted-in to the collection of their health information may revoke
their consent at any time, including as a result of these concerns or as a result of changes to our data policies that we have implemented
or may implement in the future. In particular, the success of our business depends in part on our ability to lawfully obtain health information
from our patients. If patients choose not to consent to the collection of their health information as a result of these concerns, or our
customers who transfer patient data to us via the use of our products refuse to do so due to concerns for data privacy or potential related
liabilities, or our consent or data privacy protection and management policies or practices are found to be unlawful, this could negatively
impact the growth potential for our business.
We have encountered potential customers in the
EU who have been reluctant, and indeed refused, to become customers due to concerns about transferring of any private patient information
from their practice in the EU into the United States. Certain such customers have indicated their opinion that such a transfer is, on
its face, non-compliant with GDPR requirements due to certain rights of the US Federal Government to seize such data from US domiciled
companies or storage facilities. We may need to expand our operations to host at least one foreign instance of our cloud-based post-processing
software products within a foreign country, such as within the European Union, in order to overcome such concerns and reach and engage
more customers to grow our business in the related territory. If we are unable to sufficiently dissuade these concerns held by certain
potential customers outside of the United States, or do not establish certain changes in our private patient health information data privacy
practices, such as moving the hosting of EU-based information to an EU-based instance of our products and storage of related patient health
information we receive via use of our products, our sales, business, financial condition, and results of operations could be harmed. We
could also encounter delays if a clinical study is suspended or terminated by us, by the IRBs or the Ethics Committees of institutions
at which such studies are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities.
Such authorities may suspend or terminate a clinical study due to a number of factors, including failure to conduct the clinical study
in accordance with regulatory requirements, including GC.
Risks related to our intellectual property
If we are unable to obtain, maintain, protect,
enforce and defend patents or other intellectual property protection for our technology, or if the scope of our patents and other intellectual
property protections is not sufficiently broad, or as a result of our existing or any future out-licenses of our intellectual property,
our competitors could develop and commercialize products similar to or competitive with our products and services, our ability to continue
to commercialize our technology, or our other products and services, may be harmed.
As with other medical device companies, our success
depends, in large part, on our ability to obtain, maintain, protect, enforce and defend a proprietary position for our products and services,
which will depend upon our success in obtaining and maintaining effective patent and other intellectual property protection in the United
States and other countries into which we may expand our business in the future that relate to our technology and any other products, their
manufacturing processes and their intended methods of use. Furthermore, our success will also depend on our ability to enforce and defend
those patents, as well as our other intellectual property. In some cases, we may not be able to obtain patents relating to our products
and services which are sufficient to prevent third parties, such as our competitors, from copying and competing with other products or
services that are the same, similar, or otherwise competitive with our products and services. Or, our competitors may have rights under
current or future out-licenses of our intellectual property which could result in our competitors developing and commercializing products
similar to or competitive with our products and services. Any failure to obtain, maintain, protect, enforce or defend patent and other
intellectual property protection with respect to our NOCISCAN product suite and related services, or other aspects of our business,
could harm our business, competitive position, financial condition and results of operations.
Changes in the patent or other intellectual property
laws, or their interpretation, in the United States and other countries may diminish our ability to protect our inventions or to obtain,
maintain, protect, enforce, and defend our patents and other intellectual property rights, and could affect the value of our intellectual
property or narrow the scope of our patents. Additionally, we cannot predict whether the patent applications we are currently pursuing
will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from
competitors or other third parties.
The patent prosecution process is expensive, time-consuming
and complex and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patents or patent applications
at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development
output in time to obtain patent protection in one, several, or all geographies. Although we enter into non-disclosure and confidentiality
agreements with parties who have access to our confidential information or patentable aspects of our research and development output,
such as our employees, corporate collaborators, outside scientific collaborators, suppliers, consultants, advisors and other third parties,
any of these parties may breach the agreements and publicly disclose such confidential information or research and development output.
If such unauthorized public disclosure occurs before a patent application is filed, it could compromise or diminish our ability to seek
patent protection. Such third parties could also breach obligations with respect to limited uses of our confidential information, which
may include (i) breaching restrictions against making or inventing improvements or modifications to, or derivations of, our confidential
technologies, and (ii) further separately applying, on their own behalf, for patent protections for such improvements, modifications,
or derivations. Such breaches may compromise our ability to obtain or enforce our own patent protections for such improvements, modifications,
or derivations. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between
our inventions and the prior art allow our inventions to be patentable over the prior art. Furthermore, the publication of discoveries
in scientific literature often lags behind the actual discoveries, and patent applications in the United States and other jurisdictions
are typically not published until 18 months after filing, or in some cases not at all. As such, we cannot be certain that we were the
first to make the inventions claimed in any of our patents or pending patent applications, or that we were the first to file for patent
protection of such inventions. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution
of patent applications, or to maintain the patents, relating to technology that we license from or license to third parties, including
by way of our license from the Board of Regents of the University of California, and we are therefore reliant on our licensors or licensees.
Therefore, these and any of our patents and patent applications may not be prosecuted and enforced in a manner consistent with the best
interests of our business. Furthermore, our license agreements may be terminated by the licensor. Defects of form in the preparation or
filing of our patents or patent applications may exist, or may arise in the future, for example, with respect to proper priority claims,
inventorship and the like, although we are unaware of any such defects that we believe are of importance. If we or any of our current
or future licensors or licensees fail to obtain, maintain, protect, enforce or defend such patents and other intellectual property rights,
such rights may be reduced or eliminated. If any of our current or future licensors or licensees are not fully cooperative or disagree
with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are
material defects in the form, preparation or prosecution of our patents or patent applications, such patents or applications may be invalid
and/or unenforceable. Any of these outcomes could impair our ability to prevent competition from third parties, which may harm our business.
The strength of patent rights generally, and particularly
the patent position of medical device companies, involves complex legal and scientific questions, can be uncertain, and has been the subject
of much litigation in recent years. This uncertainty includes changes to the patent laws through either legislative action to change statutory
patent law or court action that may reinterpret existing law or rules in ways affecting the scope or validity of issued patents. Our current
or future patent applications may fail to result in issued patents in the United States or foreign countries with claims that cover our
products, including our technology. Even if patents do successfully issue from our patent applications, third parties may challenge the
validity, enforceability or scope of such patents, which may result in such patents being narrowed, invalidated or held unenforceable.
Any successful challenge to our patents could deprive us of exclusive rights necessary for the successful commercialization of our products,
including our NOCISCAN product suite. Furthermore, even if they are unchallenged, our patents may not adequately protect our technology
or any other products we develop, provide exclusivity for these products or prevent others from designing around our claims. If the scope
of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors
from commercializing similar or identical products could be adversely affected. If the breadth or strength of protection provided by the
patents we hold or pursue with respect to our products is challenged, it could dissuade companies from collaborating with us to develop,
or threaten our ability to commercialize, our technology.
Patents have a limited lifespan. In the United
States, the natural expiration of a utility patent is generally 20 years after its effective filing date and the natural expiration of
a design patent is generally 14 years after its issue date, unless the filing date occurred on or after May 13, 2015, in which case the
natural expiration of a design patent is generally 15 years after its issue date. However, the actual protection afforded by a patent
varies from country to country, and depends upon many factors, including the type of patent, the scope of its coverage, any terminal disclaimers
filed or to be filed, overlap in claimed subject matter with other patents in the portfolio, the availability of regulatory-related extensions,
the availability of legal remedies in a particular country and the validity and enforceability of the patent. Various extensions may be
available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our technology, we
may be open to competition. Further, if we encounter delays in our development efforts, the period of time during which we could market
our technology under patent protection would be reduced and, given the amount of time required for the development, testing and regulatory
review of planned or future technology and products, patents protecting such technology and products might expire before or shortly after
such products are commercialized. For information regarding the expiration dates of patents in our patent portfolio, see “Business—Intellectual
Property.” Our U.S. issued patents are expected to expire between January 3, 2026 and March 15, 2033, without taking into account
all possible patent term adjustments, extensions, or abandonments, and assuming payment of all appropriate maintenance, renewal, annuity,
and other governmental fees. As our patents expire, the scope of our patent protection will be reduced, which may reduce or eliminate
any competitive advantage afforded by our patent portfolio. As a result, our patent portfolio may not provide us with sufficient rights
to exclude others from commercializing products similar or identical to ours.
Moreover, the coverage claimed in a patent application
can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications
licensed to us or assigned to us, currently or in the future, issue as patents, they may not issue in a form that will provide us with
any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive
advantage. Any patents assigned to us may be challenged, narrowed, circumvented or invalidated by third parties. Consequently, we do not
know whether our NOCISCAN product suite or our other products will be protectable or remain protected by valid and enforceable patents.
Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative products in a non-infringing
manner, which could harm our business, financial condition and results of operations.
Some of our patents and patent applications may
be co-owned or cross-licensed with third parties. If we give up, do not pursue, or are unable to obtain an exclusive license to any such
third-party co-owners’ or licensee’s interest in such patents or patent applications, such co-owners or cross-licensees may
be able to license or sub-license, respectively, their rights to other third parties, including our competitors, and our competitors could
market competing products and technology. In addition, we may need the cooperation of any such co-owners or co-licensees of our patents
in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could harm
our sales, business, financial condition and results of operations.
We rely on a License from the Regents of the University
of California, as well as other aspects of our own patented technology and intellectual property, in order to be able to use and sell
various proprietary technologies that are material to our business, as well as technologies which we intend to use in our future commercial
activities. Our rights to use these licensed technologies and the inventions claimed in the licensed patents, are subject to the continuation
of, and our compliance with the terms of the license. The License provides that for so long as we pay patent prosecution costs, the Regents
of the University of California will diligently prosecute and maintain the United States and foreign patents comprising the Patent Rights
using counsel of its choice, and the UCSF Regents' counsel will take instructions only from The Regents of the University of California
has the right to terminate the agreement upon advanced notice in the event of a default by us. The agreement will expire upon the expiration
or abandonment of the last of the licensed patents. The patents subject to the agreement expire between 2025 and 2029. The loss of this
license would materially negatively affect our ability to pursue our business objectives and result in material harm to our business operations.
We may not be successful in obtaining or maintaining
necessary rights to any products or processes we may have or develop through acquisitions and in-licenses.
We may find it necessary or prudent to acquire,
obtain, or maintain licenses to intellectual property or proprietary rights held by third parties that we may identify as necessary or
important to our business operations. However, we may be unable to acquire, secure, or maintain such licenses to any intellectual property
or proprietary rights from third parties that we identify as necessary for our technology or any future products we may develop. The acquisition
or licensing of third-party intellectual property or proprietary rights is a competitive area, and our competitors may pursue strategies
to acquire or license third party intellectual property or proprietary rights that we may consider attractive or necessary. Our competitors
may have a competitive advantage over us due to their size, capital resources and greater development and commercialization capabilities.
In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to
acquire or license third party intellectual property or proprietary rights on terms that would allow us to make an appropriate return
on our investment or at all. We have an existing license with the Board of Regents of the University of California, and which covers multiple
patents and patent applications for inventions that are incorporated into our products, and if we are unable to maintain this license,
we may not be able to legally market or sell our current or future products, which would harm our sales, business, financial condition,
and results of operations. If we are unable to successfully acquire or license third-party intellectual property or proprietary rights
that we require for making, using, or selling our products or services, or to maintain the existing licenses to intellectual property
rights we have, we may have to abandon the development, manufacturing, marketing, or selling of our related products that require those
rights, which could harm our sales, business, financial condition, and results of operations.
Patents directing to our technology could be
found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, which could harm
our business, financial condition and results of operations.
The issuance of a patent is not conclusive as
to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United
States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office (“USPTO”),
or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or IPR, or interference proceedings
or other similar proceedings challenging our patent rights. An adverse determination in any such submission, proceeding or litigation
could reduce the scope of, or invalidate or render unenforceable, such patent rights, allow third parties to commercialize our products
and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing
third-party patent rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority
of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our priority of invention
or other features of patentability with respect to our patents and patent applications. Such challenges may result in loss of patent rights,
in loss of exclusivity, or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others
from using or commercializing similar or identical products or limit the duration of the patent protection of our products. Such proceedings
also may result in substantial cost and require significant time from our management, even if the eventual outcome is favorable to us.
In addition, if we initiate legal proceedings
against a third party to enforce a patent relating to our products, the defendant could counterclaim that such patent is invalid or unenforceable.
In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for
a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness
or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent
withheld relevant information from the USPTO, or made a false or misleading statement, or otherwise committed inequitable conduct, during
prosecution. Defenses of these types of claims, regardless of their merit, would involve substantial litigation expense, would result
in reputational harm, and would be a substantial diversion of employee resources from our business. Third parties may also raise claims
challenging the validity or enforceability of our patents before administrative bodies in the United States or abroad, even outside the
context of litigation, including through re-examination, post-grant review, IPR, interference proceedings, derivation proceedings and
equivalent or similar proceedings in foreign jurisdictions (such as opposition proceedings). Such proceedings could result in the revocation
of, cancellation of or amendment to our patents in such a way that they no longer relate to our products. The outcome for any particular
patent following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example,
we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. Moreover,
potential third-party claims that are validated in a final ruling or determination regarding inequitable conduct with respect to securing
or enforcing a patent could also potentially give rise to other adverse claims, which may include business torts or other causes of action
regarding our enforcement of that patent, and could also potentially carry over and apply downstream to other patents that are related
to (e.g. claim of priority) the instant patent. If a defendant or other third party were to prevail on a legal assertion of invalidity
or unenforceability, we would lose at least part, and potentially all, of the patent protection for the patents raised in such a claim.
Such a loss of patent protection would harm our sales, business, financial condition, and results of operations.
The medical device industry is characterized
by patent litigation and in the future we could become subject to actual or threatened patent or other intellectual property litigation
alleging our products or services infringe or misappropriate third party rights, which could be costly to address and defend, result in
the diversion of management’s time and efforts, require us to pay damages, or prevent us from making, using, or selling our existing
or future products.
Patent litigation is prevalent in the medical
device and diagnostic sectors. Our commercial success depends, in part, upon our ability and that of our suppliers to manufacture, market,
sell, and use our proprietary technology without infringing, misappropriating or otherwise violating the intellectual property or proprietary
rights of third parties. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding
intellectual property rights with respect to our products. Third parties may assert infringement claims against us based on existing or
future intellectual property rights, regardless of merit. If we are found to infringe a third party’s intellectual property rights,
we could be required to incur costs to obtain a license from such third party to continue developing, making, using, or selling our products
and services. We may also elect to enter into such a license in order to settle pending or threatened litigation. However, we may not
be able to obtain any required license on commercially reasonable terms, or at all. Even if we were able to obtain a license, it could
be non-exclusive, thereby giving our competitors access to the same technologies or methods licensed to us and could require us to pay
significant royalties and other fees. We could be forced, including by court order, to cease commercializing the infringing product or
service. In addition, we could be found liable for monetary damages, which may be significant. If we are found to have willfully infringed
a third-party patent, we could be required to pay treble damages and attorneys’ fees. A finding of infringement could prevent us
from commercializing our planned products in commercially important territories or force us to cease some of our business operations,
which could harm our business and cause brand and reputational harm. An adverse infringement determination in one territory where such
a claim might be brought could also potentially carry over to influence other similarly adverse claims being brought, and/or adverse results
of those additional claims, in other territories where we have or seek a commercial presence. We could also be forced to redesign or otherwise
change those products or services that use or implicate the allegedly infringing intellectual property, which could be costly, disruptive
and infeasible.
Many of our employees were previously employed
at, and many of our current advisors and consultants are employed by, universities or other biotechnology, medical device, healthcare,
or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, advisors
and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we,
or these employees, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such
employee’s former employer. Furthermore, although these agreements may be difficult to enforce, we may in the future be subject
to claims that these individuals are violating non-compete agreements with their former employers. These and other claims that we have
misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business, including
with respect to the infringement claims discussed above.
Even if we are successful in defending against
intellectual property claims, litigation or other legal proceedings relating to such claims, the claims and related defense may still
cause us to incur significant expenses, cause reputational harm, and could distract our technical and management personnel from their
normal responsibilities. If we fail in defending any such claims, in addition to paying monetary damages or other settlements, we may
lose valuable intellectual property rights or personnel, which could harm our business, financial condition and results of operations.
We could potentially be required, or be forced or choose among other options, to negotiate a settlement of third party infringement claims
that may include cross-licensing of our own patent or other intellectual property rights with the third party bringing the initial adverse
claim against us. This could result in our inability to protect our products and services as exclusively proprietary only to us, and allow
the third party to compete against us, with respect to the inventions or technologies related to those out-licensed rights, and which
could also diminish the value of our products, services, and overall business and company, and harm our sales, business, financial condition,
and results of operations. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings
or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial negative impact
on the price of our shares of common stock. Such litigation or proceedings could substantially increase our operating losses and reduce
our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such
litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively
than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of
litigation or other intellectual property related proceedings could harm our business, financial condition and results of operations.
Obtaining and maintaining our patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies,
and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Obtaining and maintaining our patent protection
depends on compliance with various procedural measures, document submissions, fee payments and other requirements imposed by government
patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity
fees and various other government fees on patents and patent applications will be due to be paid to the USPTO and various government patent
agencies outside of the United States over the lifetime of our patents and applications. The USPTO and various non-U.S. government agencies
require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process.
In some cases, an intentional lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There
are situations, however, in which non-compliance can result in the abandonment or lapse of the patent or patent application, resulting
in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to
enter the market with similar or identical products or technology, which could harm our business, financial condition and results of operations.
Certain legal or contractual requirements, and/or rights of others involved in our development or products, may permit the U.S. government
to disclose our confidential information to third parties. To the extent any of our current or future intellectual property is generated
through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply. For example, the National Institute
of Health and the Regents of the University of California have limited rights to use certain of our patents and patent applications for
research. Any exercise by the government of any of the foregoing rights could harm our business, financial condition, results of operations
and prospects.
If we fail to comply with our obligations in
any current or future agreements under which we license intellectual property rights from third parties or otherwise experience disruptions
to our business relationships with our licensors, we could lose license rights that are important to our business.
We are, and may become, party to license or collaboration
agreements with third parties to advance our research or allow commercialization of our products. Such agreements may impose numerous
obligations, such as development, diligence, payment, commercialization, funding, milestone, royalty, sublicensing, insurance, patent
prosecution, enforcement and other obligations on us and may require us to meet development timelines, or to exercise certain efforts
to develop and commercialize licensed products, in order to maintain the licenses. In spite of our best efforts, our licensors might conclude
that we have materially breached such license agreements and might therefore terminate the license agreements, thereby removing or limiting
our ability to develop and commercialize products and technologies covered by these license agreements.
We have an existing license with the Regents of
the University of California which covers multiple patents and patent applications for inventions that are incorporated into our products.
Any termination of this or other licenses could result in the loss of significant rights and could harm our ability to commercialize our
products and competitors or other third parties may have the freedom to seek regulatory approval of, and to market, products identical
to ours, at least to the extent of products and services that incorporate the features captured by those previously licensed patent rights
and assuming our licensor permits such competitive activities, either passively or via further out licensing, under their remaining patent
rights. If we lose our licensed patent rights, we may also be required to cease our development and commercialization of certain of our
products. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results
of operations, and prospects.
Disputes may also arise between us and our licensors
regarding intellectual property subject to a license agreement, including:
| |
· |
the scope of rights granted under the license agreement and other interpretation-related
issues; |
| |
· |
whether and the extent to which our technology and processes infringe, misappropriate
or otherwise violate intellectual property rights of the licensor that are not subject to the license agreement; |
| |
· |
our right to sublicense patent and other rights to third parties under collaborative
development relationships; |
| |
· |
our diligence obligations with respect to the use of the licensed technology
in relation to our development and commercialization of our products, and what activities satisfy those diligence obligations; |
| |
· |
the priority of invention of any patented technology; and |
| |
· |
the ownership of inventions and know-how resulting from the joint creation or
use of intellectual property by our future licensors and us and our partners. |
In addition, the agreements under which we may
license intellectual property or technology from third parties are likely to be complex and certain provisions in such agreements may
be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what
we believe to be the scope of our rights to the relevant intellectual property, or increase what we believe to be our financial or other
obligations under the relevant agreement, either of which could have a material adverse effect on our sales, business, financial condition
or results of operations. Moreover, if disputes over intellectual property that we may license prevent or impair our ability to maintain
future license agreements on acceptable terms, we may be unable to successfully develop and commercialize the affected products, which
could have a material adverse effect on our sales, business, financial conditions or results of operations.
Our existing license with the Regents of the University
of California, in particular, includes both exclusive rights, as applied to certain aspects of their patent rights under the license,
and partial-exclusive and co-exclusive rights as applied to certain other aspects of the Licensor’s patent rights, under which we
have rights for diagnostic-related patent claims. The balance of remaining rights for therapy-related claims are exclusively licensed
to another third-party company. There are risks that the interpretation of which patent rights apply to us under our license, versus which
patent rights apply to the other third-party company under their license, could be the subject of disagreement or dispute, the existence
of which, and potential adverse result from which, could diminish the scope of rights we actually have. This could also be the subject
of disagreement or dispute with respect to patent prosecution matters along the examination path of applications toward seeking issued
patents. Any of the above could diminish, or prevent, our ability to commercialize all aspects of our products as intended, and which
could result in harm to our sales, business, financial condition, or result of operations.
Our existing license also includes exclusive rights
to certain patents which are co-owned by us and the Board of Regents of the University of California, in relation to inventions that have
been determined to be jointly invented by separate but joint inventors that are under different obligation of assignment to us and them.
If we fail to maintain and/or lose those license rights to one or more of these co-owned patents and patent applications, others would
have the ability to commercialize, or license the ability to commercialize, products or services covered by those patents competitively
against us. This would result in us losing exclusive proprietary advantage with respect to technologies and methods relating to those
patents, which could harm our sales, business, financial condition, and results of operations.
If we are unable to obtain patent term extension
under the Hatch-Waxman Amendments, our business may be materially harmed.
Depending upon the timing, duration and specifics
of FDA marketing approval of our products, one or more of the U.S. patents assigned or licensed to us may be eligible for limited patent
term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.
The Hatch-Waxman Amendments permit a patent restoration term of up to five years for a patent covering an approved product as compensation
for effective patent term lost during product development and the FDA regulatory review process. However, even if, at the relevant time,
we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to exercise due diligence
during the testing phase or regulatory review process, to fail to apply within applicable deadlines or prior to expiration of relevant
patents or otherwise to fail to satisfy applicable requirements. Moreover, the time period of the extension or the scope of patent protection
afforded could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent
term beyond 14 years from approval and only those claims covering the approved product, a method for using it or a method for manufacturing
it may be extended. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we
request, the period during which we can enforce our patent rights for the applicable product will be shortened and our competitors may
obtain approval of competing products following our patent expiration. As a result, our ability to generate revenues could be adversely
affected. Further, if this occurs, our competitors may take advantage of our investment in development and studies by referencing our
clinical and preclinical data and launch their product earlier than might otherwise be the case. If we do not have adequate patent protection
or other exclusivity for our products, our business, financial condition or results of operations could be adversely affected.
We have limited foreign intellectual property
rights and may not be able to protect our intellectual property and proprietary rights throughout the world, which could harm our business,
financial condition and results of operations.
We have limited intellectual property rights outside
the United States. Filing, prosecuting and defending patents on our products in all countries throughout the world would be prohibitively
expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Consequently,
we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling
or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies
in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing
products to territories where we have patent protection but enforcement is not as strong as in the United States. While we do not currently
operate or sell our products outside of the United States, these products may compete with our products, and our patents or other intellectual
property rights may not be effective or sufficient to prevent them from competing. Patent protection must ultimately be sought on a country-by-country
basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection
in certain countries, and we will not have the benefit of patent protection in such countries, which may impede on our ability to grow
outside of the United States.
Many companies have encountered significant problems
in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly
certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which
could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual
property and proprietary rights generally. Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions
could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk
of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties
to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may
not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world
may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Many countries have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of
patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could
materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant
to our business, our competitive position may be impaired, and our business, financial condition and results of operations may be harmed.
Changes in U.S. patent laws, or patent laws
in other countries and jurisdictions, could diminish the value of patents in general, thereby impairing our ability to protect our products.
Changes in either the patent laws or interpretation
of the patent laws in the United States, or elsewhere, could increase the uncertainties and costs surrounding the prosecution of patent
applications and the enforcement or defense of issued patents. Assuming that other requirements for patentability are met, prior to March
2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, generally
the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act, or the
America Invents Act, enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that
other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention
regardless of whether a third party, who may have filed a patent application later, was the first to actually invent the claimed invention.
A third party that files a patent application in the USPTO after March 2013, but before we filed a patent application for the same invention
(as defined by claims), could therefore be awarded a patent covering an invention of ours even if we had made the invention before it
was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Since
patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance,
we could continue incurring costs without being certain that we were the first to file any patent application related to our products
or the first to invent any of the inventions claimed in our patents or patent applications.
The America Invents Act also includes a number
of significant changes that affect the way patent applications are prosecuted and also may affect patent litigation. These include allowing
third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent
by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of
a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate
a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid
even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly,
a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged
by the third party as a defendant in a district court action. Additionally, USPTO proceedings provide a venue for challenging the validity
of patents at a cost must lower than district court litigation and on much faster timelines. This lower-cost, faster and potentially more
potent tribunal for challenging patents could itself increase the likelihood that our own patents will be challenged. Therefore, the America
Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and
the enforcement or defense of our issued patents. In addition, future actions by the U.S. Congress, the federal courts and the USPTO could
cause the laws and regulations governing patents to change in unpredictable ways. Any of the foregoing could harm our business, financial
condition and results of operations.
In addition, recent U.S. Supreme Court rulings
have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.
In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created
uncertainty with respect to the validity and enforceability of patents, once obtained. For example, after the filing of our earlier filed
patent applications, from which we have received granted patents and also continue to prosecute additional patent applications under priority
filing claims, certain laws and interpretation of those laws changed. This includes, in particular, new changes that diminish or make
it more difficult to obtain, enforce, or defend as valid, claims related to medical diagnostics, any methods, and in particular any methods
involving the human body or medical procedures. Our patent portfolio is principally related to medical diagnostic methods, which in many
cases merge these multiple areas of patent laws that have since been changed. Some of our patents were issued prior to certain such changes
in the laws occurring, which could potentially result in certain risks that the patents which were initially valid when granted, under
the laws at that time, had become invalid due to the later changes in the laws. Moreover, some of our patents were granted after these
changes in the laws, but these may still be subject to risk of challenge due to uncertainty in interpreting and applying these newer changes
in the laws related to medical diagnostic methods to our issued patent claims. Depending on future actions by the U.S. Congress, the federal
courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to
obtain new patents or to enforce our existing patents and patents that we might obtain in the future. We cannot predict how this and future
decisions laws or regulations by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Any similar adverse changes
in the patent laws of other jurisdictions could also harm our business, financial condition, results of operations and prospects.
We may be subject to claims, including third-party
claims of intellectual property infringement, misappropriation or other violations against us or our collaborators, challenging the ownership
or inventorship of our intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from
third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization
of one or more of our products.
The medical device industry is highly competitive
and dynamic. Due to the focused research and development that is taking place by several companies, including us and our competitors in
this field, the intellectual property landscape is in flux and it may remain uncertain in the future. As such, we may be subject to claims
that current or former employees, collaborators or other third parties have an interest, either as an owner, co-owner, or otherwise, in
our patents, trade secrets or other intellectual property as an inventor or co-inventor. Additionally, we could become subject to significant
intellectual property-related litigation and proceedings relating to our or third-party intellectual property and proprietary rights.
For example, we may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved
in developing our products, or could face third-party claims of intellectual property infringement, misappropriation or other violations,
including by a licensor from whom we’ve licensed certain intellectual property. These risks apply to our existing license from the
Regents of the University of California, both in relation to patent rights we co-own with them as a result of joint invention between
our and their respective inventors, and in relation to co-existent license rights that we share with another third-party company in some
of those patent rights, as further summarized above.
Litigation may be necessary to defend against
these and other claims challenging inventorship of our patents, trade secrets or other intellectual property. If we fail in defending
any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership
of, or right to use, intellectual property that is important to our products. If we were to lose exclusive ownership of such intellectual
property, other owners may be able to license their rights to other third parties, including our competitors. We also may be required
to obtain and maintain licenses from third parties, including parties involved in any such disputes. Such licenses may not be available
on commercially reasonable terms, or at all, or may be non-exclusive. If we are unable to obtain and maintain such licenses, we may need
to cease the development, manufacture and commercialization of one or more of our products. The loss of exclusivity or the narrowing of
our patent claims could limit our ability to stop others from using or commercializing similar or identical technology and products. Even
if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management
and other employees. Any of the foregoing could harm our business, financial condition and results of operations.
Additionally, our commercial success depends,
in part, on our and any potential future collaborators’ ability to develop, manufacture, market and sell any products that we may
develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the patents and other intellectual
property or proprietary rights of third parties. It is uncertain whether the issuance of any third-party patent would require us or any
potential collaborators to alter our development or commercial strategies, obtain licenses or cease certain activities. The medical device
industry is characterized by extensive litigation regarding patents and other intellectual property rights, as well as administrative
proceedings for challenging patents, including interference, inter partes or post-grant review, derivation and reexamination proceedings
before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions.
Third parties, including our competitors, may
currently have patents or obtain patents in the future and claim that the manufacture, use or sale of our products infringes upon these
patents. We have not conducted an extensive search of patents issued or assigned to other parties, including our competitors, and no assurance
can be given that patents containing claims relating to our products, parts of our products, technology or methods do not exist, have
not been filed or could not be filed or issued. In addition, because patent applications can take many years to issue and because publication
schedules for pending patent applications vary by jurisdiction, there may be applications now pending of which we are unaware and which
may result in issued patents which our current or future products infringe. Also, because the claims of published patent applications
can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that
we infringe. Unintentionally abandoned patents or applications can also be revived, so there may be recently revived patents or applications
of which we are unaware. As the number of competitors in our market grows and the number of patents issued in this area increases, the
possibility of patent infringement claims against us escalates. Moreover, we may face claims from non-practicing entities, or NPEs, which
have no relevant product revenue and against whom our own patent portfolio may have no deterrent effect. Third parties may in the future
claim that our products infringe or violate their patents or other intellectual property rights.
Defense of infringement claims, regardless of
their merit or outcome, would involve substantial litigation expense and would be a substantial diversion of management and other employee
resources from our business, and may impact our reputation. In the event of a successful claim of infringement against us, we may be enjoined
from further developing or commercializing the infringing products and/or have to pay substantial damages for use of the asserted intellectual
property, including treble damages and attorneys’ fees were we found to willfully infringe such intellectual property. Claims that
we have misappropriated the confidential information or trade secrets of third parties could harm our business, financial condition and
results of operations. We also might have to redesign any our allegedly infringing products or technologies, which may be impossible or
require substantial time and monetary expenditure.
Engaging in litigation, including to defend against
third-party infringement claims is very expensive, particularly for a company of our size, and time-consuming. In addition, there could
be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or
investors perceive these results to be negative, it could have a substantial negative impact on our common stock price. Such litigation
or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any
future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation
or proceedings adequately. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively
than we can because of greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting
from the initiation and continuation of patent litigation or other proceedings against us could impair our ability to compete in the marketplace.
The occurrence of any of the foregoing could harm our business, financial condition and results of operations.
We may become involved in lawsuits to protect
or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents, or the patents
of any current or future licensing partners, or we may be required to defend against claims of infringement. Our ability to enforce our
patent rights against competitors who infringe our patents depends on our ability to detect such infringement. It may be difficult to
detect infringers who do not advertise the components or processes that are used in their products or services. Moreover, it may be difficult
or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product. For example, many of
our patents relate to methods and related computer processing architectures and structures for post-processing data. The use of these
methods and structures may not be obvious or certain to assess, and may not be possible or at least may be challenging to reveal or confirm
by reverse engineering, based on limited evidence that might be available to us, such as for example from only being able to observe the
results of using those methods or architectures. We may not prevail in any lawsuits that we initiate and the damages or other remedies
awarded if we were to prevail may not be commercially meaningful.
In addition, our patents or the patents of our
licensing partners also may become involved in inventorship, priority or validity disputes. For example, although we try to ensure that
our employees, consultants and advisors are not in breach of any past contractual obligations and do not use the proprietary information
or know-how of others in the work that they do for us, we may in the future become subject to claims that we or these individuals have,
inadvertently or otherwise, used or disclosed intellectual property, including trade secrets or other proprietary information, of their
former university or employer. Additionally, we may be subject to claims from third parties challenging intellectual property rights we
regard as our own, based on claims that our agreements with employees or consultants obligating them to assign intellectual property to
us are ineffective or in conflict with prior or competing contractual obligations to assign inventions to a previous employer, or to another
person or entity. Furthermore, while it is our policy to require all employees and contractors to execute agreements assigning relevant
intellectual property to us, we may also be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops
intellectual property that we regard as our own. These assignment agreements may not be self-executing or adequate in scope, and may be
breached or challenged, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to
determine the ownership of what we regard as our intellectual property. We may not have adequate remedies for any such breaches, and such
claims could harm our business, financial condition and results of operations.
To counter or defend against such claims can be
expensive and time-consuming and it may be necessary or we may desire to enter into a license to settle any such claims; however, there
can be no assurance that we would be able to obtain a license on commercially reasonable terms, if at all. In an infringement proceeding,
a court may decide that our patent is invalid or unenforceable or may refuse to stop the other party from using the technology at issue
on the grounds that our patents do not cover such technology. An adverse result in any litigation proceeding could put one or more of
our patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required
in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by
disclosure during litigation.
Even if resolved in our favor, litigation or other
legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our management
and other personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions
or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could
have a substantial negative impact on our common stock price. Such litigation or proceedings could substantially increase our operating
losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may
not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be
able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources
and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent
litigation or other proceedings could harm our ability to compete in the marketplace, including ability to hire new employees or contract
with independent sales representatives. Additionally, we may lose valuable intellectual property rights or personnel. Any of the foregoing
could harm our business, financial condition and results of operations.
If our trademarks and trade names are not adequately
protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed.
Our registered and unregistered trademarks or
trade names may be challenged, infringed, circumvented, declared generic or determined to be violating or infringing on marks held by
others. We may not be able to protect our rights to these trademarks and trade names, which we need to build or sustain name recognition
among potential partners, customers and patients in our markets of interest. At times, competitors or other third parties may adopt trade
names or trademarks similar to ours, thereby impeding our ability to continue to build brand identity and possibly leading to market confusion.
In fact, a practice exists with international scope, and which may become manifest in a given case in any or only certain territories,
in which certain third parties will deliberately secure or allege they own trademarks or tradenames that are specifically being first
used by another party in order to extort license fees or damages in those territories in which the original user of the mark had not filed
or perfected its rights to the mark. In addition, there could be potential trade name or trademark infringement, or dilution claims brought
by owners of other trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks, trade names,
domain names or other intellectual property, then we may not be able to compete effectively, and our business may be adversely affected.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names or other intellectual property
may be ineffective, could result in substantial costs, diversion of resources, or adverse impact to our brand and could harm our sales,
business, financial condition, and results of operations.
Intellectual property rights do not necessarily
address all potential threats, and limitations in intellectual property rights could harm our business, financial condition and results
of operations.
The degree of future protection afforded by our
intellectual property rights is uncertain because intellectual property rights have limitations, may evolve, and may not adequately protect
our business or permit us to maintain our competitive advantage. For example:
| |
· |
others may be able to make products that are similar to our products or utilize
similar technology but that are not covered by the claims of our patents or that incorporate certain technology in our products that is
in the public domain; |
| |
· |
our intellectual property strategy may be limited, we may not seek protection
for intellectual property that may ultimately become relevant to our business or our invention disclosure process may prove insufficient
to encourage inventors to come forward with protectable intellectual property; |
| |
· |
we, or our current or future licensors or collaborators, might not have been
the first to make the inventions related to the applicable issued patent or pending patent application assigned or licensed to us now
or in the future; |
| |
· |
we, or our current or future licensors or collaborators, might not have been
the first to file patent applications covering certain of our or their inventions; |
| |
· |
we, or our current or future licensors or collaborators, may fail to meet our
obligations to the U.S. government regarding any future patents and patent applications funded by U.S. government grants, leading to the
loss or unenforceability of patent rights; |
| |
· |
others may independently develop similar or alternative technologies or duplicate
any of our technologies without infringing our intellectual property rights; |
| |
· |
it is possible that our current or future pending patent applications will not
lead to issued patents; |
| |
· |
it is possible that there are prior public disclosures that could invalidate
our patents, or parts of our patents; |
| |
· |
it is possible that there are unpublished applications or patent applications
maintained in secrecy that may later issue with claims related to our products or technology similar to ours; |
| |
· |
it is possible that our patents or patent applications omit individuals that
should be listed as inventors or include individuals that should not be listed as inventors, which may cause these patents or patents
issuing from these patent applications to be held invalid or unenforceable; |
| |
· |
issued patents that we hold rights to may be held invalid or unenforceable,
including as a result of legal challenges by our competitors or other third parties; |
| |
· |
the claims of our patents or patent applications, if and when issued, may not
cover our products or technologies; |
| |
· |
the laws of foreign countries may not protect our proprietary rights or the
rights of current or future licensors or collaborators to the same extent as the laws of the United States; |
| |
· |
the inventors of our patents or patent applications may become involved with
competitors, develop products or processes that design around our patents, or become hostile to us or the patents or patent applications
on which they are named as inventors; |
| |
· |
our competitors or other third parties might conduct research and development
activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive
products for sale in our major commercial markets; |
| |
· |
we have engaged in scientific collaborations in the past and will continue to
do so in the future and our collaborators may develop adjacent or competing products that are outside the scope of our patents; |
| |
· |
we may not develop additional proprietary technologies that are patentable; |
| |
· |
our trade secrets may be misappropriated, without an ability to know or reverse
engineer the misappropriation, or we may lose trade secret protections based on a failure to properly establish or maintain them; |
| |
· |
certain employees, consultants, or other collaborators may be engaged on terms
that do not prevent them from inventing improvements, modifications, alterations, derivations of our technologies and methods, or otherwise
from inventing alternative or new technologies or methods and pursuing them outside of and competitive with the company; |
| |
· |
the patents of others may harm our business; or |
| |
· |
we may choose not to file a patent in order to maintain certain trade secrets
or know-how, and a third party may subsequently file a patent covering such intellectual property, and thereby potentially preventing
us from continuing to use those related technologies or practice those related methods. |
Any of the foregoing could harm our business,
financial condition and results of operations.
If we are unable to protect the confidentiality
of our other proprietary information, our business and competitive position may be harmed.
In addition to patent protection, we also rely
on other proprietary rights, including protection of trade secrets, know-how and other confidential or proprietary information that is
not patentable or that we elect not to patent. However, such information can be difficult to protect, and some courts, for instance, are
less willing or unwilling to protect trade secrets. To maintain the confidentiality of our trade secrets and proprietary information,
we rely heavily on confidentiality provisions that we have in contracts with our employees, consultants, collaborators, suppliers, customers,
and others upon the commencement of their relationship with us. We cannot guarantee that we have entered into such agreements with each
party that may have or have had access to our trade secrets or proprietary technology and processes. Furthermore, we may not be able to
prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by such third parties, despite the existence
generally of these confidentiality restrictions. These contracts may not provide meaningful protection or equitable remedies for our trade
secrets, know-how, or other proprietary information in the event of any unauthorized use, misappropriation, or disclosure of such trade
secrets, know-how, or other proprietary information. There can be no assurance that such third parties will not breach their agreements
with us, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or independently
developed by competitors. Despite the protections we do place on our intellectual property or other proprietary rights, monitoring unauthorized
use and disclosure of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual
property or other proprietary rights have or will be adequate. Trade secret violations are often a matter of state law, and the criteria
for protection of trade secrets can vary among different jurisdictions. In addition, the laws of many foreign countries will not protect
our intellectual property or other proprietary rights to the same extent as the laws of the United States. Consequently, we may be unable
to prevent our proprietary technology from being exploited abroad, which could affect our ability to expand to foreign markets or require
costly efforts to protect our products.
We also license rights to use certain proprietary
information and technology from third parties. The use of such proprietary information and technology is therefore subject to the obligations
of the applicable license agreement between us and the owner. For example, the software we developed for our technology includes the use
of open source software that is subject to the terms and conditions of the applicable open source software licenses that grant us permission
to use such software. The owner of any such proprietary information or technology also might not enforce or otherwise protect its rights
in the proprietary information or technology with the same vigilance that we would, which would allow competitors to use such proprietary
information and technology without having to adhere to a license agreement with the owner.
To the extent our intellectual property or other
proprietary information protection is incomplete, we are exposed to a greater risk of direct competition. A third party could, without
authorization, copy or otherwise obtain and use our products or technology, or develop similar products or technology. Our competitors
could purchase our products and attempt to reverse engineer or replicate some or all of the competitive advantages we derive from our
development efforts or design around our protected products or technology. Our failure to secure, protect and enforce our intellectual
property rights could substantially harm the value of our products, brand and business. The theft or unauthorized use or publication of
our trade secrets and other confidential business information could reduce the differentiation of our products, substantially and adversely
impact our sales and commercial operations and harm our business. Additionally, the value of our investment in development or business
acquisitions could be reduced and third parties might make claims against us related to losses of their confidential or proprietary information.
Any of the foregoing could materially and adversely affect our business, financial condition and results of operations.
Further, it is possible that others will independently
develop the same or similar technology or product or otherwise obtain access to our unpatented technology, and in such cases, we could
not assert any trade secret rights against such parties. Costly and time-consuming litigation could be necessary to enforce and determine
the scope of our trade secret rights and related confidentiality and nondisclosure provisions. If we fail to obtain or maintain trade
secret protection, or if our competitors otherwise obtain our trade secrets or independently develop technology or products similar to
and potentially competing with our products, our competitive market position could be materially and adversely affected. In addition,
some courts are less willing or unwilling to protect trade secrets and agreement terms that address non-competition are difficult to enforce
in many jurisdictions and might not be enforceable in certain cases.
We also seek to preserve the integrity and confidentiality
of our data and other confidential information by maintaining physical security of our premises and physical and electronic security of
our information technology systems. While we have confidence in these individuals, organizations, systems and tools, agreements or security
measures may be breached, whereby detecting the disclosure or misappropriation of confidential information and enforcing a claim that
a party illegally disclosed or misappropriated confidential information is difficult, expensive and time-consuming, and the outcome is
unpredictable. Further, we may not be able to obtain adequate remedies for any breach.
Our inability to use software licensed from
third parties, or our use of open source software under license terms that interfere with our proprietary rights, could disrupt our business.
Our products, including our technology and methods
used, include the use of open source software that is subject to the terms and conditions of the applicable open source software licenses
that grant us permission to use such software. Although we monitor our use of open source software, the terms of many open source licenses
to which we are subject have not been interpreted by U.S. or foreign courts, and there is a risk that such licenses could be construed
in a manner that imposes unanticipated conditions or restrictions on our ability to provide our technology to our customers. Moreover,
we cannot ensure that we have not incorporated additional open source software in our products in a manner that is inconsistent with the
terms of the applicable license or our current policies and procedures. In the future, we could be required to seek licenses from third
parties in order to continue offering our solutions, which licenses may not be available on terms that are acceptable to us, or at all.
Claims related to our use of open source software could also result in litigation, require us to purchase costly licenses or require us
to devote additional research and development resources to change the software underlying our technology, any of which would have a negative
effect on our business, financial condition and operating results and may not be possible in a timely manner. We and our customers may
also be subject to suits by parties claiming infringement due to the reliance by our products on certain open source software, and such
litigation could be costly for us to defend or subject us to injunctions enjoining us from the sale of our products that contain open
source software.
Alternatively, we may need to re-engineer our
products or discontinue using portions of the functionality provided by our products. In addition, the terms of open source software licenses
may require us to provide software that we develop using such software to others on unfavorable terms, such as by precluding us from charging
license fees, requiring us to disclose our source code, requiring us to license certain of our own source code under the terms of the
applicable open source license or requiring us to provide notice on our products using such code. Any such restriction on the use of our
own software, or our inability to use open source or third-party software, could result in disruptions to our business or operations,
or delays in our development of future products or enhancements of our existing products, such as our RNS System, which could impair our
business.
Public health crises may have an adverse effect
on certain aspects of our business, results of operations, financial condition, and cash flows. The nature and extent of future impacts
are highly uncertain and unpredictable.
Our business is subject to risks associated with
public health crises, including epidemics and pandemics such as COVID-19. In particular, the preventative and precautionary measures that
we and other businesses, communities, and governments may take to mitigate the spread of the disease could lead to restrictions on, and
disruptions in, business and personal activities that reduce the demand for deferrable and emergent medical procedures such as surgical
interventions to treat low back pain. It is not possible to predict the timing of deferrable medical procedures and, to the extent individuals
and hospital systems de-prioritize, delay or cancel these procedures, our business, results of operations, financial condition, and cash
flows could be negatively affected.
To date we have not experienced material disruptions
in our business operations. However, while it is not possible at this time to estimate the impact that COVID-19 or other epidemic disease
could have on our business in the future, particularly as we advance our product development and marketing, the measures taken by the
governmental authorities, and any future epidemic disease outbreaks could: (i) disrupt our operations and the manufacture or shipment
of MRIs and MRSs used with our products and in our research, preclinical studies and clinical trials (ii) delay, limit or prevent our
employees and consultants from continuing research and development activities (iii) impede our clinical trial initiation and recruitment
(iv) impede the ability of patients to continue in clinical trials, including the risk that participants enrolled in our clinical trials
will contract COVID-19 or other epidemic disease while the clinical trials are ongoing, which could impact the results of clinical trials,
and impede testing, monitoring, data collection and analysis and other related activities, any of which could delay our studies and clinical
trials and increase our development costs, and have a material adverse effect on our business, financial condition and results of operations.
The COVID-19 pandemic and any future epidemic disease could also potentially affect the business of the FDA or comparable foreign regulatory
authorities, which could result in delays in meetings related to planned clinical trials.
Other risks facing our company
If product liability lawsuits are brought against
us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our technology. The expense and
potential unavailability of insurance coverage for liabilities resulting from our technology could harm our business and our ability to
sell our technology.
We face an inherent risk of product liability
as a result of the marketing and sale of our technology. Although we have established internal procedures designed to minimize risks that
may arise from quality issues, there can be no assurance that we will eliminate or mitigate occurrences of these issues and associated
liabilities. Our products and services are diagnostic in nature and involve an exam that is non-invasive using other third-party MR scanner
products and technologies. Those exams are also conducted by other third party MR service providers. The results of using our products
are also intended to provide information to doctors that help them perform a diagnosis for their patient, using all other diagnostic information
that is available to them. The downstream results from those diagnoses may also lead to certain treatments being performed, which are
decided upon between that treating doctor and the patient (and related payers), and which are conducted by that treating doctor on the
patient. We are not responsible for the performance of those MR scanners, nor for the performance of the MR service providers for conducting
those patient exams using the MR scanners, nor for the final diagnosis performed by a doctor as assisted via the results of our products
in combination with other available information, nor for the decisions and performance on conducting treatments or other on-going patient
care, or the patient outcomes from that care, following the use of our diagnostic assistance product. However, there are risks that certain
liability exposures or claims could be threatened or actually filed against us with respect to the performance or results of these other
activities around and relating to, but not directly caused by, the use of our products, including with respect to the use of our products
in the overall patient care regimen that might result in adverse patient outcomes. Even if we successfully defend any such allegation
or claim, this could involve significant risk of liability exposure and significant cost and diversion of resources and focus.
If we cannot successfully defend ourselves against
product liability claims, we may incur substantial liabilities or be required to limit or halt commercialization of our products. Regardless
of the merits or eventual outcome, liability claims may result in:
| |
· |
decreased demand for our technology; |
| |
· |
injury to our brand or reputation; |
| |
· |
initiation of investigations by regulators; |
| |
· |
costs to defend the related litigation; |
| |
· |
increased insurance premiums; |
| |
· |
a diversion of management’s time and our resources; |
| |
· |
substantial monetary awards to trial participants or patients; |
| |
· |
regulatory investigations, product recalls, withdrawals or labeling, marketing
or promotional restrictions; |
| |
· |
loss of revenue; |
| |
· |
exhaustion of any available insurance and our capital resources; and |
| |
· |
the inability to market and sell our products. |
We believe we have adequate product liability
insurance, but it may not prove to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive.
We currently carry product liability insurance in the amount of $5 million in the aggregate. In the future, we may not be able to maintain
or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains
various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to obtain
sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the
marketing and sale of products we may develop. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed
our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay
such amounts, which would harm our business, financial condition and results of operations. In addition, any product liability claims
brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing
coverage, harm our patient-focused brand, negatively impact our reputation in the industry, significantly increase our expenses and reduce
product sales.
Some of our customers may also have difficulty
in procuring or maintaining liability insurance to cover their operations, including their use of our products. Medical malpractice carriers
are withdrawing coverage in certain states or substantially increasing premiums. If this trend continues or worsens, our customers may
discontinue using our products and potential additional customers may opt against purchasing our products due to the cost or inability
to procure insurance coverage.
The failure of third parties to meet their
contractual, regulatory and other obligations could adversely affect our business.
We rely on licensors, suppliers, vendors, partners,
consultants, and other third parties to research, develop, and partake in both the commercialization of our technology, as well as manage
certain parts of our business. Using these third parties poses a number of risks, such as:
| |
· |
they may not perform to our standards or legal requirements; |
| |
· |
they may not produce reliable results; |
| |
· |
they may not perform in a timely manner; |
| |
· |
they may not maintain confidentiality of our proprietary information; |
| |
· |
disputes may arise with respect to ownership of rights to products developed
with our partners; and |
| |
· |
disagreements could cause delays in, or termination of, the research, development
or commercialization of our products or result in litigation or arbitration. |
If and as any of one or more of these identified
parties might be replaced in the future by another party with whom we might engage or rely upon for similar technological or business
purposes, or to the extent we may expand our business to involve and rely on still more additional parties for similar purposes as those
listed (e.g. additional MR scanner vendors), similar risks would apply to those other parties.
Moreover, some third parties may be located in
markets subject to political and social risk, corruption, infrastructure problems and natural disasters, in addition to country-specific
privacy and data security risk given current legal and regulatory environments. Failure of third parties to meet their contractual, regulatory
and other obligations may materially affect our business.
Litigation and other legal proceedings may
harm our business.
From time to time in the future we may become
involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee matters,
tort or contract claims, federal regulatory investigations, private rights of action, securities class action and other legal proceedings
or investigations, which could have a negative impact on our reputation, business and financial condition and divert the attention of
our management from the operation of our business.
Litigation is inherently unpredictable and can
result in excessive or unanticipated verdicts, judgements, and/or injunctive relief that affect how we operate our business. We could
incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business,
or both. There may be an increase in the scope of these or other matters or there may be additional lawsuits, claims, proceedings or investigations
in the future, which could harm our business, financial condition and results of operations. Adverse publicity about regulatory or legal
action against us, irrespective of outcome, could damage our reputation and brand image, undermine our customers’ confidence and
reduce long-term demand for our products, even if the regulatory or legal action is unfounded or not material to our operations.
Our operating results may fluctuate across
periods, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations
or any guidance we may provide.
Our quarterly and annual operating results may
fluctuate across periods, which makes it difficult for us to predict our future operating results. Accordingly, the results of any one
quarter or period should not be relied upon as an indication of future performance. Our quarterly and annual operating results may fluctuate
due to a variety of factors, many of which are outside of our control, including, but not limited to:
| |
· |
The level of demand for our technology and any future technology, which may
vary significantly from period to period; |
| |
· |
Expenditures that we may incur to acquire, develop or commercialize additional
technology; |
| |
· |
The timing and cost of obtaining regulatory approvals or clearances to expand
our indications and get future approvals of any future technology or features; |
| |
· |
Pricing pressures; |
| |
· |
Our ability to expand the geographic reach of our commercial efforts; |
| |
· |
The degree of competition in our industry and any change in the competitive
landscape of our industry, including consolidation among our competitors or future partners; |
| |
· |
Coverage and reimbursement policies with respect to our technology, and potential
future technology that compete with our products; |
| |
· |
The timing and success or failure of preclinical or clinical studies for expanding
the indications of our technology or any future technology we develop or competing technology; |
| |
· |
Positive or negative coverage in the media or clinical publications of our technology
or technology of our competitors or our industry; |
| |
· |
The timing and cost of, and level of investment in, research, development, licenses,
regulatory approval, commercialization activities, acquisitions and other strategic transactions, or other significant events relating
to our technology, which may change from time to time; |
| |
· |
The cost of developing our technology, which may vary depending on the terms
of our agreements with third-party; and |
| |
· |
Future accounting pronouncements or changes in our accounting policies. |
The cumulative effects of these factors could
result in fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results
on a period-to-period basis may not be meaningful. Further, our historical results are not necessarily indicative of results expected
for any future period, and quarterly results are not necessarily indicative of the results to be expected for the full year or any other
period. Investors should not rely on our past results as an indication of our future performance.
This variability and unpredictability could also
result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating
results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, it could harm our business,
financial condition, and results or operations.
We will incur increased costs as a result of
operating as a public company, and our management and board of directors will be required to devote substantial time to compliance with
our public company responsibilities and corporate governance practices.
As a public company, we will incur significant
legal, accounting and other expenses that we did not incur as a private company. We expect such expenses to further increase after we
are no longer an emerging growth company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing
requirements of the Nasdaq Capital Market, and other applicable securities rules and regulations impose various requirements on public
companies. Furthermore, most senior members of our management team as well as our board of directors do not have significant experience
with operating a public company. As a result, our management, board of directors, and other personnel will have to devote a substantial
amount of time to compliance with these requirements. Moreover, these rules and regulations will increase our legal and financial compliance
costs and will make some activities more time-consuming and costly. We cannot predict or estimate the amount of additional costs we will
incur as a public company or the timing of such costs.
Risks related to the ownership of our common stock and IPO Warrants
Our stock price may be volatile, and the value
of our common stock and IPO Warrants may decline.
The market price of our common stock and IPO Warrants
may be highly volatile and may fluctuate or decline substantially as a result of a variety of factors, some of which are beyond our control
or are related in complex ways, including:
| • | Actual or anticipated fluctuations in our financial condition
and results of operations; |
| • | Variance in our financial performance from expectations of securities
analysts or investors; |
| • | Changes in the coverage decisions, reimbursement or pricing of
our technology; |
| • | Changes in our projected operating and financial results; |
| • | Changes in laws or regulations applicable to our technology; |
| • | Announcements by us or our competitors of significant business
developments, acquisitions, or new offerings; |
| • | Publicity associated with issues related to our technology; |
| • | Our involvement in regulatory investigations or litigation; |
| • | Future sales of our common stock or other securities, by us or
our stockholders, as well as the anticipation of lock-up releases; |
| • | Changes in senior management or key personnel; |
| • | The trading volume of our common stock; |
| • | Changes in the anticipated future size and growth rate of our
market; |
| • | General economic, regulatory, and market conditions, including
economic recessions or slowdowns; |
| • | The impact of the COVID-19 pandemic; |
| • | Changes in the structure of healthcare payment systems; and |
| • | Developments or disputes concerning our intellectual property
or other proprietary rights. |
Broad market and industry fluctuations, as well
as general economic, political, regulatory, and market conditions, may negatively impact the market price of our common stock. In addition,
given the relatively small expected public float of shares of our common stock on the Nasdaq Capital Market, the trading market for our
shares may be subject to increased volatility. In the past, securities class action litigation has often been brought against a company
following a decline in the market price of its securities. This risk is especially relevant for us, because medical device companies have
experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a
diversion of management’s attention and resources, which could harm our reputation and our business.
A significant portion
of our total outstanding shares may be sold into the market, which could cause the market price of our common stock to drop significantly,
even if our business is performing well.
Sales of a substantial number of shares of our
common stock in the public market could occur at any time. These sales, or the perception in the market that holders of a large number
of shares intend to sell shares, could reduce the market price of our common stock.
You may experience additional dilution if any
of our outstanding common stock warrants are exercised.
If the holders of any of our outstanding common
stock warrants exercise their warrants, you will experience dilution at the time they exercise their warrants.
The issuance of common
stock to White Lion pursuant to the Equity Line Purchase Agreement may cause substantial dilution to our existing shareholders, and the
sale of such shares acquired by White Lion could cause the price of our common stock to decline.
Under our Equity Line
Purchase Agreement with White Lion, the Company has the right, but not the obligation to require White Lion to purchase, from time to
time, up to of $10,000,000 in aggregate gross purchase price of newly issued shares of the Company’s common stock. Through February
26, 2024, the Company has sold 750,000 shares to White Lion for total proceeds of $2,912,481.We currently have an effective registration
statement that registers for resale by White Lion up to 2,500,000 shares of common stock that we may issue to White Lion under the Equity
Line Purchase Agreement. After White Lion has acquired shares under the Equity Line Purchase Agreement, it may sell all, some or none
of those shares. Sales to White Lion by us pursuant to the Equity Line Purchase Agreement under this prospectus may result in substantial
dilution to the interests of other holders of our common stock.
The sale of a
substantial number of shares to White Lion, or anticipation of such sales, could make it more difficult for us to sell equity or
equity-related securities in the future at a time and at a price that we might otherwise desire. The number of shares of our common
stock ultimately offered for resale by White Lion is dependent upon the number of shares of common stock issued to the White Lion
pursuant to the Equity Line Purchase Agreement. Depending on a variety of factors, including market liquidity of our common stock,
the issuance of shares to the Selling Securityholder may cause the trading price of our common stock to decline.
The price of our common stock may be volatile
and fluctuate substantially, which could result in substantial losses for investors in our common stock.
Our common stock price is likely to be volatile.
The stock market in general and the market for bio-technology companies in particular, has experienced extreme volatility that has often
been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your
common stock at or above your investment price. The market price for our common stock may be influenced by many factors, including:
| |
· |
the success of competitive products or technologies; |
| |
|
|
| |
· |
regulatory or legal developments in the United States, |
| |
|
|
| |
· |
the recruitment or departure of key personnel; |
| |
|
|
| |
· |
the level of expenses related to any of our product candidates, and our commercialization
efforts; |
| |
|
|
| |
· |
actual or anticipated changes in our development timelines; |
| |
|
|
| |
· |
our ability to raise additional capital; |
| |
|
|
| |
· |
disputes or other developments relating to proprietary rights, including patents,
litigation matters and our ability to obtain patent protection for our product candidates; |
| |
|
|
| |
· |
significant lawsuits, including patent or stockholder litigation; |
| |
|
|
| |
· |
variations in our financial results or those of companies that are perceived
to be similar to us; |
| |
|
|
| |
· |
general economic, industry and market conditions; and |
| |
|
|
| |
· |
the other factors described in this “Risk Factors” section. |
If our quarterly operating
results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore,
any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe
that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our
future performance.
In the past, following
periods of volatility in the market price of a company’s securities, securities class-action litigation often has been instituted
against that company. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert
management’s attention and resources.
Because we do not
expect to pay dividends for the foreseeable future, investors seeking cash dividends should not purchase shares of our common stock.
We have never declared or paid any cash dividends
on our common stock. We currently intend to retain future earnings, if any, to finance the expansion of our business. As a result, we
do not anticipate paying any cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of
our Board of Directors after taking into account various factors, including but not limited to our financial condition, operating results,
cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. Accordingly, investors seeking
cash dividends should not purchase our shares.
If securities analysts
do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could
decline.
The trading market for
our common stock will rely, in part, on the research and reports that industry or financial analysts publish about us or our business.
We do not currently have, and may never obtain, research coverage by industry or financial analysts. If no, or few, analysts commence
coverage of us, the trading price of our stock would likely decrease. Even if we do obtain analyst coverage, if one or more of the analysts
covering our business downgrade their evaluations of our stock, the price of our stock could decline. If one or more of these analysts
cease to cover our stock, we could lose visibility in the market for our stock, which in turn could cause our stock price to decline.
We are an emerging growth company and a smaller
reporting company, and our compliance with the reduced reporting and disclosure requirements applicable to emerging growth companies and
smaller reporting companies could make our common stock less attractive to investors.
We are an emerging growth company, as defined
in the JOBS Act, and we expect to take advantage of certain exemptions from various reporting requirements that are applicable to other
public companies that are not emerging growth companies, including the auditor attestation requirements of Section 404, reduced disclosure
obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding
a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved
and extended adoption period for accounting pronouncements.
Even after we no longer qualify as an emerging
growth company, we may still qualify as a “smaller reporting company,” which would allow us to continue to take advantage
of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this prospectus and our
periodic reports and proxy statements.
We cannot predict whether investors will find
our common stock less attractive as a result of our reliance on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
We will remain an emerging growth company until
the earliest of (i) the end of the fiscal year following the fifth anniversary of the completion of our IPO, (ii) the first fiscal year
after our annual gross revenues exceed $1.235 billion, (iii) the date on which we have, during the immediately preceding three-year
period, issued more than $1.00 billion in non-convertible debt securities, or (iv) the end of any fiscal year in which the market value
of our common stock held by non-affiliates exceeds $700 million as of the end of the second quarter of that fiscal year.
Provisions in our corporate charter and our
bylaws and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent
attempts by our stockholders to replace or remove our current management.
The anti-takeover provisions of the Delaware General
Corporation Law (the “DGCL”) may discourage, delay or prevent a change in control by prohibiting us from engaging in a business
combination with an interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change
in control would be beneficial to our existing stockholders.
Provisions in our corporate charter and our bylaws
discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including
transactions in which you might otherwise receive a premium for your shares. These provisions also could limit the price that investors
might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition,
because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent
any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members
of our board of directors. Among other things, these provisions:
| |
· |
allow the authorized number of our directors to be changed
only by resolution of our board of directors; |
| |
|
|
| |
· |
limit the manner in which stockholders can remove directors
from the board; |
| |
|
|
| |
· |
establish advance notice requirements for stockholder proposals
that can be acted on at stockholder meetings and nominations to our board of directors; |
| |
|
|
| |
· |
require that stockholder actions must be effected at a
duly called stockholder meeting and prohibit actions by our stockholders by written consent; |
| |
|
|
| |
· |
limit who may call stockholder meetings; |
| |
|
|
| |
· |
authorize our board of directors to issue preferred stock
without stockholder approval, which could be used to institute a stockholder rights plan, or so-called “poison pill,”
that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been
approved by our board of directors; and |
Moreover, because we are incorporated in Delaware,
we are governed by the provisions of Section 203 of the DGCL, which prohibits a person who owns in excess of 15% of our outstanding
voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired
in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Our amended and restated certificate of incorporation
provides that the Court of Chancery of the State of Delaware or, under certain circumstances, the federal district courts of the United
States of America will be the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders,
which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers,
employees or agents.
Our amended and restated certificate of incorporation
provides that the Court of Chancery of the State of Delaware (or, if the Court of Chancery of the State of Delaware lacks subject matter
jurisdiction, any state court located within the State of Delaware or, if all such state courts lack subject matter jurisdiction, the
federal district court for the District of Delaware) is the sole and exclusive forum for the following types of actions or proceedings
under Delaware statutory or common law for:
| |
· |
any derivative action or proceeding brought on our behalf; |
| |
· |
any action asserting a breach of fiduciary duty; |
| |
· |
any action arising pursuant to the Delaware General Corporation Law, our amended
and restated certificate of incorporation, or our amended and restated bylaws; and |
| |
· |
any action asserting a claim against us that is governed by the internal-affairs
doctrine. |
These provisions would not apply to suits brought
to enforce a duty or liability created by the Exchange Act or any claim for which the federal district courts of the United States of
America have exclusive jurisdiction. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state
courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims.
Our stockholders cannot waive compliance with
the federal securities laws and the rules and regulations thereunder. Any person or entity purchasing or otherwise acquiring any interest
in shares of our capital stock will be deemed to have notice of, and consented to, the provisions of our amended and restated certificate
of incorporation described in the preceding sentences.
To prevent having to litigate claims in multiple
jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated
certificate of provides that the federal district courts of the United States will be the exclusive forum for resolving any complaint
asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions
are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum
provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of
our amended and restated certificate of incorporation in effect upon the effectiveness of our IPO. This may require significant additional
costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced
by a court in those other jurisdictions.
These exclusive forum provisions may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees,
which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find either exclusive-forum
provision in our amended and restated certificate of incorporation in effect upon the effectiveness of our IPO to be inapplicable or unenforceable
in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which
could harm our business and financial condition.
Risks Relating to this
Offering
You will experience immediate dilution as a
result of this offering and may experience additional dilution in the future.
The public offering price
for the Units offered hereby will be substantially higher than the net tangible book value per share of our common stock immediately after
this offering. If you purchase Units in this offering, you will incur substantial and immediate dilution in the net tangible book value
of your investment. Net tangible book value per share represents the amount of total tangible assets less total liabilities, divided by
the number of shares of our common stock then outstanding. To the extent that options that are currently outstanding are exercised, there
will be further dilution to your investment. We may also issue additional common stock, options and other securities in the future that
may result in further dilution of your shares of our common stock.
The best efforts structure of this offering may
have an adverse effect on our business plan.
The placement agent is offering the securities
in this offering on a best efforts basis. The placement agent is not required to purchase any securities, but will use its best efforts
to sell the securities offered. As a “best efforts” offering, there can be no assurance that the offering contemplated hereby
will ultimately be consummated or will result in any particular amount of proceeds being made available to us. The success of this offering
will impact our ability to use the proceeds to execute our business plan. We may have insufficient capital to implement our business
plan, potentially resulting in greater operating losses unless we are able to raise the required capital from alternative sources. There is no
assurance that alternative capital, if needed, would be available on terms acceptable to us, or at all.
Future sales of our common stock, or the perception
that such sales may occur, could depress the trading price of our common stock.
After the completion of this offering, we expect
to have 7,150,585 shares of our common stock outstanding, which may be resold in the public market immediately after this offering.
We, each of our officers and directors have signed lock-up agreements for a period of 90 days following the date of this prospectus,
subject to specified exceptions. See “Plan of Distribution.”
The placement agent may, in its sole discretion and
without notice, release all or any portion of the shares of our common stock subject to lock-up agreements. As restrictions
on resale end, the market price of our common stock could drop significantly if the holders of these shares of our common stock sell
them or are perceived by the market as intending to sell them. These factors could also make it more difficult for us to raise additional
funds through future offerings of our common stock or other securities.
We have broad discretion in the use of the net
proceeds we receive from this offering and may not use them effectively.
Our management will have broad discretion in the
application of the net proceeds we receive in this offering, including for any of the purposes described in the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether our management is using
the net proceeds appropriately. Because of the number and variability of factors that will determine our use of our net proceeds from
this offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these
funds effectively could result in financial losses that could have a material adverse effect on our business and cause the price of our
common stock to decline. Pending their use, we may invest our net proceeds from this offering in short-term, investment-grade, interest-bearing
securities. These investments may not yield a favorable return to our stockholders.
The Common Warrants
are speculative in nature.
Our Common Warrants do not confer any rights of
common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right
to acquire shares of our common stock at a fixed price for a limited period of time. Specifically, holders of the Common Warrants may
exercise their right to acquire the common stock and pay an exercise price of $0.58, prior to 5 years from the date of issuance, after
which date any unexercised Common Warrants will expire and have no further value.
Holders of Pre-Funded
Warrants and Common Warrants will have no rights as a common stockholder until such holders exercise their Pre-Funded Warrants and Common
Warrants, respectively, and acquire our common stock.
Until holders of Pre-Funded
Warrants and Common Warrants acquire shares of our common stock upon exercise of the Pre-Funded Warrants and Common Warrants, as the case
may be, holders of Pre-Funded Warrants and Common Warrants will have no rights with respect to the shares of our common stock underlying
such Pre-Funded Warrants and Common Warrants. Upon exercise of the Pre-Funded Warrants and Common Warrants, the holders thereof will be
entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
There is no public
market for the Pre-Funded Warrants or Common Warrants in this offering.
There is no established
public trading market for the Pre-Funded Warrants or Common Warrants, and we do not expect a market to develop. In addition, we do not
intend to apply for listing of the Pre-Funded Warrants or Common Warrants on any securities exchange or recognized trading system.
Absence of a public
trading market for the Pre-Funded Warrants or Common Warrants may limit your ability to resell the Pre-Funded Warrants or Common Warrants.
There is no established
trading market for the Pre-Funded Warrants or Common Warrants to be issued pursuant to this offering, and they will not be listed for
trading on Nasdaq or any other securities exchange or market, and the Pre-Funded Warrants or Common Warrants may not be widely distributed.
Purchasers of the Pre-Funded Warrants or Common Warrants may be unable to resell the Pre-Funded Warrants or Common Warrants or sell them
only at an unfavorable price for an extended period of time, if at all.
The market price
of our common stock may never exceed the exercise price of the Common Warrants issued in connection with this offering.
The Common Warrants being
issued in connection with this offering become exercisable upon issuance and will expire five years from the date of issuance. The market
price of our common stock may never exceed the exercise price of the Common Warrants prior to their date of expiration. Any Warrants not
exercised by their date of expiration will expire worthless and we will be under no further obligation to the Warrant holder.
MARKET AND INDUSTRY DATA
Unless otherwise indicated,
information contained (or incorporated by reference) in this prospectus concerning our industry and the markets in which we operate is
based on information from independent industry and research organizations, other third-party sources and management estimates. Management
estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well
as data from our internal research, and are based on assumptions made by us upon reviewing such data and our knowledge of such industry
and markets which we believe to be reasonable. Although we believe the data from these third-party sources is reliable, we have not independently
verified any third-party information. In addition, projections, assumptions and estimates of the future performance of the industry in
which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those
described in “Risk Factors” and “Information Regarding Forward-Looking Statements.” These and other factors could
cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
USE OF PROCEEDS
We estimate that the net proceeds from the Offering
of 5,175,000 Units will be approximately $2.5 million assuming no issuance of Pre-Funded Warrants and no exercise of the Common Warrants
issued in connection with this offering, after deducting expenses relating to this offering payable by us estimated at approximately $460,105,
including placement agent fees and expenses and excluding any proceeds received upon exercise of any Common Warrants.
| | |
| | |
% of Total | |
| Gross Proceeds from Offering | |
$ | 3,001,500 | | |
| 100% | |
| | |
| | | |
| | |
| Use of Proceeds | |
| | | |
| | |
| Placement Agent Fees and Expenses | |
$ | 210,105 | | |
| 7% | |
| Offering Expenses | |
$ | 250,000 | | |
| 8% | |
| Debt repayment | |
$ | 305,000 | | |
| 10% | |
| General & Admin | |
$ | 800,000 | | |
| 27% | |
| R&D | |
$ | 400,000 | | |
| 13% | |
| Sales & Mktg | |
$ | 1,036,395 | | |
| 35% | |
| Total Use of Proceeds | |
$ | 3,001,500 | | |
| 100% | |
We intend to use the
net proceeds from this offering, together with our existing cash, to fund market development and clinical evidence, product development
and quality, general and administration support, retire outstanding debt, and other general corporate purposes.
Our expected use of net
proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of
this prospectus, we cannot predict with complete certainty all of the particular uses for the net proceeds to be received upon the completion
of this offering or the actual amounts that we will spend on the uses set forth above. We believe opportunities may exist from time to
time to expand our current business through the acquisition or in-license of complementary product candidates. While we have no current
agreements for any specific acquisitions or in-licenses at this time, we may use a portion of the net proceeds for these purposes.
Pending the uses described
above, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade
instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
DIVIDEND POLICY
We have not declared or
paid any cash dividends on our capital stock since our inception. We intend to retain future earnings, if any, to finance the operation
and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future.
CAPITALIZATION
The following table describes our cash and capitalization
as of December 31, 2023:
| |
· |
On an actual basis; and |
| |
|
|
| |
· |
on a pro forma as-adjusted basis to give effect to 1) the sale of 452,343
shares of our common stock to White Lion Capital, LLC for proceeds of $1,449,532 pursuant to an equity line common stock purchase agreement,
since December 31, 2023, 2) the issuance of 644,142 shares of common stock in exchange for $1,519,779 principal and accrued interest on
unsecured non-convertible notes, since December 31, 2023, and 3) the sale of 5,175,000 Units in this offering at a public offering price
of $0.58 per Unit and after deducting the placement agent commissions and estimated offering expenses payable by us. |
You should read this information together with our financial statements and related notes incorporated
by reference in this prospectus and the information set forth under the headings “Use of Proceeds” in
this prospectus and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” incorporated
by reference in this prospectus.
| |
|
December
31, 2023 |
|
| |
|
|
|
|
Pro Forma |
|
| |
|
Actual* |
|
|
as-adjusted |
|
| (Several financial statement line items excluded for presentation purposes) |
|
|
|
|
|
|
|
|
| Cash |
|
$ |
1,031,069 |
|
|
$ |
8,021,996 |
|
| Common Stock (825,459 and 7,150,585 shares) |
|
|
8 |
|
|
|
71 |
|
| Additional Paid-in Capital |
|
|
43,553,523 |
|
|
|
49,064,166 |
|
| Accumulated deficit |
|
|
(44,281,526 |
) |
|
|
(44,281,526 |
) |
| Total Shareholders’ Equity |
|
$ |
(727,995 |
) |
|
$ |
4,782,711 |
|
| * |
December 31, 2023 “Actual” Common Stock and Additional Paid-in
Capital has been restated to give effect to the 1-for-16 reverse stock split effective January 3, 2024. |
The number of shares
of common stock issued and outstanding, actual and pro forma as adjusted, in the table above is based on our actual shares of our common
stock which were outstanding as of December 31, 2023 (13,206,229), which shares we have restated to 825,459 shares to give
effect to the 1-for-16 reverse stock split effective as of 5:00 pm Eastern Time on January 3, 2024, and excludes the following items
(which are calculated as of February 26, 2024 and have been adjusted to give effect to the reverse stock split):
| |
· |
136,124
shares of our common stock issuable upon the
exercise of outstanding stock options granted under our 2015 Stock Plan, |
| |
· |
33,334
shares of our common stock issuable upon the exercise of outstanding stock options granted under our 2022 Stock Plan, |
| |
· |
24,211
shares of our common stock issuable upon the settlement of outstanding restricted stock units (“RSUs) options granted under
our 2022 Stock Plan, |
| |
· |
122,108
shares of our common stock reserved for future grant under our 2022 Stock Plan, |
| |
· |
155,610
shares of common stock issuable upon the exercise of our outstanding Nasdaq-listed IPO Warrants, |
| |
· |
154,730
shares of common stock issuable upon the exercise of outstanding privately placed warrants, |
| |
· |
10,825
shares of common stock reserved for issuance upon the exercise of an outstanding IPO underwriter representative common stock warrant,
and |
| |
· |
up to
$7,087,517 worth of common stock that may be sold in the future by the Company to White Lion from time to time pursuant
to the Equity Line Purchase Agreement. |
DILUTION
If you invest in this offering,
your ownership interest will be diluted to the extent of the difference between the public offering price per share and the as
adjusted net tangible book value per share of our common stock immediately after this offering.
Historical net tangible book value (deficit)
per share is determined by dividing our total tangible assets (which excludes deferred offering costs) less our total liabilities by
the total number of shares of common stock outstanding. Our historical net tangible book value (deficit) as of December 31, 2023,
was ($1,896,618), or ($2.30) per share, based on 825,459 shares of common stock outstanding as of that date,
after restating for the reverse stock split of the Company’s outstanding common stock which was effective at a ratio of 1-for-16
shares as of 5:00 pm Eastern Time on January 3, 2024.
After giving effect to 1) the sale of 452,343
shares of our common stock to White Lion Capital, LLC for proceeds of $1,449,532 pursuant to an equity line common stock purchase agreement,
since December 31, 2023, 2) the issuance of 644,142 shares of common stock in exchange for $1,519,779 principal and accrued interest on
unsecured non-convertible notes, since December 31, 2023, and 3) the sale of 5,175,000 Units in this offering, at a public offering price
of $0.58 per share, after deducting the placement agent commissions and estimated offering expenses payable by us, our pro forma as-adjusted
net tangible book value as of December 31, 2023 would have been approximately $3.6 million, or $0.51 per share. This represents an immediate
increase in as adjusted net tangible book value of $2.81 per share to our existing stockholders and an immediate dilution of $0.07 per
share to new investors participating in this offering.
The following table illustrates this dilution
per share:
| Public offering price per share |
|
|
|
|
|
$ |
0.58 |
|
| Historical net tangible
book value per share as of December 31, 2023 |
|
$ |
(2.30 |
) |
|
|
|
|
| Increase in net tangible
book value per share attributable to new investors participating in this offering |
|
|
2.81 |
|
|
|
|
|
| Pro forma as adjusted
net tangible book value per share as of December 31, 2023 after this offering |
|
|
|
|
|
|
0.51 |
|
| Dilution per share to
new investors participating in this offering |
|
|
|
|
|
$ |
0.07 |
|
The foregoing table and calculations are based
on our actual shares of common stock outstanding as of December 31, 2023 (13,206,229), which shares we have restated to
825,459 shares to give effect to the 1-for-16 reverse stock split effective as of 5:00 pm Eastern Time on January 3, 2024, and
excludes the following items (which are calculated as of February 26, 2024 and have been adjusted to give effect to the reverse
stock split):
| |
· |
136,124 shares of our common stock issuable upon the exercise of outstanding stock options granted under our 2015 Stock Plan, |
| |
· |
33,334 shares of our common stock issuable upon the exercise of outstanding stock options granted under our 2022 Stock Plan, |
| |
· |
24,211
shares of our common stock issuable upon the settlement of outstanding restricted stock Units (“RSUs) options granted under
our 2022 Stock Plan, |
| |
· |
122,108
shares of our common stock reserved for future grant under our 2022 Stock Plan, |
| |
· |
155,610 shares of common stock issuable upon the exercise of our outstanding Nasdaq-listed IPO Warrants, |
| |
· |
154,730 shares of common stock issuable upon the exercise of outstanding privately placed warrants, |
| |
· |
10,825 shares of common stock reserved for issuance upon the exercise of an outstanding IPO underwriter representative common stock warrants, and, |
| |
· |
up to $7,087,517 worth of common stock that may be sold in the future by the Company to White Lion from time to time pursuant to the Equity Line Purchase Agreement. |
Market
Price of and Dividends on Common Equity and Related Stockholder Matters
Our
common stock has been traded on the Nasdaq Stock Market under the symbol “ACON”
since our IPO on April 21, 2022. Our IPO Warrants have been traded on the Nasdaq Stock Market
under the symbol “ACONW” since our IPO on April 21, 2022. As of January 1,
2024, there were approximately 137 holders of record of our common stock and 1
holder of record of our IPO Warrants. These numbers are based on the actual number of holders
registered at such date and do not include holders whose shares are held in “street
name” by brokers and other nominees.
Dividends
We have never paid any
cash dividends on our common stock. We currently intend to retain all available funds and any future earnings for use in the operation
of our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future. Any future determination
to declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results,
capital requirements, general business conditions and other factors that our board of directors may deem relevant.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
You should read the
following discussion and analysis of our financial condition and results of operations in conjunction with the audited financial statements
(prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and related notes
included elsewhere in this prospectus. The following discussion contains
forward-looking statements that are subject to risks and uncertainties. See “Special Note Regarding Forward-Looking Statements”
for a discussion of the uncertainties, risks, and assumptions associated with those statements. Actual results could differ materially
from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and
elsewhere in this prospectus, particularly in the section entitled “Risk Factors.” Unless we state otherwise or the context
otherwise requires, the terms “we,” “us,” “our” and the “Company” refer to Aclarion,
Inc.
Overview
Aclarion is a healthcare
technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers,
and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market
with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful
discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine
for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers
demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source
of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain,
giving physicians clarity to optimize treatment strategies.
To date, we have financed
our operations primarily through private placements of preferred shares and debt financing, PPP loans that were forgiven, an equity line,
and an initial public offering on April 21, 2022.
Since our inception we
have incurred significant operating losses. As of December 31, 2023, we had an accumulated deficit of approximately $44.3 million. Our
ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful commercialization and continued
development of our SaaS platform. We expect that our expenses and capital requirements will increase substantially in connection with
our ongoing activities, particularly if and as we:
| |
· |
identify and support Key Opinion Leader (“KOL”) physicians and radiologists to help secure local payer coverage decisions and spine society support for our technology; |
| |
· |
expand the network of imaging centers and physicians using NOCISCAN in each market such that the technology is widely available to patients covered by payers; |
| |
· |
support surgeons, radiologists, Physical Medicine and Rehabilitation physicians, chiropractors, physical therapists, regenerative therapy physicians and medical device companies that address low back pain to initiate studies and report results; |
| |
· |
build and expand clinical trials and registries to provide real world evidence of better outcomes when using Nociscan to help determine which discs to treat; |
| |
· |
pursue value-based care contracts to share in
the profits that result from the improved surgical outcomes we believe our technology enables in DLBP patients;
hire additional business development, product
management, operational and marketing personnel; |
| |
· |
add operational and general administrative personnel which will support our product development programs, commercialization efforts, and our transition to operating as a public company. |
Our primary near-term
growth strategy is to secure payer contracts (including insurance companies, self- insured employers, Medicare, Medicaid, workmen’s
compensation boards et. al.) to cover our Category III CPT codes. We believe that with favorable payer coverage, the Company has the opportunity
to more efficiently engage physicians and imaging centers that will adopt our technology.
As a result, we may need
substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate
significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other
capital sources, which may include collaborations with other companies or other strategic transactions.
As of December 31, 2023,
we had cash of approximately $1.0 million. Subsequent to December 31, 2023, the Company raised capital using an equity line (refer to
Note 17 to our financial statements -- Subsequent Events), and as of February 1, 2024, the Company had approximately $1.5 million of
cash, which we believe will fund our operating expenses and capital expenditure requirements into the second quarter of 2024, up to
our first maturity repayment on our unsecured non-convertible note repayment which is due in April 2024. We have based this estimate
on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity
and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be
assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly
delay, scale back, or discontinue the commercialization or further development of our SaaS platform.
Corporate Information
We were formed under the name Nocimed, LLC, a
limited liability company in January 2008, under the laws of the State of Delaware. In February 2015, Nocimed, LLC was converted into
Nocimed, Inc. a Delaware corporation. On December 3, 2021, we changed our name to Aclarion, Inc. Our principal executive offices are located
at 8181 Arista Place, Suite 100, Broomfield, Colorado 80021. Our main telephone number is (833) 275-2266. Our internet website is www.aclarion.com.
The information contained in, or that can be accessed through, our website is not incorporated by reference and is not a part of this
prospectus.
Results of operations
Operating activities:
The following table summarizes
our results of operations for the twelve months ended December 31, 2023, and 2022.
| | |
Year Ended December 31, | | |
| |
| | |
2023 | | |
2022 | | |
2022 to 2023 | |
| | |
| | |
(restated) | | |
$ Change | |
| Revenue | |
| | | |
| | | |
| | |
| Revenue | |
$ | 75,404 | | |
$ | 60,444 | | |
$ | 14,960 | |
| Cost of revenue | |
| 75,728 | | |
| 65,298 | | |
| 10,430 | |
| Gross profit (loss) | |
| (324 | ) | |
| (4,854 | ) | |
| 4,530 | |
| | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | |
| Operating expenses: | |
| | | |
| | | |
| | |
| Sales and marketing | |
| 757,004 | | |
| 498,003 | | |
| 259,001 | |
| Research and development | |
| 873,336 | | |
| 1,067,992 | | |
| (194,656 | ) |
| General and administrative | |
| 3,245,317 | | |
| 3,990,719 | | |
| (745,402 | ) |
| Total operating expenses | |
| 4,875,657 | | |
| 5,556,714 | | |
| (681,057 | ) |
| | |
| | | |
| | | |
| | |
| Income (loss) from operations | |
| (4,875,981 | ) | |
| (5,561,568 | ) | |
| 685,587 | |
| | |
| | | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | | |
| | |
| Interest expense | |
| (608,288 | ) | |
| (1,507,546 | ) | |
| 899,258 | |
| Changes in fair value of warrant and derivative liabilities | |
| 646,319 | | |
| – | | |
| 646,319 | |
| Loss on issuance of warrants | |
| (72,862 | ) | |
| – | | |
| (72,862 | ) |
| Other, net | |
| (562 | ) | |
| 521 | | |
| (1,083 | ) |
| Total other income (expense) | |
| (35,393 | ) | |
| (1,507,025 | ) | |
| 1,471,632 | |
| | |
| | | |
| | | |
| | |
| Income (loss) before income taxes | |
| (4,911,374 | ) | |
| (7,068,593 | ) | |
| 2,157,219 | |
| Income tax provision | |
| | | |
| – | | |
| | |
| Net income (loss) | |
$ | (4,911,374 | ) | |
$ | (7,068,593 | ) | |
$ | 2,157,219 | |
| | |
| | | |
| | | |
| | |
| Dividends accrued for preferred stockholders | |
$ | – | | |
$ | (415,523 | ) | |
$ | 415,523 | |
| Net income (loss) allocable to common stockholders | |
$ | (4,911,374 | ) | |
$ | (7,484,116 | ) | |
$ | 2,572,742 | |
| Net income (loss) per share allocable to common shareholders | |
$ | (8.82 | ) | |
$ | (19.61 | ) | |
$ | 10.79 | |
| Weighted average shares of common stock outstanding, basic
and diluted | |
| 556,808 | | |
| 381,598 | | |
| 175,210 | |
Years ended December 31, 2023, and 2022
Total revenues. Total revenue for the year
ended December 31, 2023, was $75,404, which was an increase of $14,960 from $60,444 for the year ended December 31, 2022. This increase
was primarily due to growing utilization of Nociscan in third-party clinical studies. Volumes and pricing were generally consistent in
each year.
Cost of Revenue. Cost of Revenue is
comprised of hosting and software costs, field support, UCSF royalty cost, NuVasive commission of 6%, partner fees (Radnet), and credit
card fees. Total Cost of Revenue was $75,728 for the year ended December 31, 2023, compared to $65,298 for the year ended December 31,
2022, an increase of 16.0%. This increase was primarily due to higher year-over-year scan volumes and related Nociscan report output.
Sales and Marketing. Sales and marketing
expenses were $757,004 for the year ended December 31, 2023, compared to $498,003 for the year ended December 31, 2022, an increase of
$259,001 or 52.0%. This increase was driven primarily by additional vesting of restricted stock units to our increased number of Key Opinion
Leaders.
Research and Development. Research
and development expenses were $873,336 for the year ended December 31, 2023, compared to $1,067,992 for the year ended December 31, 2022,
a decrease of $194,656 or 18.2%. This decrease was primarily due to a $123,828 contract milestone payment to UCSF in April 2022, related
to the initial public offering, and reduced expense in 2023 clinical services.
General and Administrative. General and
administrative expenses were $3,245,317 for the year ended December 31, 2023, a decrease of $745,402 or 18.7%, from $3,990,719 for the
year ended December 31, 2022. This decrease in general and administrative expenses was driven primarily by a higher 2022 compensation
expense related to the vesting of the Executive Chairman’s and executive’s outstanding common stock options, offset in part
by higher legal and accounting fees in 2023.
Interest Expense. Total Interest
expense was $608,288 for the year ended December 31, 2023, a decrease of $899,258, from the $1,507,546 for the year ended December
31, 2022. This decrease was driven primarily by the $1.3 million beneficial conversion rate charged to interest expense in 2022 for
the conversion of all accrued interest on the Company’s outstanding secured promissory notes into common shares and common
stock warrants in connection with the April 2022, initial public offering. The 2023 interest expense was primarily due to the
amortization of the note discount associated with the unsecured non-convertible promissory notes described in Note 11 to our
financial statements – Short Term Notes, Convertible Debt, and Derivative Liabilities.
Changes in Fair Value of Warrant and Derivative
Liabilities. In the year ended December 31, 2023, the Company recorded $646,319 of changes in the fair value of the warrant and derivative
liabilities associated with unsecured non-convertible promissory notes described in Note 4 – Fair Value Measurements and Note 11 – Short
Term Notes, Convertible Debt, and Derivative Liabilities to our financial statements.
Other Net Expenses. During the year
ended December 31, 2023, Other Net expenses were $562, which included bank interest, government fees, and realized exchange rate gain
(losses).
Net income (loss). The Company experienced
a net loss of $4,911,374 for the year ended December 31, 2023, compared to a net loss of $7,068,593 for the year ended December 31, 2022.
In general, the year ended December 31, 2023 excluded two significant expenses that were present during the year 2022, that being the
compensation expense related to the vesting of the Executive Chairman’s and other executive’s outstanding common stock options,
and the $1.3 million beneficial conversion rate charged to interest expense for the conversion of all accrued interest on the Company’s
outstanding secured promissory notes into common shares and common stock warrants in connection with the April, 2022,
initial public offering.
Critical accounting
policies and use of estimates
Our Management’s
Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared
in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related
disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses
and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known
trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate
our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.
While our significant
accounting policies are described in more detail in the notes to our financial statements, we believe that the following accounting policies
are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
The Company derives its revenues from one source,
the delivery of Nociscan reports to medical professionals. Revenues are recognized when a contract with a customer exists, and the control
of the promised services are transferred to our customers. The amount of revenue recognized reflects the consideration we expect to receive
in exchange for those services. Substantially all our revenues are generated from contracts with customers in the United States.
Equity-based compensation
The Company accounts for stock-based awards in
accordance with provisions of ASC Topic 718, Compensation—Stock Compensation, under which the Company recognizes the grant-date
fair value of stock-based awards issued to employees and nonemployee board members as compensation expense on a straight-line basis over
the vesting period of the award, while awards containing a performance condition are recognized as expense when the achievement of the
performance criteria is achieved. The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock
options. The Company records expense for forfeitures in the periods they occur.
Until our April 2022 IPO, we were a private company
with no active public market for our common equity. Therefore, we had periodically determined the overall value of our company and the
estimated per share fair value of our common equity at their various dates using contemporaneous valuations performed in accordance with
the guidance outlined in the American Institute of CPA’s Practice Aid. Since a public trading market for our common stock has been
established in connection with the completion of our IPO, the fair value of the Company’s common stock underlying its equity awards
is the quoted market price of the Company’s common stock on the grant date.
Going
Concern
As of December 31, 2023, we had cash of approximately
$1.0 million. Subsequent to December 31, 2023, the Company raised capital using an equity line (refer to Note 17 – Subsequent Events
to our financial statements), and as of February 1, 2024, the Company had approximately $1.5 million of cash, which we believe will fund
our operating expenses and capital expenditure requirements into the second quarter of 2024, up to our first maturity repayment on
our unsecured non-convertible note repayment which is due in April 2024. The Company has based these estimates, however, on assumptions
that may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need
to raise additional funds to continue funding our technology development and commercialization efforts over the following twelve months.
Management has plans to secure such additional funding.
As a result of the Company’s recurring losses
from operations, and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding
the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to
the Company’s ability to continue as a going concern.
Liquidity and capital
resources
Sources of liquidity
To date, we have financed
our operations primarily through private placements of preferred shares and debt financing, PPP loans that were forgiven, an equity line,
and an initial public offering on April 21, 2022.
Through December 31,
2023, we raised an aggregate of $32,603,097 of gross proceeds from $19,319,098 of preferred and common stock, $2,928,541 from the sale
of convertible notes that were later converted to equity, $370,191 of PPP loans that were forgiven, $8,527,318 of net proceeds from the
April 2022 IPO, and $1,457,949 of net proceeds from an equity line.
We issued a $2,000,000
promissory note in June 2021 that was repaid in April 2022.
On May 16, 2023, the
Company entered into a securities purchase agreement with accredited investors for an unsecured non-convertible note financing. The Company
received $1,250,000 of gross proceeds, with out-of-pocket issuance costs of $203,575. On September 1, 2023, the Company closed the second
tranche of this financing. The Company received an additional $750,000 of gross proceeds, with out-of-pocket issuance costs of $92,738.
On November 1, 2023, the Company entered into a securities purchase agreement with accredited investors for an unsecured non-convertible
note financing. The Company received an additional $250,000 of gross proceeds, with out-of-pocket issuance costs of $65,363.
Subsequent to December
31, 2023, the Company entered into a series of Exchange Agreements with accredited investors and issued additional common shares using
the equity line. See Note 17 – Subsequent Events to our financial statements for more information.
As of December 31, 2023,
we had cash, including $10,000 of restricted cash, of $1,031,069. As of February 1, 2024, the Company had approximately $1.5 million
of cash, which we believe will fund our operating expenses and capital expenditure requirements into the second quarter of 2024, up
to our first maturity repayment on our unsecured non-convertible note repayment which is due in April 2024. Management is actively
managing our cash position and working to secure longer-term funding in the first quarter of 2024.
Cash flows
The following table summarizes
our sources and uses of cash for each of the periods presented:
| | |
Year Ended December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
(restated) | |
| Cash used in operating activities | |
$ | (3,646,947 | ) | |
$ | (4,949,112 | ) |
| Cash used in investing activities | |
| (119,522 | ) | |
| (207,870 | ) |
| Cash provided by financing activities | |
| 3,314,732 | | |
| 6,187,258 | |
| Net increase (decrease) in cash and cash equivalents | |
$ | (451,737 | ) | |
$ | 1,030,276 | |
Operating activities
During the year ended December 31, 2023, net cash
used in operating activities was $3,646,947. This use of cash consisted primarily of compensation and benefit expense, officers’
liability insurance, consulting, tax and audit fees, and maintain our quality system. Cash outlays in the year 2023 were relatively lower
than the year 2022 due to longer procure-to-pay cycles. During the twelve months ended December 31, 2022, operating activities used $4,949,112,
consisting primarily of compensation and benefit expense, consulting, and professional fees.
Investing activities
During the year ended December 31, 2023, and 2022,
investing activities used $119,522 and $207,870 of cash, respectively. These investing activities consisted almost entirely of patent
and license maintenance.
Financing activities
During the year ended December 31, 2023, net cash
provided by financing activities was $3,314,732, which included $2,250,000 of proceeds from unsecured non-convertible note financings,
1,462,949 of proceeds from an equity line, and $398,217 of cash issuance costs related to both the equity line and debt. During the year
ended December 31, 2022, net cash provided by financing activities was $6,187,258, which included $8,552,318 of initial public offering
proceeds (net of underwriter compensation and deductions but excluding $25,000 pre-payment in 2021), $2,000,000 repayment of promissory
notes, and $365,060 of IPO issuance costs.
Funding requirements
Developing medical technology
products is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate meaningful revenues.
Accordingly, we may need to obtain substantial additional funds to achieve our business objectives.
Adequate additional funds
may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity securities,
current stockholders’ ownership interests may be diluted. Any debt or preferred equity financing, if available, may involve agreements
that include restrictive covenants that may limit our ability to take specific actions, such as incurring additional debt, making capital
expenditures, or declaring dividends, which could adversely impact our ability to conduct our business, and may require the issuance of
warrants, which could potentially dilute existing stockholders’ ownership interests.
If we raise additional
funds through licensing agreements and strategic collaborations with third parties, we may have to relinquish valuable rights to our technology,
future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are
unable to raise additional funds, we may be required to delay, limit, reduce and/or terminate development of our product candidates or
any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop
and market ourselves.
Contractual obligations and commitments
Our prior office lease and sublease expired on
June 30, 2022. The Company does not have any contractual obligations not otherwise on our balance sheet as of December 31, 2023.
Off-balance sheet
arrangements
We did not have, during
the periods presented, and we do not currently have any off-balance sheet arrangements as defined in the rules and regulations of the
Securities and Exchange Commission (“SEC”).
Recently issued accounting
pronouncements
We have reviewed all
recently issued standards and have determined that, other than as disclosed in Note 2 to our financial statements appearing at the end
of this prospectus, such standards will not have a material impact on our financial statements or do not otherwise apply to our
operations.
Emerging growth company
and smaller reporting company status
The JOBS Act permits
an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards
applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected not to “opt
out” of this extended transition period and, as a result, we will not adopt new or revised accounting standards on the relevant
dates on which adoption of such standards is required for public entities. Accordingly, our financial statements may not be comparable
to other public companies that do not elect the extended transition period.
We are also a “smaller
reporting company” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue
was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either
(i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million
during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If
we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from
certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may
choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar
to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Interest rate sensitivity
We had cash and restricted cash totaling $1,031,069
as of December 31, 2023. These amounts are invested primarily in demand deposit accounts and money market funds. We consider all highly
liquid debt instruments purchased with a maturity of three months or less and SEC-registered money market mutual funds to be cash equivalents.
The primary objectives of our investing activities are capital preservation, meeting our liquidity needs and, with respect to investing
client funds, generating interest income while maintaining the safety of principal. We do not enter into investments for trading or speculative
purposes.
Our cash equivalents are subject to market risk
due to changes in interest rates. The market value of fixed rate securities may be adversely affected due to a rise in interest rates,
while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future
investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if we are forced
to sell securities that decline in market value due to changes in interest rates.
Business
Overview
Aclarion is a healthcare technology company that
leverages Magnetic Resonance Spectroscopy (“MRS”), and proprietary biomarkers to optimize clinical treatments. Aclarion’s
technology addresses the $134.5B U.S. low back and neck pain market, which according to a 2020 JAMA (Journal of the American Medical Association)
article is now the most costly healthcare condition in the United States. The Company is currently utilizing Artificial Intelligence (“AI”)
to assist in quality control processes that flag spectroscopy data indicative of a poor MRS study. The use of AI in this application is
early in its development cycle and is expected to evolve with further research and development. The Company is capturing in databases
both the raw spectroscopy data and the post-processed spectral data from every Nociscan completed in order to utilize this data as future
training data to teach a machine learning algorithms to associate MRS data with clinical outcomes. The use of AI in this application is
aspirational and we intend this type of AI research and development to be an ongoing process applied not only to the various treatment
paths associated with back pain, such as conservative therapies, regenerative and cell therapies and surgical intervention, but also to
potentially expand into other clinical explorations involving the diagnosis of brain, breast and prostate tumors.
The Company, which has limited sales to date, is
addressing the chronic low back pain market by initially focusing on improving the outcomes of surgical interventions to treat chronic
discogenic low back pain. In this initial application, Aclarion technology is intended to assist surgeons in determining the optimal surgical
procedure for a patient undergoing surgery for pain isolated to their lumbar spine (the “lumbar spine” is comprised of the
five (5) lower vertebrae, L-1 to L-5). Through clinical studies we intend to extend the application of our technology beyond surgical
decisioning to help with managing large segments of low back pain patients from the point of initial MRI through to episode resolution.
We believe this will expand the use of our technology to supporting treatment decisions for chronic low back pain patients undergoing
conservative therapies such as physical therapy or biologic and cell therapies aimed at regenerating the lumbar discs. We plan to expand
the application of our technology beyond the lumbar spine to address neck pain populations in addition to low back pain populations. To
expand the application of our technology for use in neck pain populations, we will need to overcome technical changes associated with
securing adequate MRS data from the cervical disc, which is significantly smaller than the lumbar disc, and there can be no assurance
the Company will be able to overcome these challenges.
The core technology Aclarion employs is MR Spectroscopy.
The patient experience when undergoing an MRS exam is exactly like that of a standard MRI, with the exception of an additional 3-5 minutes
for each disc undergoing a spectroscopy exam. Whereas a standard MRI produces a signal that is converted into anatomical images, an MRS
produces a signal that is converted into a waveform that identifies the chemical composition of tissues. Just like with standard MRIs,
the data from spectroscopy is useless without technologies that can process the data. Aclarion has developed proprietary signal processing
software that transforms spectroscopy data into clear biomarkers. These biomarkers, which are exclusively licensed from the Regents of
University of California, San Francisco (“UCSF”), are the key data inputs for our proprietary algorithms that, when applied,
determine if an intervertebral disc is consistent with pain. Our patent portfolio includes 22 U.S. Patents, 17 Foreign Patents, 6 pending
U.S. patent applications, and 7 pending Foreign patent applications, including patents and patent applications exclusively licensed from
Regents of the University of California.
We believe one of the biggest issues driving the
cost of treating low back and neck pain patients to the top of the list for healthcare spending is that there is no objective, cost effective
and noninvasive diagnostics to reliably identify the source of a patient’s pain. We believe the poor surgical outcomes for chronic
DLBP are largely due to difficulties in reliably and accurately diagnosing the specific spinal discs that are causing pain. The current
primary diagnostic standard is the MRI, which is useful for showing abnormal structures and tissue dehydration, but, we believe, cannot
reliably identify specific discs that are causing pain. To diagnose specific discs that are causing pain, a needle-based Provocation Discogram
test (“PD Test”) has been developed. PD Tests have been shown to be highly accurate when performed properly. However, a PD
Test is invasive, subjective, and unpleasant for the patient as the patient needs to be awake in order to tell the physician if the pain
the physician is purposefully causing in the disc is the same as the pain the patient feels when they are experiencing a back pain episode.
In addition, recent evidence has shown that the action of inserting a needle into a normal disc during a discogram procedure leads to
an increased rate of degeneration in these previously normal discs. Based on the limitations and concerns of the PD Test, we believe there
is a significant need for an objective, accurate, personalized, and noninvasive diagnostic test that can reliably determine if an individual
disc is a pain generator. By providing physicians information about whether a disc has the chemical and structural makeup consistent with
pain or not, we believe the treatment plan for each patient will lead to more efficient and targeted care that, will in turn, result in
lower costs and healthier patient outcomes.
Aclarion has taken the first steps to demonstrate
the potential use of our technology in helping to improve the outcome of surgical intervention for discogenic low back pain patients by
publishing a clinical study in the European Spine Journal in April 2019. The study illustrated that when all discs identified as consistent
with pain by our technology were included in a surgical treatment, 97% of the patients met the criteria for “clinical improvement”.
This compared to only 54% of patients meeting the criteria for clinical improvement if a disc that our technology identified as consistent
with pain, was not included in the surgical treatment.
In April 2023, Aclarion advanced the evidence
of our technology with a peer-reviewed journal article detailing the Gornet 2-year outcomes published in the European Spine Journal. The
2-year outcomes were durable with 1-year outcomes previously published in 2019. At 2-years follow-up, 85% of patients improved when disc(s)
identified as consistent with pain by our technology were included in a surgical treatment, compared to only 63% of patients when disc(s)
identified as consistent with pain were not treated or disc(s) identified as consistent without pain were treated.
The results of the 2019 published study led the
CPT committee to approve four Category III codes for our technology in January 2021. The NIH also included our technology as one of the
handful of technologies selected to participate in their $150 million Back Pain Consortium (BACPAC) Research Program, an NIH translational,
patient-centered effort to address the need for effective and personalized therapies for chronic low back pain. In 2022, the NIH subsequently
selected our technology to be included in their prospective randomized follow-on study that resulted from BACPAC. This new study is called
Biomarkers for the Evaluation of Spinal Treatments (BEST) and is designed to evaluate several technologies that provide data about a patient
to see if these technologies can identify subgroups of chronic LBP patients that do better with one of four treatments being evaluated
in the study.
Evolving science coupled with the understanding of
degenerative painful discs has suggested that lumbar discs may become painful due to certain chemical changes, which changes cannot be
identified using standard lumbar MRI imaging. However, an application of MRI scanners called Magnetic Resonance Spectroscopy has been
developed by manufacturers of MRI equipment. MRSs are different than MRIs. An MRI generates images of body structures, while an MRS analyzes
the relative amounts of various chemicals in body tissues.
Aclarion has developed a software application called
NOCISCAN® which uses the existing MRS capabilities of many commercially available scanners to non-invasively analyze the chemical
makeup of intervertebral discs in the spine. The software post-processes the MRS exam data and detects the presence of chemical biomarkers
that we, in conjunction with spine researchers at UCSF, have demonstrated to be associated with degenerative pain and structural integrity
of the lumbar discs. After processing the MRS exam data, we send the ordering clinician a report that details how to interpret the results
of the MRS exam. We believe these results help clinicians make quicker and more informed decisions about which lumbar discs are painful,
and which are not. We believe the ordering clinician can use this information to determine the optimal treatment plan for an individual
patient.
Because we believe that spectroscopy is not widely
used for any clinical purposes today, there are practical limitations to the market opportunity that must be addressed. We believe the
two biggest limitations may be the lack of deployment of spectroscopy software across the installed base of existing MRIs worldwide, and
the fact that only certain MR scanner models are compatible with our technology. For compatible MRI sites that do not currently have spectroscopy
software installed, the onetime cost of the software ranges from $25,000 to $50,000. Currently, our NOCISCAN platform is only compatible
with certain MR scanner models provided by SIEMENS, of which there are an estimated 1,500 in the United States, and 4,320 worldwide. We
plan to collaborate with other MRI scanner vendors, as well as SIEMENS, to establish compatibility with their respective scanners and
MRS capabilities for use with our products. That may allow us to include discounted pricing on spectroscopy software for MRI sites interested
in providing DLBP patients with the NOCISCAN offering.
The first application of Aclarion’s technology
is focused on improving surgical decision making when surgical intervention is being contemplated for patients with low back pain. The
Company’s first commercial product, which we have named “NOCISCAN”, utilizes our proprietary biomarkers and algorithms
to provide surgeons with information about which intervertebral discs are determined to be consistent with generating pain, and which
are not. We believe that surgeons can use this information to better plan their surgical treatments and improve outcomes in their patients.
In a clinical study published in the European Spine Journal in April 2019 it was shown that in patients where all discs identified as
painful by NOCISCAN were included in the surgical treatment that 97% of those patients met the criteria for significant clinical improvement.
This compared to only 54% of surgical patients meeting the criteria for significant clinical improvement when discs identified as painful
by NOCISCAN were omitted from the surgical treatment, or discs identified as not painful by NOCISCAN were included in the treatment. Some
authors of this study had a financial relationship with Aclarion, who sponsored the study.
In April 2023, Aclarion advanced the evidence
of our technology with a peer-reviewed journal article detailing the Gornet 2-year outcomes published in the European Spine Journal. The
2-year outcomes were durable with 1-year outcomes previously published in 2019. At 2-years follow-up, 85% of patients improved when disc(s)
identified as consistent with pain by our technology were included in a surgical treatment, compared to only 63% of patients when disc(s)
identified as consistent with pain were not treated or disc(s) identified as consistent without pain were treated.
Based on the results of this clinical study, the
Company believes that use of NOCISCAN could become the standard protocol for assisting in the treatment plan of patients with low back
pain undergoing surgical intervention. Utilizing the results of our European Spine Journal Study, we applied to the American Medical Association
for CPT codes to begin the process of securing insurance coverage to pay for NOCISCAN. On January 1, 2021, Category III CPT codes became
effective. The Company is now executing its plan to commercialize NOCISCAN. See “Reimbursement” below.
The core technology underlying NOCISCAN is the
use of MR spectroscopy to identify the chemical makeup of intervertebral discs with a focus on identifying specific proprietary biomarkers
known to be correlated to pain and to the structural degradation of discs. We believe this technology, in combination with advanced machine
learning and AI platforms, has the potential to not only become included in the standard of care for patients undergoing surgical intervention
for low back pain, but to become a core data input for optimally managing entire segments of patients suffering from low back and neck
pain.
Industry Overview
Low Back Pain
According to the Global Burden of Disease Study
2017, low back pain (LBP) is among the top three causes for years lived with disability. A 2020 JAMA (Journal of the American Medical
Association) article established the cost of low back and neck pain at $134.5B in the U.S, making it the most costly healthcare condition
in the United States, surpassing cardiac disease, diabetes and cancer.
Low back pain (LBP) can
be caused by many different problems and abnormalities along and around the spine, other than DLBP, including conditions such as spondylolisthesis
or instability of the vertebral bodies, vertebral body fractures, facet pathologies, central canal and foraminal stenosis, disc herniations,
pars fracture, congenital abnormalities and tumors. Many of the causes of low back pain are readily detected by standard MRI imaging of
the spine, which reveals clear structural abnormalities, i.e., fractures and tumors. However, in many cases the source of the pain is
not clear. As a result, the success rates of surgical care for LBP ranges from 41 to 57%, with 5-16% early complication and reoperation
rates also reported.
We believe that poor
surgical outcomes for discogenic LBP are largely due to difficulties in reliably and accurately diagnosing the specific spinal discs that
are causing pain. The current primary diagnostic standard, lumbar MRI, is useful for showing abnormal structures and tissue dehydration,
but, we believe, cannot reliably identify specific discs that are causing pain. To diagnose specific discs that are causing pain, a needle-based
Provocation Discogram test (“PD Test”) has been developed. A PD Test has been shown to be highly accurate when performed properly.
However, a PD Test is invasive, subjective and unpleasant for the patient, as the patient is required to be awake in order to tell the
physician if the pain the physician is purposefully causing in the disc is the same as the pain the patient feels when they are experiencing
a back pain episode. In addition, recent evidence has shown that the action of inserting a needle into a normal disc during PD Test, leads
to an increased rate of degeneration in these previously normal discs.
Due to the current lack
of uniform acceptance of a diagnostic platform to safely and reliably diagnose the specific discs that cause DLBP, patients with DLBP
are faced with the options of surgical intervention with a risk of a poor surgical outcomes, or, non-surgical treatment with powerful
pain killing drugs, such as opiates and synthetic opiates. Those patients who choose surgery and have a poor surgical outcome with no
surgical alternatives will be faced with the possibility of enduring disabling, intractable pain, and often extended dangerous pain medication
use.
Diagnostic Imaging
Diagnostic imaging involves
the use of non-invasive procedures to generate representations of internal anatomy and function that can be recorded on film or digitized
for display on a video monitor. Diagnostic imaging procedures facilitate the early diagnosis and treatment of diseases and disorders and
may reduce unnecessary invasive procedures, often minimizing the cost and amount of care for patients. Diagnostic imaging procedures include
MRI, CT, PET, nuclear medicine, ultrasound, mammography, X-ray and fluoroscopy.
While X-ray remains the
most commonly performed diagnostic imaging procedure, one of the fastest growing procedures is the MRI. The number of MRI scans performed
annually in the United States continues to grow due to its wider acceptance by physicians and third party payers, an increasing number
of applications for their use and a general increase in demand due to the aging population. MRI has long been a widely accepted diagnostic
standard of care for spine and low back pain, including discogenic low back pain patients, which is the target medical condition for our
diagnostic products.
Diagnostic Imaging
Settings
Diagnostic imaging services
are typically provided in one of the following settings:
Fixed-site,
freestanding outpatient diagnostic facilities
These facilities range
from single-modality to multi-modality facilities and are generally not owned by hospitals or clinics. These facilities depend upon physician
referrals for their patients and generally (although not always) do not maintain dedicated, contractual relationships with hospitals or
clinics. In fact, these facilities may compete with hospitals or clinics that have their own imaging systems to provide services to patients.
These facilities bill third-party payers, such as managed care organizations, insurance companies, Medicare or Medicaid, and workers’
compensation providers.
Hospitals
Many hospitals provide both inpatient and outpatient
diagnostic imaging services, typically on site or at a dedicated center located on or nearby the hospital campus. These can be owned and
operated by the hospital and provide imaging services to inpatients as ordered or outpatients through physician referrals. The hospital
normally bills third-party payors such as managed care organizations, insurance companies, Medicare or Medicaid, and workers’ compensation
providers. We have entered into joint ventures with certain hospitals both provide and manage their diagnostic imaging services, allowing
them to leverage our industry expertise.
Mobile
Imaging
While many hospitals
own or lease their own equipment, certain hospitals provide diagnostic imaging services by contracting with providers of mobile imaging
services. Using specially designed trailers, mobile imaging service providers transport imaging equipment and provide services to hospitals
and clinics on a part-time or full-time basis, thus allowing small to mid-size hospitals and clinics that do not have the patient demand
to justify fixed on-site access to advanced diagnostic imaging technology. Diagnostic imaging providers contract directly with the hospital
or clinic and are typically reimbursed directly by them. We do not provide mobile imaging services. The cloud-based software products
and services we do provide, however, are compatible for use for post-processing data that may be acquired by certain MR scanners that
are deployed in a mobile imaging setting and model.
Company History
Aclarion’s technology was originally invented,
and initially tested, via successful proof of concept by Aclarion co-Founder and head of our Scientific Advisory Board, Jeffrey Lotz,
PhD, at the University of California San Francisco (“UCSF”). Early research, which was published in a major peer-reviewed
journal in 2005, was premised upon a growing suspicion and interest that discs may become painful due to chemical changes, in particular
elevated acidity related to hypoxia, that are not tested using a standard MRI. With that theory in mind, Dr. Lotz’s initial study
looked to identify chemical biomarkers for painful discs using MRS, which applies a pulsed magnetic field to tissues in order to vibrate
the different chemicals in that tissue and generate a spectrum that allows for measuring those different chemicals based on their different
peaks along that spectrum. NMR equipment was used to conduct MRS chemical analysis of painful discs that were surgically removed for DLBP
fusion surgery versus normal, non-painful discs that were surgically removed from spinal deformity (i.e. scoliosis) patients for lumbar
spine reconstruction. Those ex vivo 11T MRS spectral measurement results showed that all (n=9) of the painful discs were distinguished
from all of the non-painful discs based on the highly repeatable (100%) differences in their ratios between lactic acid, a painful chemical
resulting from hypoxia, and proteoglycan, a structural chemical of the disc that holds water for hydration. It was observed that with
degenerative painful discs, proteoglycan reduces with the degeneration, and lactic acid elevates with the pain. Hence, the MRS-based test
and identifiable structural and degenerative pain biomarkers were able to be identified.
This work became the subject of the first patent granted
to the Regents of the University of California and exclusively licensed to Aclarion. Thereafter, a strategic collaboration with SIEMENS,
a major MRI equipment manufacturer, was initiated and a clinical study, the Gornet Study, involving 73 surgical patients was published
in the European Spine Journal, a major peer-reviewed publication (See “Clinical Evidence” below). Our NOCICALC and NOCOGRAM
products were subsequently registered with the FDA, CE marked and launched in the US, EU, and UK markets through a customer pay model
since insurance codes were not yet in existence.
License Agreement with the Regents of the University of California
On January 8, 2008, the Company entered into an
Exclusive License Agreement which was amended and restated on December 9, 2014, (the “License Agreement”) with the Regents
of the University of California, and was further amended on March 31, 2017. The License Agreement
encompassed certain intellectual property and patents covering inventions generally characterized as systems, materials, and methods to
localize and evaluate pain and degenerative properties of tissue, molecular markers that differentiate painful from non-painful discs;
and MR Spectroscopy System and Method for diagnosing painful and non-painful intervertebral discs.
Pursuant to the License Agreement, the Company
obtained a worldwide, exclusive license to intellectual property including certain patent rights related to the patents and technology
which the Company utilizes. Under the License Agreement, we agreed to pay a royalty fee of 4% (subject to reduction to a minimum of 2%
of net sales, in the event the Company pays a royalty on revenues to a third party) of net sales of the licensed products or technology
and 10% of gross revenues we may receive from possible sub-licensees, affiliates or joint venture partners. Additionally, we agreed to
pay a minimum annual royalty fee of $50,000, accountable against actual earned royalties, plus other costs and expenses related to the
prosecution of existing or future patents related to the technology, and certain additional one-time fees that were contingent upon the
occurrence of certain defined milestones.
The License Agreement also provides that for so
long as we pay patent prosecution costs, the Regents of the University of California will diligently prosecute and maintain the United
States and foreign patents comprising the Patent Rights using counsel of its choice, and the UC Regents' counsel will take instructions
only from The Regents of the University of California.
Upon completion of our April 2022 IPO, we were
required to pay the Regents of the University of California a contingent one-time “Indexed Milestone Payment” of an amount
of cash determined by multiplying the amount of shares outstanding at such time the Company raises $1 million in capital, by 3% and then
multiplying the 3% number by the IPO price. On May 2, 2022, we paid the amount of $123,828 to satisfy the Indexed Milestone Payment obligation
included within the license agreement.
The Regents of the University of California has
the right to terminate the License Agreement upon advanced notice in the event of a default by us. The License Agreement will expire upon
the expiration or abandonment of the last of the licensed patents. The patents subject to the License Agreement expire between 2025 and
2029.
We rely on this license, as well as other aspects
of our own patented technology and intellectual property, in order to be able to use and sell various proprietary technologies that are
material to our business, as well as technologies which we intend to use in our future commercial activities. Our rights to use these
licensed technologies and the inventions claimed in the licensed patents, are subject to the continuation of, and our compliance with
the terms of the license. The loss of this license would materially negatively affect our ability to pursue our business objectives and
result in material harm to our business operations.
Transactions with NuVasive, Inc.
In 2015, NuVasive, Inc. (“NuVasive”)
purchased approximately $2.0 million of the Company’s Series B preferred shares. NuVasive and the Company also entered into a marketing
agreement pursuant to which NuVasive would be the exclusive, other than the Company, marketing provider for the Company’s technology
and NuVasive would receive a commission (the “Commission”) of all sales of the technology made by NuVasive. In conjunction
with the marketing agreement, the Company entered into a Right of First Offer (“ROFO”) Agreement pursuant to which the Company
agreed that in the event that the Company determined to enter into a sale event (defined to include a sale of 50% or more of the Company’s
outstanding voting securities, a sale of substantially all of the Company’s assets, or a sale or exclusive license of substantially
all of the Company’s intellectual property) NuVasive would have the right to receive notice (“ROFO Notice”), and NuVasive
would have a 60-day period to determine whether it wanted to acquire the Company on terms set forth in the ROFO Notice. The ROFO obligations
will expire 42 months after the FDA issues its first regulatory clearance of a Company product or service. The ROFO obligations do not
apply to any proposed sale event in which the acquisition price is $40 million or more.
In February 2020, NuVasive agreed to purchase
$308,720 of convertible notes, convertible into Series B-1 preferred shares and in connection with such purchase, was issued a warrant
to purchase 171,511 shares of common stock at an exercise price of $.18 per share.
In February 2020, NuVasive and the Company also
entered into an amended and restated commission agreement (the “Commission Agreement”), pursuant to which the Company agreed
to pay NuVasive a commission of 6% of certain revenues of the Company related to Aclarion’s Nociscan technology through December
31, 2023, and issued to NuVasive the right to receive the Company’s preferred shares subject to the terms of a $2 million “SAFE”
(Simple Agreement for Future Equity). The SAFE provided that NuVasive would receive $2 million of capital stock if the Company would raise
a minimum of $10.0 million of new capital on or before December 31, 2020, which was later extended to June 30, 2021. If the $10.0 million
was not raised, the Company would issue to NuVasive 1,584,660 Series B-2 preferred shares. The $10.0 million was not raised and the Company
issued 1,584,660 Series B-2 preferred shares to NuVasive in December 2021. In connection with the Commission Agreement, NuVasive agreed
that: (i) NuVasive would cease to market the Company’s technology, (ii) NuVasive would reduce their Commission to 6%, and (iii)
Commissions to NuVasive would terminate on December 31, 2023. In December 2021, NuVasive’s convertible notes were converted into
Series B-3 preferred shares.
Products and Solutions
Aclarion has developed a software application called
NOCISCAN®. The product uses the existing MRS capabilities of many commercially available scanners to non-invasively analyze the chemical
makeup of intervertebral discs in the spine. The software post-processes the MRS exam data and detects the presence of chemical biomarkers
that Aclarion, in conjunction with spine researchers at UCSF, have demonstrated to be associated with degenerative pain and structural
integrity of the lumbar discs. After processing the MRS exam data, Aclarion sends the ordering clinician a report that details how to
interpret the results of the MRS exam. We believe these results help clinicians make faster and more informed decisions about which lumbar
discs are painful, and which are not. We believe the ordering clinician can then use this information to determine the optimal treatment
plan for an individual patient.
NOCISCAN is entirely non-invasive and only briefly
extends an otherwise standard MRI exam. The MRI scan is the most frequently used type of pulse sequence for operating Nuclear Magnetic
Resonance (NMR) scanners. It uses a powerful magnet to apply a pulsed magnetic field to a patient, sensors to detect radio waves that
emanate from the resonant vibrations of different chemicals in the body in response to that pulsed magnetic field and a computer to create
detailed images of tissue structures in the patient based on those detected chemical signals. Because water and fat are the most prevalent
chemicals in the body, standard MRI images are typically based on the different levels of water and fat between different tissues. MRS,
however, is another type of pulse sequence that uses NMR scanners in a similar way as an MRI, but instead of using the chemical resonances
to create an image, MRS creates a spectrum for a tissue with different peaks that represent many different chemicals, in addition to water
and fat, in that tissue. The relative amounts of those chemicals can be calculated by measuring their respective spectral peaks. While
MRS has been used previously for diagnosing certain cancers (e.g. brain, breast, prostate) by measuring unique chemical biomarkers for
tumors, NOCISCAN uses MRS for measuring the relative levels of degenerative pain and structural integrity biomarkers in discs. The relative
levels of degenerative pain and structural integrity biomarkers are derived through the use of proprietary post processing technologies.
The platform used to conduct
a NOCISCAN involves: (i) an MRS exam of an intervertebral disc performed according to a proprietary protocol, (ii) a data transfer portal
to securely transfer data from the MRS exam to Aclarion’s cloud based post-processer technology, (iii) post-processor technology
that identifies biomarker peaks and leverages calculation tables that evaluate a number of ratios of biomarker peaks, where pain biomarkers
are in the numerator and structural biomarkers are in the denominator, and (iv) a final diagnostic report called a Nocigram that identifies
discs as painful or not.
(a) NOCISCAN
MRS Exam Protocol: We have developed a custom software protocol and technique for using commercially available MRS pulse sequences
in scanning intervertebral discs which extends the time of a standard lumbar MRI exam by an average of about 30 minutes for 5 lumbar discs.
The custom protocol is a proprietary series of settings and instructions for MRS to conduct the NOCISCAN exam to obtain optimal and
reliable MRS data. This protocol is not a product sold by the Company. The software protocol was created by Aclarion for insertion within
a pre-existing software file format and is downloaded onto the MRS by the MRS owner, for use within the MRS’s operating system environment.
Currently, our software protocol is compatible with only certain MRS models and operating systems available from SIEMENS, as those SIEMENS
models specifically provide for user-defined customizations available for running our custom pulse sequences on SIEMENS MRS equipment.
(b) Data
Transfer: Data is routinely transferred from MR scanners to externally hosted cloud post-processors in many settings and applications,
with an existing market of products and protocols for doing so. Aclarion provides MR imaging providers two options for data transfer:
(1) a licensed proprietary imaging data transfer platform provided by AMBRA® Health, and (2) NOCIWEB®, a custom developed web-interface
developed and offered by Aclarion.
(c) The
NOCISCAN Post-Processor Suite: This comprises the products that Aclarion currently markets and sells. The post-processor technology
requires MRS exam data acquired only according to Aclarion’s proprietary MRS exam protocols described in (a) above. The NOCISCAN
Post-Processor Suite comprises of two software products that interact with each other:
| |
· |
NOCICALC® receives the raw un-processed NOCISCAN
MRS exam data and post-processes that raw data into final spectra, and performs various degenerative pain biomarker calculations from
those spectra, for each disc examined. NOCICALC is Registered as a Class I Medical Device with the FDA. |
| |
· |
NOCIGRAM® further processes the NOCICALC results into
individual NOCISCORES, on a 0-10 scale, that represent the different relative levels of degenerative pain biomarkers the various discs
examined in the patient. High/low NOCISCORE ranges are also correlated to painful (indicated as “NOCI+” result) versus non-painful
(indicated as a “NOCI-result). The NOCISCORE scale was developed according to a reference PD TEST that was used as a standard control
in a peer reviewed clinical development trial for our technology. The post-processed MRS results are shown in an intuitive NOCIGRAM
report with reference to certain MRI images of the related patient’s lumbar spine. The NOCIGRAM report is provided to the physician
to aide in the physician’s diagnosis and treatment planning. NOCIGRAM is commercially available in the United States as “Clinical
Decision Support Software” under the 21st Century Cures Act, and as such is not considered a medical device nor regulated
by the FDA. |
Advantages over current technology and procedures
NOCISCAN provides new information to help doctors
better diagnose which intervertebral discs may contribute to patients back pain and thereby assist in treatment planning and potentially
improve patient outcomes.
More specifically, current standards of care for
the diagnostic workup of LBP include lumbar X-Ray and MRI and less prevalently, needle-based provocative discography testing (PD Tests).
While lumbar X-Ray and MRI can show various pathologic structural abnormalities and degeneration and can be helpful for diagnosing certain
non-discogenic sources of pain, these techniques are unreliable for identifying painful discs in LBP patients. The PD TEST is another
test that typically follows MRI for the purpose of identifying painful discs. PD Tests have been shown to be highly accurate when performed
properly, however, a PD Test is invasive, subjective and unpleasant for the patient as the patient needs to be awake in order to tell
the physician if the pain the physician is purposefully causing in the disc is the same as the pain the patient feels when they are experiencing
a back pain episode. In addition, recent evidence has shown that the action of inserting a needle into a normal disc during a discogram
procedure leads to an increased rate of degeneration in these previously normal discs. We believe NOCISCAN advantages include: (a)
enhancing the ability and value of otherwise standard lumbar MRI exams to, for the first time, reliably identify chemically painful discs
causing DLBP; and (b) providing a “Virtual Discogram™” as an entirely non-invasive, objectively quantitative, pain-free,
non-significant risk, and more widely adoptable alternative to needle-based PD exams (which share none of those advantages).
More specifically, NOCISCAN offers many specific
advantages to the marketplace, from a diagnostic point of view, including:
| |
1) |
Readily and widely adoptable; |
| |
4) |
Nonsignificant risk to patients; |
| |
5) |
Objective, quantitative diagnostic information; |
| |
6) |
Enhances the diagnostic value of MR exams for painful disc diagnosis in DLBP patients; |
| |
7) |
Correlative to the modern standard and accurate technique of PD diagnostic exams
for DLBP diagnosis - but without the invasive, painful, subjective, potentially harmful, and limited adoptability shortcomings of PD; |
| |
8) |
First and only known ability to non-invasively assess degenerative painful disc
chemistry; |
| |
9) |
More informed ability to reliably diagnose painful vs. non-painful discs; |
| |
10) |
More informed ability to predict the potential for ASD to develop or advance in
discs next to neighboring discs that are initial surgical targets; |
| |
11) |
More informed ability to reliably diagnose actual ASD in discs following a prior
surgery in neighboring discs; |
| |
12) |
Potential for improved patient outcomes in DLBP patients resulting from more informed
diagnostic acuity for painful vs. non-painful discs and related targeted treatment planning; and |
| |
13) |
The only known non-invasive disc chemistry measurement and monitoring tool to support
clinical research, development, and evaluation of new therapies, e.g. injectable biologics/cell therapies, that have therapeutic mechanisms
of action related to disc chemistry interactions and changes. |
NOCISCAN incorporates many patented technologies
and features that we believe provide several technical advantages to the MRS field in general. Prior applications of MRS, e.g. for brain,
prostate, or breast cancer diagnosis encountered technical challenges related to acquiring reliably robust spectra for making accurate
quantitative chemical measurements. These technical challenges resulted in poor sensitivity and specificity for prior MRS products addressing
clinical applications. The novel features and advantages provided in the NOCISCAN platform are designed to address the technical and
diagnostic challenges of MRS in the past. Accordingly, we believe Aclarion improvements do not only propose benefits for disc MRS, but
potentially for other MRS applications more broadly. Improvements in processing raw MRS data incorporated in Aclarion IP are summarized
below:
| |
1) |
Introducing novel signal processing approaches for enhanced
reliability of the underlying spectra and related chemical biomarker ‘peak’ measurements: |
| |
a) |
increased signal noise ratio or “SNR” for more
reliably identifying and measuring chemical peaks - in particular, by averaging spectra from multiple acquisitions using (i) only strong
acquired signals and filtering out weak ones (“frame editing”), and (ii) a “smart” form of frequency shift correction
to align multiple acquisitions for “coherent” averaging; and |
| |
b) |
detecting spectral artifacts that might compromise the reliability
of spectral peak measurements and related chemical measurements, and which can occasionally result from technical issues during MRS exams
in the scanner (generally observed in <10% of discs), and then either: (i) correct for the artifact (e.g. patient motion artifact correction),
or (ii) identify the compromised MRS acquisition as a technical failure and unable to perform reliable spectroscopic measurement (i.e.,
occasionally supplanting a risk for inaccurate diagnosis instead of a technical failure and indeterminate diagnostic result). |
| |
2) |
Basing diagnostic results on relative, normalized comparisons
of the differences between chemical biomarkers for multiple different disc tissues in the same patient vs. assigning diagnostic thresholds
for chemical measurements that are empirically derived from a separate clinical trial patient population and are not patient specific. |
| |
3) |
Evaluating only multi-chemical “degenerative pain”
biomarkers that use ratios between spectral peaks for chemicals associated with (i) pain and (ii) structural degeneration, thus providing
for: (a) a two-fold and bi-directional sensitivity in the combined biomarker from both the ratio’s numerator (pain biomarker) and
its denominator (structural degeneration biomarker), and (b) reduction of patient anatomy-dependent variables in the MRS data to thereby
enhance the personalization of the data and increase the generalizability of the diagnostic algorithms across diverse populations. |
| |
4) |
Using multi-peak spectral ranges, representing multiple different
painful acids, as a single pain biomarker used in the combined ratios for degenerative pain biomarkers (e.g. “LAAL” painful
chemical biomarker range combining adjacent Lactic Acid
and ALanine peaks, and “ALPA” combining Alanine,
Lactic acid, and Propionic Acid
peaks) – thereby removing the need for accurately differentiating each individual peak, and thus reducing the risk for inaccuracy
in the spectral measurements and diagnostic interpretations. |
Clinical Evidence
We have pursued a clinical study (the “Gornet
Study”) to demonstrate the benefits of our technology to surgeons, imaging centers, third party payers, and patients. Without strong
clinical data in support of our technology to improve clinical outcomes, the opportunity to secure new reimbursement codes and change
existing treatment pathways would be limited.
In a clinical study sponsored by us, and authored
by, among others, a spine surgeon who has a financial interest in the Company. and published in the European Spine Journal in April 2019,
it was shown that 97% of the treated patients met the criteria for significant clinical improvement, where all discs identified as painful
by NOCISCAN were included in the surgical treatment. This compared to 54% of surgical patients achieving clinically significant improvement
when discs identified as painful by NOCISCAN were omitted from the surgical treatment, or discs identified as not painful by NOCISCAN
were included in the treatment. Some authors of this study had a financial relationship with Aclarion, who sponsored the study.
This clinical study included 139 chronic low back
pain patients who collectively underwent a NOCISCAN exam across 623 lumbar discs. Seventy-three patients underwent surgical intervention,
consisting of fusion or disc replacement, and reached six months follow up. Clinical improvement post surgically was evaluated using the
industry standard Oswestry Disability Index (ODI), and the Visual Analog Scale (VAS). ODI evaluates patient disability on a scale of 1-100
with a higher score indicating less impairment. VAS evaluates subjective pain on a scale of 1-10 with a lower score indicating less pain.
Significant clinical improvement in the study was defined as a 15-point improvement in ODI and a 2-point improvement in VAS. NOCISCAN
data was not used in surgical decision making.
Post-operatively, patients were separated into
various groups for analysis. One group consisted of patients where the surgical intervention included every disc that was identified by
NOCISCAN as painful. This group consisted of 36 patients with 26 undergoing a one-level surgical procedure and 10 undergoing a two-level
surgical procedure. 97% (35 of 36) of the patients in this category met the criteria for significant clinical improvement. The one failure
in this group did meet the VAS requirement and missed the ODI cutoff of 15 by only one point.
In another group consisting of 13 patients, a
disc identified as painful by NOCISCAN was not included in the surgical intervention. In this group only 54% (7 of 13) of patients
met the criteria for clinically significant improvement.
In April 2023, Aclarion advanced the evidence of our technology with
a peer-reviewed journal article detailing the Gornet 2-year outcomes published in the European Spine Journal. The 2-year outcomes were
durable with 1-year outcomes previously published in 2019. At 2-years follow-up, 85% of patients improved when disc(s) identified as consistent
with pain by our technology were included in a surgical treatment, compared to only 63% of patients when disc(s) identified as consistent
with pain were not treated or disc(s) identified as consistent without pain were treated.
We believe the results of this study indicates
that using NOCISCAN data to help determine the appropriate level for surgical intervention will significantly improve the outcomes
for patients undergoing spine surgery for back pain. However, the Gornet Study was a single (relatively small) clinical study at a single
clinical center sponsored by us, and authored by, among others, a spine surgeon who has a financial interest in the Company, and there
can be no assurance that the results of such study accurately support our conclusions related to the market opportunity of our products.
Market Opportunity
The current NOCISCAN product addresses the $10B
that is spent in the U.S. on spine fusion procedures annually. Our early clinical evidence points to a marked improvement in surgical
outcomes when discs identified as painful by our technology are included in the surgical treatment. We believe this market is actionable
now and a significant portion of the proceeds of our IPO will be directed towards commercializing this market opportunity.
As we continue our commercialization efforts,
we plan to track patients through clinical registries in order to build on our early clinical evidence. We expect to use these registries
to track NOCISCAN patients regardless of what treatment path they may follow. Through the date of this prospectus, NOCISCAN has
only been evaluated in formal clinical studies for patients primarily undergoing surgical interventions for fusion or disc replacement.
The Company plans on expanding clinical registries to capture patients undergoing surgical interventions for back pain that include all
surgical interventions, not just fusion and disc replacement procedures. If we are able to correlate specific MRS findings to improved
surgical outcomes for all spine surgeries, we believe this would expand the size of our market opportunity in the U.S. from what we believe
is $10B, to an estimated $40B, inclusive of pre-surgical conservative therapy costs. However, there can be no assurance that we will be
successful in marketing our products, regardless of the size of the estimated market.
Our ultimate objective for NOCISCAN is to address
the entire low back and neck pain market which at $134.5B annually represents the largest amount of healthcare dollars spent to treat
any disease. To address this market, our current algorithms will need to expand to include advanced machine learning techniques that incorporate
multiple data inputs besides the chemical composition of discs. These additional inputs will all need to be correlated to clinical outcomes
for treatments ranging from physical therapy to regenerative therapies, and surgical interventions. To further this process, we have been
selected as a participant in a $150M NIH funded study (the NIH BACPAC Initiative”) focused on evaluating the most promising data
inputs for predicting the optimal treatment path for back pain patients and in the NIH’s follow on BEST study to evaluate the clinical
efficacy of using these data inputs for improving clinical results.
In addition to participation in external studies such
as the NIH BACPAC and BEST initiatives, we expect to create our own internal data by adding patients undergoing conservative and regenerative
treatment plans to our clinical registries correlating NOCISCAN results to outcomes in order to utilize AI to associate spectroscopy signals
with the optimal treatment pathway. If we are successful in demonstrating the clinical effectiveness of these associations, we intend
to expand our market opportunity to the management of entire segments of low back and neck pain patients, thereby, we believe, increasing
the size of our addressable market. However, there can be no assurance that we will be successful in marketing our products, regardless
of the size of the estimated market.
Although we believe that we are addressing a large
U.S. and European market, there are practical limitations to the market opportunity that must be overcome by us. We believe the two biggest
limitations are the lack of deployment of spectroscopy software across the install base of existing MRI’s worldwide and the fact
that only certain MR scanner models are compatible with our technology. For compatible MRI machines, that do not have spectroscopy hardware
and software installed, the onetime cost of the hardware and software ranges from $25,000 to $50,000. Currently, our NOCISCAN platform
is only compatible with certain MR scanner models provided by SIEMENS, of which there are an estimated 1,500 in the United States, and
4,320 worldwide. We plan to collaborate with other MRI scanner vendors to establish compatibility of their respective scanners and MRS
capabilities for use with our products, to include discounted pricing on spectroscopy software for MRI sites interested in providing DLBP
patients with the NOCISCAN offering.
Plan of Operation and Growth Strategies
Our primary near-term growth strategy is to secure
payer contracts to cover our Category III CPT codes. We believe that with favorable payer coverage decisions comes the opportunity to
more efficiently market to spine surgeons and imaging centers to adopt our technology.
The Company is currently generating the vast majority
of its revenue directly from patients paying out of pocket. With the introduction of Category III CPT codes and the proceeds of our IPO,
the Company is transitioning to full commercial operations.
In order to effectively commercialize our technology,
the Company has completed its initial plan to gain the support of up to ten leading spine surgeons as Key Opinion Leaders (KOL) who believe
Nociscan technology will help them with surgical decisions in their practices. These KOL surgeons are leaders in their field and will
be assisting the Company in generating important clinical data in support of Nociscan, and using that data to help the Company in discussions
with payers to secure positive payment decisions for our Category III CPT codes.
Based primarily on our KOL surgeons and the
strength of physician engagement in markets, the Company is prioritizing the following markets:
| 1. | NYC Metropolitan Area |
| 2. | San Francisco, CA |
| 3. | Chicago, IL |
| 4. | Phoenix, AZ |
| 5. | Miami, FL |
| 6. | Denver & Colorado Springs, CO |
| 7. | Detroit, MI |
| 8. | Indianapolis |
Once a positive local payment decision is secured
in a geographical area, we intend to place a market manager and a team of business development professionals into each market to focus
on expanding physician support and securing favorable coverage decisions from additional payers in the market. The objective in each market
is to expand the provider network to include additional imaging centers and surgeons so there is increasing geographical coverage. We
believe increasing our footprint in each market will grow volume and revenue through increased pressure on payers to expand positive coverage
decisions across all of the varied plans associated with each payer.
We believe the following strategies will contribute
to growth in the prescription and use of NOCISCAN.
| |
· |
Enhance our multi-tiered sales/marketing/branding campaign
targeted at (i) referring physicians, (ii) MR imaging providers, (iii) DLBP patients, (iv) spine implant equipment suppliers, (v) injectable
biologics and cell therapy providers, (vi) MR scanner vendors, (vii) third party payors, and (viii) employers, all to grow awareness and
demand for NOCISCAN; |
| |
· |
Increase third party payer reimbursement coverage via reimbursement
code utilization, payer negotiations, growing clinical evidence dossier via published registry studies and Randomized Control Trials (“RCT”),
and converting temporary Category III CPT codes into permanent CPT Category I codes see “Third Party Reimbursement ” below; |
| |
· |
Expand MR scanner compatibility to additional scanner models,
including within the Siemens product lines and other manufacturers/vendors; |
| |
· |
Expand into international markets; |
| |
· |
Evolve the adaptations and positioning of our products to support
new emerging technologies, and clinical trials, in particular for injectable biologic and cell therapies; |
| |
· |
Continue to conduct clinical trials, and publish clinical trial
results in peer-reviewed journals in relevant fields to our business (e.g. MR/radiology, spine, and pain); |
| |
· |
Continue to engage and expand Key Opinion Leader (“KOL”)
advisory boards and specialty medical society support for supporting and driving awareness of our products and services to wider audiences
of potential customers and other stakeholders; and |
| |
· |
Pursue additional applications of our technology, including other regions
of the spine (e.g., thoracic, cervical), areas of the anatomy outside of the spine, and integrative use of our diagnostic platform with
other diagnostic platforms and tests to potentially improve the management and outcomes of populations of low back and neck pain patients. |
Strategic Relationships
Siemens
The NOCISCAN product suite is currently compatible
for use only with certain MR scanner models and configurations provided by SIEMENS. We are not subject to any exclusivity agreement or
obligations with SIEMENS, nor do we have any fee sharing, royalty, or other exchange of moneys or payments between us and Siemens. The
nexus for our focused relationship with Siemens resulted from our determination that Siemens scanner models were optimally positioned
to support our product. We have had a collaborative relationship with Siemens since 2011.
On May 2, 2012, following a prior period of informal
collaboration, we entered a Memorandum of Understanding (“MOU”) with SIEMENS, under which SIEMENS agreed to support Aclarion’s
research and development of what later became the NOCISCAN product suite for compatible use with SIEMENS scanners. The MOU included
the development of certain custom features and technical support that SIEMENS would make available to support the development effort by
Aclarion. The relationship was non-exclusive. The MOU was replaced by a Strategic Collaboration Agreement for Phased Commercialization
of the SIEMENS-compatible NOCISCAN Product of Aclarion, Inc. (the “SIEMENS Agreement”) that we entered into with SIEMENS
Healthcare GmbH on December 31, 2017. This agreement comprised a collaboration to identify, onboard and provide technical support for
the SIEMENS-compatible NOCISCAN platform with early commercial users in the European Union, including a free trial period for those
initial commercial users to activate and use the SIEMENS SVS pulse sequence option package that is required to be purchased by our customers
in order to perform disc MRS according to the specifications for compatible use with our products. The SIEMENS Agreement also provided
for plans for global joint marketing, potential business model/fee agreement and a potential integration of the NOCISCAN product suite
into the SIEMENS Next Generation Frontier App Store model. While these plans have not yet been realized, the agreement still remains in
effect through automatic extensions and we are in on-going dialogue and negotiations toward some, or possibly all, of these objectives.
The Siemens Agreement is terminable.at any time by either party if such party is of the opinion that the goals of the Collaborative Agreement
cannot be achieved for technical, economic and/or clinical reasons. If Siemens were to terminate its relationship with the Company, it
would have a material adverse effect on our business. Further, there can be no assurance that there will be any joint marketing or that
future financial arrangements between us and SIEMENs will be established, and even if established, that such agreements will be successful
or profitable.
RadNet
Two of the Company’s imaging centers that
are fully operational to perform NOCISCAN’s are owned by RadNet, Inc., (“RadNet”) a leading provider of outpatient imaging
centers in the United States. RadNet currently own 357 outpatient imaging centers across seven states. Larry Tannenbaum is one of our
former board members and leads the radiology section of our Medical Advisory Board. The New York/New Jersey area is one of our top targets
for early commercialization post IPO and we expect to leverage RadNet’s extensive relationship with commercial payers to secure
introductions that we believe will lead to early coverage decisions from payers in support of our growth plans. Although we have ambitions
to grow the RadNet relationship, the current arrangement is limited to the flow of revenue between Aclarion and RadNet for the performance
of an MRS exam by RadNet and the subsequent generation of a Nociscan report by Aclarion.
Reimbursement
Current Procedural Terminology or “CPT”
codes are developed by the American Medical Association (“AMA”) to describe a wide range of health care services provided
by physicians, hospitals and other health care professionals. These codes are utilized to communicate with: other physicians, hospitals,
and insurers for claims processing. There are three categories of CPT Codes: Category I, Category II, and Category III (also often referred
to interchangeably as “Levels”):
| |
· |
Category I CPT codes are used for reporting devices and drugs
(including vaccines) required for the performance of a service or procedure, services or procedures performed by physicians and other
health care providers, services or procedures performed intended for clinical use, services or procedures performed according to current
medical practice, and services or procedures that meet CPT requirements. These codes are billable for reimbursement. |
| |
· |
Category II CPT Codes are used for reporting performance measures
reducing the necessity for chart review and medical records abstraction. |
| |
· |
Category III CPT codes are used for reporting emerging technology
in a number of capacities including services or procedures recently performed on humans, clinical trials and etc. These codes are temporary
codes and must be accepted for placement in Level I by the CPT committee within five years, be renewed for another five more years, or
be removed from the book. |
Our NOCISCAN product suite was initially commercialized
without existing CPT codes or other pathways for seeking reimbursement coverage from third party payers. Accordingly, to date, the commercial
uses of our products have been principally paid for directly by patients or their spine surgery care provider. The first third party payer
reimbursement occurred in May 2021 via the payment of a Workman’s Compensation claim in Colorado.
Effective January 1, 2021, a previously retired
Category I CPT Code 76390 for MR Spectroscopy was reinstated and reactivated by the Centers for Medicare and Medicaid Services (“CMS”).
This resulted from our own direct efforts with CMS in hopes of achieving this result. In addition, also effective January 1, 2021, the
AMA approved four new Category III CPT Codes for performing MRS exams specifically on intervertebral discs. More specifically, these codes
were assigned respectively to: (i) determine and localize discogenic pain via SVS (0609T), (ii) transmit the MRS derived biomarker data
for software analysis (0610T), (iii) post-process the biomarker data for algorithmic analysis to determine relative chemical differences
between discs (0611T), and (iv) interpret and report those results. Ambulatory Payment Classification (“APC”) pricing assignments
were also made by CMS for three of these Level 1 T-codes, while the fourth (0612T) was not priced and left for us, or interpreting doctors,
to negotiate payment pricing amounts with Medicare Administrative Contractors (MACs) and third-party payers. The creation, activation,
and APC pricing assignment of these four new Level 3 codes was also the result of our Company directly pursuing and negotiating with the
AMA toward these interim objectives. We intend to further explore APC assignments such as a New Technology APC to ensure our NOCISCAN
product suite is assigned an APC that is appropriate in terms of clinical characteristics and resource costs.
The table below further explains these four new
Level III CPT Codes:
| CPT
Code |
Description |
| 0609T |
MRS, determination
and localization of discogenic pain (cervical, thoracic, or lumbar); acquisition of single voxel data, per disc, in ≥3 discs |
| 0610T |
MRS, determination
and localization of discogenic pain (cervical, thoracic, or lumbar); transmit biomarker data for software analysis |
| 0611T |
MRS, determination
and localization of discogenic pain (cervical, thoracic, or lumbar); postprocessing for algorithmic analysis of biomarker data for determination
of relative chemical differences between discs |
| 0612T |
MRS, determination
and localization of discogenic pain (cervical, thoracic, or lumbar); interpretation and report |
Due to a lack of operating capital, we have not
yet begun to seek reimbursement coverage or promote or suggest our customers use these codes. However, we plan to use the proceeds of
our public offering to hire the personnel and expend our financial resources do so. The Category III Codes become more valuable and useful
upon being converted into Level I, when widespread reimbursement coverage is expected to be achievable. We plan to support conversion
of codes from Category III to Category I by advancing multiple clinical studies and related peer-reviewed clinical publications intended
to further support improved patient outcomes (such as success rates following DLBP surgeries), and various economic advantages to be achieved
by incorporating the use of our NOCISCAN platform into the DLBP patient’s healthcare journey. However, there can be no assurance
that the Category III codes will be converted and replaced with corresponding Level I Codes, and if there is a delay in the conversion
of the Codes to Level 1 or there is ultimately no conversion of Codes to Level I, our business will be materially adversely affected.
Further, even if the Codes are converted to Level 1, there can be no assurance that we will be successful in increasing the use of our
technology by patients and health care professionals.
Intellectual Property - Licenses, Patents and
Trademarks
We rely on a combination of licenses, patents,
trade secrets, copyrights and trademarks, as well as contractual protections to establish and protect our intellectual property rights.
Our success depends in part on our ability to obtain and maintain intellectual property protection for our technology. We seek to protect
our technology and any potential future technology related to our NOCISCAN platform through a variety of methods, including seeking
and maintaining patents intended to cover current and future technology, their methods of use and processes, and any other inventions
that are commercially important to the development of our business. We seek to obtain domestic and foreign patent protection which includes,
in addition to filing and prosecuting patent applications in the United States, typically filing counterpart patent applications in additional
countries where we believe such foreign filing is likely to be beneficial, including Europe, Australia, Canada, China, Japan, India and
South Africa.
On December 9, 2014, the Company entered into
an amended and restated exclusive license agreement (the “License Agreement”) with the Regents of the University of California
for certain inventions, generally
characterized as systems, materials, and methods to localize and evaluate pain and degenerative properties of tissue, molecular
markers that differentiate painful from non-painful discs; and MR Spectroscopy System and Method for diagnosing painful and non-painful
intervertebral discs (collectively
the “Invention”).
Pursuant to the License Agreement, the Company
obtained a royalty-bearing, worldwide, exclusive license to the Invention, including certain patent rights related to the patents and
technology the Company uses. Under the agreement, we agreed to pay a royalty of 4% of net sales of the licensed products. Additionally,
we agreed to pay a minimum annual royalty fee starting on the third anniversary of the effective date of the agreement, which escalates
each anniversary and is currently $50,000. UCSF has the right to terminate the agreement upon advanced notice in the event of a default
by us. The agreement will expire upon the expiration or abandonment of the last of the licensed patents. The U.S. patents subject to the
agreement expire between 2026 and 2029, without considering any possible patent term adjustment or extensions and assuming payment of
all appropriate maintenance, renewal, annuity, or other governmental fees.
As of December 1, 2023, our intellectual property
portfolio has 22 issued patent and 6 pending patent applications in the U.S., and 17 patent grants and 7 pending patent applications outside
the United States. The overall patent portfolio includes patents and patent applications that are (i) assigned exclusively to the Company,
(ii) assigned exclusively to the Regents of the University of California but exclusively licensed to the Company, and (iii) assigned to
both the Company and the Regents of the University of California (also exclusively licensed to the Company). Many of these patents relate
to, inventions involved in, the Company’s first product, the NOCISCAN product suite for post-processing disc MRS exam data. Others
relate to potential enhancements of the NOCISCAN disc MRS exam (as conducted at the MR scanner) and also other alternative diagnostic
approaches (e.g. molecular imaging and gene expression testing). Our portfolio of patents and patent applications, if issued, are expected
to expire between January 30, 2026 and June 16, 2037 in the U.S., in each case without considering any possible patent term adjustments
or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Our intellectual property portfolio includes four
patent families (each reflecting multiple families, if based on different original applications), that relate to our NOCISCAN technology and/or
to other potential future pipeline products.
The first patent family is directed to inventions
for signal processing techniques to include leveraging artificial intelligence technologies for improving the quality, reliability, and
accuracy of MRS-based chemical biomarker measurements and related diagnostic interpretations. Many of these patented inventions are included
in our NOCICALC product under the NOCISCAN Suite and cover uses specifically for disc MRS, and for MRS in any other tissues. This first
family includes 8 issued patents and 1 pending patent application assigned to the Company in the US, and 3 issued patents and 1 pending
patent application outside the U.S. (Europe and Australia). All of these are assigned to the Company. The U.S. granted patents and pending
patent applications, if issued, are expected to expire between October 14, 2029 and March 15, 2033, without considering any possible patent
term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The second patent family relates to inventions for
novel diagnostic systems and methods for providing diagnostically useful information based on MRS-based chemical biomarkers. Many of these
patented inventions are incorporated in our NOCIGRAM product and related diagnostic report under the NOCISCAN Suite and relate to uses
specifically for discogenic pain, conditions related to discs more generally, and more broadly any degenerative pain-related diagnosis
in any tissue. This family includes patents relating to diagnosing degenerative painful discs (and other tissues) using the primary degenerative
pain biomarkers evaluated by our NOCIGRAM product. The second patent family includes 6 issued patents and 3 pending patent applications
in the US, and 9 patent grants and 6 pending patent applications outside the U.S. (Europe, Australia, Canada, China, Japan, India, South
Africa). These are either assigned to the Regents of the University of California or assigned to both the Regents of the University of
California and the Company, in all cases with the UC’s rights exclusively licensed to the Company. The U.S. granted patents and
pending patent applications, if issued, are expected to expire between January 30, 2026 and June 16, 2037, without considering any possible
patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Our third patent family relates to inventions that
enhance the efficiency and reliability of certain aspects related to conducting MRS exams at the MR scanner. This includes enhancing the
efficiency and quality of NOCISCAN disc MRS exams and other applications of MRS in general. These patented inventions are not currently
incorporated into our commercial products but are in the research and development phase for potential pipeline products. This third patent
family includes 3 issued US patents that are expected to expire on November 23, 2031, without considering any possible patent term adjustment
or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. These patents are all
assigned to the Company. This patent family also includes a pending U.S. patent application that relates to the use of Artificial Intelligence
for enhancing MRS exams, which is in the research and development phase for potential pipeline products.
Our fourth patent family relates to inventions for
other novel diagnostic systems and methods that represent potential future pipeline products, or otherwise provide potential exclusionary
rights against related potential competitive threats. This includes patents related to discogenic pain diagnosis using molecular imaging
and/or gene expression testing. The fourth patent family includes 4 issued patents and 1 pending patent application in the US, and 5 patent
grants outside the U.S. (Europe, Canada, China). These patents are assigned to the Regents of the University of California and exclusively
licensed to the Company (and in certain aspects, co-exclusively licensed under which the Company has exclusive rights to diagnostic aspects
and another third-party licensee has limited exclusive rights to only certain treatment aspects). The U.S. granted patents and pending
patent applications, if issued, are expected to expire between September 21, 2026 and May 29, 2029, without considering any possible patent
term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
We cannot be sure that patents will be granted
with respect to any of our pending patent applications or with respect to any patent applications we may own or license in the future.
We cannot be sure that any of our existing patents or any patents we may own or license in the future will be useful in protecting our
technology. Please see “Risk Factors — Risks Related to Our Intellectual Property” for additional
information on the risks associated with our intellectual property strategy and portfolio.
We continually assess and refine our intellectual
property strategies to fortify our position. We file additional patent applications when our intellectual property strategy warrants such
filings. We intend to pursue additional intellectual property protection to the extent that we believe it would be beneficial and cost-effective.
Our ability to stop third parties from making, using, selling, offering to sell, importing or otherwise commercializing any of our patented
inventions, either directly or indirectly, will depend in part on our success in obtaining, defending and enforcing patent claims that
relate to our technology, inventions, and improvements. With respect to our intellectual property, we cannot provide any assurance that
any of our current or future patent applications will result in the issuance of patents in any particular jurisdiction, or that any of
our current or future issued patents will effectively protect any of our tests or technology from infringement or prevent others from
commercializing infringing tests or technology. Even if our pending patent applications are granted as issued patents, those patents may
be challenged, circumvented or invalidated by third parties. Consequently, we may not obtain or maintain adequate patent protection for
any of our tests or technology.
In addition to our reliance on patent protection
for our inventions and technology, we also rely on trade secrets, know-how, confidentiality agreements and continuing technological innovation
to develop and maintain our competitive position. For example, some elements of our analytics techniques and processes, computational-biological
algorithms and related processes and software are based on unpatented trade secrets and know-how that are not publicly disclosed. Although
we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees, advisors
and consultants, these agreements may be breached, and we may not have adequate remedies for any breach. In addition, third parties may
independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or
disclose our technology. As a result, we may not be able to meaningfully protect our trade secrets. For further discussion of the risks
relating to intellectual property, see the section titled “Risk Factors — Risks Related to our Intellectual Property.”
The Company holds the following trademarks for
its previous corporate brand name as well as for its key products and brands (“®” designates registered trademark, “™”
designates unregistered trademark under common law protection):
NOCIMED®Corporate brand name
NOCISCAN® - Primary data acquisition exam
(procedure) and software-based post-processing suite (product)
NOCIGRAM® - Post-processed report, one of
two products in the NOCISCAN product suite
NOCISCORE® - Feature of NOCIGRAM Report
NOCICALC™ - MRS spectral processor and biomarker
calculator, one of two products in the NOCISCAN suite
NOCI+™ - Feature of NOCIGRAM Report
NOCI-™ - Feature of NOCIGRAM Report
NOCImild™ - Feature of NOCIGRAM Report
NOCIWEB™ - Web-hosted user interface
SI-SCORE™ - Feature of NOCIGRAM Report
VIRTUAL DISCOGRAM™ - Additional name associated
with NOCIGRAM
With respect to involved
meanings, the recurrent prefix term “NOCI” among these marks is derived from Latin origins for “pain” (e.g.
nerves that report pain are called “nociceptors”).
Research and Development
Research and Development (“R&D”)
activities at Aclarion primarily explore the use of AI, our post-processing technologies and clinical registry data to expand the use
of our technology.
The Company is researching the application of
AI and machine learning platforms to analyze both the raw spectroscopy data and the post-processed signal to evaluate whether AI platforms
can more efficiently and more effectively associate MRS data with clinical outcomes. We expect this type of AI research and development
to be an ongoing process applied not only to the various treatment paths associated with back pain, i.e., conservative therapies, regenerative
and cell therapies and surgical intervention, but to potentially expand into other clinical explorations involving the diagnosis of brain,
breast and prostate tumors.
Clinical research at Aclarion includes the building
of clinical registries that provide the data inputs required to train the AI models to improve the efficiency and effectiveness of our
technology for surgical decisioning as well as extend the use of our technology for potentially optimizing the treatment of neck and low
back pain through other interventions.
Clinical registries track the MRS results for
each disc being evaluated and correlates the MRS signature of the disc to patient specific data such as MRI imaging, Oswestry Disability
Index (ODI) and Visual Analog Scores (VAS). These methods are proven tools to assess low back pain, clinical treatments performed and
to identify conservative therapies such as physical therapy and chiropractic intervention, regenerative and cell therapies or surgical
interventions. By tracking specific treatments applied to each patient over time and correlating the effectiveness of those treatments
to the MRS data of each disc, we expect to create a large repository of clinical data that can be used to train advanced machine learning
algorithms that correlate MRS signatures from specific discs to improved outcomes from conservative and regenerative therapies.
Government Regulation
United States FDA.
In the United States, the FDA has broad regulatory
powers with respect to pre-clinical and clinical testing of new medical devices and the designing, manufacturing, labeling, storage, record
keeping, marketing, advertising, promotion, distribution, post-approval monitoring and reporting and import and export of medical devices.
Unless an exemption applies, federal law and FDA regulations require that all new or significantly modified medical devices introduced
into the market be preceded either by a pre-market notification clearance order under section 510(k) of the Federal Food, Drug
and Cosmetic Act (FDCA), or an approved Denovo or pre-market approval (PMA) application. Under the FDCA, medical devices are classified
into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each
medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness. Class I
devices are those for which safety and effectiveness can be reasonably assured by adherence to a set of regulations, referred to as General
Controls, which require compliance with the applicable portions of the FDA’s Quality System Regulation (QSR) facility registration
and product listing, reporting of adverse events and malfunctions and appropriate, truthful and non-misleading labeling, advertising and
promotional materials. Some Class I devices, also called Class I reserved devices, also require premarket clearance by the FDA
through the 510(k) premarket notification process described below. Most Class I products are exempt from the premarket notification
requirements, and subject only to registration requirements (which the FDA does not typically review, thus determined and submitted solely
by the applicant product owner).
Class II devices are those that are subject
to the General Controls, as well as Special Controls as deemed necessary by the FDA, which can include performance standards, guidelines
and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and
clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process. Under the 510(k) process,
the manufacturer must submit to the FDA a premarket notification, demonstrating that the product for which clearance has been sought is
substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28,
1976 for which the FDA had not yet called for the submission of pre-market approval applications. To be substantially equivalent, the
proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the
predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the
predicate device. Clinical data is sometimes required to support substantial equivalence.
After a 510(k) notice is submitted, the FDA
determines whether to accept it for substantive review. If it lacks necessary information for substantive review, the FDA will refuse
to accept the 510(k) notification. If it is accepted for filing, the FDA begins a substantive review. By statute, the FDA is required
to complete its review of, and clear or deny, a 510(k) notification within 90 days of receiving the 510(k) notification.
As a practical matter, clearance often takes longer, and clearance is never assured. Although many 510(k) premarket notifications
are cleared without clinical data, the FDA may require further information, including clinical data, to make a determination regarding
substantial equivalence, which may significantly prolong the review process. If the FDA agrees that the device is substantially equivalent,
it will grant clearance to commercially market the device.
After a device receives 510(k) clearance,
any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended
use, will require a new 510(k) clearance or, depending on the modification, could require a De Novo or PMA application. The FDA requires
each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s
determination. If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required
for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device
until 510(k) clearance or approval of a De Novo or PMA application is obtained. If the FDA requires us to seek 510(k) clearance
or approval of a De Novo or PMA application for any modifications to a previously cleared product, we may be required to cease marketing
or recall the modified device until we obtain this clearance or approval. In addition, in these circumstances, we may be subject to significant
regulatory fines or penalties for failure to submit the requisite PMA application(s). In addition, the FDA is currently evaluating the
510(k) process and may make substantial changes to industry requirements.
Class III devices include devices deemed
by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, in addition to those
deemed not substantially equivalent following the 510(k) process. The safety and effectiveness of Class III devices cannot be
reasonably assured solely by the General Controls and Special Controls described above. Therefore, these devices are subject to the PMA
application process, which is generally more costly and time consuming than the 510(k) process.
In the event a device might be considered Class
III due to lack of an equivalent predicate device, but which does not pose a significant risk to patients, it may be ‘down-classified’
to a relatively newer De Novo pathway for pre-market notification review and approval, which typically involves burdens and review cycle
times between what are typical for 510(k) and PMA pathways. In addition to the above classifications and related FDA regulatory pathways
in the United States, certain technologies that were previously considered medical devices have recently been reclassified and not considered
a medical device, and thus not regulated by the FDA. On December 13, 2016 the 21st Century Cures Act (“Cures Act”)
was signed into law (Public Law 114-255, 130 STAT. 1033), and was designed to help accelerate medical product development and bring new
innovations and advances to patients who need them faster and more efficiently. Section 3060 of the Cures Act was created as an amendment
to section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which addressed how medical devices are defined. This outlined
software functions that would be exempt from FDA regulation, such as those used for administrative purposes, encouraging a healthy lifestyle,
electronic health records, clinical laboratory test results and related information, and clinical decision tools.
In the United States, the NOCISCAN product
suite is only partially regulated as a medical device by the FDA. The NOCICALC product is considered a Class I “exempt”
medical device and is registered as such with the FDA under product Classification “Calculator/Data Processing Module, for Clinical
Use,” Product Code “JQP,” Regulation Number 862.2100, and Registration Number 3015426626.
The process to determine whether a product can
be considered a Class I “exempt” medical device consists of self-determining whether the product is adequately described by
one of the existing categories classified by the FDA. In conjunction with our regulatory consultants, we determined that the product Classification
“Calculator/Data Processing Module, for Clinical Use,” adequately described our NOCICALC product.
In contrast, we believe the NOCIGRAM product
is considered Clinical Decision Support software (CDS) under the 21st Century Cures Act and not a medical device. As such,
we believe NOCIGRAM is not regulated by the FDA. Our conclusion that NOCISCAN would be considered Clinical Decision Support software
(“CDS”), which under the 21st Century Cures Act’ is not a device and therefore exempted from medical device regulation,”
is based upon the following analysis:
Under the Cures Act provision, a software product
is not considered a device if it meets the following four elements:
| |
· |
"[Not] intended to acquire, process, or analyze a medical
image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;" |
| |
· |
"[I]ntended ... for the purpose of... displaying, analyzing,
or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice
guidelines);" |
| |
· |
"[I]ntended ... for the purpose of... supporting or providing
recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition;" and |
| |
· |
"[I]ntended ... for the purpose of... enabling such health
care professional to independently review the basis for such recommendations that such software presents so that it is not the intent
that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding
an individual patient."4 |
Since December 13, 2016, the FDA has issued draft
guidance which provides further insight into the interpretation of the above four elements. The draft guidance, entitled “Clinical
and Patient Decision Support Software” (Dec. 2017) (“Draft Guidance”), reviews section 520(o)(l)(E) of the FDC Act and provides
additional clarity on each element.
With respect to the last element listed above,
the Draft Guidance elaborates on what is meant by allowing health professionals to "independently" review the basis for recommendations
such that the CDS software is not intended to be "primarily" relied upon in a diagnosis or treatment decision. To that end, according
to the Draft Guidance, the user must be told: "(I) The purpose or intended use of the software function; (2) The intended user (e.g.,
ultrasound technicians, vascular surgeons); (3) The inputs used to generate the recommendation (e.g., patient age and gender); and (4)
The rationale or support for the recommendation.
As described above, FDA will not regulate software
that meets the four requirements in the Cures Act as a medical device. Although there are some ambiguities as to the meaning of the relevant
statutory terms, we believe NOCIGRAM meets all four of these requirements.
First, the NOCIGRAM is not intended to acquire,
process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.
Rather, it receives information from the NOCICALC, which separately performs such operations and produces a table of calculated disc
chemistry ratio values for each disc examined. It is this table that the NOCIGRAM references in performing its analysis.
Second, NOCIGRAM is intended for the purpose
of displaying, analyzing, or printing medical information about a patient or other medical information. The NOCISCORE Table and graphical
plots provide medical information about the patient and analyze the data into classifications.
Third, NOCIGRAM is intended for the purpose
of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition.
The information generated by the product is intended to support recommendations on how to manage patients presenting with low back pain
that may be discogenic in nature. It does this by providing additional disc chemistry-based information to be considered by the physician
in combination with other available patient information.
The fourth element of the statute is also met
by NOCIGRAM, although the requirements for this element are more involved than the other three elements. This element requires a means
for the health care professional to independently review the basis for any recommendation to prevent primary reliance on the software.
In its recent Draft Guidance, FDA provides four elements that can be used to determine whether the CDS software allows for independent
review: whether it explains (1) the purpose or intended use; (2) the intended user; (3) the inputs used to generate the recommendation;
and (4) the rationale for the recommendation.
The NOCIGRAM explains the purpose of the intended
use. It instructs the user that it is intended to provide analyses of chemical ratio information obtained from the NOCICALC product,
which was separately derived from data via an MRS device, for the purpose of supporting recommendations about diagnosing and/or treating
patients with certain back conditions. This information is explained in the product labeling. The product labeling also explicitly states
that the intended user is a professional medical healthcare provider trained and skilled in diagnosing and recommending treatment options
for low back pain and related lumbar spine disorders. Thus, both the first and second elements set forth in the Draft Guidance are satisfied.
As to the third element, the inputs used to generate
any calculations for the health care professional consist of the chemical ratio information obtained from the NOCICALC device, and
also the adjustment and analysis factors (e.g. weighting and thresholding/ranges) for analyzing that disc chemistry data. The labeling
for NOCIGRAM will describe the NOCICALC outputs as the source disc chemistry data, and will also reference the published clinical
trial results (i.e. correlations to discogram results) and related adjustment and analysis factors. This satisfies the third element.
The fourth element requires that the health care
professional is able to independently review the rationale for the CDS software recommendation. FDA's Draft Guidance indicates that the
sources supporting a recommendation should, among other things, be publicly available. Tracking the statute, FDA suggests that clinical
practice guidelines and published literature would fit this description. The Company intends to publish the various factors (i.e. weighting
and thresholds) applied to adjusting and analyzing the various input chemical ratios, and the correlative analysis to the PD reference
test (as well as certain related treatment outcomes), in medical literature in marketing NOCIGRAM. The user is informed of the medical
literature in the instructions for use of NOCIGRAM.
Moreover, the physician-user will have three means
to independently verify the results of the NOCIGRAM. First, the user can manually input the adjustment factors and thresholding of
the ratios as custom inputs for the NOCICALC product to derive the same custom output results from NOCICALC as those results provided
by NOCIGRAM. Second, the user can independently (apart from NOCICALC) perform these same factor-adjusted and threshold classifier calculations
based on the values obtained from NOCICALC using the methods described in publicly available literature. Third, the user can further verify
the NOCI+/- results of the NOCIGRAM, which are correlated to discogram as a reference test based on clinical trial data, by conducting
a discogram on the same discs in the patient. This will either confirm or disprove the correlation of NOCI+/ - to discogram results in
those particular discs in that specific patient. These three verification options sufficiently address the issue of a proprietary database
or algorithm that is essentially a "black box" to users, creating primary reliance on the CDS software rather than aiding informed
decision making.
However, although we believe the above analysis
is reasonable, whenever a company self classifies, there is a risk that FDA could disagree with the classification. Accordingly, in that
context, it is possible that FDA could potentially disagree that the NOCIGRAM falls under the CDS software exemption to the definition
of a device and there can be no assurance that the FDA will agree with our conclusion and in the event the FDA does not agree, our business
would be severely negatively impacted.
FDA clearance or approval, when granted, may entail
limitations on the indicated uses for which a product may be marketed, and such product approvals, once granted, may be withdrawn if problems
occur after initial marketing. Manufacturers of FDA-regulated products are subject to pervasive and continuing post-approval governmental
regulation, including, but not limited to: (i) the registration and listing regulation, which requires manufacturers to register all manufacturing
facilities and list all medical devices placed into commercial distribution, (ii) the QSR, which requires manufacturers, including third
party manufacturers, to follow stringent design, validation, testing, production, control, supplier/contractor selection, complaint handling,
documentation and other quality assurance procedures during the manufacturing process, (iii) labeling regulations and unique device identification
requirements, (iv) advertising and promotion requirements, (v) restrictions on sale, distribution or use of a device, (vi) PMA annual
reporting requirements, (vii) the FDA’s general prohibition against promoting products for unapproved or “off-label”
uses, (viii) the Medical Device Reporting (MDR) regulation, which requires that manufacturers report to the FDA if their device may have
caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious
injury if it were to reoccur, (ix) medical device correction and removal reporting regulations, which require that manufacturers report
to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy
a violation of the FDCA that may present a risk to health; recall requirements, including a mandatory recall if there is a reasonable
probability that the device would cause serious adverse health consequences or death; an order of repair, replacement or refund, (x) device
tracking requirements, and (xi) post-approval study and post-market surveillance requirements. The FDA has also established a Unique Device
Identification (“UDI”) system that was phased in over a period of years. The UDI system requires manufacturers to mark certain
medical devices distributed in the United States with unique device identifiers.
The FDA recently finalized its guidance for managing
post-market cybersecurity for connected medical devices. This guidance places additional expectations on our technology to build in cybersecurity
controls when we design and develop our devices to assure safe performance in the face of cyber threats. It is also incumbent on us to
monitor third party software for new vulnerabilities and verify and validate any software updates or patches meant to address vulnerabilities.
Our facilities, records and manufacturing processes
are subject to periodic unscheduled inspections by the FDA. Failure to comply with the applicable United States medical device regulatory
requirements could result in, among other things, warning letters, untitled letters, fines, injunctions, consent decrees, civil penalties,
unanticipated expenditures, repairs, replacements, refunds, recalls or seizures of products, operating restrictions, total or partial
suspension of production, the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other
countries, the FDA’s refusal to grant future premarket clearances or approvals, withdrawals or suspensions of current product clearances
or approvals and criminal prosecution.
Coverage and Reimbursement.
Government and private sector initiatives to limit
the growth of healthcare costs, including price regulation and competitive pricing, coverage and payment policies, comparative effectiveness
therapies, technology assessments and managed care arrangements, are continuing in many countries where we do business, including the
United States, Europe and Asia. As a result of these changes, the marketplace has placed increased emphasis on the delivery of more cost-effective
medical therapies. In addition, because there is generally no separate reimbursement from third-party payers to our customers for many
of our products, the additional costs associated with the use of our products can impact the profit margin of our customers. Accordingly,
these various initiatives have created increased price sensitivity over healthcare products generally and may impact demand for our products
and technologies.
Healthcare cost containment efforts have also
prompted domestic hospitals and other customers of medical devices to consolidate into larger purchasing groups to enhance purchasing
power, and this trend is expected to continue. The medical device industry has also experienced some consolidation, partly in order to
offer a broader range of products to large purchasers. As a result, transactions with customers are larger, more complex and tend to involve
more long-term contracts than in the past. These larger customers, due to their enhanced purchasing power, may attempt to increase the
pressure on product pricing.
Significant healthcare reforms have had an impact
on medical device manufacturer and hospital revenues. The Patient Protection and Affordable Care Act as amended by the Health Care and
Education and Reconciliation Act of 2010, collectively referred to as the Affordable Care Act, is a sweeping measure designed to expand
access to affordable health insurance, control healthcare spending and improve healthcare quality. Many states have also adopted or are
considering changes in healthcare policies, in part due to state budgetary pressures. Ongoing uncertainty regarding implementation of
certain aspects of the Affordable Care Act makes it difficult to predict the impact the Affordable Care Act or state law proposals may
have on our business.
Other Healthcare Laws.
In addition to FDA restrictions on marketing and
promotion of drugs and devices, other federal and state laws restrict our business practices. These laws include, without limitation,
data privacy and security laws, anti-kickback and false claims laws, and transparency laws regarding payments or other items of value
provided to healthcare providers.
As a participant in the healthcare industry, we
are subject to extensive regulations protecting the privacy and security of patient health information that we receive, including the
Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and
Clinical Health Act of 2009 (HITECH), which was enacted as part of the American Recovery and Reinvestment Act of 2009. Among other things,
these regulations impose extensive requirements for maintaining the privacy and security of individually identifiable health information,
known as “protected health information.” The HIPAA privacy regulations do not preempt state laws and regulations relating
to personal information that may also apply to us. Our failure to comply with these regulations could expose us to civil and criminal
sanctions.
The HIPAA provisions also created federal criminal
statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare
benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program,
willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering
up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for
healthcare benefits, items or services. A person or entity does not need to have actual knowledge of the statutes or specific intent to
violate them in order to have committed a violation. Also, many states have similar fraud and abuse statutes or regulations that may be
broader in scope and may apply regardless of payer, in addition to items and services reimbursed under Medicaid and other state programs.
The federal Anti-Kickback Statute prohibits, among
other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate),
directly or indirectly, overtly or covertly, to induce or in return for the purchasing, leasing, ordering, or arranging for or recommending
the purchase, lease or order of items or services for which payment may be made, in whole or in part, under Medicare, Medicaid or other
federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. Although there
are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and
safe harbors are drawn narrowly. Further, a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
The federal False Claims Act prohibits, among
other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval
to the federal government, or knowingly making, using or causing to be made or used a false record or statement material to a false or
fraudulent claim to the federal government. A claim includes “any request or demand” for money or property presented to the
U.S. Government. Medical device manufacturers have been held liable under these laws if they are deemed to cause the submission of false
or fraudulent claims by, for example, providing customers with inaccurate billing or coding information.
These laws impact the kinds of financial arrangements
we may have with potential users of our technology. They particularly impact how we structure our marketing, including discount practices,
customer support, education and training programs, physician consulting, research grants and other service arrangements. If our operations
are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us, we may be subject
to penalties, including potentially significant criminal and civil and administrative penalties, damages, fines, disgorgement, imprisonment,
exclusion from participation in government healthcare programs, contractual damages, reputational harm, and the curtailment or restructuring
of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
Additionally, there has been a trend towards increased
federal and state regulation of payments and other transfers of value provided to healthcare professionals or entities. The federal Physician
Payment Sunshine Act requires that certain device manufacturers track and report to the government information regarding payments and
other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their
family members. A manufacturer’s failure to submit timely, accurately and completely the required information for all payments,
transfers of value or ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year,
and up to an aggregate of $1 million per year for “knowing failures.” Certain states also mandate implementation
of compliance programs, impose restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts,
compensation and other remuneration to healthcare professionals and entities.
We are subject to similar laws in foreign countries
where we conduct business. For example, within the EU, the control of unlawful marketing activities is a matter of national law in each
of the member states. The member states of the EU closely monitor perceived unlawful marketing activity by companies. We could face civil,
criminal, and administrative sanctions if any member state determines that we have breached our obligations under its national laws. Industry
associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached
our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition
could be adversely affected.
Other Foreign Healthcare Regulations
We are also subject to regulation in the foreign
countries in which we manufacture and market our products. For example, the commercialization of certain products, including certain medical
devices, in the EU is regulated under a system that presently requires all such products sold in the EU to bear the CE mark—an international
symbol of adherence to quality assurance standards.
The International Medical Device Regulators Forum
has implemented a global approach to auditing manufacturers of medical devices. This audit system, called the Medical Device Single Audit
Program (“MDSAP”), provides for an annual audit of a medical device manufacturer by a certified body on behalf of various
regulatory authorities. Current authorities participating in MDSAP include the Therapeutic Goods Administration of Australia, Brazil’s
Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals
and Medical Devices Agency and the FDA. It is expected that more regulatory authorities will participate in MDSAP in the future.
We, and other medical device manufacturers, are
currently adjusting to major changes in the EU’s decades-old regulatory framework which governs market access to the EU. The Medical
Devices Regulation (“MDR”) went into effect on May 26, 2021 and replaces the EU’s prior Medical Device Directive (93/42/EEC).
Our NOCISCAN product suite is subject to these
EU regulations, and is CE Marked via self-certification as a Class I medical device. However, this was secured prior to enactment of the
MDR. Under the MDR, we expect to be considered a Class II medical device and subject to stricter requirements for pre-market review and
certification for CE Marking by a Notified Body, including with respect to clinical data that must be submitted in support of our claimed
indications and labeling. However, manufacturers of certain classes of currently approved medical devices will have a transition time
to meet certain aspects of the new requirements under the MDR. A grace period until May 2024 is provided for Class I medical devices
that were self-certified for CE Marking prior to the MDR conversion to become CE Mark certified as a Class II medical device by a Notified
Body. We are still, however, required to continue monitoring and ensuring our on-going compliance with certain other provisions under
the new MDR requirements with respect to post-market surveillance of our products, as of May 2021.
The EU Parliament has voted to extend the Medical Device Regulation
(MDR 2017/745) transition period. The extension will see the May 2024 deadline postponed until 2027 for higher-risk Class III and implantable
IIb devices, and May 2028 for lower-risk Class I, IIa, and other IIb devices.
The MDR differs in several important ways from
the EU’s prior MDD directives for medical devices and active implantable medical devices. The most significant changes in the regulation
include:
| |
· |
The definition of medical devices covered under the MDR will
be significantly expanded to include devices that may not have a medical intended purpose, such as colored contact lenses. Also included
in the scope of the regulation are devices designed for the purpose of “prediction and prognosis” of a disease or other health
condition; |
| |
· |
Device manufacturers will be required to identify at least
one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new MDR.
The organization must document the specific qualifications of this individual relative to the required tasks; |
| |
· |
The MDR requires rigorous post-market oversight of medical
devices; |
| |
· |
The MDR will allow the EU Commission or expert panels to publish
“Common Specifications”, such as requirements for technical documentation, risk management, or clinical evaluation, which
devices shall be required to meet; |
| |
· |
Devices will be reclassified according to risk, contact, duration,
and invasiveness; |
| |
· |
Systematic clinical evaluation will be required for Class IIa
and Class IIb medical devices; and |
| |
· |
All currently approved devices must be recertified in accordance
with the new MDR requirements. |
Following Brexit, certain medical devices,
including our products, are also required to meet the local regulatory requirements within the U.K., separate and apart from EU regulations
that previously also covered commercial practices in the U.K. While our CE Mark still applies for the U.K., other U.K. requirements for
regulatory monitoring and compliance must also be met. Our quality and regulatory compliance systems and practices are currently in the
process of being updated for ensuring compliance with the applicable U.K. regulations.
General Data Protection Regulation
The implementation on May 25, 2018 of
the General Data Protection Regulation (“GDPR”), a regulation in the EU on data protection and privacy for all
individuals in the EU and the European Economic Area (“EEA”), applies to all enterprises, regardless of location, that
are doing business in the EU or that collect and analyze data tied to EU and EEA residents. GDPR creates a range of new compliance
obligations, including stringent technical and security controls surrounding the storage, use, and disclosure of personal
information, and significantly increases financial penalties for noncompliance (including possible fines of up to 4% of global
annual turnover for the preceding financial year or €20 million (whichever is higher) for the most serious
infringements).
In July 2020, the European Commission invalidated
the EU.-U.S. Privacy Shield framework, of which we were registrants. This has resulted in some uncertainty related to continuing obligations
and future data transfer compliance obligations.
California Consumer Privacy Act
The California Consumer Privacy Act, “CCPA”,
became effective on January 1, 2020 along with a number of complex privacy regulations affecting the processing of personal information
of California residents. If we fail to comply with the CCPA, we may be subject to significant financial penalties or adverse regulatory
actions. In addition to the CCPA, the California legislature is exploring additional regulations to expand the scope and depth of the
state’s data protection controls.
Competition
In the diagnostic and connected care markets,
competition is also based on a variety of factors including product performance, functionality, value and breadth of sales and service
organization. We believe that currently, there is a scarcity of new diagnostic platforms on the market, or otherwise proposed and approaching
the market, that are competitive with our products for our primary intended discogenic low back pain indication. Accordingly, our primary
competition resides with the current diagnostic standards over which our products are intended to improve – in particular, X-ray,
lumbar MRI, and provocative discography (PD). While we believe our products are positioned for synergistic use with lumbar MRI, and to
enhance the diagnostic value of lumbar MR exams, the existing reliance on MRI as a standard of care for our indication, and other potential
enhancements to those platforms and techniques, nonetheless also represent competition. To the extent these other platforms represent
our primary competitors, they are mainly provided by large, well-capitalized companies with significant market share and resources. Our
competitors have more established sales and marketing programs than we do and have greater name recognition. These competitors also have
long operating histories and may have more established relationships with our potential customers. In addition to competing for market
share, competitors may develop or acquire patents or other rights that may limit our ability to compete.
Competition could result
in price reductions, reduced margins and loss of our potential market share. We believe that our NOCISCAN product suite is superior
to currently known competition in this market as follows:
| |
· |
We believe we are superior to standard lumbar MRI because: |
| |
o |
Standard lumbar MRI only indicates structural defects, degeneration,
and hydration, which have not been well correlated to identifying painful discs in DLBP patients, whereas our products have been highly
correlated to pain as indicated by positive Provocation Discogram results in a clinical trial published in a major peer-reviewed spine
journal; |
| |
|
|
| |
o |
Standard lumbar MRI does not identify nor allow for measuring
levels of acidic chemicals, such as lactic acid, that have been identified as a source of causing discs to become painful, and which we
both identify and measure objectively and quantitatively; and |
| |
|
|
| |
o |
Patient outcomes from surgeries following standard lumbar MRI
diagnosis, but without the benefit of or following our diagnosis, have resulted in a much lower <60% success rate versus much higher
>90% success rates shown for patient outcomes following surgeries that treat painful discs identified via our diagnostic products,
as also demonstrated in the same published clinical trial referenced above. |
| |
· |
We believe we are superior to standard Provocation Discogram
(PD) because: |
| |
o |
PD is highly invasive, whereas our test is entirely non-invasive; |
| |
|
|
| |
o |
PD is painful by deliberate design, whereas our test is entirely
pain-free; |
| |
|
|
| |
o |
PD has certain risks of harm, including certain reports of
>1% risk of infection and increased risks of accelerating degeneration and/or herniation rates in discs after receiving needle injections
form PD, whereas our test is non-significant risk and no more risky that standard lumbar MRI or other applications of MRS; |
| |
o |
PD is subjective, based both on patient reporting of subjective
pain and physician subjectivity in interpreting results, whereas our test is entirely objective; and |
| |
|
|
| |
o |
PD is often performed, for optimal reliability and accuracy,
with a CT scan to evaluate the distribution of injected dye in and around the disc, which requires a second diagnostic imaging exam and
additional related costs, and which also exposes the patient to radiation, whereas our test is only a single exam, is more cost effective,
and is entirely radiation free. |
Employees
As of February 26, 2024, we had 6 total
employees, 2 of whom were engaged in full-time research and development activities, 1 engaged in strategy and business development, and
3 of whom were engaged in general administration. We believe that we maintain good relations with our employees.
Legal Proceedings
From time to time, we may be involved in litigation
relating to claims arising out of our operations in the normal course of business. We are not currently a party to any material legal
proceedings, the adverse outcome of which, in our management’s opinion, individually or in the aggregate, could have a material
adverse effect on the results of our operations or financial position. There are no material proceedings in which any of our directors,
officers or affiliates or any registered or beneficial stockholder of more than 5% of our common stock is an adverse party or has a material
interest adverse to our interest.
Segment Information
We operate in a single operating segment and a
single reporting segment. Operating segments are defined as components of an enterprise about which separate financial information is
regularly evaluated by the chief operating decision maker function (which is fulfilled by our chief executive officer) in deciding how
to allocate resources and in assessing performance. Our chief executive officer allocates resources and assesses performance based upon
financial information at the level. Since we operate in one operating segment, all required financial segment information is presented
in the financial statements.
Our corporate information
We were formed under the name Nocimed, LLC, a
limited liability company in January 2008, under the laws of the State of Delaware. In February 2015, Nocimed, LLC was converted into
Nocimed, Inc. a Delaware corporation. On December 3, 2021, we changed our name to Aclarion, Inc. Our principal executive offices are located
at 8181 Arista Place, Suite 100, Broomfield, Colorado 80021. Our main telephone number is (833) 275-2266. Our internet website is www.aclarion.com.
The information contained in or accessible from our website is not incorporated into this Annual Report, and you should not consider it
part of this Annual Report. We have included our website address in this Annual Report solely as an inactive textual reference.
Implications of being an emerging growth company and a smaller
reporting company
We qualify as an “emerging growth company”
as defined in the Jumpstart our Business Startups Act of 2012 (the “JOBS Act”). An emerging growth company may take advantage
of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:
| |
· |
inclusion of only two years, as compared
to three years, of audited financial statements in addition to any required unaudited interim financial statements with correspondingly
reduced Management’s Discussion and Analysis of Financial Condition and Results of Operations
disclosure; |
| |
|
|
| |
· |
an exemption from the auditor attestation
requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley
Act”); |
| |
|
|
| |
· |
an exemption from compliance with any
new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”) requiring mandatory audit firm rotation; |
| |
|
|
| |
· |
reduced disclosure about executive compensation
arrangements; and |
| |
|
|
| |
· |
an exemption from the requirement to seek
non-binding advisory votes on executive compensation or golden parachute arrangements. |
We may take advantage of these provisions until
we are no longer an emerging growth company. We will remain an emerging growth company until the earliest of (1) the last day of the fiscal
year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenue of at least
$1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is
held by non-affiliates exceeds $700 million as of the prior December 31st, and (2) the date on which we have issued more than $1.0 billion
in non-convertible debt during the prior three-year period.
We have taken advantage of the reduced reporting
requirements in this Annual Report. Accordingly, the information contained herein may be different from the information you receive from
other public companies that are not emerging growth companies.
The JOBS Act permits an emerging growth company
such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public
companies until those standards would otherwise apply to private companies.
We are also a “smaller reporting company”
meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100
million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value
of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently
completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting
company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements
that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two
most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies,
smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Available Information
Our internet address is www.aclarion.com. Our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports can be found
on our investor relations website, free of charge, as soon as reasonably practicable after we electronically file such material with,
or furnish it to, the SEC. Information contained on our website is not incorporated by reference into this prospectus. The SEC maintains
a public website, www.sec.gov, which includes information about and the filings of issuers that file electronically with the SEC.
Management,
Governance, Director Compensation, Executive Compensation
Executive officers and directors
Set forth below are the names, ages and positions of our executive
officers and directors as of February 26, 2024.
| Name |
|
Age |
|
Position(s) held |
|
Served as a Director
and/or Officer Since |
|
Executive Officers |
|
|
|
|
|
|
| Jeff Thramann, M.D. |
|
59 |
|
Executive Chairman and Director |
|
2020(1) |
| Brent Ness |
|
57 |
|
Chief Executive Officer, President and Director |
|
2021(2) |
| John Lorbiecki |
|
61 |
|
Chief Financial Officer |
|
2021(3) |
| Ryan Bond |
|
52 |
|
Chief Strategy Officer |
|
2021(4) |
| |
|
|
|
|
|
|
| Non-Employee Directors |
|
|
|
|
|
|
| |
|
|
|
|
|
|
| Scott Breidbart, M.D. |
|
68 |
|
Director |
|
(5) |
| Steve Deitsch |
|
52 |
|
Director |
|
(5) |
| David Neal |
|
52 |
|
Director |
|
(6) |
| William Wesemann |
|
67 |
|
Director |
|
(6) |
| Amanda Williams |
|
46 |
|
Director |
|
(5) |
_______________
| (1) |
Dr. Thramann has been a director since 2020. He was appointed Executive Director as of March 2021, and became Executive
Chairman as of April 21, 2022. |
| (2) |
Mr. Ness was appointed CEO and a director on September 15, 2021. |
| (3) |
Mr. Lorbiecki was appointed Chief Financial Officer on October 1, 2021. |
| (4) |
Mr. Bond was appointed Chief Strategy Officer on September 15, 2021. |
| (5) |
Ms. Williams, Mr. Deitsch, and Dr. Breidbart have been directors since April 21, 2022. |
| (6) |
Mr. Wesemann and Mr. Neal have been directors since 2016. |
Executive Officers
Jeff Thramann, M.D., Executive Chairman
and Director: Jeff Thramann has been a director since September, 2020. He was also an executive Director since March 2021, which
is an executive officer of the Company. He transitioned to Executive Chairman at the time of our April 2022 IPO. He oversees strategic
initiatives, capitalization and governance at the company. This includes day-to-day involvement in working with senior management to establish
the strategic vision of the Company, assist in KOL development, work with the Chief Executive Officer and Chief Financial Officer on financial
plans, clinical reimbursement and product strategies, and assisting the Chief Executive Officer in recruitment and hiring of senior executives
and the pursuit of business development activities. His responsibilities also include leading investor relations efforts, building the
board of directors and leading board meetings. Dr. Thramann is currently the founder and Executive Chairman of Auddia Inc. (NASDAQ: AUUD),
a technology company that is reinventing how consumers interact with audio through an AI platform that enables unique consumer experiences
across radio and podcast listening. Dr. Thramann founded Auddia Inc. in January 2012. In 2002, Dr. Thramann was the founder (and became
the chairman) of Lanx, LLC (“Lanx”). Lanx was an innovative medical device company focused on the spinal implant market that
created the interspinous process fusion space with the introduction of its patented Aspen product. Lanx was sold to Biomet, Inc., an international
orthopedic conglomerate, in November, 2013. Concurrent with Lanx, in July, 2006 Dr. Thramann was the founder and chairman of ProNerve,
LLC (“ProNerve”). ProNerve was a healthcare services company that provided monitoring of nerve function during high-risk surgical
procedures affecting the brain and spinal cord. ProNerve was sold to Waud Capital Partners, a private equity firm, in 2012. Prior to ProNerve
and concurrent with Lanx, Dr. Thramann was the founder and chairman of U.S. Radiosurgery (“USR”). USR is a healthcare services
company that provides advanced radiosurgical treatments for tumors throughout the body. USR became the largest provider of robotic guided
CyberKnife treatments of such tumors in the U.S. and was sold to Alliance Healthcare Services (NASDAQ: AIQ) in April, 2011. From July,
2001 through April, 2008, Dr. Thramann was the founder and senior partner of Boulder Neurosurgical Associates, a neurosurgical practice
serving Boulder County, Colorado. Dr. Thramann is the named inventor on over 100 U.S. and international issued and pending patents. He
completed his neurosurgical residency and complex spinal reconstruction fellowship at the Barrow Neurological Institute in Phoenix, AZ,
in June, 2001. He is a graduate of Cornell University Medical College in New York City and earned his Bachelor of Science degree in electrical
engineering management at the U. S. Military Academy in West Point, NY.
Brent Ness, Chief Executive Officer. Mr.
Ness became our Chief Executive Officer on September 15, 2021. From December 2019 through April 2021, he was a consultant and then became
President and Chief Commercial Officer of Cleerly, Inc. (“Cleerly”). Cleerly is a developer of an AI enabled non-invasive
digital care pathway aimed at improving clinicians understanding of their patients’ risk of sudden coronary death. At Cleerly, Mr.
Ness co-led efforts to create a partnership with Canon, Inc. who co-markets Cleerly solutions as part of their offerings. From March 2016
to December 2019, Mr. Ness was the Chief Operating Officer of Mighty Oak Medical (“Mighty Oak”) whose principal products progressed
from pre-FDA clearance through an international full market launch of their platform called FIREFLY. FIREFLY is a 3D Printed patient
specific solution that is intended to provide spine surgeons with a highly accurate alternative to navigation and robotic applications
in the spinal navigation space. FIREFLY involves the use of CT scans as the core data upon which sophisticated pre-surgical plans are
created along with guides and bone models. From 2014 through 2016, Mr. Ness was the Chief Commercial Officer of HeartFlow, Inc. (“Heartflow”).
HeartFlow is a medical technology company that created and developed a non-invasive cardiac test enabling physicians to make more informed
decisions for their patients with suspected coronary heart disease. Mr. Ness led the business from pre-FDA clearance through a global
expansion of early adopter sites. Along with the senior leadership team at HeartFlow, he deployed a strong clinical evidence-based approach
in the early launch of the SaaS platform to engage Key Opinion Leader Physicians and the third-party payer community. This resulted in
the issuance of Category III CPT Codes and multiple private payer coverage decisions. From 2008 through 2013, he was President of ProNerve,
LLC, (“ProNerve"). ProNerve is a provider of intraoperative neuromonitoring services which involves the use of a variety of
electro-physiological monitoring procedures during spine and brain surgery, to allow early warning and avoidance of injury to nervous
system structures. As President of ProNerve, Mr. Ness presided over a roll up of the highly fragmented Interoperative Nerve Monitoring
Industry. From 2004 to 2008, Mr. Ness served as Vice President- Global Sales and Marketing for Medtronic Navigation, a division of Medtronic,
Inc. Earlier in his career he was employed by GE Healthcare as Director of Corporate Accounts and for Philips North America as Vice President
of Sales Operations, which companies are suppliers of diagnostic imaging equipment.
Mr. Ness currently serves as an advisor to Mighty
Oak Medical, K2 Capital and Cleerly. Mr. Ness has a Bachelor’s Degree in Marketing from the University of North Dakota and an MBA
from the University of Colorado.
John Lorbiecki, Chief Financial Officer:
Mr. Lorbiecki became our Chief Financial Officer on October 1, 2021. He has over 25 years of financial management and operational experience
which includes serving as the divisional CFO for two business units within Medtronic, Inc. From January 2019 through October 1, 2021,
Mr. Lorbiecki was a principal of Strategic Finance Solutions LLC, a financial consulting company. From April 2021 to October 2021, he
also advised Fusion Robotics LLC through their merger with Integrity Implants Inc., now doing business as Accelus Inc. From January 2020
through April 2021, Mr. Lorbiecki held the lead finance role at Honeybee Robotics, an aerospace company that designs and builds advanced
robotic systems. He led the financial dimensions of the strategic planning process, managed monthly project reviews to measure progress
and ensure economic targets were met, and oversaw monthly accounting activities. From March 2017 through July 2018, he served as Chief
Operating Officer at Colorado Therapeutics LLC, a medical startup focused on innovative biologic soft tissue repair products where he
was instrumental in completing the relocation of the company headquarters and increasing manufacturing capacity. From 1991 through 2017
he was with Medtronic, among the largest medical device companies in the world. He led sales operations, including pricing and contracting,
for the Cardiac Surgery Division, and moved through other business unit and corporate financial leadership roles. Mr. Lorbiecki has a
Bachelor’s Degree in Economics from the University of St. Thomas where he graduated magna cum laude and an MBA from the University
of Chicago Booth School of Business.
Ryan Bond, Chief Strategy Officer: Mr.
Bond became our Chief Strategy Officer in September 2021. From December 2018 to August 2021, he has been our Vice President, Business
Development, where he led business development, sales and marketing including a limited commercial launch of Aclarion’s cloud-based
SaaS with early adopters in the US, EU, and UK, Mr. Bond coordinated multiple research trials sponsored by our customers, where Aclarion’s
proprietary, adjunctive diagnostic technology is employed. Mr. Bond was instrumental in working with reimbursement consultants to gain
Category III CPT Codes for Aclarion with assigned APC rates and advocating to CMS for the removal of a long-standing non-coverage policy
for magnetic resonance spectroscopy (MRS, CPT Code 76390). From November 2014 to September 2018 Mr. Bond was Director, Healthcare Solutions
at NuVasive, a company in the global spine market. While at NuVasive, he led several strategic initiatives involving strategic partnerships,
channel development, pricing, contracting, and sales training. From 2005 to 2014, Mr. Bond was with Accelero Health Partners (“Accelero”),
a consulting firm focused on musculoskeletal service line development using a combination of strategic organizational development programs
and a proprietary cloud-based business intelligence tool that discretely measured a cadre of clinical, functional, operational, and volume-based
metrics, while simultaneously illustrating the interrelated cause-effect of each. In 2006, Accelero was acquired by Zimmer Holdings. Mr.
Bond serves on an Advisory Board to the College of Business at Ohio University, where he earned a Bachelor’s of Science Degree in
Engineering from the Russ College of Engineering and Technology.
Non-employee directors
Scott Breidbart, M.D., Director: Dr.
Scott Breidbart has been consulting in the healthcare industry since November 2021. Before that, he was the Chief Medical Officer of Affinity
Health Plans from January 2018 until its purchase in November 2021. From October 2016 to January 2018, he was Chief Medical Officer of
Solera Health and from October 2015 to September 2016, he was the Chief Clinical Officer of Emblem Health. From November 2008 to October
2015, Mr. Breidbart served as the Chief Medical Officer of Empire BlueCross BlueShield, and from May 1998 to August 2008 he had various
roles in medical management for HealthNet. Dr. Breidbart practiced pediatric endocrinology for ten years on the faculty of New York Medical
College. He is Board Certified in Pediatrics and Pediatric Endocrinology and is licensed to practice medicine in NY. He holds a BA in
Mathematics from Yale, an MD from Columbia, and an MBA from Pace University. We believe Dr. Breidbart’s experience with medical management and medical reimbursement matters provides
him with the appropriate set of skills to serve as a member of our board of directors.
Steve Deitsch, Director: Steve Deitsch
is currently the CFO of Paragon 28, a medical device company focused on surgical implants for the foot and ankle. Steve has extensive
strategic, operational, and financial leadership experience at both publicly traded and privately held companies. From April 2017 to
August 2019, Mr. Deitsch served as Senior Vice President and Chief Financial Officer of BioScrip, Inc., which is now part of Option Care
Health, Inc. (NASDAQ: BIOS). From August 2015 to April 2017, Mr. Deitsch served as Executive Vice President, Chief Financial Officer
and Corporate Secretary of Coalfire, Inc., a leading cyber-security firm owned by The Carlyle Group. Steve served as the Chief Financial
Officer of the Zimmer Biomet Spine, Bone Healing, and Microfixation business from July 2014 to July 2015 and as Vice President Finance,
Biomet Corporate Controller from February 2014 to July 2014. Mr. Deitsch was the Chief Financial Officer of Lanx from September
2009 until it was acquired by Biomet in October 2013. From 2002 to 2009, Mr. Deitsch also served in various senior financial leadership
roles at Zimmer Holdings, Inc. (now part of Zimmer Biomet, Inc.), including Vice President Finance, Reconstructive and Operations, and
Vice President Finance, Europe. Steve is a director and audit committee chair of Auddia Inc. (NASDAQ: AUUD), since February of 2021.
Mr. Deitsch holds a B.S. in Accounting from Ball State University and has an in-active CPA license. We believe Mr. Deitsch’s financial, management and healthcare experience provides him with the appropriate
set of skills to serve as a member of our board of directors.
David Neal, Director: Mr. Neal
has been a director since September 2016. He is the founder and a current member of SC Capital 1 LLC which was formed in 2016. SC
Capital 1 LLC is a securitized LLC formed to invest in breakthrough medical technologies and therapies. Also, from April 2015 to the
present, he has been a partner of Frontier Wealth Enterprises, LLC a financial services firm providing advice-based financial
services to high-net worth families. From 2000 to 2015, he held various positions with UBS, including Portfolio Manager and manager
of a Regional Office in Wichita Kansas. He was on the Hutchinson Regional Medical Center board of directors for 9 years and
currently is a member of the board of the Hutchinson Community Foundation. He holds a Bachelor of Sport Science degree from the
University of Kansas and a Master of Management Science degree from the John Cook School of Business at Saint Louis University. We
believe Mr. Neal’s experience in medical technology investment provides him with the appropriate set of skills to serve as a
member of our board of directors.
William (Bill) Wesemann, Director: Mr.
Wesemann has been a director since 2016. Mr. Wesemann has been an independent businessman and investor since June 2002. Prior to 2002
his experience included serving in chief executive, sales leadership, and advisory roles at technology companies. Since 2004, he has been
a director of LivePerson (Nasdaq: LPSN), a global technology company that develops conversational commerce and AI software. He is also
a director of Stationhead, Inc. (commencing in 2019), a consumer social audio platform; and a director of Mylio, Inc (commencing in 2013)
a photo management company. Mr. Wesemann received a B.A. from Glassboro State College (Rowan University). We believe Mr. Wesemann’s experience in technology investing provides him with the appropriate set of skills
to serve as a member of our board of directors.
Amanda Williams, Director: Ms. Williams
has been Senior Vice President for Clinical and Regulatory at MedAlliance, a Cordis company, which is a healthcare company focused on
treating peripheral and coronary artery disease with the Selution drug coated balloon, since August 2023. From September 2018 to May 2023,
she was the Senior Vice President of Clinical, Quality and Regulatory at ViewRay, Inc. (Nasdaq: VRAY), a healthcare company that integrates
real time MRI imaging of tumors with the delivery of high dose radiation for improved treatment accuracy. From December, 2017, to September,
2018, she was the Head of Regulatory with the Image Guided Therapy Devices and Systems divisions of Philips. From July, 2010 to December,
2017 Ms. Sequira was the Senior Director (2010-2013) and Vice President (2013-2017) of Clinical and Regulatory with The Spectranetics
Corp., (now part of Philips), and from 2003 to 2010 she was Manager, and then Director of Regulatory of AGA Medical Corp (now part of
Abbott). Prior to these roles, she worked as a Regulatory Specialist with Vascular Solutions and as a Chemist with GE – Osmonics.
In these positions, she worked on a diverse range of products, including cardiovascular treatment, implantable heart defect device, combination
drug/device and large capital equipment (both imaging and treatment) devices. At Spectranetics, she led teams that completed multiple
global randomized clinical studies. She holds a Master of Science in Regulatory from Northeastern University and a Bachelor of Science
in Chemistry from the University of Minnesota. We believe Ms. Williams’ medical clinical and regulatory matters provides her with
the appropriate set of skills to serve as a member of our board of directors.
Section 16(a) Beneficial Ownership Reporting Compliance
Following our IPO, Section 16(a) of the Exchange
Act requires our directors, executive officers, and persons holding more than 10% of our common stock to report their initial ownership
of the common stock and other equity securities and any changes in that ownership in reports that must be filed with the SEC. The SEC
has designated specific deadlines for these reports, and we must identify in our Annual Report on Form 10-K those persons who did not
file these reports when due.
Based solely on a review of reports furnished
to us, or written representations from reporting persons, we believe all directors, executive officers, and 10% owners timely filed all
reports regarding transactions in our securities required to be filed in 2023 by Section 16(a) under the Exchange Act.
Election of Officers
Our executive officers are appointed by, and serve
at the discretion of, our board of directors. There are no family relationships among any of our directors or executive officers.
Composition of the Board of Directors
Our board of directors currently consists of seven
members. Four of our directors are independent within the meaning of the independent director guidelines of the Nasdaq Stock Market.
Each director’s term continues until the
election and qualification of his successor, or his earlier death, resignation or removal. Our restated certificate of incorporation and
restated bylaws authorize only our board of directors to fill vacancies on our board of directors.
Board Leadership Structure and Role in Risk
Oversight
Our corporate governance guidelines provide that
unless the board chair is an independent director, the board shall appoint a Lead Independent Director. The Lead Independent Director
chairs the executive sessions of the independent directors, coordinates the activities of the other independent directors and performs
such other duties as deemed necessary by the board from time to time. Because our Executive Chairman Dr. Thramann is not independent,
the board has appointed William Wesemann to serve as our Lead Independent Director.
Risk is inherent with every business, and how
well a business manages risk can ultimately determine its success. We face a number of risks, including credit risk, interest rate risk,
liquidity risk, operational risk, strategic risk and reputation risk. Management is responsible for the day-to-day management of risks
we face, while the board, as a whole and through its committees, has responsibility for the oversight of risk management. In its risk
oversight role, the board has the responsibility to satisfy itself that the risk management processes designed and implemented by management
are adequate and functioning as designed. To do this, the board meets regularly with management to discuss strategy and the risks we face.
In addition, the Audit Committee regularly monitors our enterprise risk, including financial risks, through reports from management. Senior
management attends the board meetings and is available to address any questions or concerns raised by the board on risk management and
any other matters. The Lead Independent Director and the independent board members work together to provide strong, independent oversight
of our management and affairs through the board’s standing committees and, when necessary, executive sessions of the independent
directors.
Director Independence
Under the rules of Nasdaq, independent directors
must comprise a majority of a listed company’s board of directors within a specified period following the completion of its IPO.
In addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a listed company’s audit, compensation
and nominating and governance committees be independent. Under the rules of Nasdaq, a director will only qualify as an “independent
director” if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director.
Audit committee members must also satisfy the
independence criteria set forth in Rule 10A-3 under the Exchange Act. In order to be considered independent for purposes of Rule 10A-3,
a member of an audit committee of a listed company may not, other than in his capacity as a member of the audit committee, the board of
directors or any other board committee: (i) accept, directly or indirectly, any consulting, advisory or other compensatory fee from the
listed company or any of its subsidiaries; or (ii) be an affiliated person of the listed company or any of its subsidiaries. We currently
satisfy the audit committee independence requirements of Rule 10A-3. Additionally, compensation committee members must not have a relationship
with us that is material to the director’s ability to be independent from management in connection with the duties of a compensation
committee member.
Our board of directors has undertaken a review
of the independence of each director and considered whether each director has a material relationship with us that could compromise his
ability to exercise independent judgment in carrying out his responsibilities. As a result of this review, our board of directors determined
that all of our directors, except for Jeffrey Thramann, Brent Ness and David Neal are “independent directors” as defined under
the applicable rules and regulations of the Securities and Exchange Commission, or SEC, and the listing requirements and rules of Nasdaq.
In making these determinations, our board of directors reviewed and discussed information provided by the directors and us with regard
to each director’s business and personal activities and relationships as they may relate to us and our management.
Committees of our board of directors
Audit Committee
Our audit committee is comprised of Bill Wesemann,
Scott Breidbart and Steve Deitsch, with Steve Deitsch serving as its chairman The composition of our audit committee meets the requirements
for independence under the current Nasdaq and SEC rules and regulations. Each member of our audit committee is financially literate. In
addition, our board of directors has determined that Stephen Deitsch is an “audit committee financial expert” as defined in
Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act. This designation does not impose on Mr. Deitsch any duties,
obligations or liabilities that are greater than are generally imposed on members of our audit committee and our board of directors. Our
audit committee is directly responsible for, among other things:
| |
· |
selecting and hiring our independent
registered public accounting firm; |
| |
· |
the qualifications, independence
and performance of our registered public accounting firm; |
| |
· |
the preparation of the audit committee
report to be included in our annual proxy statement; |
| |
· |
our compliance with legal and regulatory
requirements; |
| |
· |
our accounting and financial reporting
processes, including our financial statement audits and the integrity of our financial statements; and |
| |
· |
reviewing and approving related-person
transactions. |
Compensation Committee
Our compensation committee is comprised of Amanda
Williams, Scott Breidbart, and Bill Wesemann, with Mr. Wesemann serving as chairman. Each member of our compensation committee is a non-employee
director, as defined by Rule 16b-3 promulgated under the Exchange Act and meets the requirements for independence under the current Nasdaq
listing standards and SEC rules and regulations. Our compensation committee is responsible for, among other things:
| |
· |
evaluating, recommending, approving
and reviewing executive officer compensation arrangements, plans, policies and programs; |
| |
· |
evaluating and recommending non-employee
director compensation arrangements for determination by our board of directors; |
| |
· |
administering our cash-based and
equity-based compensation plans; and |
| |
· |
overseeing our compliance with regulatory
requirements associated with the compensation of directors, officers and employees. |
Nominating and Governance Committee
Our nominating and governance committee is comprised
of Bill Wesemann, Scott Breidbart, and Amanda Williams, with Amanda Williams serving as its chairman. Each member of our nominating and
governance committee meets the requirements for independence under the current Nasdaq listing standards. Our nominating and governance
committee is responsible for, among other things:
| |
· |
identifying, considering and recommending
candidates for membership on our board of directors; |
| |
· |
overseeing the process of evaluating
the performance of our board of directors; and |
| |
· |
advising our board of directors
on other corporate governance matters. |
Consideration of Director Nominees
Director Qualifications
There are no specific minimum qualifications that
the Board requires to be met by a director nominee recommended for a position on our board, nor are there any specific qualities or skills
that are necessary for one or more members of our board to possess, other than as are necessary to meet the requirements of the rules
and regulations applicable to us. The Nominating and Governance Committee considers a potential director candidate’s experience,
areas of expertise and other factors relative to the overall composition of our board and its committees, including the following characteristics:
experience, judgment, commitment (including having sufficient time to devote to the Company), skills, diversity, and expertise appropriate
for the Company. In assessing potential directors, the Nominating and Governance Committee may consider the current needs of the board
and the Company to maintain a balance of knowledge, experience and capability in various areas.
Stockholder Nominations
In accordance with our bylaws, a stockholder wishing
to nominate a director for election at an annual meeting of stockholders must timely submit a written proposal of nomination to us at
our executive offices. To be timely, a written proposal of nomination for an annual meeting of stockholders must be received at least
90 calendar days but no more than 120 calendar days before the first anniversary of the date on which we held our annual meeting of stockholders
in the immediately preceding year; provided, however, that in the event that the date of the annual meeting is
advanced or delayed more than 30 calendar days from the anniversary of the annual meeting of stockholders in the immediately preceding
year, the written proposal must be received: (i) at least 90 calendar days but no more than 120 calendar days prior to the date of the
annual meeting; or (ii) no more than 10 days after the date we first publicly announce the date of the annual meeting.
Each written proposal for a nominee must contain:
(1) the name, age, business address and residence address of such nominee, (2) the principal occupation or employment of such nominee,
(3) the class and number of shares of each class of capital stock of the Company which are owned of record and beneficially by such nominee,
(4) the date or dates on which such shares were acquired and the investment intent of such acquisition, (5) a statement whether such nominee,
if elected, intends to tender, promptly following such person's failure to receive the required vote for election or reelection at the
next meeting at which such person would face election or re-election, an irrevocable resignation effective upon acceptance of such resignation
by the board, and (6) such other information concerning such nominee as would be required to be disclosed in a proxy statement soliciting
proxies for the election of such nominee as a director in an election contest (even if an election contest is not involved), or that is
otherwise required to be disclosed pursuant to Section 14 of the 1934 Act and the rules and regulations promulgated thereunder (including
such person’s written consent to being named as a nominee and to serving as a director if elected).
A stockholder interested in submitting a nominee
for election to the board should refer to our bylaws for additional requirements. Upon receipt of a written proposal of nomination meeting
these requirements, the Nominating and Governance Committee of the Board will evaluate the nominee in accordance with its charter and
the characteristics listed above.
Evaluating Nominees for Director
Our Nominating and Corporate Governance Committee
considers director candidates that are suggested by members of the committee, other members of our Board, members of management, advisors
and our stockholders who submit recommendations in accordance with the requirements set forth in our Bylaws, as described above. Our Board
has in the past engaged a third-party search firm to identify potential candidates for consideration by the Nominating and Governance
Committee and election to our Board. The Nominating and Corporate Governance Committee may, in the future, retain third-party search firms
to identify Board candidates on terms and conditions acceptable to the Nominating and Corporate Governance Committee to assist in the
process of identifying or evaluating director candidates. The Nominating and Corporate Governance Committee evaluates all nominees for
director using the same approach whether they are recommended by stockholders or other sources. The Nominating and Corporate Governance
Committee reviews candidates for director nominees in the context of the current composition of our Board and committees, the operating
requirements of the Company and the long-term interests of our stockholders. In conducting this assessment, the Nominating and Corporate
Governance Committee considers the director nominee’s qualifications, diversity, skills and such other factors as it deems appropriate
given the current needs of the Board, the committees and the Company, to maintain a balance of knowledge, experience, diversity and capability.
In the case of incumbent directors whose terms of office are set to expire, the Nominating and Corporate Governance Committee reviews
such directors’ overall service to the Board, the committees and the Company during their term, including the number of meetings
attended, level of participation, quality of performance and any other relationships and transactions that might impair such directors’
independence. In the case of new director candidates, the Nominating and Corporate Governance Committee will also determine whether the
nominee must be independent for Nasdaq purposes, which determination will be based upon applicable Nasdaq listing standards and applicable
SEC rules and regulations. Although we do not have a formal diversity policy, when considering diversity in evaluating director nominees,
the Nominating and Corporate Governance Committee focuses on whether the nominees can contribute varied perspectives, skills, experiences
and expertise to the Board.
The Nominating and Corporate Governance Committee
will evaluate the proposed director’s candidacy, including proposed candidates recommended by stockholders, and recommend whether
the Board should nominate the proposed director candidate for election by our stockholders.
Stockholder Communications with the Board
Any stockholder or interested party who desires
to contact our board, or specific members of our board, may do so electronically by sending an email to our CFO at the following address:
jlorbiecki@aclarion.com. Alternatively, a stockholder may contact our board, or specific members of our board, by writing to: Aclarion,
Inc., 8181 Arista Place, Suite 100, Broomfield, Colorado, 80021, Attn: CFO. All such communications will be initially received and processed
by the office of our CFO. Communications concerning accounting, audit, internal accounting controls and other financial matters will be
referred to the Chair of the Audit Committee. Other matters will be referred to the board, the non-employee directors or individual directors,
as appropriate.
The board has instructed the CFO to review all
communications so received and to exercise his discretion not to forward to the board correspondence that is inappropriate such as business
solicitations, frivolous communications and advertising, routine business matters and personal grievances. However, any director may at
any time request the CFO to forward any and all communications received by the CFO but not forwarded to the directors.
Compensation committee interlocks and insider
participation
None of the current members of our compensation
committee has ever been an executive officer or employee of ours. None of our executive officers currently serves, or has served during
the last completed fiscal year, on the compensation committee or board of directors of any other entity that has one or more executive
officers serving as a member of our board of directors or compensation committee.
Code of Business Conduct and Ethics
Our board of directors has adopted a code of business
conduct and ethics that applies to all of our employees, officers and directors, including our Chief Executive Officer and other executive
and senior officers. The full text of our code of business conduct and ethics is posted on the investor relations section of our website.
The reference to our website address in this prospectus does not include or incorporate by reference the information on our website into
this prospectus. We intend to disclose future amendments to certain provisions of our code of business conduct and ethics, or waivers
of these provisions, on our website or in public filings to the extent required by the applicable rules.
Number of Meetings
During 2023,
the board held a total of nine meetings. Our Audit Committee held seven meetings in 2023, our Compensation Committee held five meetings
in 2023, and our Nominating and Governance Committee held one meeting. Each director attended at least 75% of the aggregate of the total
number of meetings of the board and the board committees on which he or she served during 2023.
Board Member Attendance at Annual Stockholder Meetings
Although we do not have a formal policy regarding
director attendance at annual stockholder meetings, directors are encouraged to attend these annual meetings absent extenuating circumstances.
Non-Employee Director Compensation
Our non-employee directors began serving on our
board following our April 2022 IPO.
Our Executive Chairman, Dr. Thramann, and our
President and Chief Executive Officer, Mr. Ness, do not receive compensation for their services as a director.
Our board of directors approved the following
compensation for our non-employee directors in 2023. Our non-employee directors receive annual cash compensation of (i) $25,000 for service
on the board (ii) $15,000 for service as the Audit Committee chair, and (iii) $5,000 for service on each board committee. All cash payments
will be made quarterly in arrears, and pro-rated for any partial quarters of service.
The following Director Compensation Table summarizes
the compensation of each of our non-employee directors for services rendered to us during the year ended December 31, 2023:
|
Name |
|
Fees
Earned or Paid in Cash ($) |
|
Stock Awards
($) |
|
Option Awards
($) |
|
All Other Compensation
($) |
|
Total
($) |
| Scott Breidbart |
|
40,000 |
|
-0- |
|
-0- |
|
-0- |
|
40,000 |
| Steve Deitsch |
|
45,000 |
|
-0- |
|
-0- |
|
-0- |
|
45,000 |
| David Neal |
|
25,000 |
|
-0- |
|
-0- |
|
-0- |
|
25,000 |
| William Wesemann |
|
40,000 |
|
-0- |
|
-0- |
|
-0- |
|
40,000 |
| Amanda Williams |
|
35,000 |
|
-0- |
|
-0- |
|
-0- |
|
35,000 |
Executive Compensation Overview
As an “emerging growth company,” we
have opted to comply with the executive compensation disclosure rules applicable to “smaller reporting companies,” as such
term is defined in the rules promulgated under the Securities Act.
This section provides an overview of the compensation
awarded to, earned by, or paid to each individual who served as our principal executive officer during our fiscal year 2023, and
our next three most highly compensated executive officers in respect of their service to our company for fiscal year 2023. Our named
executive officers, or the Named Executive Officers, for the year ended December 31, 2023, are:
| |
· |
Jeffrey Thramann,
Executive Chairman; |
| |
· |
Brent Ness,
Chief Executive Officer; |
| |
· |
John Lorbiecki,
Chief Financial Officer; and |
| |
· |
Ryan Bond,
Chief Strategy Officer. |
Summary Compensation Table Year Ended December
31, 2023
The following table contains information about
the compensation paid to or earned by each of our Named Executive Officers during the two most recently completed fiscal years.
| Name
and Principal Position |
Year |
Salary
($) |
|
Bonus
($)(1)(2) |
|
Stock
Awards
($) |
|
Option
Awards
($)(3) |
|
All Other Compensation
($) |
|
Total
($) |
|
| Jeff
Thramann, Executive Director |
2023 |
|
300,000 |
|
|
|
|
– |
|
|
– |
|
– |
|
|
300,000 |
|
| |
2022 |
|
300,000 |
|
18,750 |
|
|
– |
|
|
252,369 |
|
– |
|
|
571,119 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Brent Ness, Chief
Executive Officer |
2023 |
|
300,000 |
|
|
|
|
– |
|
|
|
|
|
|
|
300,000 |
|
| |
2022 |
|
300,000 |
|
118,750(4) |
|
|
– |
|
|
90,704 |
|
– |
|
|
509,454 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ryan Bond, Chief
Strategy Officer |
2023 |
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
| |
2022 |
|
200,000 |
|
19,532(5) |
|
|
– |
|
|
– |
|
– |
|
|
219,532 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| John Lorbiecki, Chief
Financial Officer |
2023 |
|
225,000 |
|
|
|
|
|
|
|
|
|
|
|
|
225,000 |
|
| |
2022 |
|
225,000 |
|
89,871(6) |
|
|
– |
|
|
19,747 |
|
– |
|
|
334,618 |
|
____________________
| (1) |
The Company has a discretionary annual cash bonus program.
The Company has not yet determined and approved annual cash bonuses for the year 2023.
|
| (2) |
Except for the amounts described below in notes
4, 5, and 6, the 2022 bonus amounts reflect cash bonus amounts earned in the 2022 year (as determined and approved by our compensation
committee in March 2023) but which amounts have not been paid to date. Such bonus amounts will not be paid until the Company has
additional funding and cash liquidity. |
| (3) |
Represents the grant date fair value of stock option awards computed
in accordance with FASB ASC Topic 718, excluding the effect of estimated forfeitures. For information regarding assumptions underlying
the valuation of equity awards, see Note 15 to our financial statements included in this prospectus. |
| (4) |
Under the terms of his employment agreement, Mr. Ness received a bonus payment of $100,000 upon the IPO completed in April 2022. |
| (5) |
The Company implemented a cash bonus plan related to the temporary
deferral of all employees’ base salaries by 50% effective as of October 16, 2020. Under this program, $8,594 was paid to Mr.
Bond in 2022. |
| (6) |
Under the terms of his employment agreement, Mr. Lorbiecki received a bonus payment of $28,125 upon the IPO completed in April 2022. |
Employment Agreements
Dr. Jeff Thramann
On June 15, 2021, we entered into an employment agreement with Dr.
Jeff Thramann. The employment agreement was retroactively made effective to March 1, 2021. The employment agreement provides that Dr.
Thramann will:
| |
· |
Receive a salary of $25,000 per
month.; |
| |
· |
Be appointed as Executive Director
(an executive officer position with the Company), as an “at will” employee, until the date of the IPO, at which time he transitioned
from Executive Director to Executive Chairman, an executive officer of the Company. |
| |
· |
Be issued
options (the “Thramann Options”) to purchase 1,204,820 shares (75,302 shares after
our January 3, 2024 reverse stock split) of common stock (the “Thramann Option Shares”) of the Company
subject to the terms and conditions set forth in the Company’s equity incentive plan, at an exercise price of $1.94 ($31.04
after our January 3, 2024 reverse stock split) per share. The options have a 10-year term. The vesting of the Thramann
Options occurred on the date of the IPO, April 21, 2022. |
Brent Ness
On September 15, 2021, we entered into an Employment
Agreement with Brent Ness. The employment agreement provides that Mr. Ness would:
| |
· |
Be appointed Chief Executive Officer
of the Company. |
| |
· |
Receive an annual base salary of
$300,000, plus an additional $100,000 if the Company completes an initial public offering and its securities are listed for trading on
Nasdaq or the NYSE. |
| |
· |
Commencing in 2022, Mr. Ness will
be eligible to receive, upon certain conditions, an annual incentive bonus up to 50% of Mr. Ness’ base salary |
| |
· |
Mr. Ness’ employment agreement
is terminable ‘at will’ by the Company. If the Company terminates Mr. Ness’ employment without cause or Mr. Ness terminates
for good reason, he is entitled to receive twelve months of base salary, (ii) up to nine months of paid health insurance under COBRA,
and (iii) any earned but unpaid bonus for a prior completed fiscal year. |
| |
· |
Be
issued options to purchase 341,365 shares (21,337 shares after our January 3, 2024 reverse stock split) of common stock of the
Company, subject to the terms and conditions set forth in the Company’s equity incentive plan, at an exercise price of $1.94
($31.04 after our January 3, 2024 reverse stock split) per share. The stock options have a 10-year term. The stock
options will vest in 48 equal installments on each monthly anniversary of the date of grant, such that the grant will become fully
vested and exercisable on the four-year anniversary of the date of grant. |
John Lorbiecki
On September 22, 2021, we entered into an Employment
Agreement with John Lorbiecki. The employment agreement provides that Mr. Lorbiecki would:
| |
· |
Be appointed Chief Financial Officer
of the Company as an “at will” employee. |
| |
· |
Receive an annual base salary of
$225,000. |
| |
· |
Commencing in 2022, Mr. Lorbiecki
will be eligible to receive, upon certain conditions, an annual incentive bonus up to 50% of Mr. Lorbiecki’s base salary. |
| |
· |
Mr. Lorbiecki’s employment
agreement is terminable ‘at will’ by the Company. If the Company terminates Mr. Lorbiecki’s employment without cause
or Mr. Lorbiecki terminates for good reason, he is entitled to receive twelve months of base salary, (ii) up to nine months of paid health
insurance under COBRA, and (iii) any earned but unpaid bonus for a prior completed fiscal year. |
| |
· |
Be issued
options to purchase 66,934 shares (4,185 shares after our January 3, 2024 reverse stock
split) of common stock of the Company subject to the terms and conditions set forth in the Company’s equity incentive
plan, at an exercise price of $1.94 ($31.04 after our January 3, 2024 reverse stock
split) per share. The stock options have a 10-year term. The stock options will vest in 48 equal installments on each monthly
anniversary of the date of grant, such that the grant will become fully vested and exercisable on the four-year anniversary of the
date of grant. |
Outstanding Equity Awards at December 31, 2023
The following table sets forth information regarding
equity awards held by our Named Executive Officers as of December 31, 2023. Information in this table
has been adjusted for our January 3, 2024 reverse stock split.
| |
|
|
|
|
|
|
Option Awards |
|
|
|
Stock Awards |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Number of |
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
Market |
|
| |
|
|
|
|
|
|
Securities |
|
|
|
Securities |
|
|
|
|
|
|
|
|
|
|
|
Shares or |
|
|
|
Value of |
|
| |
|
|
|
|
|
|
Underlying |
|
|
|
Underlying |
|
|
|
|
|
|
|
|
|
|
|
Units of |
|
|
|
Shares or |
|
| |
|
|
|
|
|
|
Unexercised |
|
|
|
Unexercised |
|
|
|
Option |
|
|
|
|
|
|
|
Stock That |
|
|
|
Units That |
|
| |
|
|
|
|
|
|
Options |
|
|
|
Options |
|
|
|
Exercise |
|
|
|
Option |
|
|
|
Have Not |
|
|
|
Have Not |
|
| |
|
|
Grant |
|
|
|
(#) |
|
|
|
(#) |
|
|
|
Price |
|
|
|
Expiration |
|
|
|
Vested |
|
|
|
Vested |
|
| Name |
|
|
Date |
|
|
|
Exercisable |
|
|
|
Unexercisable |
|
|
|
($) |
|
|
|
Date |
|
|
|
(#) |
|
|
|
($) |
|
| Dr. Jeffrey Thramann |
|
|
9/27/2021 |
|
|
|
75,302 |
|
|
|
– |
|
|
|
$31.04 |
|
|
|
9/27/2031 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
9/14/2022 |
|
|
|
11,581 |
|
|
|
– |
|
|
|
$31.04 |
|
|
|
9/14/2032 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Brent Ness |
|
|
9/27/2021 |
|
|
|
12,002 |
|
|
|
9,335 |
|
|
|
$31.04 |
|
|
|
9/27/2031 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
9/14/2022 |
|
|
|
2,658 |
|
|
|
2,067 |
|
|
|
$31.04 |
|
|
|
9/14/2032 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ryan Bond |
|
|
2/19/2019 |
|
|
|
1,339 |
|
|
|
– |
|
|
|
$21.44 |
|
|
|
2/19/2029 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
9/4/2021 |
|
|
|
382 |
|
|
|
– |
|
|
|
$31.04 |
|
|
|
9/4/2031 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| John Lorbiecki |
|
|
9/27/2021 |
|
|
|
2,267 |
|
|
|
1,918 |
|
|
|
$31.04 |
|
|
|
9/27/2031 |
|
|
|
– |
|
|
|
– |
|
| |
|
|
9/14/2022 |
|
|
|
558 |
|
|
|
472 |
|
|
|
$31.04 |
|
|
|
9/14/2032 |
|
|
|
– |
|
|
|
– |
|
Certain
Relationships and Related Party Transactions
In addition to the executive officer and director
compensation arrangements discussed above, below we describe transactions since January 1, 2019 to which we have been or will be a participant,
in which the amount involved in the transaction exceeds or will exceed $120,000 and in which any of our directors, executive officers
or beneficial holders of more than 5% of any class of our capital stock, or 5% security holders, or any immediate family member of, or
person sharing the household with, any of these individuals, had or will have a direct or indirect material interest.
In 2021, we paid a total of $125,324 to the
Regents of the University of California pursuant to our License Agreement with them Professor Jeffrey Lotz, PhD. who was a director
of the Company prior to our IPO is a Director of the Company, is the Vice Chair of Orthopedic Research at UCSF. Dr. Lotz continues
to serve as a member of our Scientific Advisory Board. We will continue to make payments to the Regents of the University of
California for the duration of our License Agreement with UCSF (See “Business- License Agreement with the Regents of the
University of California” above).
We have entered into a number of investment and
commercial transactions with Nuvasive. See “Business – Transactions with Nuvasive.”
Since January 2019, SC Capital 1 LLC and Clark
Gunderson, M.D. have invested in (i) our Series B-1 preferred stock financing and (ii) our 6% convertible preferred note financing. Such
investments were made on the same terms offered to other investors. David Neal, one of our directors, is the founder and a current member
of SC Capital 1, LLC. Until December 2022, SC Capital 1 LLC owned more than 10% of our outstanding common shares.
On February 16, 2023, we entered into a securities
purchase agreement with Jeffrey Thramann, our Executive Chairman pursuant to which we issued and sold one (1) share of the Company’s
newly designated Series A Preferred Stock for an aggregate purchase price of $1,000.
The share of Series A Preferred Stock will have
15,000,000 votes and will vote together with the outstanding shares of the Company’s common stock as a single class exclusively
with respect to any proposal to amend the Company’s Certificate of Incorporation to effect a reverse stock split of the Company’s
common stock. The share of Series A Preferred Stock will be voted, without action by the holder, on any such reverse stock split proposal
in the same proportion as shares of common stock are voted on such proposal (excluding any common shares that are not voted).
The Series A Preferred Stock otherwise has no
voting rights, except as may otherwise be required by the General Corporation Law of the State of Delaware. The share of Series A Preferred
Stock is not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The
share of Series A Preferred Stock has no rights with respect to any distribution of assets of the Company, including upon a liquidation,
bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily.
The holder of the Share of Series A Preferred Stock will not be entitled to receive dividends of any kind. The share of Series A Preferred
Stock shall be redeemed in whole, but not in part, at any time (i) if such redemption is ordered by our board in its sole discretion or
(ii) automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing a reverse stock split. Upon
such redemption, the holder of the Series A Preferred Stock will receive consideration of $1,000.00 in cash. We redeemed the one outstanding
share of Series A preferred stock on March 28, 2023.
Policy for approval of related-person transactions
We have adopted a related-person transaction policy
that requires audit committee review and approval of any transaction, arrangement or relationship in which we are a participant and one
of our executive officers, directors, director nominees or each person whom we know to beneficially own more than 5% of our outstanding
common stock (a “5% stockholder”) (or their immediate family members), each of whom we refer to as a “related person,”
has a direct or indirect material interest.
Principal
Stockholders
The following table sets forth information regarding
the beneficial ownership of our common stock as of February 26, 2024 by (i) each person who beneficially owned more than 5% of our outstanding
shares of common stock, (ii) each director, (iii) each Named Executive Officer and (iv) all of our directors and executive officers as
a group. Unless otherwise indicated, the address of each executive officer and director is c/o listed below is c/o Aclarion, Inc., 8181
Arista Place, Suite 100, Broomfield, Colorado 80021.
The number of shares of common stock “beneficially
owned” by each stockholder is determined under rules issued by the SEC regarding the beneficial ownership of securities. This information
is not necessarily indicative of beneficial ownership for any other purpose. Under these rules, beneficial ownership of shares of our
common stock includes (1) any shares as to which the person or entity has sole or shared voting power or investment power, and (2) any
shares as to which the person or entity has the right to acquire beneficial ownership within 60 days after February 26, 2024.
The calculations set forth below are based upon
1,975,585 shares of common stock outstanding at February 26, 2024 (and giving effect to our January 3, 2024 reverse stock split). Unless
otherwise indicated below, and subject to community property laws where applicable, to our knowledge, all persons named in the table have
sole voting and investment power with respect to their shares of common stock. The After Offering column below has been calculated based
on 5,175,000 Units at an offering price of $0.58 per Unit.
| |
|
Prior to Offering |
|
|
After Offering |
|
| Name of Beneficial Owner |
|
Amount and
Nature of
Beneficial
Ownership |
|
|
Approximate
Percentage
of Outstanding
Shares of
Common Stock |
|
|
Amount and
Nature of
Beneficial
Ownership |
|
|
Approximate Percentage
of Outstanding Shares of
Common Stock |
|
| 5% Stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| None |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Executive Officers and Directors: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Jeff Thramann (1) |
|
|
86,882 |
|
|
|
4.2% |
|
|
|
86,882 |
|
|
|
1.2% |
|
| Brent Ness (2) |
|
|
18,174 |
|
|
|
* |
|
|
|
18,174 |
|
|
|
* |
|
| John Lorbiecki (3) |
|
|
4,658 |
|
|
|
* |
|
|
|
4,658 |
|
|
|
* |
|
| Ryan Bond (4) |
|
|
4,284 |
|
|
|
* |
|
|
|
4,284 |
|
|
|
* |
|
| David Neal (5) |
|
|
18,201 |
|
|
|
* |
|
|
|
18,201 |
|
|
|
* |
|
| William Wesemann (6) |
|
|
7,127 |
|
|
|
* |
|
|
|
7,127 |
|
|
|
* |
|
| Amanda Williams (7) |
|
|
2,516 |
|
|
|
* |
|
|
|
2,516 |
|
|
|
* |
|
| Stephen Deitsch (7) |
|
|
2,516 |
|
|
|
* |
|
|
|
2,516 |
|
|
|
* |
|
| Scott Breidbart (7) |
|
|
2,516 |
|
|
|
* |
|
|
|
2,516 |
|
|
|
* |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| All directors and executive officers as a group (9 persons) |
|
|
146,874 |
|
|
|
7.0% |
|
|
|
146,874 |
|
|
|
2.0% |
|
* denotes beneficial ownership less than 1.0%
___________________
| (1) |
Represents outstanding
stock options held by Dr. Thramann. |
| (2) |
Mr. Ness’ beneficial
ownership includes 1,281 common shares, 16,830 vested options, and 63 IPO Warrants, and excludes 9,229 unvested options. |
| (3) |
Mr. Lorbiecki’s beneficial ownership
includes 1,400 common shares and 3,257 vested options, and excludes 1,954 unvested options. |
| (4) |
Mr. Bond’s beneficial
ownership includes 1,250 common shares, 1,721 vested options, and 1,313 IPO Warrants. |
| (5) |
Mr, Neal’s beneficial
ownership includes 11,658 common shares, 2,150 IPO Warrants, and 4,393 vested options. |
| (6) |
Mr. Wesemann’s
beneficial ownership includes 3,296 common shares, 3,143 vested stock options, and 688 IPO Warrants, and excludes 1,422 unvested
stock options. |
| (7) |
Includes 2,516 vested
stock options and excludes 1,422 unvested stock options. |
DESCRIPTION OF CAPITAL STOCK
The following description is intended as a
summary of our certificate of incorporation (which we refer to as our “charter”) and our bylaws, each of which is filed as
an exhibit to the registration statement of which this prospectus forms a part, and to the applicable provisions of the Delaware General
Corporation Law. Because the following is only a summary, it does not contain all of the information that may be important to you. For
a complete description, you should refer to our charter and bylaws.
We have two classes of securities registered under
Section 12 of the Exchange Act. Our shares of common stock are listed on The Nasdaq Stock Market under the trading symbol “ACON.”
Our IPO Warrants are listed on the Nasdaq Stock Market under the trading symbol “ACONW.”
Authorized Capital Stock
Our authorized capital stock consists of 200,000,000
shares of common stock, par value $0.00001 per share, and 20,000,000 shares of preferred stock, par value $0.00001 per share.
Common Stock
The holders of our common stock are entitled to
one vote for each share held on all matters submitted to a vote of the stockholders. The holders of our common stock do not have any cumulative
voting rights. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds
legally available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock. Our common stock has
no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.
In the event of our liquidation, dissolution or
winding up, holders of our common stock will be entitled to share ratably in all assets remaining after payment of all debts and other
liabilities and any liquidation preference of any outstanding preferred stock. Each outstanding share of common stock is duly and validly
issued, fully paid and non-assessable.
Preferred Stock
Our board will have the authority, without further
action by our stockholders, to issue up to 20,000,000 shares of preferred stock in one or more series and to fix the rights, preferences,
privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting
rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of,
such series, any or all of which may be greater than the rights of common stock. The issuance of our preferred stock could adversely affect
the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon our
liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in control
of our company or other corporate action.
No shares of preferred stock are currently outstanding.
We redeemed the one outstanding share of Series A preferred stock on March 28, 2023.
Anti-Takeover Effects of Delaware Law and Provisions
of our Charter and our Bylaws
Certain provisions of the DGCL and of our charter
and our bylaws could have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons
considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board of directors rather than pursue
non-negotiated takeover attempts. These provisions include the items described below.
Delaware Anti-Takeover
Statute
We are subject to the provisions
of Section 203 of the DGCL. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business
combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes
an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203, a business combination
between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:
| |
· |
before the
stockholder became interested, our Board approved either the business combination or the transaction which resulted in the stockholder
becoming an interested stockholder; |
| |
|
|
| |
· |
upon consummation of the
transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of
the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the
voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances,
but not the outstanding voting stock owned by the interested stockholder; or |
| |
|
|
| |
· |
at or after the time the
stockholder became interested, the business combination was approved by our Board and authorized at an annual or special meeting
of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested
stockholder. |
Section 203 defines a business
combination to include:
| |
· |
any merger
or consolidation involving the corporation and the interested stockholder; |
| |
|
|
| |
· |
any sale, transfer, lease,
pledge, exchange, mortgage or other disposition involving the interested stockholder of 10% or more of the assets of the corporation; |
| |
|
|
| |
· |
subject to exceptions,
any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
or |
| |
|
|
| |
· |
the receipt by the interested
stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203
defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation
and any entity or person affiliated with or controlling or controlled by the entity or person.
Board Composition and
Filling Vacancies
Our charter provides that
stockholders may remove directors only for cause and only by the affirmative vote of the holders of at least two-thirds of our outstanding
common stock. Our charter and bylaws authorize only our board of directors to fill vacant directorships, including newly created seats.
In addition, the number of directors constituting our board of directors may only be set by a resolution adopted by a majority vote of
our entire board of directors. These provisions would prevent a stockholder from increasing the size of our board of directors and then
gaining control of our board of directors by filling the resulting vacancies with its own nominees. This makes it more difficult to change
the composition of our board of directors but promotes continuity of management.
No Written Consent of
Stockholders
Our charter and bylaws provide
that all stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholders
may not take any action by written consent in lieu of a meeting. This limit may lengthen the amount of time required to take stockholder
actions and would prevent the amendment of our bylaws or removal of directors by our stockholders without holding a meeting of stockholders.
Meetings of Stockholders
Our charter and bylaws provide
that only a majority of the members of our Board then in office, our Executive Chairman or our Chief Executive Officer may call special
meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special
meeting of stockholders.
Advance Notice Requirements
Our bylaws provide advance
notice procedures for stockholders seeking to bring matters before our annual meeting of stockholders or to nominate candidates for election
as directors at our annual meeting of stockholders. Our bylaws also specify certain requirements regarding the form and content of a
stockholder’s notice. These provisions might preclude our stockholders from bringing matters before our annual meeting of stockholders
or from making nominations for directors at our annual meeting of stockholders if the proper procedures are not followed. We expect that
these provisions might also discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s
own slate of directors or otherwise attempting to obtain control of our company.
Amendment to our Charter
and Bylaws
The DGCL, provides, generally,
that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s certificate
of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as the case may be, requires a greater
percentage. Our bylaws may be amended or repealed by a majority vote of our board of directors or the affirmative vote of the holders
of at least two-thirds of the votes that all our stockholders would be entitled to cast in an annual election of directors. In addition,
the affirmative vote of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast in an election
of directors is required to amend or repeal or to adopt certain provisions of our charter.
Undesignated preferred
stock
Our charter provides for
20,000,000 authorized shares of preferred stock. The existence of authorized but unissued shares of preferred stock may enable our board
to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the
due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests
of our stockholders, our board could cause shares of convertible preferred stock to be issued without stockholder approval in one or
more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder
or stockholder group. In this regard, our charter grants our board broad power to establish the rights and preferences of authorized
and unissued shares of preferred stock. The issuance of shares of preferred stock could decrease the amount of earnings and assets available
for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers, including voting
rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of us.
Choice of Forum
Our charter provides that
the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings: any derivative
action or proceeding brought on behalf of the Company, any action asserting a claim of breach of a fiduciary duty owed by any director,
officer or other employee of the Company to the Company or the Company’s stockholders, any action asserting a claim against the
Company arising pursuant to any provision of the DGCL or the Company’s certificate of incorporation or bylaws, or any action asserting
a claim against the Company governed by the internal affairs doctrine. Our charter also provides that unless the Company consents in
writing to the selection of an alternative forum, the federal district courts of the United States of America shall be the exclusive
forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Despite the fact that the certificate
of incorporation provides for this exclusive forum provision to be applicable to the fullest extent permitted by applicable law, Section
27 of the Exchange Act, creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the
Exchange Act or the rules and regulations thereunder and Section 22 of the Securities Act, creates concurrent jurisdiction for federal
and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
As a result, this provision of the Company’s certificate of incorporation would not apply to claims brought to enforce a duty or
liability created by the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. However, there is
uncertainty as to whether a Delaware court would enforce the exclusive federal forum provisions for Securities Act claims and that investors
cannot waive compliance with the federal securities laws and rules and regulations thereunder.
Unless the Company consents
in writing to the selection of an alternative forum, the federal district courts of the United States of America shall be the exclusive
forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
Nasdaq-Listed IPO Warrants
Each IPO Warrant represents
the right to purchase one share of common stock at an exercise price of $4.35 (pre-split),
or $69.60 (after giving effect to our January 3, 2024 reverse stock split). The IPO Warrants are exercisable
beginning April 21, 2022, will terminate on the 5th anniversary date the IPO Warrants are first exercisable. The exercise price and number
of shares for which each IPO Warrant may be exercised is subject to adjustment in the event of stock dividends, stock splits, reorganizations
or similar events affecting our common stock.
Holders of the IPO Warrants
may exercise their IPO Warrants to purchase shares of our common stock on or before the termination date by delivering an exercise notice,
appropriately completed and duly signed. Payment of the exercise price for the number of shares for which the IPO Warrants is being exercised
must be made within two trading days following such exercise. In the event that the registration statement relating to the IPO Warrant
shares (the “IPO Warrant Shares”) is not effective, a holder of IPO Warrants may only exercise its IPO Warrants for a net
number of IPO Warrant Shares pursuant to the cashless exercise procedures specified in the IPO Warrants. IPO Warrants may be exercised
in whole or in part, and any portion of an IPO Warrant not exercised prior to the termination date shall be and become void and of no
value. The absence of an effective registration statement or applicable exemption from registration does not alleviate our obligation
to deliver common stock issuable upon exercise of an IPO Warrant.
Upon the holder’s
exercise of an IPO Warrant, we will issue the shares of common stock issuable upon exercise of the IPO Warrant within three trading days
of our receipt of notice of exercise, subject to timely payment of the aggregate exercise price therefor.
The shares of common stock
issuable on exercise of the IPO Warrants will be, when issued in accordance with the IPO Warrants, duly and validly authorized, issued
and fully paid and non-assessable. We will authorize and reserve at least that number of shares of common stock equal to the number of
shares of common stock issuable upon exercise of all outstanding warrants.
If, at any time an IPO Warrant
is outstanding, we consummate any fundamental transaction, as described in the IPO Warrants and generally including any consolidation
or merger into another corporation, the consummation of a transaction whereby another entity acquires more than 50% of our outstanding
common stock, or the sale of all or substantially all of our assets, or other transaction in which our common stock is converted into
or exchanged for other securities or other consideration, the holder of any IPO Warrants will thereafter receive upon exercise of the
IPO Warrants, the securities or other consideration to which a holder of the number of shares of common stock then deliverable upon the
exercise or conversion of such IPO Warrants would have been entitled upon such consolidation or merger or other transaction.
The IPO Warrants are not
exercisable by their holder to the extent (but only to the extent) that such holder or any of its affiliates would beneficially own in
excess of 4.99% of our common stock.
Amendments and waivers of
the terms of the IPO Warrants require the written consent of the holder of such IPO Warrants and us. The IPO Warrants were issued in
book-entry form under a warrant agent agreement between V-Stock Transfer Company, Inc. as warrant agent, and us, and shall initially
be represented by one or more book-entry certificates deposited with The Depository Trust Company, or DTC, and registered in the name
of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.
You should review a copy
of the warrant agent agreement and the form of the IPO Warrants, each of which are included as exhibits to the registration statement
of which this prospectus is a part.
Transfer Agent, Registrar,
Warrant Agent
The transfer agent and
registrar for our common stock and the warrant agent for our IPO Warrants is VStock Transfer LLC, 18 Lafayette Place, Woodmere, NY 11598.
At February 26, 2024, after giving effect
to our January 3, 2024 reverse stock split, there were 1,975,585 shares of our common stock outstanding, and approximately 137 stockholders
of record. No shares of our preferred stock are outstanding.
Other Outstanding Warrants
At February 26, 2024, after giving effect
to our January 3, 2024 reverse stock split, we had 154,730 other outstanding common stock warrants (in addition to our IPO Warrants described
above). The terms of these warrants are (i) 123,566 warrants with a per share exercise price of $0.58 and expiring 2028, (ii) 26,673
warrants with a per share exercise price of $69.60 and expiring 2027, and (iii) 4,491 warrants with a per share exercise price of $0.0002
and expiring 2028.
The per share exercise price of the warrants described
in clause (i) is subject to a “ratchet” adjustment if the Company issues securities at an effective per share price lower
than the then effective warrant exercise price.
These warrants have a net exercise provision under
which its holder may, in lieu of payment of the exercise price in cash, surrender the warrant and receive a net amount of shares based
on the fair market value of the underlying shares at the time of exercise of the warrant after deduction of a number of shares equal in
value to the aggregate exercise price. The warrants contain provisions for the adjustment of the exercise price and the number of shares
issuable upon the exercise of the warrant in the event of certain stock dividends, stock splits, reorganizations, reclassifications and
consolidations.
In connection with our April 2022 IPO, we issued
a warrant (the “IPO Representative’s Warrant”), which enables our IPO underwriter to purchase up to an aggregate of
10,825 post-split shares of Common Stock, at an
exercise price equal to $87.04 per share. The IPO Representative’s Warrant may be exercised
beginning on October 26, 2022 until April 26, 2027.
DESCRIPTION OF SECURITIES
WE ARE OFFERING
We
are offering Units, each Unit consisting of one share of common stock and two Common
Warrants each to purchase one share of common stock. We are also offering to each purchaser
whose purchase of shares of common stock in this offering would otherwise result in the purchaser,
together with its affiliates, beneficially owning more than 4.99% (or, at the election of
the holder, 9.99%) of our outstanding shares of common stock immediately following the consummation
of this offering, the opportunity to purchase, if the purchaser so chooses, Units containing
Pre-Funded Warrants in lieu of shares of common stock that would otherwise result in the
purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the holder,
9.99%) of our outstanding shares of common stock. For each Pre-Funded Warrant we sell (without
regard to any limitation on exercise set forth therein), the number of shares of common stock
we are offering will be decreased on a one-for-one basis. Because two Common Warrants
are being sold together in this offering with each share of common stock or, in the alternative,
each Pre-Funded Warrant to purchase one share of common stock, the number of Common Warrants
sold in this offering will not change as a result of a change in the mix of the shares of
common stock and Pre-Funded Warrants sold.
We are also registering the shares of common
stock issuable from time to time upon exercise of the Common Warrants and Pre-Funded Warrants included in the Units offered hereby.
Our Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The shares of common
stock (or Pre-Funded Warrants) and the Common Warrants comprising our Units are immediately separable and will be issued
separately in this offering.
The following summary of certain terms and provisions
of the Pre-Funded Warrants and Common Warrants offered hereby is not complete and is subject to and qualified in its entirety by the
provisions of the form of Pre- Funded Warrant, and the form of Common Warrant, which are filed as exhibits to the registration statement
of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions set forth in the form of
Pre-Funded Warrant and the form of Common Warrant.
Exercisability. The Pre-Funded
Warrants are exercisable at any time after their original issuance until they are exercised in full. The Common Warrants are immediately
exercisable at any time after their original issuance up to the date that is five years after their original issuance. Each of the
Common Warrants and the Pre-Funded Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us
a duly executed exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying
the Common Warrants or Pre-Funded Warrants under the Securities Act is effective and available for the issuance of such shares, or an
exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately
available funds for the number of shares of common stock purchased upon such exercise. If a registration statement registering the issuance
of the shares of common stock underlying the Common Warrants or Pre-Funded Warrants under the Securities Act is not effective or available,
the holder may, in its sole discretion, elect to exercise the Common Warrant or Pre-Funded Warrant through a cashless exercise, in which
case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth
in the Common Warrant or Pre-Funded Warrant. No fractional shares of common stock will be issued in connection with the exercise of a
Common Warrant or Pre-Funded Warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional
amount multiplied by the exercise price.
Exercise Limitation. A holder
will not have the right to exercise any portion of the Pre-Funded Warrants or Common Warrants if the holder (together with its affiliates)
would beneficially own in excess of 4.99% (or, upon election by a holder prior to the issuance of any Pre-Funded Warrant or Common Warrant,
9.99%) of the number of shares of our shares of common stock outstanding immediately after giving effect to the exercise, as such percentage
ownership is determined in accordance with the terms of the Pre-Funded Warrant or Common Warrant. However, any holder may increase or
decrease such percentage to any other percentage not in excess of 9.99%, upon at least 61 days’ prior notice from
the holder to us with respect to any increase in such percentage.
Exercise Price. The
exercise price for the Pre-Funded Warrants is $0.00001 per share. The exercise price per whole share of common stock purchasable
upon exercise of the Common Warrants is $0.58 per share. The exercise price of Common Warrants may also be reduced to any amount and
for any period of time at the sole discretion of our board of directors. The exercise price and number of shares of common stock
issuable upon exercise will adjust in the event of certain stock dividends and distributions, stock splits, stock combinations,
reclassifications or similar events affecting our shares of common stock.
Transferability. Subject
to applicable laws, the Common Warrants and the Pre-Funded Warrants may be offered for sale, sold, transferred or assigned without our
consent.
Exchange Listing. We do not
intend to apply for the listing of the Common Warrants or Pre-Funded Warrants offered in this offering on any stock exchange. Without
an active trading market, the liquidity of the Common Warrants and the Pre-Funded Warrants will be limited.
Warrant Agent. The Common
Warrants and Pre-Funded Warrants are expected to be issued in registered form under a warrant agreement between VStock Transfer, LLC,
as warrant agent, and us. The Common Warrants and Pre-Funded Warrants shall initially be represented only by one or more global warrants
deposited with the warrant agent, as custodian on behalf of The Depository Trust Company (DTC) and registered in the name of Cede &
Co., a nominee of DTC, or as otherwise directed by DTC.
Rights as a Stockholder. Except
as otherwise provided in the Common Warrants or the Pre-Funded Warrants or by virtue of such holder’s ownership of our shares of
common stock, the holder of a Common Warrant or Pre-Funded Warrant does not have the rights or privileges of a holder of our shares of
common stock, including any voting rights, until the holder exercises the Common Warrant or Pre-Funded Warrant.
Fundamental Transactions. In
the event of a fundamental transaction, as described in the Common Warrants and the Pre-Funded Warrants and generally including, with
certain exceptions, any reorganization, recapitalization or reclassification of our shares of common stock, the sale, transfer or other
disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition
of more than 50% of our outstanding shares of common stock, or any person or group becoming the beneficial owner of 50% of the voting
power represented by our outstanding shares of common stock, the holders of the Common Warrants and the Pre-Funded Warrants will be entitled
to receive upon exercise of the Common Warrants or the Pre-Funded Warrants the kind and amount of securities, cash or other property
that the holders would have received had they exercised the Common Warrants or the Pre-Funded Warrants immediately prior to such fundamental
transaction. Additionally, as more fully described in the Common Warrant, in the event of certain fundamental transactions, the holders
of the Common Warrants will be entitled to receive consideration in an amount equal to the Black Scholes value of the Common Warrants
on the date of consummation of such transaction.
Governing Law. The Pre-Funded
Warrants, the Common Warrants and Warrant Agreement are governed by New York law.
The material terms and provisions of our common stock
and each other class of our securities are described under the caption “Description of Capital Stock” in this prospectus.
SHARES ELIGIBLE FOR FUTURE
SALE
Future sales of our common
stock, including shares issued upon exercise of outstanding options and warrants, in the public market after this offering, or the perception
that those sales may occur, could cause the prevailing market price for our common stock to fall or impair our ability to raise equity
capital in the future. As described below, only a limited number of shares of our common stock will be available for sale in the public
market after consummation of this offering due to contractual and legal restrictions on resale described below. Future sales of our common
stock in the public market either before (to the extent permitted) or after restrictions lapse, or the perception that those sales may
occur, could adversely affect the prevailing market price of our common stock at such time and our ability to raise equity capital at
a time and price we deem appropriate.
Sale of outstanding shares
Except as otherwise noted,
all information in this prospectus reflects and assumes (i) no sale of Pre-Funded Warrants in this offering, which, if sold, would reduce
the number of shares of common stock that we are offering on a one-for-one basis and (ii) no exercise of the Common Warrants issued in
this offering.
Upon the closing of this offering, we will have
outstanding 7,150,585 shares of common stock.
Except for outstanding shares that are held by
our affiliates, substantially all of our outstanding shares may be resold in the public market immediately (i) without any restriction
or (ii) with minimal restrictions in compliance with the SEC’s Rule 144 (as described below) as applied to sales by non-affiliates.
Unless purchased by our affiliates, the 5,175,000
shares sold in this offering, the 10,350,000 shares issuable upon the exercise of the Common Warrants, and the 155,610 shares issuable
upon the exercise of our outstanding IPO Warrants may be resold in the public market immediately without any restriction.
Lock-up agreements
In connection with this
offering, we, our officers and our directors agreed that, for a period of 90 days from February 26, 2024 (the date of this prospectus),
we and they will not, without the prior written consent of Maxim Group, LLC dispose of or hedge any shares or any securities convertible
into or exchangeable for our common stock, subject to certain exceptions.
Maxim Group, LLC in their
sole discretion may release any of the securities subject to these lock-up agreements at any time. If the restrictions under the lock-up
agreements are waived, shares of our common stock may become available for resale into the market, subject to applicable law, which could
reduce the market price for our common stock. See “Plan of Distribution.”
Rule 144
In general, under Rule 144,
as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act, for at least 90 days,
a person (or persons whose shares are required to be aggregated) who is not deemed to have been one of our “affiliates” for
purposes of Rule 144 at any time during the three months preceding a sale, and who has beneficially owned restricted securities within
the meaning of Rule 144 for at least six months, including the holding period of any prior owner other than one of our “affiliates,”
is entitled to sell those shares in the public market (subject to the lock-up agreements referred to above, if applicable) without complying
with the manner of sale, volume limitations or notice provisions of Rule 144, but subject to compliance with the public information requirements
of Rule 144.
Rule 144(a)(1) defines an
“affiliate” of an issuing company as a person that directly, or indirectly through one or more intermediaries, controls,
or is controlled by, or is under common control with, such issuer. Directors, officers and holders of ten percent or more of the Company’s
voting securities (including securities which are issuable within the next sixty days) are deemed to be affiliates of the issuing company.
If such a person has beneficially owned the shares proposed to be sold for at least one year, including the holding period of any prior
owner other than “affiliates,” then such person is entitled to sell such shares in the public market without complying with
any of the requirements of Rule 144 (subject to the lock-up agreements referred to above, if applicable).
In general, under Rule 144,
as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act for at least 90 days,
our “affiliates,” as defined in Rule 144, who have beneficially owned the shares proposed to be sold for at least six months,
including the holding period of any prior owner other than one of our “affiliates,” are entitled to sell in the public market,
upon expiration of any applicable lock-up agreements and within any three-month period, a number of those shares of our common stock
that does not exceed the greater of:
| |
· |
1%
of the number of common shares then outstanding; or |
| |
|
|
| |
· |
the
average weekly trading volume of our common stock on the Nasdaq during the four calendar weeks preceding the filing of a notice on
Form 144 with respect to such sale. |
Such sales under Rule 144
by our “affiliates” or persons selling shares on behalf of our “affiliates” are also subject to certain manner
of sale provisions, notice requirements and to the availability of current public information about us.
Rule 701
The Rule 701 exemption is
not available to Exchange Act reporting companies. In general, under Rule 701 as currently in effect, any of our employees, directors,
officers, consultants or advisors who acquired common stock from us in connection with a written compensatory stock or option plan or
other written agreement in compliance with Rule 701 under the Securities Act before the effective date of our IPO registration statement
(to the extent such common stock is not subject to a lock-up agreement) is entitled to rely on Rule 701 to resell such shares beginning
90 days after we become subject to the public company reporting requirements of the Exchange Act. Our affiliates can resell shares in
reliance on Rule 144 without having to comply with the holding period requirement, and non-affiliates of the Company can resell shares
in reliance on Rule 144 without having to comply with Rule 144’s current public information and holding period requirements in
Rule 144. Accordingly, subject to any applicable lock-up agreements, beginning 90 days after our IPO, under Rule 701 persons who are
non-affiliates may resell those shares without complying with the minimum holding period or public information requirements of Rule 144,
and affiliates of the Company may resell those shares without compliance with Rule 144’s minimum holding period requirements.
PLAN OF DISTRIBUTION
We are offering 5,175,000 Units at a public offering
price of $0.58 per Unit, for gross proceeds of approximately $3.0 million before deduction of placement agent commissions and offering
expenses, in a best-efforts offering. There is no minimum amount of proceeds that is a condition to closing of this offering. The actual
amount of gross proceeds, if any, in this offering could vary substantially from the gross proceeds from the sale of the maximum amount
of securities being offered in this prospectus.
Pursuant to a placement agency agreement, dated
as of February 26, 2024, we have engaged Maxim Group LLC to act as our exclusive placement agent (the “Placement Agent”) to
solicit offers to purchase the securities offered by this prospectus. The Placement Agent is not purchasing or selling any securities,
nor is it required to arrange for the purchase and sale of any specific number or dollar amount of securities, other than to use its “reasonable
best efforts” to arrange for the sale of the securities by us. Therefore, we may not sell the entire amount of securities being
offered. Investors purchasing securities offered hereby will have the option to execute a securities purchase agreement with us. In addition
to the rights and remedies available to all investors in this offering under federal and state securities laws, the investors which enter
into a securities purchase agreement will also be able to bring claims of breach of contract against us. Investors who do not enter into
a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities in this offering.
The Placement Agent may engage one or more subagents or selected dealers in connection with this offering.
The placement agency agreement provides that the
Placement Agent’s obligations are subject to conditions contained in the placement agency agreement.
We will deliver the securities being issued to
the investors upon receipt of investor funds for the purchase of the securities offered pursuant to this prospectus. There is no arrangement
for funds to be received in escrow, trust or similar arrangement and the Units will be offered at a fixed price and are expected to be
issued in a single closing. We expect to deliver the securities being offered pursuant to this prospectus on or about February 27, 2024.
Placement Agent Fees, Commissions and Expenses
Upon the closing of this offering, we will pay
the placement agent a cash transaction fee equal to 7% of the aggregate gross cash proceeds to us from the sale of the securities in the
offering. In addition, we will reimburse the placement agent for its out-of-pocket expenses incurred in connection with this offering,
including the fees and expenses of the counsel for the placement agent, up to $100,000.
The following table shows the public offering price,
placement agent fees and proceeds, before expenses, to us.
| | |
Per Unit | | |
Total | |
| Public offering price | |
$ | 0.5800 | | |
$ | 3,001,500 | |
| Placement agent fees (1) | |
$ | 0.0406 | | |
$ | 210,105 | |
| Proceeds, before expenses, to us (2) | |
$ | 0.5394 | | |
$ | 2,791,395 | |
| (1) |
Does not include additional compensation the Placement Agent will receive and reimbursement for out-of-pocket expenses incurred in connection with this offering as described above. |
| (2) |
The amount of offering proceeds to us presented in this table assumes no Pre-Funded Warrants are issued in lieu of shares of common stock and does not give effect to any exercise of the Common Warrants. |
We estimate that the total
expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding
the placement agent commission, will be approximately $250,000, all of which are payable by us. This figure includes, among other things,
the placement agent’s fees and expenses (including the legal fees, costs and expenses for the placement agent’s legal counsel)
up to $100,000.
Lock-Up Agreements
We, and our officers and directors have agreed,
subject to limited exceptions, for a period of 90 days after the closing of this offering, not to offer, sell, contract to sell, pledge,
grant any option to purchase, make any short sale or otherwise dispose of, directly or indirectly any shares of common stock or any securities
convertible into or exchangeable for our common stock either owned as of the date of the underwriting agreement or thereafter acquired
without the prior written consent of Maxim Group, LLC. Maxim Group, LLC may, in its sole discretion and at any time or from time to time
before the termination of the lock-up period, without notice, release all or any portion of the securities subject to lock-up agreements.
Indemnification
We have agreed to indemnify the placement agent against
certain liabilities, including liabilities under the Securities Act, and to contribute to payments that the placement agent may be required
to make for these liabilities.
Regulation M
The placement agent may be deemed to be an underwriter
within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale
of the securities sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities
Act. As an underwriter, the placement agent would be required to comply with the requirements of the Securities Act and the Exchange
Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing
of purchases and sales of our securities by the placement agent acting as principal. Under these rules and regulations, the placement
agent (i) may not engage in any stabilization activity in connection with our securities and (ii) may not bid for or purchase any of
our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until
it has completed its participation in the distribution.
Electronic Distribution
A prospectus in electronic format may be made available
on a website maintained by the placement agent. In connection with the offering, the placement agent or selected dealers may distribute
prospectuses electronically. No forms of electronic prospectus other than prospectuses that are printable as Adobe® PDF will be used
in connection with this offering.
Other than the prospectus in electronic format, the
information on the placement agent’s website and any information contained in any other website maintained by the placement agent
is not part of the prospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed
by us or the placement agent in its capacity as placement agent and should not be relied upon by investors.
Certain Relationships
The placement agent and its affiliates have provided
and may in the future provide, from time to time, investment banking and financial advisory services to us in the ordinary course of
business, for which they may receive customary fees and commissions. In April 2021, the placement agent acted as lead underwriter for us in connection with our IPO. We entered into
an underwriting agreement with the placement agent in connection with such offering, pursuant to which the placement agent received fees.
Determination of Offering Price and Common Warrant
Exercise Price
The actual offering
price of the securities we are offering, and the exercise price of the Common Warrants included in the Units that we are offering, were
negotiated between us, the placement agent and the investors in the offering based on the trading of our shares of Common Stock
prior to the offering, among other things. Other factors considered in determining the public offering price of the securities we are
offering, as well as the exercise price of the Common Warrants that we are offering include our history and prospects, the stage of development
of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management,
the general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.
Transfer Agent, Warrant Agent and Registrar
The transfer agent, warrant agent and registrar for
our common stock is vStock Transfer LLC, at 18 Lafayette Place, Woodmere, NY 11598. The transfer agent’s telephone number is (212)
828-8436.
Selling Restrictions
Canada. The securities may be sold
in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National
Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients,
as defined in National Instrument 31 103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale
of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements
of applicable securities laws.
Securities legislation in certain provinces or territories
of Canada may provide a purchaser with remedies for rescission or damages if this prospectus supplement (including any amendment thereto)
contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit
prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable
provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with
a legal advisor.
Pursuant to section 3A.3 of National Instrument
33 105 Underwriting Conflicts (NI 33 105), the placement agents are not required to comply with the disclosure requirements
of NI 33-105 regarding placement agents conflicts of interest in connection with this offering.
European Economic Area. In relation
to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a “Relevant Member State”)
an offer to the public of any securities may not be made in that Relevant Member State, except that an offer to the public in that Relevant
Member State of any securities may be made at any time under the following exemptions under the Prospectus Directive, if they have been
implemented in that Relevant Member State:
| |
· |
to any legal entity which
is a qualified investor as defined in the Prospectus Directive; |
| |
|
|
| |
· |
to fewer than 100 or, if the Relevant Member
State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified
investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent
of the representatives for any such offer; or |
| |
|
|
| |
· |
in any other circumstances falling within Article 3(2) of the Prospectus
Directive, provided that no such offer of securities shall result in a requirement for the publication by us or any placement agents of
a prospectus pursuant to Article 3 of the Prospectus Directive. |
For the purposes of this provision, the expression
an “offer to the public” in relation to any securities in any Relevant Member State means the communication in any form and
by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide
to purchase any securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that
Member State, the expression “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including the 2010
PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in the
Relevant Member State, and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.
Israel. This document does not constitute
a prospectus under the Israeli Securities Law, 5728-1968, or the Securities Law, and has not been filed with or approved by the Israel
Securities Authority. In the State of Israel, this document is being distributed only to, and is directed only at, and any offer of the
shares is directed only at, investors listed in the first addendum, or the Addendum, to the Israeli Securities Law, consisting primarily
of joint investment in trust funds, provident funds, insurance companies, banks, portfolio managers, investment advisors, members of the
Tel Aviv Stock Exchange, placement agents, venture capital funds, entities with equity in excess of NIS 50 million and “qualified
individuals”, each as defined in the Addendum (as it may be amended from time to time), collectively referred to as qualified investors
(in each case purchasing for their own account or, where permitted under the Addendum, for the accounts of their clients who are investors
listed in the Addendum). Qualified investors will be required to submit written confirmation that they fall within the scope of the Addendum,
are aware of the meaning of same and agree to it.
United Kingdom. Each placement agent
has represented and agreed that:
| |
· |
it has only communicated or caused to be communicated
and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning
of Section 21 of the Financial Services and Markets Act 2000 (the FSMA) received by it in connection with the issue or sale of the
securities in circumstances in which Section 21(1) of the FSMA does not apply to us; and |
| |
|
|
| |
· |
it has complied and will comply with all applicable
provisions of the FSMA with respect to anything done by it in relation to the securities in, from or otherwise involving the United
Kingdom. |
Switzerland. The securities may not
be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (the SIX) or on any other stock exchange or regulated
trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses
under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff.
of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this
document nor any other offering or marketing material relating to the securities or the offering may be publicly distributed or otherwise
made publicly available in Switzerland.
Neither this document nor any other offering or marketing
material relating to the offering, or the securities have been or will be filed with or approved by any Swiss regulatory authority. In
particular, this document will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market Supervisory
Authority FINMA, and the offer of securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment
Schemes (CISA). Accordingly, no public distribution, offering or advertising, as defined in CISA, its implementing ordinances and notices,
and no distribution to any non-qualified investor, as defined in CISA, its implementing ordinances and notices, shall be undertaken in
or from Switzerland, and the investor protection afforded to acquirers of interests in collective investment schemes under CISA does
not extend to acquirers of securities.
Australia. No placement document, prospectus,
product disclosure statement or other disclosure document has been lodged with the Australian Securities and Investments Commission (ASIC),
in relation to the offering.
This prospectus does not constitute a prospectus,
product disclosure statement or other disclosure document under the Corporations Act 2001 (the Corporations Act) and does not purport
to include the information required for a prospectus, product disclosure statement or other disclosure document under the Corporations
Act.
Any offer in Australia of the securities may only
be made to persons (the Exempt Investors) who are “sophisticated investors” (within the meaning of section 708(8) of the
Corporations Act), “professional investors” (within the meaning of section 708(11) of the Corporations Act) or otherwise
pursuant to one or more exemptions contained in section 708 of the Corporations Act so that it is lawful to offer the securities without
disclosure to investors under Chapter 6D of the Corporations Act.
The securities applied for by Exempt Investors in
Australia must not be offered for sale in Australia in the period of 12 months after the date of allotment under the offering, except
in circumstances where disclosure to investors under Chapter 6D of the Corporations Act would not be required pursuant to an exemption
under section 708 of the Corporations Act or otherwise or where the offer is pursuant to a disclosure document which complies with Chapter
6D of the Corporations Act. Any person acquiring securities must observe such Australian on-sale restrictions.
This prospectus contains general information only
and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does not
contain any securities recommendations or financial product advice. Before making an investment decision, investors need to consider
whether the information in this prospectus is appropriate to their needs, objectives and circumstances, and, if necessary, seek expert
advice on those matters.
Notice to Prospective Investors in the Cayman
Islands. No invitation, whether directly or indirectly, may be made to the public in the Cayman Islands to subscribe for our
securities.
Taiwan. The securities have not been
and will not be registered with the Financial Supervisory Commission of Taiwan pursuant to relevant securities laws and regulations and
may not be sold, issued or offered within Taiwan through a public offering or in circumstances which constitutes an offer within the
meaning of the Securities and Exchange Act of Taiwan that requires a registration or approval of the Financial Supervisory Commission
of Taiwan. No person or entity in Taiwan has been authorized to offer, sell, give advice regarding or otherwise intermediate the offering
and sale of the securities in Taiwan.
Notice to Prospective Investors in Hong Kong.
The contents of this prospectus have not been reviewed by any regulatory authority in Hong Kong. You are advised to exercise caution
in relation to the offer. If you are in any doubt about any of the contents of this prospectus, you should obtain independent professional
advice. Please note that (i) our shares may not be offered or sold in Hong Kong, by means of this prospectus or any document other than
to “professional investors” within the meaning of Part I of Schedule 1 of the Securities and Futures Ordinance (Cap.571,
Laws of Hong Kong) (SFO) and any rules made thereunder, or in other circumstances which do not result in the document being a “prospectus”
within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong) (CO) or which do not constitute an offer or invitation to the
public for the purpose of the CO or the SFO, and (ii) no advertisement, invitation or document relating to our shares may be issued or
may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere) which is directed at,
or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities
laws of Hong Kong) other than with respect to the shares which are or are intended to be disposed of only to persons outside Hong Kong
or only to “professional investors” within the meaning of the SFO and any rules made thereunder.
Notice to Prospective Investors in the People’s
Republic of China. This prospectus may not be circulated or distributed in the PRC and the shares may not be offered or sold,
and will not offer or sell to any person for re-offering or resale directly or indirectly to any resident of the PRC except pursuant
to applicable laws, rules and regulations of the PRC. For the purpose of this paragraph only, the PRC does not include Taiwan and the
special administrative regions of Hong Kong and Macau.
CERTAIN MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
The following is a general discussion of certain material
U.S. federal income tax considerations relating to the acquisition, ownership and disposition of Units, consisting of shares of common
stock and Common Warrants, the acquisition, ownership and disposition of Units consisting of Pre-Funded Warrants and Common Warrants (such
Units are referred to in this discussion as “pre-funded Units”), the acquisition, ownership, and disposition of shares of
common stock acquired as part of the Units, the acquisition, ownership, and disposition of Pre-Funded Warrants acquired as part of the
pre-funded Units, the exercise, disposition, or expiration of Common Warrants acquired as part of the Units or pre-funded Units, the acquisition,
ownership, and disposition of shares of common stock received upon exercise of the Pre-Funded Warrants, and the acquisition, ownership,
and disposition of shares of common stock received upon exercise of the Common Warrants (the “warrant shares”), all as acquired
pursuant to this prospectus. This discussion is based on current provisions of the Internal Revenue Code of 1986, as amended (the “Internal
Revenue Code”), existing and proposed U.S. Treasury Regulations promulgated or proposed thereunder and current administrative and
judicial interpretations thereof, all as in effect as of the date of this prospectus and all of which are subject to change or to differing
interpretation, possibly with retroactive effect. This summary does not discuss the potential effects, whether adverse or beneficial,
of any proposed legislation that, if enacted, could be applied on a retroactive or prospective basis. We have not sought and will not
seek any rulings from the Internal Revenue Service (the “IRS”), regarding the matters discussed below. There can be no assurance
that the IRS or a court will not take a contrary position.
This discussion is limited to U.S. holders and non-U.S.
holders who hold Units, pre-funded Units, shares of common stock, Pre-Funded Warrants, Common Warrants, or warrant shares, as applicable,
as a capital asset within the meaning of Section 1221 of the Internal Revenue Code (generally, as property held for investment). This
discussion does not address all aspects of U.S. federal income taxation, such as the U.S. alternative minimum income tax and the additional
tax on net investment income, nor does it address any aspect of state, local or non-U.S. taxes, or U.S. federal taxes other than income
taxes, such as federal estate and gift taxes. Except as provided below, this summary does not address tax reporting requirements. This
discussion does not consider any specific facts or circumstances that may apply to a holder and does not address the special tax considerations
that may be applicable to particular holders, such as:
| |
· |
insurance companies; |
| |
|
|
| |
· |
tax-exempt organizations
and governmental organizations; |
| |
|
|
| |
· |
banks or other financial
institutions; |
| |
|
|
| |
· |
brokers or dealers in securities
or foreign currency; |
| |
|
|
| |
· |
traders in securities who
elect to apply a mark-to-market method of accounting; |
| |
|
|
| |
· |
real estate investment
trusts, regulated investment companies or mutual funds; |
| |
|
|
| |
· |
pension plans; |
| |
|
|
| |
· |
controlled foreign corporations; |
| |
|
|
| |
· |
passive foreign investment
companies; |
| |
|
|
| |
· |
corporations organized
outside the United States, any state thereof, or the District of Columbia that are nonetheless treated as U.S. persons for U.S. federal
income tax purposes; |
| |
|
|
| |
· |
persons that own (directly,
indirectly or constructively) more than 5% of the total voting power or total value of our common stock; |
| |
|
|
| |
· |
corporations that accumulate
earnings to avoid U.S. federal income tax; |
| |
|
|
| |
· |
persons subject to the
alternative minimum tax; |
| |
|
|
| |
· |
U.S. expatriates and certain
former citizens or long-term residents of the United States; |
| |
|
|
| |
· |
persons that have a “functional
currency” other than the U.S. dollar; |
| |
|
|
| |
· |
persons that acquire
Units, pre-funded Units, shares of common stock, Pre-Funded Warrants, Common Warrants or warrant shares as compensation for
services; |
| |
|
|
| |
· |
owners that hold our stock
as part of a straddle, hedge, conversion transaction, synthetic security or other integrated investment; |
| |
|
|
| |
· |
holders subject to special
accounting rules; |
| |
|
|
| |
· |
S corporations (and shareholders
thereof); |
| |
|
|
| |
· |
partnerships or other entities
treated as partnerships for U.S. federal income tax purposes (and partners or other owners thereof); and |
| |
|
|
| |
· |
U.S. holders that are
subject to taxing jurisdictions other than, or in addition to, the United States with respect to their Units, pre-funded Units,
shares of common stock, Pre-Funded Warrants, Common Warrants or warrant shares, or that hold such securities in connection with a
trade or business, permanent establishment or fixed base outside the United States. |
If an entity or arrangement taxable as a partnership
(or other “pass-through entity) for U.S. federal income tax purposes holds our Units, pre-funded Units, shares of common stock,
Pre-Funded Warrants, Common Warrants or warrant shares, the U.S. federal income tax treatment of such entity (or arrangement) and the
partners (or other owners) of such entity generally will depend on the status of the partners, the activities of the entity and certain
determinations made at the partner level. This summary does not address the tax consequences to any such owner. Partners (or other owners)
of entities or arrangements that are classified as partnerships or as “pass-through” entities for U.S. federal income tax
purposes should consult their own tax advisors regarding the U.S. federal, U.S. federal net investment income, U.S. federal alternative
minimum, U.S. federal estate and gift, U.S. state and local, and non-U.S. tax consequences arising from and relating to the acquisition,
ownership, and disposition our Units, pre-funded Units, shares of common stock, Pre-Funded Warrants, Common Warrants or warrant shares.
For purposes of this discussion, the term “U.S.
holder” means a beneficial owner of our Units, pre-funded Units, shares of common stock, Pre-Funded Warrants, Common Warrants or
warrant shares that is, for U.S. federal income tax purposes:
| |
· |
an individual who is a
citizen or resident of the United States; |
| |
|
|
| |
· |
a corporation created or
organized in or under the laws of the United States, any state thereof or the District of Columbia; |
| |
|
|
| |
· |
an estate the income of
which is subject to U.S. federal income taxation regardless of its source; or |
| |
|
|
| |
· |
a trust, if (1) a U.S.
court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to
control all substantial decisions of the trust or (2) the trust has a valid election to be treated as a U.S. person under applicable
U.S. Treasury Regulations. |
A “non-U.S. holder” is a beneficial owner
of our Units, pre-funded Units, shares of common stock, Pre-Funded Warrants, Common Warrants or warrant shares that is neither a U.S.
holder nor a partnership (or other entity treated as a partnership for U.S. federal income tax purposes).
THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES
ONLY AND IS NOT, AND IS NOT INTENDED TO BE, LEGAL OR TAX ADVICE. PROSPECTIVE INVESTORS SHOULD CONSULT THEIR OWN TAX ADVISORS REGARDING
THE U.S. FEDERAL, STATE, LOCAL, AND NON-U.S. INCOME, ESTATE AND OTHER TAX CONSIDERATIONS OF ACQUIRING, HOLDING AND DISPOSING OF OUR UNITS,
PRE-FUNDED UNITS, SHARES OF COMMON STOCK, PRE-FUNDED WARRANTS, WARRANTS OR WARRANT SHARES.
U.S. Federal Income Tax Consequences of the Acquisition
of Units or Pre-Funded Units
For
U.S. federal income tax purposes, the acquisition by a U.S. holder or a non-U.S. holder of
a Unit will be treated as the acquisition of one share of common stock and two Common Warrants.
The purchase price for each Unit will be allocated among these two components in proportion
to their relative fair market values at the time the Unit is purchased by the U.S. holder
or non-U.S. holder. This allocation of the purchase price for each Unit will establish a
U.S. holder’s or non-U.S. holder’s initial tax basis for U.S. federal income
tax purposes in the one share of common stock and the two Common Warrants that comprise each
Unit.
For this purpose, we will allocate $0.57 of the
purchase price for the Unit to the share of common stock, and $0.01 of the purchase price for the Unit to the Common Warrant. However,
the IRS will not be bound by such allocation of the purchase price for the Units, and therefore, the IRS or a U.S. court may not respect
the allocation set forth above. Each U.S. holder and non-U.S. holder should consult its own tax advisor regarding the allocation of the
purchase price for the Units.
For U.S. federal income tax purposes, the acquisition
by a U.S. holder or a non-U.S. holder of a pre-funded Unit will be treated as the acquisition of one Pre-Funded Warrant and two Common
Warrants. The purchase price for each pre-funded Unit will be allocated among these two components in proportion to their relative fair
market values at the time the pre-funded Unit is purchased by the U.S. holder or non-U.S. holder. This allocation of the purchase price
for each pre-funded Unit will establish a U.S. holder’s or non-U.S. holder’s initial tax basis for U.S. federal income tax
purposes in the one Pre-Funded Warrant and two Common Warrants that comprise each pre-funded Unit.
For this purpose, we will allocate $0.56999 of the
purchase price for the pre-funded Unit to the Pre-Funded Warrant, and $0.01 of the purchase price for each pre-funded Unit to the Common
Warrant. However, the IRS will not be bound by such allocation of the purchase price for the pre-funded Units, and therefore, the IRS
or a U.S. court may not respect the allocation set forth above. Each U.S. holder and non-U.S. holder should consult its own tax advisor
regarding the allocation of the purchase price for the pre-funded Units.
Treatment of Pre-Funded Warrants
Although it is not entirely free from doubt, we believe
that a Pre-Funded Warrant should be treated as a separate class of common shares for U.S. federal income tax purposes and a U.S. holder
or non-U.S. holder of Pre-Funded Warrants should generally be taxed in the same manner as a holder of shares of common stock except as
described below. Accordingly, no gain or loss should be recognized upon the exercise of a Pre-Funded Warrant and, upon exercise, the holding
period of a Pre-Funded Warrant should carry over to the shares of common stock received. Similarly, the tax basis of the Pre-Funded Warrant
should carry over to the shares of common stock received upon exercise, increased by the exercise price of $0.00001 per share. However,
such characterization is not binding on the IRS, and the IRS may treat the Pre-Funded Warrants as warrants to acquire shares of common
stock. If so, the amount and character of a U.S. holder’s or non-U.S. holder’s gain with respect to an investment in Pre-Funded
Warrants could change. Accordingly, each U.S. holder and non-U.S. holder should consult its own tax advisors regarding the risks associated
with the acquisition of a Pre-Funded Warrant pursuant to this prospectus (including potential alternative characterizations). The balance
of this discussion generally assumes that the characterization described above is respected for U.S. federal income tax purposes.
In certain limited circumstances, a U.S. holder may
be permitted to undertake a cashless exercise of Pre-Funded Warrants into shares of common stock. The U.S. federal income tax treatment
of a cashless exercise of Pre-Funded Warrants into shares of common stock is unclear, and the tax consequences of a cashless exercise
could differ from the consequences upon the exercise of a Pre-Funded Warrant described in the preceding paragraph. U.S. holders should
consult their own tax advisors regarding the U.S. federal income tax consequences of a cashless exercise of Pre-Funded Warrants.
U.S. Holders
U.S. Federal Income Tax Consequences
of the Exercise, Disposition or Expiration of Common Warrants or Certain Adjustments to the Common Warrants
Exercise of Common Warrants
A U.S. holder should not recognize gain or loss on
the exercise of Common Warrants and related receipt of warrant shares (unless cash is received in lieu of the issuance of a fractional
warrant share). A U.S. holder’s initial tax basis in the warrant shares received on the exercise of Common Warrants should be equal
to the sum of (a) such U.S. holder’s tax basis in such Common Warrants plus (b) the exercise price paid by such U.S. holder on the
exercise of such Common Warrants. It is unclear whether a U.S. holder’s holding period for the warrant shares received on the exercise
of Common Warrants would commence on the date of exercise of the Common Warrants or the day following the date of exercise of the Common
Warrants.
In certain limited circumstances, a U.S. holder may
be permitted to undertake a cashless exercise of Common Warrants into warrant shares. The U.S. federal income tax treatment of a cashless
exercise of Common Warrants into warrant shares is unclear, and the tax consequences of a cashless exercise could differ from the consequences
upon the exercise of Common Warrants described in the preceding paragraph. U.S. holders should consult their own tax advisors regarding
the U.S. federal income tax consequences of a cashless exercise of Common Warrants.
Disposition of Common Warrants
A U.S. holder will recognize gain or loss on the sale
or other taxable disposition of a Common Warrant in an amount equal to the difference, if any, between (a) the amount of cash plus the
fair market value of any property received and (b) such U.S. holder’s tax basis in the Common Warrant sold or otherwise disposed
of. Any such gain or loss generally will be a capital gain or loss, which will be long-term capital gain or loss if the Common Warrant
is held for more than one year. Deductions for capital losses are subject to complex limitations under the Internal Revenue Code.
Expiration of Common Warrants Without Exercise
Upon the lapse or expiration of a Common Warrant,
a U.S. holder will recognize a loss in an amount equal to such U.S. holder’s tax basis in the Common Warrant. Any such loss generally
will be a capital loss and will be long-term capital loss if the Common Warrant is held for more than one year. Deductions for capital
losses are subject to complex limitations under the Internal Revenue Code.
Certain Adjustments to the Common Warrants
Under Section 305 of the Internal Revenue Code, an adjustment to the number
of warrant shares that will be issued on the exercise of the Common Warrants, or an adjustment to the exercise price of the Common Warrants,
may be treated as a constructive distribution to a U.S. holder of the Common Warrants if, and to the extent that, such adjustment has
the effect of increasing such U.S. holder’s proportionate interest in the “earnings and profits” or our assets, depending
on the circumstances of such adjustment (for example, if such adjustment is to compensate for a distribution of cash or other property
to our shareholders). Adjustments to the exercise price of Common Warrants made pursuant to a bona fide reasonable adjustment formula
that has the effect of preventing dilution of the interest of the holders of the Common Warrants should generally not be considered to
result in a constructive distribution. Any such constructive distribution would be taxable whether or not there is an actual distribution
of cash or other property. (See more detailed discussion of the rules applicable to distributions made by us at “Distributions
on Shares of Common Stock, Pre-Funded Warrants and Warrant Shares” below).
U.S. Federal Income Tax Consequences of the
Acquisition, Ownership, and Disposition of Shares of Common Stock, Pre-Funded Warrants and Warrant Shares
Distributions on Shares of Common Stock, Pre-Funded
Warrants and Warrant Shares
A U.S. holder that receives a distribution, including
a constructive distribution, with respect to a share of common stock, Pre-Funded Warrant or warrant share (as well as any constructive
distribution on a Common Warrant as described above) will be required to include the amount of such distribution in gross income as a
dividend to the extent of our current and accumulated “earnings and profits”, as computed under U.S. federal income tax principles.
To the extent that a distribution exceeds our current and accumulated “earnings and profits”, such distribution will be treated
first as a tax-free return of capital to the extent of a U.S. holder’s tax basis in the shares of common stock, Pre-Funded Warrants
or warrant shares and thereafter as gain from the sale or exchange of such shares of common stock, Pre-Funded Warrants or warrant shares
(see “Sale or Other Taxable Disposition of Shares of Common Stock, Pre-Funded Warrants and/or Warrant Shares” below).
Dividends received on shares of common stock, Pre-Funded Warrants or warrant shares may be eligible for a dividends received deduction,
subject to certain restrictions relating to, among others, the corporate U.S. holder’s taxable income, holding period and debt financing.
Dividends paid by us to non-corporate U.S. holders, including individuals, generally will be eligible for the preferential tax rates applicable
to long-term capital gains for dividends, provided certain holding period and other conditions are satisfied. The dividend rules are complex,
and each U.S. holder should consult its own tax advisor regarding the application of such rules.
Sale or Other Taxable Disposition of Shares of
Common Stock, Pre-Funded Warrants and/or Warrant Shares
Upon the sale or other taxable disposition of shares
of common stock, Pre-Funded Warrants or warrant shares, a U.S. holder generally will recognize capital gain or loss in an amount equal
to the difference between (a) the amount of cash plus the fair market value of any property received and (b) such U.S. holder’s
tax basis in such shares of common stock, Pre-Funded Warrants or warrant shares sold or otherwise disposed of. Gain or loss recognized
on such sale or other taxable disposition generally will be long-term capital gain or loss if, at the time of the sale or other taxable
disposition, the shares of common stock, Pre-Funded Warrants or warrant shares have been held for more than one year. Preferential tax
rates may apply to long-term capital gain of a U.S. holder that is an individual, estate, or trust. There are no preferential tax rates
for long-term capital gain of a U.S. holder that is a corporation. Deductions for capital losses are subject to significant limitations
under the Internal Revenue Code.
Non-U.S. Holders
U.S. Federal Income Tax Consequences of the
Exercise, Disposition or Expiration of Common Warrants or Certain Adjustments to the Common Warrants
Exercise of Common Warrants
A non-U.S. holder generally will not recognize gain
or loss on the exercise of Common Warrants and related receipt of warrant shares (unless cash is received in lieu of the issuance of a
fractional warrant share and certain other conditions are present, as discussed below under “Gain on Sale, Exchange or Other
Taxable Disposition of Shares of Common Stock, Pre-Funded Warrants, Common Warrants and Warrant Shares”). A non-U.S. holder’s
initial tax basis in the warrant shares received on the exercise of Common Warrants should be equal to the sum of (i) the non-U.S. holder’s
tax basis in the Common Warrants, plus (ii) the exercise price paid by the non-U.S. holder on the exercise of the Common Warrants. It
is unclear whether a non-U.S. holder’s holding period for the warrant shares received on the exercise of Common Warrants would commence
on the date of exercise of the Common Warrants or the day following the date of exercise of the Common Warrants.
In certain limited circumstances, a non-U.S. holder
may be permitted to undertake a cashless exercise of Common Warrants into warrant shares. The U.S. federal income tax treatment of a cashless
exercise of Common Warrants into warrant shares is unclear, and the tax consequences of a cashless exercise could differ from the consequences
upon the exercise of Common Warrants described in the preceding paragraph. Non-U.S. holders should consult their own tax advisors regarding
the U.S. federal income tax consequences of a cashless exercise of Common Warrants.
Disposition of Common Warrants
A non-U.S. Holder will recognize gain or loss on the
sale or other taxable disposition of a Common Warrant in an amount equal to the difference, if any, between (a) the amount of cash plus
the fair market value of any property received and (b) such non-U.S. holder’s tax basis in the Common Warrant sold or otherwise
disposed of. Any such gain or loss generally will be a capital gain or loss, which will be long-term capital gain or loss if the Common
Warrant is held for more than one year. Any such gain recognized by a non-U.S. holder will be taxable for U.S. federal income tax purposes
according to rules discussed under the heading “Gain on Sale, Exchange or Other Taxable Disposition of Shares of Common Stock,
Pre-Funded Warrants, Common Warrants and Warrant Shares” below.
Expiration of Common Warrants without Exercise
Upon the lapse or expiration of a Common Warrant,
a non-U.S. holder will recognize loss in an amount equal to such non-U.S. holder’s tax basis in the Common Warrant. Any such loss
generally will be a capital loss and will be long-term capital loss if the Common Warrants are held for more than one year. Deductions
for capital losses are subject to complex limitations under the Internal Revenue Code.
Certain Adjustments to the Common Warrants
Under Section 305 of the Internal Revenue Code, an
adjustment to the number of warrant shares that will be issued on the exercise of the Common Warrants, or an adjustment to the exercise
price of the Common Warrants, may be treated as a constructive distribution to a non-U.S. holder of the Common Warrants if, and to the
extent that, such adjustment has the effect of increasing such non-U.S. holder’s proportionate interest in our “earnings and
profits” or assets, depending on the circumstances of such adjustment (for example, if such adjustment is to compensate for a distribution
of cash or other property to our shareholders). Adjustments to the exercise price of a Common Warrant made pursuant to a bona fide reasonable
adjustment formula that has the effect of preventing dilution of the interest of the holders of the Common Warrants should generally not
result in a constructive distribution. See the more detailed discussion of the rules applicable to distributions made by us under the
heading “Distributions on Shares of Common Stock, Pre-Funded Warrants and Warrant Shares” below.
U.S. Federal Income Tax Consequences of the
Acquisition, Ownership, and Disposition of Shares of Common Stock, Pre-Funded Warrants and Warrant Shares
Distributions on Shares of Common Stock, Pre-Funded
Warrants and Warrant Shares
If we pay distributions of cash or property with respect
to our shares of common stock, Pre-Funded Warrants or warrant shares, those distributions generally will constitute dividends for U.S.
federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal
income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free
return of the non-U.S. holder’s investment, up to such holder’s tax basis in its shares of common stock, Pre-Funded Warrants
or warrants shares, as applicable. Any remaining excess will be treated as capital gain, subject to the tax treatment described below
under the heading “— Gain on Sale, Exchange or Other Taxable Disposition of Shares of Common Stock, Pre-Funded Warrants,
Common Warrants and Warrant Shares.” Dividends paid to a non-U.S. holder generally will be subject to withholding of U.S. federal
income tax at a 30% rate, or such lower rate as may be specified by an applicable income tax treaty between the United States and such
holder’s country of residence. In the case of any constructive distribution, it is possible that this tax would be withheld from
any amount owed to the non-U.S. holder, including, but not limited to, distributions of cash, shares of common stock or sales proceeds
subsequently paid or credited to that holder. If we are unable to determine, at the time of payment of a distribution, whether the distribution
will constitute a dividend, we may nonetheless choose to withhold any U.S. federal income tax on the distribution as permitted by U.S.
Treasury Regulations. If we are a USRPHC (as defined below) and we do not qualify for the Regularly Traded Exception (as defined below),
distributions which constitute a return of capital will be subject to withholding tax unless an application for a withholding certificate
is filed to reduce or eliminate such withholding.
Distributions that are treated as effectively connected
with a trade or business conducted by a non-U.S. holder within the United States are generally not subject to the 30% (or lower rate
as may be specified by an applicable tax treaty) withholding tax if the non-U.S. holder provides a properly executed IRS Form W-8ECI
stating that the distributions are not subject to withholding because they are effectively connected with the non-U.S. holder’s
conduct of a trade or business in the United States. If a non-U.S. holder is engaged in a trade or business in the United States and
the distribution is effectively connected with the conduct of that trade or business, the distribution will generally have the consequences
described above for a U.S. holder (subject to any modification provided under an applicable income tax treaty). Any U.S. effectively
connected income received by a non-U.S. holder that is treated as a corporation for U.S. federal income tax purposes may also, under
certain circumstances, be subject to an additional “branch profits tax” at a 30% rate (or such lower rate as may be specified
by an applicable income tax treaty).
A non-U.S. holder who claims the benefit of an applicable
income tax treaty between the United States and such holder’s country of residence generally will be required to provide a properly
executed IRS Form W-8BEN or W-8BEN-E, as applicable, and satisfy applicable certification and other requirements. A non-U.S. holder that
is eligible for a reduced rate of U.S. withholding tax under an income tax treaty generally may obtain a refund or credit of any excess
amounts withheld by timely filing an appropriate claim with the IRS. Non-U.S. holders should consult their own tax advisors regarding
their entitlement to benefits under a relevant income tax treaty.
Gain on Sale, Exchange or Other Taxable Disposition
of Shares of Common Stock, Pre-Funded Warrants, Common Warrants and Warrant Shares
Subject to the discussions below in“—Information
Reporting and Backup Withholding” and “—Foreign Account Tax Compliance Act,” a non-U.S. holder
generally will not be subject to U.S. federal income tax on gain recognized on a sale, exchange or other taxable disposition of our shares
of common stock, Pre-Funded Warrants, Common Warrants, or warrant shares unless:
| |
· |
the gain is effectively connected with the non-U.S.
holder’s conduct of a trade or business in the United States and, if an applicable income tax treaty so provides, the gain
is attributable to a permanent establishment maintained by the non-U.S. holder in the United States; in these cases, the non-U.S.
holder will be taxed on a net income basis at the regular graduated rates and in the manner applicable to a U.S. holder, and, if
the non-U.S. holder is a corporation, an additional branch profits tax at a rate of 30%, or a lower rate as may be specified by an
applicable income tax treaty, may also apply; |
| |
|
|
| |
· |
the non-U.S. holder is an individual present
in the United States for 183 days or more in the taxable year of the disposition and certain other conditions are met, in which case
the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty) on the
amount by which such non-U.S. holder’s capital gains allocable to U.S. sources exceed capital losses allocable to U.S. sources
during the taxable year of the disposition; or |
| |
|
|
| |
· |
we are or have been a “U.S. real property holding corporation”
(“USRPHC”) for U.S. federal income tax purposes at any time during the shorter of the non-U.S. holder’s holding
period or the 5-year period ending on the date of disposition of shares of common stock, Pre-Funded Warrants, Common Warrants or warrant
shares; provided, with respect to the shares of common stock and warrant shares, that as long as our shares of common stock are regularly
traded on an established securities market as determined under the U.S. Treasury Regulations (the “Regularly Traded Exception”),
a non-U.S. holder would not be subject to taxation on the gain on the sale of shares of common stock or warrant shares under this rule
unless the non-U.S. holder has owned: (i) more than 5% of our shares of common stock at any time during such 5-year or shorter period;
(ii) Pre-Funded Warrants with a fair market value on the date acquired by such holder greater than the fair market value on that date
of 5% of our shares of common stock; (iii) Common Warrants with a fair market value on the date acquired by such holder greater than the
fair market value on that date of 5% of our shares of common stock; or (iv) aggregate equity securities of ours with a fair market value
on the date acquired in excess of 5% of the fair market value of our shares of common stock on such date (in any case, a “5%
Shareholder”). Since the Common Warrants are not expected to be listed on a securities market, the Common Warrants are unlikely
to qualify for the Regularly Traded Exception. Special rules apply to the Pre-Funded Warrants. Non-U.S. holders holding Pre-Funded Warrants
should consult their own tax advisors regarding such rules. In determining whether a non-U.S. holder is a 5% Shareholder, certain attribution
rules apply in determining ownership for this purpose. We believe that we are not currently, and do not anticipate becoming in the future,
a USRPHC for U.S. federal income tax purposes. However, we can provide no assurances that we are not currently, or will not become , a
USRPHC, or if we are or become a USRPHC, that the shares of common stock, Pre-Funded Warrants, Common Warrants or warrant shares will
meet the Regularly Traded Exception at the time a non-U.S. holder purchases such securities or sells, exchanges or otherwise disposes
of such securities. Non-U.S. holders should consult with their own tax advisors regarding the consequences to them of investing in a USRPHC.
If we are a USRPHC, a non-U.S. holder will be taxed as if any gain or loss were effectively connected with the conduct of a trade or business
as described above in “Distributions on Shares of Common Stock, Pre-Funded Warrants and Warrant Shares” in the event
that (i) such holder is a 5% Shareholder, or (ii) the Regularly Traded Exception is not satisfied during the relevant period. |
Information Reporting and Backup Withholding
Distributions on, and the payment of the proceeds
of a disposition of, our shares of common stock, Pre-Funded Warrants and warrant shares generally will be subject to information reporting
if made within the United States or through certain U.S.-related financial intermediaries. Information returns are required to be filed
with the IRS and copies of information returns may be made available to the tax authorities of the country in which a holder resides
or is incorporated under the provisions of a specific treaty or agreement.
Backup withholding may also apply if the holder fails
to provide certification of exempt status or a correct U.S. taxpayer identification number and otherwise comply with the applicable backup
withholding requirements. Generally, a holder will not be subject to backup withholding if it provides a properly completed and executed
IRS Form W-9 or appropriate IRS Form W-8, as applicable. Backup withholding is not an additional tax. Amounts withheld under the backup
withholding rules may be refunded or credited against the holder’s U.S. federal income tax liability, if any, provided certain
information is timely filed with the IRS.
Foreign Account Tax Compliance Act
Sections 1471 through 1474 of the Internal Revenue
Code (commonly referred to as “FATCA”) impose a separate reporting regime and potentially a 30% withholding tax on
certain payments, including payments of dividends on our shares of common stock, Pre-Funded Warrants and warrant shares. Withholding under
FATCA generally applies to payments made to or through a foreign entity if such entity fails to satisfy certain disclosure and reporting
rules. These rules generally require (i) in the case of a foreign financial institution, that the financial institution agree to identify
and provide information in respect of financial accounts held (directly or indirectly) by U.S. persons and U.S.-owned entities, and, in
certain instances, to withhold on payments to account holders that fail to provide the required information, and (ii) in the case of a
non-financial foreign entity, that the entity either identify and provide information in respect of its substantial U.S. owners or certify
that it has no such U.S. owners.
FATCA withholding also potentially applies to payments
of gross proceeds from the sale or other disposition of our shares of common stock, Pre-Funded Warrants and warrant shares. Proposed U.S.
Treasury Regulations, however, would eliminate FATCA withholding on such payments, and the U.S. Treasury Department has indicated that
taxpayers may rely on this aspect of the proposed U.S. Treasury Regulations until final U.S. Treasury Regulations are issued.
Non-U.S. holders typically will be required to furnish
certifications (generally on the applicable IRS Form W-8) or other documentation to provide the information required by FATCA or to establish
compliance with or an exemption from withholding under FATCA. FATCA withholding may apply where payments are made through a non-U.S. intermediary
that is not FATCA compliant, even where the non-U.S. holder satisfies the holder’s own FATCA obligations.
The United States and a number of other jurisdictions
have entered into intergovernmental agreements to facilitate the implementation of FATCA. Any applicable intergovernmental agreement may
alter one or more of the FATCA information reporting and withholding requirements. You are encouraged to consult with your own tax advisor
regarding the possible implications of FATCA on your investment in our shares of common stock, Pre-Funded Warrants or warrant shares,
including the applicability of any intergovernmental agreements.
THE ABOVE SUMMARY IS NOT INTENDED TO CONSTITUTE
A COMPLETE ANALYSIS OF ALL TAX CONSIDERATIONS APPLICABLE TO PROSPECTIVE INVESTORS WITH RESPECT TO THE ACQUISITION, OWNERSHIP, AND DISPOSITION
OF UNITS, PRE-FUNDED UNITS, SHARES OF COMMON STOCK, PRE-FUNDED WARRANTS, WARRANTS OR WARRANT SHARES. PROSPECTIVE INVESTORS SHOULD CONSULT
THEIR OWN TAX ADVISORS AS TO THE TAX CONSIDERATIONS APPLICABLE TO THEM IN LIGHT OF THEIR OWN PARTICULAR CIRCUMSTANCES.
LEGAL MATTERS
Carroll Legal LLC, Denver,
CO will pass upon the validity of the shares of common stock offered hereby for us. The placement agent is represented by Ellenoff Grossman
& Schole LLP.
EXPERTS
Haynie & Company,
independent registered public accounting firm, has audited the financial statements of the Company as of December 31, 2023 and for the
year ended December 31, 2023, as set forth in their report included herein. The report of Haynie & Company contains an explanatory
paragraph about the ability of the Company to continue as a going concern. The 2023 financial statements of the Company are included
in this prospectus and elsewhere in this registration statement in reliance of Haynie & Company’s report, given on their authority
as experts in accounting and auditing.
CohnReznick LLP, independent
registered public accounting firm, has audited the restated financial statements of the Company as of December 31, 2022 and for the year
ended December 31, 2022, as set forth in their report included herein. The report of CohnReznick LLP contains an explanatory paragraph
about the ability of the Company to continue as a going concern. The restated 2022 financial statements of the Company are included in
this prospectus and elsewhere in this registration statement in reliance of CohnReznick LLP’s report, given on their authority as
experts in accounting and auditing.
CHANGE IN ACCOUNTANTS
In
2023, CohnReznick LLP resigned as our independent registered public accounting firm and
we retained Haynie & Company, as our independent registered public accounting firm. We had no disagreements with CohnReznick on any
matter of accounting principles or practices, financial statements disclosure, or auditing scope of procedures during our most recent
fiscal year prior to our change in independent registered public accounting firm,
which, if not resolved to the satisfaction of CohnReznick, would have caused it to make reference to the matter in its report.
WHERE YOU CAN FIND MORE
INFORMATION
We have filed with the SEC
a registration statement on Form S-1 under the Securities Act with respect to the shares of our common stock being offered by this prospectus.
This prospectus, which constitutes part of that registration statement, does not contain all of the information set forth in the registration
statement or the exhibits and schedules that are part of the registration statement. Some items included in the registration statement
are omitted from the prospectus in accordance with the rules and regulations of the SEC. For further information with respect to us and
the common stock offered in this prospectus, we refer you to the registration statement and the accompanying exhibits and schedules filed
therewith. Statements contained in this prospectus regarding the contents of any contract or any other document that is filed as an exhibit
to the registration statement are not necessarily complete, and each such statement is qualified in all respects by reference to the
full text of such contract or other document filed as an exhibit to the registration statement.
We are subject to the information
and periodic reporting requirements of the Exchange Act, and we file periodic reports, proxy statements and other information with the
SEC. These periodic reports, proxy statements and other information are available for inspection and copying at the public reference
room of the SEC. The SEC also maintains a website that contains reports, proxy and information statements and other information regarding
registrants that file electronically with the SEC. The address of the SEC website is www.sec.gov.
You may access our annual
reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished
pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after
such material is electronically filed with, or furnished to, the SEC.
Our website address is www.aclarion.com.
The reference to our website address does not constitute incorporation by reference of the information contained on our website, and
you should not consider information on our website to be part of this prospectus.
You may also request a copy
of these filings, at no cost to you, by writing or telephoning us at the following address:
Aclarion, Inc.
Attn: Investor Relations
8181 Arista Place, Suite
100
Broomfield, Colorado 80021
Telephone: (833) 275-2266
Index
to Financial Statements
Report of Independent
Registered Public Accounting Firm
To the Board of Directors and
Stockholders of Aclarion, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheet
of Aclarion, Inc. (the Company) as of December 31, 2023, and the related statements of operations, changes in stockholders’ equity
(deficit), and cash flows for the year then ended, and the related notes (collectively referred to as the financial statements). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023,
and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted
in the United States of America.
Substantial Doubt about the Company’s
Ability to Continue as a Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the
Company has suffered recurring losses from operations and has a deficiency in shareholders’ equity that raise substantial doubt
about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required
to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ Haynie & Company
Haynie & Company
Salt Lake City, Utah
February 21, 2024
We have served as the Company’s auditor since 2023.
PCAOB ID 0457
Report
of Independent Registered Public Accounting Firm
To the Board of Directors and
Stockholders
Aclarion, Inc.
Broomfield, Colorado
Opinion on the Financial Statements
We have audited the accompanying
balance sheet of Aclarion, Inc. (the “Company”) as of December 31, 2022, and the related statements of operations, changes
in stockholders’ equity (deficit) and cash flows for the year then ended, and the related notes (collectively referred to as the
financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the
Company at December 31, 2022, and the results of its operations and its cash flows for the year then ended, in conformity with accounting
principles generally accepted in the United States of America.
Restatement to correct the 2022 financial statements
As discussed in Note 3 to the financial statements,
the 2022 financial statements have been restated to correct misstatements.
The financial statements of the Company as of
December 31, 2022, before the effects of the adjustments for the correction of the errors described in Note 3, were audited by Daszkal
Bolton LLP who issued an unqualified opinion on those statements in their report, containing explanatory language that substantial doubt
exists about the entity’s ability to continue as a going concern, dated February 27, 2023. Effective March 1, 2023, CohnReznick
LLP acquired certain people and assets of Daszkal Bolton LLP.
Going Concern Uncertainty
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
suffered recurring losses from operations and an accumulated deficit that raise substantial doubt about its ability to continue as a going
concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements
are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ CohnReznick LLP
CohnReznick LLP
We have served as the
Company’s auditor from 2021 (such date takes into account the acquisition of certain people and assets of Daszkal Bolton LLP by
CohnReznick LLP effective March 1, 2023) to 2023
Sunrise, Florida
June 12, 2023, except for Note 1, 2024 Reverse Stock Split, Note 7
SUPPLEMENTAL FINANCIAL INFORMATION Prepaids and other current assets and Accrued and other liabilities, and Note 14, Net Loss Per Share
of Common Stock, as to which the date is February 21, 2024
Aclarion, Inc.
Balance Sheets
December 31, 2023 and 2022
| | |
| | | |
| | |
| | |
| | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
(restated) | |
| ASSETS | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 1,021,069 | | |
$ | 1,472,806 | |
| Restricted cash | |
| 10,000 | | |
| 10,000 | |
| Accounts receivable, net | |
| 13,270 | | |
| 18,569 | |
| Prepaids & other current assets | |
| 245,030 | | |
| 199,701 | |
| Total current assets | |
| 1,289,369 | | |
| 1,701,076 | |
| | |
| | | |
| | |
| Non-current assets: | |
| | | |
| | |
| Property and equipment, net | |
| 1,782 | | |
| 3,346 | |
| Intangible assets, net | |
| 1,168,623 | | |
| 1,210,207 | |
| Total non-current assets | |
| 1,170,405 | | |
| 1,213,553 | |
| | |
| | | |
| | |
| Total assets | |
$ | 2,459,774 | | |
$ | 2,914,629 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 760,535 | | |
$ | 462,202 | |
| Accrued and other liabilities | |
| 857,722 | | |
| 226,469 | |
| Note payable, net of discount | |
| 1,125,724 | | |
| – | |
| Warrant liability | |
| 289,165 | | |
| – | |
| Derivative liability | |
| 121,326 | | |
| – | |
| Liability to issue equity | |
| 33,297 | | |
| – | |
| Total current liabilities | |
| 3,187,769 | | |
| 688,671 | |
| | |
| | | |
| | |
| Commitments and contingencies (See Note 12) | |
| – | | |
| – | |
| | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders' equity (deficit) | |
| | | |
| | |
| Common stock - $0.00001 par value, 200,000,000 authorized and 825,459 and 491,345 shares issued and outstanding (see Note 13) | |
| 8 | | |
| 5 | |
| Additional paid-in capital | |
| 43,553,523 | | |
| 41,596,106 | |
| Accumulated deficit | |
| (44,281,526 | ) | |
| (39,370,153 | ) |
| Total stockholders’ equity (deficit) | |
| (727,995 | ) | |
| 2,225,958 | |
| | |
| | | |
| | |
| Total liabilities and stockholders’ equity (deficit) | |
$ | 2,459,774 | | |
$ | 2,914,629 | |
See Accompanying Notes to Financial Statements
Aclarion, Inc.
Statements of Operations
For the Years Ended December 31, 2023, and 2022
| | |
| | | |
| | |
| | |
| | |
| |
| | |
Year Ended December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
(restated) | |
| Revenue | |
| | | |
| | |
| Revenue | |
$ | 75,404 | | |
$ | 60,444 | |
| Cost of revenue | |
| 75,728 | | |
| 65,298 | |
| Gross profit (loss) | |
| (324 | ) | |
| (4,854 | ) |
| | |
| | | |
| | |
| Operating expenses: | |
| | | |
| | |
| Sales and marketing | |
| 757,004 | | |
| 498,003 | |
| Research and development | |
| 873,336 | | |
| 1,067,992 | |
| General and administrative | |
| 3,245,317 | | |
| 3,990,719 | |
| Total operating expenses | |
| 4,875,657 | | |
| 5,556,714 | |
| | |
| | | |
| | |
| Income (loss) from operations | |
| (4,875,981 | ) | |
| (5,561,568 | ) |
| | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | |
| Interest expense | |
| (608,288 | ) | |
| (1,507,546 | ) |
| Changes in fair value of warrant and derivative liabilities | |
| 646,319 | | |
| – | |
| Loss on issuance of warrants | |
| (72,862 | ) | |
| – | |
| Other, net | |
| (562 | ) | |
| 521 | |
| Total other income (expense) | |
| (35,393 | ) | |
| (1,507,025 | ) |
| | |
| | | |
| | |
| Income (loss) before income taxes | |
| (4,911,374 | ) | |
| (7,068,593 | ) |
| Income tax provision | |
| – | | |
| – | |
| Net income (loss) | |
$ | (4,911,374 | ) | |
$ | (7,068,593 | ) |
| | |
| | | |
| | |
| Dividends accrued for preferred stockholders | |
$ | – | | |
$ | (415,523 | ) |
| Net income (loss) allocable to common stockholders | |
$ | (4,911,374 | ) | |
$ | (7,484,116 | ) |
| Net income (loss) per share allocable to common stockholders | |
$ | (8.82 | ) | |
$ | (19.61 | ) |
| Weighted average shares of common stock outstanding, basic and diluted | |
| 556,808 | | |
| 381,598 | |
See Accompanying Notes to Financial Statements
Aclarion,
Inc.
Statements of Changes in Stockholders' Equity
(Deficit)
For the Years Ended December 31, 2023
and 2022 (restated)
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
Series A | | |
Series A-1, A-2, A-3, A-4 | | |
Series B, B-1 | |
| | |
Preferred Stock | | |
Preferred Stock | | |
Preferred Stock | |
| | |
Shares | | |
Value | | |
Shares | | |
Value | | |
Shares | | |
Value | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| Balance, December 31, 2021 | |
| – | | |
$ | – | | |
| 6,247,695 | | |
$ | 62 | | |
| 12,434,500 | | |
$ | 124 | |
| Share-based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Preferred stock dividend payable | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Conversion of preferred stock
to common stock | |
| – | | |
| – | | |
| (6,247,695 | ) | |
| (62 | ) | |
| (12,434,500 | ) | |
| (124 | ) |
| Conversion of preferred dividends
payable to common stock | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Conversion of accrued interest
on promissory notes | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of common stock and warrants
related to IPO, net issuance costs | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of common shares | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of warrants | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| IPO issuance costs | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Exercise of convertible note warrants | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Net income (loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Balance, December 31, 2022 | |
| – | | |
$ | – | | |
| – | | |
$ | – | | |
| – | | |
$ | – | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Balance, December 31, 2022 | |
| – | | |
$ | – | | |
| – | | |
$ | – | | |
| – | | |
$ | – | |
| Share-based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of common shares | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Proceeds from sale of Series A preferred stock | |
| 1 | | |
| 1,000 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Redemption of Series A preferred stock | |
| (1 | ) | |
| (1,000 | ) | |
| – | | |
| – | | |
| – | | |
| – | |
| Commitment shares - note financing | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of warrants - note financing | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Issuance of common shares - equity line | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Commitment common shares - equity line | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Common share issuance costs -
equity line | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Cashless exercise of pre-funded warrants | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Conversion of vested restricted stock units to common shares | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Common share - stock split round up | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Net income (loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
| Balance, December 31, 2023 | |
| – | | |
$ | – | | |
| – | | |
$ | – | | |
| – | | |
$ | – | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
Series B-2, B-3 | | |
| | |
| | |
Additional | | |
| | |
| |
| | |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Accumulated | | |
| |
| | |
Shares | | |
Value | | |
Shares | | |
Value | | |
Capital | | |
Deficit | | |
Total | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| Balance, December 31, 2021 | |
| 5,812,809 | | |
$ | – | | |
| 56,605 | | |
$ | 1 | | |
$ | 19,054,243 | | |
| (31,886,036 | ) | |
$ | (12,831,606 | ) |
| Share-based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,186,658 | | |
| – | | |
| 1,186,658 | |
| Preferred stock dividend payable | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (415,523 | ) | |
| (415,523 | ) |
| Conversion of preferred stock
to common stock | |
| (5,812,809 | ) | |
| – | | |
| 204,945 | | |
| 2 | | |
| 7,102,472 | | |
| – | | |
| 7,102,287 | |
| Conversion of preferred dividends
payable to common stock | |
| – | | |
| – | | |
| 61,534 | | |
| 1 | | |
| 4,272,420 | | |
| – | | |
| 4,272,421 | |
| Conversion of accrued interest
on promissory notes | |
| – | | |
| – | | |
| 26,673 | | |
| – | | |
| 1,855,158 | | |
| – | | |
| 1,855,158 | |
| Issuance of common stock and warrants
related to IPO, net issuance costs | |
| – | | |
| – | | |
| 135,313 | | |
| 1 | | |
| 8,552,338 | | |
| – | | |
| 8,552,340 | |
| Issuance of common shares | |
| – | | |
| – | | |
| 2,500 | | |
| – | | |
| 102,000 | | |
| – | | |
| 102,000 | |
| Issuance of warrants | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,280 | | |
| – | | |
| 1,280 | |
| IPO issuance costs | |
| – | | |
| – | | |
| – | | |
| – | | |
| (530,463 | ) | |
| – | | |
| (530,463 | ) |
| Exercise of convertible note warrants | |
| – | | |
| – | | |
| 3,776 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Net income (loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (7,068,593 | ) | |
| (7,068,593 | ) |
| Balance, December 31, 2022 | |
| – | | |
$ | – | | |
| 491,345 | | |
$ | 5 | | |
$ | 41,596,106 | | |
$ | (39,370,153 | ) | |
| 2,225,958 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Balance, December 31, 2022 | |
| – | | |
$ | – | | |
| 491,345 | | |
$ | 5 | | |
$ | 41,596,106 | | |
$ | (39,370,153 | ) | |
$ | 2,225,958 | |
| Share-based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| 456,000 | | |
| – | | |
| 456,000 | |
| Issuance of common shares | |
| – | | |
| – | | |
| 1,852 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Proceeds from sale of Series A preferred stock | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,000 | |
| Redemption of Series A Preferred stock | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,000 | ) |
| Commitment shares - note financing | |
| – | | |
| – | | |
| 21,210 | | |
| – | | |
| 175,619 | | |
| – | | |
| 175,619 | |
| Issuance of warrants - note financing | |
| – | | |
| – | | |
| – | | |
| – | | |
| 67,500 | | |
| – | | |
| 67,500 | |
| Commitment common shares - equity
line | |
| – | | |
| – | | |
| 11,719 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Common share issuance costs -
equity line | |
| – | | |
| – | | |
| – | | |
| – | | |
| (204,647 | ) | |
| – | | |
| (204,647 | ) |
| Issuance of common shares - equity
line | |
| – | | |
| – | | |
| 285,938 | | |
| 3 | | |
| 1,462,946 | | |
| – | | |
| 1,462,949 | |
| Cashless exercise of pre-funded
warrants | |
| – | | |
| – | | |
| 3,396 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Conversion of vested restricted
stock units to common shares | |
| – | | |
| – | | |
| 9,930 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Common share - stock split round
up | |
| – | | |
| – | | |
| 70 | | |
| – | | |
| – | | |
| – | | |
| – | |
| Net income (loss) | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (4,911,374 | ) | |
| (4,911,374 | ) |
| Balance, December 31, 2023 | |
| – | | |
$ | – | | |
| 825,459 | | |
$ | 8 | | |
$ | 43,553,523 | | |
$ | (44,281,526 | ) | |
| (727,995 | ) |
See Accompanying Notes to Financial Statements
Aclarion, Inc.
Statements of Cash Flows
For the Years Ended December 31, 2023, and 2022
| | |
| | |
| |
| | |
Year Ended
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
(restated) | |
| Cash flows from operating activities | |
| | | |
| | |
| Net income (loss) | |
$ | (4,911,374 | ) | |
$ | (7,068,593 | ) |
| Adjustments to reconcile net income (loss) to net cash used in operation
activities: | |
| | | |
| | |
| Depreciation and amortization | |
| 162,670 | | |
| 143,622 | |
| Share-based compensation | |
| 456,001 | | |
| 1,186,658 | |
| Amortization of deferred issuance costs | |
| 497,656 | | |
| – | |
| Changes in fair value of warrants and derivative | |
| (646,319 | ) | |
| – | |
| Non-cash interest related to bridge funding | |
| 98,685 | | |
| – | |
| Warrants issued as non- cash finance charge | |
| 72,862 | | |
| – | |
| Share-based vendor payments | |
| – | | |
| 102,000 | |
| Loss on disposal of furniture and equipment | |
| – | | |
| 3,789 | |
| Interest conversion discount settled in equity | |
| – | | |
| 1,299,507 | |
| | |
| | | |
| – | |
| Change in assets and liabilities | |
| | | |
| | |
| Accounts receivable | |
| (1,491 | ) | |
| (12,290 | ) |
| Prepaids and other current assets | |
| (38,539 | ) | |
| (87,522 | ) |
| Accounts payable | |
| 220,633 | | |
| (603,102 | ) |
| Accrued and other liabilities | |
| 448,459 | | |
| (113,893 | ) |
| Accrued interest on promissory
and convertible notes | |
| (6,190 | ) | |
| 200,712 | |
| Net cash (used in) operations | |
| (3,646,947 | ) | |
| (4,949,112 | ) |
| | |
| | | |
| | |
| Investing Activities | |
| | | |
| | |
| Proceeds from sale of furniture | |
| – | | |
| 1,000 | |
| Intangible assets - Patents | |
| (119,522 | ) | |
| (208,870 | ) |
| Net cash (used in) investing activities | |
| (119,522 | ) | |
| (207,870 | ) |
| | |
| | | |
| | |
| Financing Activities | |
| | | |
| | |
| Bridge funding issuance costs | |
| (323,301 | ) | |
| – | |
| Equity line issuance costs | |
| (74,916 | ) | |
| – | |
| Proceeds from equity line | |
| 1,462,949 | | |
| – | |
| Proceeds from issuance of promissory notes | |
| 2,250,000 | | |
| – | |
| Proceeds from sale of Series A preferred stock | |
| 1,000 | | |
| – | |
| Redemption of Series A Preferred stock | |
| (1,000 | ) | |
| – | |
| IPO cash issuance costs | |
| – | | |
| (365,060 | ) |
| Repayment of promissory notes | |
| – | | |
| (2,000,000 | ) |
| Issuance of common stock and warrants
related to IPO, net deductions | |
| – | | |
| 8,552,318 | |
| Net cash provided by financing
activities | |
| 3,314,732 | | |
| 6,187,258 | |
| | |
| | | |
| | |
| Net increase (decrease) in cash and cash equivalents | |
| (451,737 | ) | |
| 1,030,276 | |
| | |
| | | |
| | |
| Cash, cash equivalents, and restricted cash, beginning
of period | |
| 1,482,806 | | |
| 452,530 | |
| Cash, cash equivalents, and restricted cash, end
of period | |
$ | 1,031,069 | | |
$ | 1,482,806 | |
| | |
| | | |
| | |
| Non- cash activities | |
| | | |
| | |
| Accrued debt issuance costs related
to bridge funding | |
| 22,150 | | |
| – | |
| Accrued debt issuance costs related to equity line | |
| 129,731 | | |
| – | |
| Issuance of warrants related to bridge funding | |
| 67,500 | | |
| – | |
| Original issuance discount (15%) related to bridge
funding | |
| 344,118 | | |
| – | |
| Liability to issue common shares | |
| 33,297 | | |
| – | |
| Issuance of commitment shares related to bridge funding | |
| 175,619 | | |
| – | |
| Fair value of warrants and derivative related to first
tranche bridge funding | |
| 742,988 | | |
| – | |
| Fair value of warrants and derivative related to second
tranche bridge funding | |
| 153,810 | | |
| – | |
| Fair value of warrants and derivative related to third
tranche bridge funding | |
| 160,012 | | |
| – | |
| Dividends accrued on preferred shares | |
| – | | |
| 415,523 | |
| Conversion of preferred stock to common stock | |
| – | | |
| 25,754,379 | |
| Conversion of preferred stock dividends to common stock | |
| – | | |
| 4,272,421 | |
| Conversion of accrued interest on promissory notes
to common stock and warrants | |
| – | | |
| 1,856,438 | |
| Issuance of underwriter's warrants related to IPO | |
| – | | |
| 199,246 | |
| Designation of prepaid expenses to IPO issuance costs | |
| – | | |
| 165,403 | |
See Accompanying Notes to Financial Statements
Aclarion, Inc.
Notes to Financial Statements
For the Year Ended December 31, 2023
NOTE 1. THE COMPANY AND BASIS OF PRESENTATION
The Company
Aclarion, Inc., formerly Nocimed, Inc., (the “Company”
or “Aclarion”) is a healthcare technology company that leverages magnetic resonance spectroscopy (“MRS”), and
a proprietary biomarker to optimize clinical treatments. The Company was formed in February 2015, is incorporated in Delaware, and has
its principal place of business in Broomfield, Colorado.
Risks and Uncertainties
The Company is subject to various risks and uncertainties
frequently encountered by companies in the early stages of development. Such risks and uncertainties include, but are not limited to,
its limited operating history, competition from other companies, limited access to additional funds, dependence on key personnel, and
management of potential rapid growth. To address these risks, the Company must, among other things, develop its customer base; implement
and successfully execute its business and marketing strategy; develop follow-on products; provide superior customer service;
and attract, retain, and motivate qualified personnel. There can be no guarantee that the Company will be successful in addressing these
or other such risks.
Initial Public Offering
On April 21, 2022, the registration statement
for our initial public offering (“IPO”) was declared effective. In connection with the effectiveness of the IPO registration
statement:
| |
· |
we
effected a 1-for-7.47
reverse stock split of our outstanding common stock (2022 Stock Split); |
| |
|
|
| |
· |
accordingly, all common share amounts and per share data presented in our condensed financial statements have been retrospectively adjusted to reflect the reverse stock split for all periods presented; |
| |
|
|
| |
· |
we filed a restated Certificate of Incorporation with the State of Delaware and we adopted new restated Bylaws; |
| |
|
|
| |
· |
certain
outstanding common stock warrants were exercised on a net share basis
for 60,408 common shares (3,776 shares after giving effect to the 2024 Stock Split); |
| |
|
|
| |
· |
24,495,004
outstanding shares of our preferred stock were converted into 3,279,117 common shares (204,945 common
shares after giving effect to the 2024 Stock Split); |
| |
|
|
| |
· |
all
accrued dividends on our outstanding Series B, B-1, B-2 and B-3 preferred stock were converted to 984,429 common shares (61,527
common shares after giving effect to the 2024 Stock Split); and |
| |
|
|
| |
· |
all
accrued interest on the Company's outstanding secured promissory notes was converted into (i) 426,768 common
shares (26,673
common shares after giving effect to the 2024 Stock Split) and (ii) warrants to purchase 426,768 shares
of common stock (26,673
common shares after giving effect to the 2024 Stock Split), with beneficial conversion rates charged to interest expense upon
conversion. |
On April 26, 2022, the Company completed its
IPO of 2,165,000 units at a public offering price of $4.35 per unit. Each unit consisted of (i) one share of common stock (equivalent
to 0.0625 of a common share following the 2024 Split) and (ii) one warrant to purchase one share of common stock (adjusted to 0.0625
of a common share following the 2024 Split) with a per share exercise price of $4.35 (adjusted to $69.60 following the 2024 Split). Following
the commencement of the IPO, the underwriters partially exercised their over-allotment option and purchased additional common stock warrants
to purchase 324,750 common shares (adjusted to 20,297
common shares following the 2024 Split). After deducting underwriter's commissions and expenses, we received net proceeds of approximately
$8.6
million and our common stock and warrants started trading on Nasdaq under the ticker symbols “ACON” and “ACONW”,
respectively.
In connection with the IPO, we issued to the
representative of the underwriters a common stock warrant to purchase 173,200 shares of common stock (10,825
shares after giving effect to the 2024 Stock Split) with an exercise price of $5.44 ($87.04 on a post-2024 Split basis) per share.
The representative's warrants are exercisable commencing October 26, 2022 and will expire on April 26, 2027.
On April 21, 2022, options to purchase
1,204,819 shares of common stock (75,301
common shares after giving effect to the 2024 Stock Split) previously awarded to the Company's Executive Chairman, Dr. Jeffrey
Thramann, vested in connection with the completion of the IPO pursuant to the terms of such options. The per share exercise price of
these options is $1.94 ($31.04 on a post-2024 Split basis) per share. The options have a 10-year term.
On April 21, 2022, in connection with the IPO,
the Company’s 2022 Aclarion Equity Incentive Plan, or “2022 Plan”, became effective. Our board of directors has appointed
the compensation committee of our board of directors as the committee under the 2022 Plan with the authority to administer the 2022 Plan.
At the 2022 Plan effective date, the aggregate number of our shares of common stock that could be issued or used for reference purposes
under the 2022 Plan could not exceed 2,000,000 shares (125,000 shares after giving effect to the 2024 Stock Split), subject to adjustments
as described in the 2022 Plan.
On April 29, 2022, in connection with the IPO,
a bonus was paid to David Neal and Brent Ness of $100,000 each. On May 13, 2022, in connection with the IPO, a bonus of $130,000 was paid
to James Peacock.
On May 2, 2022, in connection with the IPO, the
Company paid the University of California - San Francisco the amount of $123,828 to satisfy the Indexed Milestone Payment obligation included
within the exclusive license agreement.
2022 Reverse Stock Split
On April 21, 2022, the Company effected a 1-for-7.47
reverse stock split (the “2022 Stock Split”) of its issued and outstanding common stock.
2024 Reverse Stock Split
In March 2023 the Company’s stockholders
approved a reverse stock split proposal at a ratio in the range of one-for-five to one-for-fifty, with the final ratio to be determined
by the Company's board in its discretion without further approval from the Company's stockholders. In January 2024, the Company's board
subsequently approved the final reverse stock split ratio of one-for-sixteen
(the “2024 Stock Split”), which resulted in a reduction in the number of outstanding shares of common stock, warrants,
stock options and restricted share units and a proportionate increase in the value of each share or strike price of the warrants and
stock options. The common stock began trading on a reverse split-adjusted basis on the NASDAQ on January 4, 2024.
As a result of the 2022 Stock Split and the 2024
Stock Split, unless described otherwise, all references to common stock, share data, per share data and related information contained
in these financial statements have been retrospectively adjusted to reflect the effect of the stock splits for all periods presented.
In addition, any fractional shares that would otherwise be issued as a result of the stock splits were rounded up to the nearest whole
share. Further, the number of shares issuable and exercise prices of stock options and warrants have been retrospectively adjusted in
these financial statements for all periods presented to reflect the 2022 Stock Split and the 2024 Stock Split.
The following tables present selected share information
reflecting on a retroactive basis the reverse stock splits as of and for the years ended December 31, 2023 and 2022:
| Equity statement information | |
| | |
| |
| | |
December 31 | |
| | |
2023 | | |
2022 | |
| Common shares issued and outstanding - pre-2024 split, 13,206,229 and 7,861,515 shares | |
$ | 132 | | |
$ | 79 | |
| Common shares issued and outstanding - post-2024 split, 825,459 and 491,345 shares | |
$ | 8 | | |
$ | 5 | |
| Additional paid-in capital - pre-2024 split | |
$ | 43,553,399 | | |
$ | 41,596,032 | |
| Additional paid-in capital - post-2024 split | |
$ | 43,553,523 | | |
$ | 41,596,106 | |
| Schedule of share information
reflecting on a retroactive basis the reverse stock splits | |
| | | |
| | |
|
| | |
Year ended December 31 | |
| | |
2023 | | |
2022 | |
| Weighted average shares outstanding, basic and diluted - pre-2024 split | |
| 8,908,934 | | |
| 6,105,569 | |
| Weighted average shares outstanding, basic and diluted - post-2024 split | |
| 556,808 | | |
| 381,598 | |
| Basic and diluted net loss per shares attributable to common stockholders - pre-2024 split | |
$ | (0.55 | ) | |
$ | (1.23 | ) |
| Basic and diluted net loss per shares attributable to common stockholders - post-2024 split | |
$ | (8.82 | ) | |
$ | (19.61 | ) |
Basis of Presentation
The accompanying financial statements have been
prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”).
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
The financial statements include some amounts
that are based on management's best estimates and judgments. The most significant estimates relate to depreciation, amortization, valuation
of capital stock, and valuation of warrants and options to purchase shares of the Company's preferred and common stock. These estimates
may be adjusted as more current information becomes available, and any adjustment could be significant.
Valuation
of Derivative Instruments
Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 815-40, Derivatives and Hedging: Contracts on an Entity’s Own Equity,
addresses whether an equity-linked contract qualifies as equity in the entity’s financial statements. Agreements where an entity
has insufficient authorized and unissued shares to settle the contract generally are accounted for as a liability and marked to fair value
through earnings each reporting period. The Company evaluates its financial instruments to determine if such instruments are liabilities
or contain features that qualify as embedded derivatives. For financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then revalued at each reporting date, with changes in the fair value reported
as charges or credits to income.
Fair Value of Financial Instruments
ASC 820, Fair Value Measurements, provides guidance
on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price,
representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions
that market participants would use in pricing an asset or a liability.
The accounting guidance classifies fair value
measurements in one of the following three categories for disclosure purposes:
Level 1 - Unadjusted quoted prices
in active markets for identical instruments that are accessible by the Company on the measurement date.
Level 2 - Quoted prices in markets
that are not active or inputs which are either directly or indirectly observable.
Level 3 - Unobservable inputs
for the instrument requiring the development of assumptions by the Company.
The Company analyzes all financial instruments
with features of both liabilities and equity under the Financial Accounting Standard Board’s (“FASB”) accounting standard
for such instruments. Under this standard, financial assets and liabilities are classified in their entirety based on the lowest level
of input that is significant to the fair value measurement.
The carrying values of the Company’s financial
instruments including cash equivalents, restricted cash, accounts receivable, and accounts payable are approximately equal to their respective
fair values due to the relatively short-term nature of these instruments. The Company’s warrant liabilities and derivative liabilities
are estimated using level 3 inputs (see Note 4).
Derivative Financial Instruments
The Company has derivative financial instruments
that are not hedges and do not qualify for hedge accounting. Changes in the fair value of these instruments are recorded in other income
(expenses), on a net basis in the Consolidated Statements of Operations and Comprehensive Loss.
Cash and Cash Equivalents
The Company considers all highly liquid instruments
purchased with an original maturity of three months or less to be cash equivalents. The Company had no
cash equivalents for all periods
presented. The Company maintains cash deposits at several financial institutions, which are insured by the Federal Deposit Insurance Corporation
up to $250,000. The Company’s cash balance may at times exceed these limits. On December 31, 2023, and 2022, the Company had approximately
$761,800 and $1,229,000, respectively, in excess of federally insured limits. The Company continually monitors its positions with, and
the credit quality of, the financial institutions with which it invests. The Company maintains no international bank accounts. As of December
31, 2023, $10,000 of the Company’s cash was restricted as collateral related to the credit card program offered by our bank.
Accounts Receivable, Less Allowance for Doubtful
Accounts
The Company estimates an allowance for doubtful
accounts based upon an evaluation of the current status of receivables, historical experience, and other factors as necessary. It is reasonably
possible that the Company’s estimate of the allowance for doubtful accounts will change. The allowance for doubtful accounts was
$0
on December 31, 2023, and 2022.
Revenue
Recognition
Revenues are recognized when a contract with a
customer exists, and at that point in time when we have delivered a Nociscan report to our customer. Revenue is recognized in the amount
that reflects the negotiated consideration expected to be received in exchange for those reports. Following the delivery of the report,
the company has no ongoing obligations or services to provide to the customer. Customers pay no other upfront, licensing, or other fees.
To date, our reports are not reimbursable under any third-party payment arrangements, The Company invoices its customers based on the
billing schedules in its sales arrangements. Payment terms range generally from 30 to 90 days, from the date of invoice.
Geographic Locations & Segments
Approximately 13% and 9% of the Company’s
revenues were generated from contracts with customers outside the United States in the years ended December 31, 2023, and 2022, respectively.
All invoices are billed in the currency of the customers and are recorded in US Dollars at the then spot rate, which automatically is
converted to dollars upon receipt and deposited in the Company’s bank. Differences between the amounts received and the amounts
initially recorded are reflected in Other Income (Expense).
Segment Disclosure
The Company
has a single operating and reporting segment, which is the delivery of Nociscan reports to our customers. The Company’s
Chief Executive Officer reviews financial information for purposes of making operating decisions and assessing financial performance.
Property and Equipment
Property and equipment are stated at cost and
are depreciated using the straight-line method over the estimated useful lives of the related assets. Furniture and fixtures are depreciated
over seven years. Computer and office equipment and computer software are depreciated over five years. Repairs and maintenance costs,
which are not considered improvements and do not extend the useful life of the property and equipment, are expensed as incurred.
Impairment of Long-Lived Assets
The Company
reviews long-lived assets, including intangible assets, property and equipment, for impairment whenever events or changes in business
circumstances indicate that the carrying amount of the assets may not be fully recoverable using pre-tax undiscounted cash flows. Impairment,
if any, is measured as the amount by which the carrying value of a long-lived asset exceeds its fair value.
Sales and Marketing Expenses
The Company expenses the costs of sales and marketing
its products and services as incurred. The primary drivers of cost have been employee payroll, website and branding development, press
releases, attendance at various industry conferences, Key Opinion Leader consulting fees in the form of restricted stock grants, and travel
expenses.
Research and Development Costs
Costs related
to research, design and development of products are charged to research and development expense as incurred. These costs include direct
compensation, benefits, and other headcount related costs for research and development personnel; costs for materials used in research
and development activities; costs for outside services and allocated portions of facilities and other corporate costs. The Company has
entered into research and clinical study arrangements with selected hospitals, cancer treatment centers, academic institutions and research
institutions worldwide. These agreements support the Company’s internal research and development capabilities.
General
& Administrative
General
and administrative expenses primarily consist of personnel and related costs, including stock-based compensation, legal fees relating
to both intellectual property and corporate matters, accounting and audit related costs, insurance, corporate communications and public
company expenses, information technology, depreciation, amortization and maintenance, and fees for consulting, business development and
other professional services.
Liquidity, Capital Resources and Going Concern
As of December 31, 2023, we had cash of
approximately $1.0 million. Subsequent to
December 31, 2023, the Company raised capital using an equity line (refer to Note 17 to our financial statements – Subsequent
Events), and as of February 1, 2024, the Company had approximately $1.5
million of cash, which we believe will fund our operating expenses and capital expenditure requirements into the second quarter of
2024, up to our first maturity repayment on our unsecured non-convertible
note repayment which is due in April 2024. The Company has based these estimates, however, on assumptions that may prove to be wrong, and could spend available financial
resources much faster than we currently expect. The Company will need to raise additional funds to continue funding our technology
development and commercialization efforts over the following twelve months. Management has plans to secure such additional
funding.
As a result of the Company’s recurring losses
from operations, and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding
the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to
the Company’s ability to continue as a going concern.
Share-Based Compensation
The Company accounts for stock-based awards in
accordance with provisions of ASC Topic 718, Compensation—Stock Compensation, under which the Company recognizes the grant-date
fair value of stock-based awards issued to employees and nonemployee board members as compensation expense on a straight-line basis over
the vesting period of the award, while awards containing a performance condition are recognized as expense when the achievement of the
performance criteria is achieved. The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock
options. The Company records expense for forfeitures in the periods they occur.
The exercise or strike price of each option is
not less than 100% of the fair market value of the Common Stock subject to the option on the date the option is granted.
The Company issues restricted stock unit awards
to non-employee consultants who are providing various services. The awards are valued at the market price on the date of the grant. The
awards vest over the contract life and based on achievement of targeted performance milestones.
On occasion, the Company grants common stock to
compensate vendors for services rendered.
Deferred Financing Costs
The Company capitalizes certain legal, accounting,
and other fees and costs that are directly attributable to in-process equity financings as deferred offering costs until such financings
are completed. Upon the completion of an equity financing, these costs are recorded as a reduction of additional paid-in capital of the
related offering. Upon the completion of the IPO in April 2022, approximately $1.5 million of offering costs related to the IPO were reclassified
to additional paid-in capital. Upon the completion of the issuance of shares pursuant to the equity line in the fourth quarter
of 2023, $204,647 of offering costs were reclassified to additional paid-in capital.
Emerging Growth Company Status
The Company is an emerging growth company, as
defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies
can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those
standards apply to private companies. The Company has elected to use this extended transition period for complying with certain new or
revised accounting standards that have different effective dates for public and private companies.
Income Taxes
The Company follows the asset and liability method
of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized for the estimated
future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period that included the enactment date. Valuation allowances are
established, when necessary, to reduce deferred tax assets to the amount expected to be realized. As of December 31, 2023, the Company
had deferred tax assets related to certain net operating losses. A valuation allowance was established against these deferred tax assets
at their full amount, resulting in a zero balance of deferred tax assets on the consolidated balance sheets as of December 31, 2023 and
2022.
NOTE 3. 2022 RESTATEMENT OF PREVIOUSLY ISSUED
FINANCIAL STATEMENTS
The full details of the restatement to the financial
statements for the year ended December 31, 2022, are reported in Note 4 to the financial statements as of December 31, 2022 that were
included by the Company in its amended annual report on Form 10-K/A filed with the Securities and Exchange Commission on June 12, 2023.
NOTE 4. FAIR VALUE MEASUREMENTS
In accordance with ASC 820 (Fair Value Measurements
and Disclosures), the Company uses various inputs to measure the outstanding warrants, certain embedded redemption features associated
with the senior note to Aclarion, Inc. on a recurring basis to determine the fair value of the liability.
| Schedule of recurring basis to determine the fair value of the liability | |
| | |
| | |
| | |
| |
| | |
Fair value measured as of December 31, 2023 | |
| | |
Fair value on December 31, 2023 | | |
Quoted prices in active markets (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
| Warrant liability | |
$ | 289,165 | | |
$ | – | | |
$ | – | | |
$ | 289,165 | |
| Derivative Liability | |
| 121,326 | | |
| – | | |
| – | | |
| 121,326 | |
| Total Fair value | |
$ | 410,491 | | |
$ | – | | |
$ | – | | |
$ | 410,491 | |
There were no transfers between Level 1, 2, and
3 during the year ended December 31, 2023.
The following table presents changes in Level
3 liabilities measures at fair value for the year ended December 31, 2023. Both observable and unobservable inputs were used to determine
the fair value positions that the Company has classified within the Level 3 category.
| Schedule of liabilities measures at fair value | |
| | |
| | |
| |
| | |
Warrant Liability | | |
Derivative Liability | | |
Total | |
| Balance - January 1, 2023 | |
$ | – | | |
$ | – | | |
$ | – | |
| Additional warrant and derivative liability | |
| 736,249 | | |
| 320,561 | | |
| 1,056,810 | |
| Change in fair value | |
| (447,084 | ) | |
| (199,235 | ) | |
| (646,319 | ) |
| Balance – December 31, 2023 | |
$ | 289,165 | | |
$ | 121,326 | | |
$ | 410,491 | |
The fair value of the embedded derivative liabilities
associated with the Senior Notes Payable was estimated using a probability weighted discounted cash flow model to measure the fair value.
This involves significant Level 3 inputs and assumptions including an (i) estimated probability and timing of certain financing events
and event of default, and (ii) the Company’s risk-adjusted discount rate.
The fair value of the warrants to purchase shares
of common stock was estimated using a Monte Carlo simulation using the following assumptions.
| Schedule of assumptions | |
| |
|
|
|
|
| | |
As of Issuance | | |
As of Dec 31, 2023 | |
| | |
Warrant Liability | | |
Warrant Liability | |
| Strike Price | |
$ | 0.63 | | |
$ | 0.27 | |
| Contractual term (years) | |
| 5.0 | | |
| 5.0 | |
| Volatility (annual) | |
| 80.0% | | |
| 80.0% | |
| Risk-free rate | |
| 3.52% | | |
| 3.89% | |
| Floor Financing price | |
$ | 0.50 | | |
$ | 0.14 | |
NOTE 5. RECENT ACCOUNTING PRONOUNCEMENTS
In August 2020, the FASB issued ASU No. 2020-06,
Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic
815-40) (“ASU 2020-06”), which simplifies the accounting for convertible instruments. The guidance removes certain accounting
models that separate the embedded conversion features from the host contract for convertible instruments. The guidance also modifies how
certain convertible instruments, that may be settled in cash or shares, impact the calculation of diluted earnings per share. ASU 2020-06
allows for a modified or full retrospective method of transition. This update is effective for emerging growth companies following private
company adoption dates in fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, and early
adoption is permitted. The Company adopted this standard as of April 1, 2022, using the modified retrospective approach. The adoption
of this standard did not have a material impact on the Company's consolidated financial statements and related disclosures.
On January 1, 2023, the Company adopted ASU 2016-13,
Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, as amended, which
replaces the incurred loss methodology with an expected loss methodology, that is referred to as a current expected loss methodology (CECL).
CECL was required to be implemented for small business reporting companies after December 31, 2022. The measurement of expected losses
under the CECL methodology is applicable to financial assets measured at amortized cost, including trade receivables, loan receivables
and held-to-maturity debt securities. It also applies to off balance sheet credit exposures not accounted for as insurance, loan commitments,
standby letters of credit, financial guarantees, and similar instruments and net investment in leases, as accounted for by the lessor
under ASC 842. In addition, ASC 326 made changes to the available for-sale debt securities. One such change is to require credit losses
be accounted for as an allowance instead of a write-down on available for-sale securities that management does not intend to sell, or
believes it is more likely than not that they will be required to sell.
The Company has adopted ASC 326 using the retrospective
approach for all financial assets measured at amortized cost, which consists of trade receivables. The Company estimates the likelihood
of collection considering trade receivables-based factors such as the creditworthiness of its customers. There are no off-balance sheet
assets or guarantees. The Company recorded no change to retained earnings due to the adoption of ASC 326.
As of this date, the Company has not purchased,
nor does it intend to purchase, debt securities, eroded or financial assets, or leases within the scope of the pronouncement. If it does,
it will use the prospective transition approach.
NOTE 6. REVENUE
Contract Balances
The timing of revenue recognition, billings, and
cash collections may result in trade, unbilled receivables, and deferred revenues on the balance sheets. At times, revenue recognition
may occur before the billing, resulting in an unbilled receivable, which would represent a contract asset. The contract asset would be
a component of accounts receivable and other assets for the current and non-current portions, respectively. In the event the Company receives
advances or deposits from customers before revenue is recognized, this would result in a contract liability. In years ending December
31, 2023, and 2022, the Company invoiced as services were performed and did not invoice in advance; the company has no contract balances.
NOTE 7. SUPPLEMENTAL FINANCIAL INFORMATION
Balance Sheets
Accounts receivable, net
Accounts receivable, net consisted
of the following:
| Schedule of accounts receivable | |
| | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
| |
| Accounts receivable (1) | |
$ | 13,270 | | |
$ | 18,569 | |
| Less: Allowance for doubtful accounts | |
| – | | |
| – | |
| Accounts receivable, net | |
$ | 13,270 | | |
$ | 18,569 | |
| (1) |
Accounts receivable denominated in foreign currencies represent less than 15% of accounts receivable in all periods. |
Prepaids and other current assets
| Schedule of prepaids and other current assets | |
| | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
| |
| Short term deposits | |
$ | 50,000 | | |
$ | 50,100 | |
| Deferred offering costs | |
| 100,588 | | |
| – | |
| Prepaid insurance D & O | |
| 34,769 | | |
| 83,478 | |
| Prepaid insurance other | |
| 17,884 | | |
| 16,475 | |
| Prepaid, other | |
| 41,635 | | |
| 49,564 | |
| Other receivables | |
| 154 | | |
| 84 | |
| | |
$ | 245,030 | | |
$ | 199,701 | |
Accounts payable
| Schedule of accounts payable | |
| | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
| |
| Accounts payable | |
$ | 758,821 | | |
$ | 457,558 | |
| Credit cards payable | |
| 1,714 | | |
| 4,644 | |
| | |
$ | 760,535 | | |
$ | 462,202 | |
Accrued and other liabilities
| Schedule of accrued and other liabilities | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
| |
| Accrued payroll | |
$ | 162,887 | | |
$ | – | |
| Accrued bonus | |
| 262,580 | | |
| 134,704 | |
| Accrued board compensation | |
| 62,500 | | |
| 31,250 | |
| Accrued committee compensation | |
| 30,000 | | |
| 15,000 | |
| Accrued audit and legal expenses | |
| 89,082 | | |
| 33,919 | |
| Investment banking and related fees | |
| 139,906 | | |
| – | |
| Accrued interest | |
| 98,685 | | |
| – | |
| Other accrued expenses | |
| 12,082 | | |
| 11,596 | |
| | |
$ | 857,722 | | |
$ | 226,469 | |
Statements of Operations
Other expense, net consisted
of the following:
| Schedule of other expense | |
| | |
| |
| | |
Year Ended December 31, | |
| Income/(Expense) | |
2023 | | |
2022 | |
| | |
| | |
| |
| Bank Interest | |
$ | 172 | | |
$ | 2,511 | |
| Taxes | |
| (1,144 | ) | |
| (800 | ) |
| Foreign Currency Gain (Loss) | |
| 145 | | |
| (1,190 | ) |
| Other | |
| 265 | | |
| – | |
| | |
$ | (562 | ) | |
$ | 521 | |
NOTE
8. LEASES
Rent expense for the year ended December 31,
2023, and 2022 was $0 and $36,070,
respectively. The Company entered into a subleasing agreement in 2021 and realized $0
and $26,340
of sublease income for the year ended December 31, 2023, and 2022. Both the lease and sublease are netted within the general
& administrative line item in the Statements of Operations. Our prior office lease and sublease expired on June 30, 2022.
NOTE 9. PROPERTY, PLANT, AND EQUIPMENT
Property and equipment are stated at cost and
are depreciated using the straight-line method over the estimated useful lives of the related assets. Furniture and fixtures are depreciated
over seven years. Computer and office equipment and computer software are depreciated over five years. Repairs and maintenance costs,
which are not considered improvements and do not extend the useful life of the property and equipment, are expensed as incurred.
The Company’s property and equipment are
as follows:
| Schedule of property and equipment | |
| | |
| |
| | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
| | |
| |
| Furniture and fixtures | |
$ | – | | |
$ | – | |
| Computer and office equipment | |
| 13,032 | | |
| 13,032 | |
| Software | |
| 42,150 | | |
| 42,150 | |
| Other Equipment | |
| – | | |
| 18,190 | |
| | |
| 55,182 | | |
| 73,372 | |
| Less: Accumulated depreciation | |
| (53,400 | ) | |
| (70,026 | ) |
| Property and equipment, net | |
$ | 1,782 | | |
$ | 3,346 | |
Depreciation expense related to property and equipment
were $1,564 and $4,500 for the years ended December 31, 2023, and 2022, respectively.
During 2022 the company received proceeds of $1,000 from the sale of
property and equipment.
Future depreciation and amortization of property,
equipment, and software is as follows:
| Schedule of future depreciation of property
and equipment | |
| |
| 2024 | |
$ | 1,186 | |
| 2025 | |
| 596 | |
| Total | |
$ | 1,782 | |
NOTE 10. INTANGIBLE ASSETS
The Company’s intangible assets are as follows:
| Schedule of intangible assets | |
| | |
| |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| | |
| | |
| |
| Patents and licenses | |
$ | 2,267,251 | | |
$ | 2,147,728 | |
| Other | |
| 5,017 | | |
| 5,017 | |
| Total intangible assets gross | |
| 2,272,268 | | |
| 2,152,745 | |
| Less: accumulated amortization | |
| (1,103,645 | ) | |
| (942,538 | ) |
| Intangible assets, net | |
$ | 1,168,623 | | |
$ | 1,210,207 | |
Amortization expense related to purchased intangible
assets was $161,107 and $139,121 for the years ended December 31, 2023, and 2022, respectively.
UC royalties are paid annually, amortized over
twelve months, and charged to cost of revenue.
Patents and trademarks are reviewed at least annually
for impairment. No impairment was recorded through December 31, 2023, and 2022, respectively.
Future amortization of intangible assets is as
follows:
| Schedule of future amortization of intangible assets | |
| |
| 2024 | |
$ | 169,002 | |
| 2025 | |
| 168,951 | |
| 2026 | |
| 168,951 | |
| 2027 | |
| 168,951 | |
| 2028 and beyond | |
| 492,768 | |
| Total | |
$ | 1,168,623 | |
NOTE 11. SHORT TERM NOTES, CONVERTIBLE DEBT,
AND DERIVATIVE LIABILITIES
Convertible Notes
As of December 31, 2022, there were no Convertible
Notes payable and outstanding. There was no convertible note activity in the year ended December 31, 2023.
Senior Notes Payable
In May 2023, the Company issued $1,437,500 unsecured senior notes that
mature on May 16, 2024 (“the Senior Notes Payable”), for cash proceeds of $1,250,000. The Senior Notes Payable contain an
original issue discount of 15.0% and accrue interest at an annual rate of 8.0%.
In September 2023, as agreed to during the issuance of the Senior Notes
Payable, the Company exercised their right to an additional financing, issuing $862,500 unsecured senior notes that mature on September
1, 2024 ("the Series B Notes Payable) for cash proceeds of $750,000. The Series B Notes Payable contain an original issue discount
of 15.0% and accrue interest at an annual rate of 8.0%.
In November 2023, the Company issued $294,118 unsecured senior notes
that mature on April 19, 2024 (“the Series C Notes Payable”), for cash proceeds of $250,000. The Senior Notes Payable contain
an original issue discount of 15.0% and accrue interest at an annual rate of 8.0%.
The Company incurred issuance costs, recorded as deferred financing
costs, of $296,313 relating to due diligence and legal costs associated with the issuance of the notes.
The Company evaluated the embedded redemption and contingent interest
features in the notes to determine if such features were required to be bifurcated as an embedded derivative liability. In accordance
with ASC 815-40, Derivatives and Hedging Activities, the embedded redemption features and contingent interest feature were accounted for
as derivative liabilities at the date of issuance and shall be adjusted to fair value at each reporting date. The Company fair valued
such derivative liabilities and recorded a debt discount at issuance of the notes of $320,561.
The Company issued warrants to purchase 1,232,156
and 744,890 shares of common stock (77,010 and 46,556 shares, respectively, after giving effect to the 2024 Stock Split) to the holders
of the Senior Notes Payable and Series C Notes Payable (collectively the “Senior Notes Warrants”) with an exercise price of
$0.6262 and $0.2856 per share ($10.02 and $4.58 post-2024 split), respectively. The Company accounted for the warrants in accordance with
the guidance contained in ASC 815 “Derivatives and Hedging” whereby under that provision these warrants did not meet the criteria
for equity treatment and were recorded as a liability. As such, these warrants are recorded at fair value as of each reporting date with
the change in fair value reported within other income in the accompanying consolidated statements of operations as “Change in fair
value of warrant liability” until the warrants are exercised, expired or other facts and circumstances lead the warrant liability
to be reclassified to stockholders’ equity. The fair value of the Senior Notes Warrants at issuance was $736,249 and was recorded
as a debt discount. The Company incurred issuance costs of $72,862 relating to the Senior Notes Warrants which was recorded as a day 1
expense due to the liability classification of such warrants.
In connection with the issuance of the Senior
Notes Payable and Series C Notes Payable, the Company paid a commitment fee in the form of 339,360 and 148,978 shares (21,210 and 9,311
shares after giving effect to the 2024 Stock Split) of unregistered common stock to the holders, respectively. The aggregate commitment
fees had a fair value at issuance of $208,916 and are recorded as a deferred financing cost.
The resulting debt discounts from the derivative liabilities, warrant
liabilities and deferred financing costs were presented as a direct deduction from the carrying amount of that debt liability and amortized
to interest expense using the effective interest rate method. For the year ended December 31, 2023, the Company recognized $497,763 in
amortization of debt discounts and deferred financing costs which is recorded in interest expense.
The following table reconciles the aggregate
amount for the Senior Notes Payable, Series B Notes Payable, and Series C Notes Payable as well as the unamortized deferred financing
costs and debt discounts relating to the derivative liabilities and warrant liabilities.
| Schedule of derivative liabilities and warrant
liabilities | |
| | | |
| | |
| | |
December 31, 2023 | | |
December 31,
2022 | |
| Note Payable | |
$ | 2,594,118 | | |
$ | – | |
| Less: Unamortized Discounts and Deferred Financing Costs | |
| | | |
| | |
| Warrants | |
| (557,582 | ) | |
| – | |
| Derivative | |
| (235,628 | ) | |
| – | |
| Deferred financing costs | |
| (675,184 | ) | |
| – | |
| |
| (1,468,394 | ) | |
| – | |
| | |
$ | 1,125,724 | | |
$ | – | |
Secured Promissory Notes Payable
In June 2021, the Company issued $2.0 million
of promissory notes that matured at the earlier of the consummation of a Qualified Financing or May 31, 2022. The promissory notes incorporated
the following major attributes: secured by a lien and security interest on substantially all of the Company’s assets; interest
accrues at 33%; holder option to convert the accrued interest into the Company securities being offered in a Qualified Financing
at 30% (i.e. 70% discount) of the price being paid by other investors in the Qualified Financing; and automatic conversion in the
case of a Qualifying IPO of the accrued interest into the Company securities being offered in the Qualifying IPO at 30% (70% discount)
of the price being paid by other investors in the Qualifying IPO. If the promissory notes remained outstanding after May 31, 2022, the
Company had the option to extend the promissory notes upon the payment of an extension fee, which consisted of warrants to purchase 150,000
shares (1,255 shares after giving effect to the 2022 and 2024 Stock Splits) with a five-year term, to purchase shares of the Company’s
common stock at a price of $ 0.01 per share ($1.20 post-2022 and 2024 splits).
On April 21, 2022, the registration statement
for our IPO was declared effective. In connection with the effectiveness of the IPO registration statement, all accrued interest on the
Company's outstanding secured promissory notes were converted into (i) 426,768 (26,673 after giving effect to the 2024 Stock Split) common
shares and (ii) warrants to purchase 426,768 shares of common stock (26,673 common shares after giving effect to the 2024 Stock Split)
with a $1,299,507 beneficial conversion rate charged to interest expense.
On April 27, 2022, the Company used $2 million
of the IPO proceeds to retire all outstanding secured promissory notes.
NOTE 12. COMMITMENTS AND CONTINGENCIES
Royalty Agreement
The Company has an exclusive license agreement
with the Regents of the University of California to make, use, sell and otherwise distribute products under certain of the Regents of
the University of California’s patents anywhere in the world. The Company is obligated to pay a minimum annual royalty of $50,000,
and an earned royalty of 4% of net sales. The minimum annual royalty will be applied against the earned royalty due for the calendar year
in which the minimum payment was made. The license agreements expire upon expiration of the patents and may be terminated earlier if the
Company so elects. The U.S. licensed patents that are currently issued expire between 2026 and 2029, without considering any possible
patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The Company recorded royalty costs of $50,000 for each of the years ended December 31, 2023, and 2022.
Additionally, the Company was obligated to make
a cash Indexed Milestone Payment to the Regents of the University of California in the event of either a change of control or an IPO.
This cash payment was calculated as follows: 28,532 (1,783 shares after giving effect to the 2024 Stock Split) of Company common stock
times the IPO price of $4.34 ($69.44 post-2024 Stock Split). On May 2, 2022, in connection with the IPO, the Company paid the University
of California - San Francisco the amount of $123,828 to satisfy the Indexed Milestone Payment obligation included within the exclusive
license agreement.
Litigation
To date, the Company has not been involved in
legal proceedings arising in the ordinary course of its business. If any legal proceeding occurs, the Company would record a provision
for a loss when it believes that it is both probable that a loss has been incurred and the amount can be reasonably estimated, although
litigation is inherently unpredictable and is subject to significant uncertainties, some of which are beyond the Company’s control.
Should any of these estimates and assumptions change or prove to have been incorrect, the Company could incur significant charges related
to legal matters that could have a material impact on its results of operations, financial position and cash flows.
Stock Option Grant to our Executive Chairman
In September 2021, the Board of Directors approved
a stock option grant of 1,204,819 shares (75,301 after giving effect to the 2024 Stock Split) to Dr. Jeffrey Thramann, our Executive Chairman.
These options were conditional, such that they vested only upon the occurrence of certain specified events, including an IPO, a next round
financing, the merger of the Company with a SPAC, or the sale of the Company. The amount of stock options that would vest upon such specified
events depended upon the terms and timing of the applicable event.
On April 21, 2022, options to purchase 1,204,819
shares of common stock (75,301 shares post-2024 Stock Split) previously awarded to Dr. Jeffrey Thramann vested in connection with the
completion of the IPO pursuant to the terms of such options. The exercise price of these options is $1.94 ($31.04 post-2024 Stock Split)
per share. The options have a 10-year term.
On September 15, 2022, the Board of Directors approved a stock option
grant to purchase an additional 185,285 (11,580 post-2024 Stock Split) shares of common stock to Dr. Thramann. The exercise price of the
options is $1.94 ($31.04 post-2024 Stock Split) per share, they are fully vested, and they have a 10-year term.
NOTE
13. STOCKHOLDERS’ EQUITY
The Company filed an Amended and Restated Certificate
of Incorporation on April 21, 2022, as part of the IPO. The Company is authorized to issue two classes of stock to be designated, respectively,
“Common Stock” and “Preferred Stock.” The total number of shares which the Company is authorized to issue is two
hundred twenty million (220,000,000) shares. Two hundred million (200,000,000) shares are authorized to be Common Stock, having a par
value per share of $0.00001. Twenty million (20,000,000) shares are authorized to be Preferred Stock, having a par value per share of
$0.00001.
Prior to the IPO, the Company had authorized two
classes of shares. These classes included shares of common stock and preferred stock. There was one authorized series of shares of common
stock and eight existing authorized series of preferred stock: Series A-1, A-2, A-3, A-4, B, B-1, B-2, and B-3.
The preferred shares converted to common shares
on a 1:1 pre-split basis immediately prior to the Stock Split on April 21, 2022. Those common shares were adjusted to reflect the 2022
Stock Split and 2024 Stock Split as described in Note 1 Reverse Stock Split.
| Preference Amounts |
|
Issue Date |
|
Total Face Value of Investment |
|
|
Issue Purchase Price/Share |
|
| |
|
|
|
|
|
|
|
|
| Series A-1 Preferred Stock |
|
12/31/2014 |
|
$ |
1,247,541 |
|
|
$ |
0.70 |
|
| Prior to its conversion to common shares, the Series A-1 had a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series A-2 Preferred Stock |
|
12/31/2014 |
|
$ |
1,114,797 |
|
|
$ |
0.77 |
|
| Prior to its conversion to common shares, the Series A-2 had a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series A-3 Preferred Stock |
|
12/31/2014 |
|
$ |
795,002 |
|
|
$ |
0.85 |
|
| Prior to its conversion to common shares, the Series A-3 had a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| Preference Amounts |
|
Issue Date |
|
Total Face Value of Investments |
|
|
Issue Purchase Price/Share |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series A-4 Preferred Stock |
|
12/31/2014 |
|
$ |
1,965,288 |
|
|
$ |
0.94 |
|
| Prior to its conversion to common shares, the Series A-4 had a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series B Preferred Stock |
|
12/5/2015 |
|
$ |
5,013,579 |
|
|
$ |
1.00 |
|
| Prior to its conversion to common shares, the Series B had a 1x senior liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| The dividend rate is 6.0% Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. |
|
| |
|
|
|
|
|
|
|
|
| Series B-1 Preferred Stock |
|
7/27/2017 |
|
$ |
1,500,000 |
|
|
$ |
1.26 |
|
| |
|
8/2/2018 |
|
$ |
5,217,698 |
|
|
$ |
1.26 |
|
| |
|
3/1/2019 |
|
$ |
2,463,328 |
|
|
$ |
1.26 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Prior to its conversion to common shares, the Series B-1 had a 1x senior liquidation preference junior to B2/B3 plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series B-2 Preferred Stock |
|
12/3/2021 |
|
$ |
1,774,819 |
|
|
$ |
1.12 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Prior to its conversion to common shares, the Series B-2 has a 1x senior liquidation preference plus participation on an as-converted to common basis, which participation was capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. Redemption is available by a majority vote of holders commencing after fifth anniversary from issuance, payable in three annual installments. |
|
| |
|
|
|
|
|
|
|
|
|
|
| Series B-3 Preferred Stock |
|
12/3/2021 |
|
$ |
5,327,468 |
|
|
$ |
1.26 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Prior to its conversion to common shares, the Series B-3 has a 2x senior liquidation preference, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. |
|
| |
|
|
|
|
|
|
|
|
|
|
| The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. Redemption is available by a majority vote of holders commencing after fifth anniversary from issuance, payable in three annual installments. |
|
Warrants
As of December 31, 2023, IPO Warrants to purchase
155,610 shares of common stock (post-split), and other warrants to purchase 165,555 shares of common stock (post-split) were outstanding.
Warrants issued in connection with the IPO
In connection with the Company’s IPO, all
accrued interest on the Company's outstanding secured promissory notes were converted into (i) 26,673 (post-2024 Stock Split) common shares
and (ii) warrants to purchase 26,673 shares of common stock (post-2024 Stock Split), with beneficial conversion rates charged to interest
expense upon conversion. These warrants have an exercise price of $69.60 (post-2024 Stock Split) per share and expiring 2027.
In the IPO, the Company sold 2,165,000 units at
a public offering price of $4.35 per unit. Each unit consisted of (i) one share of common stock (equivalent to 0.0625 of a common share
following the 2024 Split) and (ii) one warrant to purchase one share of common stock (adjusted to 0.0625 of a common share following the
2024 Split) warrant with a per share exercise price of $4.35 (adjusted to $69.60 following the 2024 Split). On April 22, 2022, the underwriters
partially exercised their over-allotment option and purchased additional common stock warrants to purchase 324,750 common shares (adjusted
to 20,297 common shares following the 2024 Split). The common stock and the IPO Warrants were immediately separable and issued separately
in the offering. The IPO Warrants are listed and tradeable on the NASDAQ stock market, immediately exercisable at the option of the holder,
and expire five years from the date of issuance.
In connection with the IPO, we issued to the representative
of the underwriters’ common stock warrants to purchase 10,825 shares of common stock (post-2024 Stock Split) with an exercise price
of $87.04 (post-2024 Stock Split) per share. The representative's warrants are exercisable commencing October 26, 2022, and will expire
on April 26, 2027.
The Company evaluated the terms of all warrants
issued at the IPO and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480,
Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. Since the Company determined that the warrants were
equity classified, the Company recorded the proceeds from the IPO, net of issuance costs, within common stock at par value and the balance
of proceeds to additional paid in capital.
Other Outstanding Warrants
As of December 31, 2023, we had other
outstanding warrants to purchase 128,057
shares of common stock (post-split) (in addition to our IPO Warrants described above). The terms of these warrants are (i) warrants
to purchase 123,566
shares of common stock (post-split) with a per share exercise price of $2.315
(post split) and expiring 2028, and warrants to purchase 4,491
common shares (post split) with a per share exercise price of $0.0002
(post-split) and expiring 2028.
The per share exercise price of the warrants
described in clause (i) above is subject to a “ratchet” adjustment if the Company issues securities at an effective per share
price lower than the then effective warrant exercise price.
White Lion Equity
Line Agreement
On October 9, 2023, the Company entered into an
equity line common stock purchase agreement (the “Equity Line Purchase Agreement”) and a related registration rights agreement
with White Lion Capital, LLC (“White Lion”). Pursuant to the Equity Line Agreement, the Company has the right, but not the
obligation to require White Lion to purchase, from time to time, up to $10,000,000 in aggregate gross purchase price of newly issued shares
of the Company’s common stock, subject to certain limitations and conditions set forth in the Equity Line Purchase Agreement.
It is anticipated that the Company may sell shares
of common stock to White Lion from time-to-time over a sales period that expires December 31, 2024. The number of shares ultimately offered
for sale to White Lion under the Equity Line Purchase Agreement is dependent upon the number of shares we elect to sell to White Lion
under the Equity Line Purchase Agreement. The actual number of shares of common stock that are sold to White Lion may depend based on
a number of factors, including the market price of our common stock during the time that the Equity Line Purchase Agreement in is effect.
The actual gross proceeds the Company may derive from the Equity Line Purchase Agreement may be less than $10.0 million, which may
impact our future liquidity. Because the price per share of each share sold to White Lion will fluctuate during the sales period, it is
not currently possible to predict the number of shares that will be sold or the actual gross proceeds to be raised in connection with
those sales, if any.
The Company currently has an effective registration
statement to register for resale by White Lion 2,500,000
shares of common stock. White Lion may ultimately purchase all or some of these shares. After White Lion has acquired shares under
the Equity Line Purchase Agreement, it may sell all, some or none of those shares. Sales to the Selling Securityholder by us pursuant
to the Equity Line Purchase Agreement may result in substantial dilution to the interests of other holders of our common stock.
The sale of a substantial number of shares to
White Lion, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future
at a time and at a price that we might otherwise desire. The number of shares of our common stock ultimately offered for resale by White
Lion is dependent upon the number of shares of common stock issued to White Lion pursuant to the Equity Line Purchase Agreement. Depending
on a variety of factors, including market liquidity of our common stock, the issuance of shares to White Lion may cause the trading price
of our common stock to decline.
In consideration for the commitments of White
Lion, as described above, the Company issued to White Lion 187,500 pre-split shares (11,719 post-2024 Stock Split) of Common Stock (the
“Commitment Shares”), having a value of $75,000 based upon the closing sale price of Common Stock on October 6, 2023.
As of December 31, 2023, the Company sold to White
Lion 4,575,000 newly issued pre-split common shares (285,938 post-2024 Stock Split) for proceeds of $1,462,949.
NOTE
14. NET LOSS PER SHARE OF COMMON STOCK
In January 2024, the Company’s board approved
the final reverse stock split ratio of one-for-sixteen, which resulted in a reduction in the number of outstanding shares of common stock
and a proportionate increase in the value of each share. The common stock began trading on a reverse split-adjusted basis on the NASDAQ
on January 4, 2024. The retrospective effect of the reverse stock split has been incorporated on a retrospective basis in the tabular
disclosures of loss per share and weighted average outstanding shares for the fiscal years 2023 and 2022 herein.
Basic and diluted net loss per share is computed
by dividing net loss attributable to stockholders by the weighted average number shares of common stock outstanding, vested restricted
stock units, and pre-funded warrants during the year. Potentially dilutive outstanding shares of common stock equivalents were excluded
from the computation of diluted net loss per share for loss periods presented because including them would have been antidilutive.
A post-split reconciliation of the numerator and
denominator used in the calculation of basic and diluted net loss per share attributable to stockholders follows:
| Schedule of reconciliation of basic and diluted net loss per share | |
| | |
| |
| | |
December 31, | |
| | |
| | |
2022 | |
| | |
2023 | | |
(restated) | |
| Numerator: | |
| | |
| |
| Net loss allocable to common shareholders used to compute basic and diluted loss per common share | |
$ | (4,911,374 | ) | |
$ | (7,484,116 | ) |
| Denominator: | |
| | | |
| | |
| Weighted average shares used to compute basic and dilutive loss per share (post-split) | |
| 556,808 | | |
| 381,598 | |
The following outstanding potentially dilutive
securities were excluded from the calculation of dilutive loss per share attributable to common stockholders because their impact would
have been antidilutive for the period presented:
| Schedule of anti-dilutive securities excluded from computation of earnings per share | |
| | |
| |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| | |
| | |
| |
| Shares issuable on Series A and B convertible preferred stock | |
| – | | |
| 51,236 | |
| Shares issuable on warrants | |
| 255,270 | | |
| 145,624 | |
| Shares issuable on restricted stock units | |
| 49,185 | | |
| 3,127 | |
| Shares issuable on options | |
| 171,033 | | |
| 155,114 | |
| | |
| 475,488 | | |
| 355,101 | |
NOTE 15. STOCK-BASED COMPENSATION
2022 Aclarion Equity Incentive Plan
On April 21, 2022, in connection with the
IPO, the Company’s 2022 Aclarion Equity Incentive Plan, or “2022 Plan”, went into effect. Our board of directors
has appointed the compensation committee of our board of directors as the committee under the 2022 Plan with the authority to
administer the 2022 Plan. The aggregate number of our shares of common stock that may be issued or used for reference purposes under
the 2022 Plan is 2,000,000
shares (125,000 post 2024 Stock Split), with an automatic increase on January 1st of each year, for a period of not more than ten
years, commencing on January 1st of the year following the year in which the IPO Date occurs and ending on (and including) January
1, 2032, in an amount equal to 5% of the total number of shares of Capital Stock outstanding on December 31st of the preceding
calendar year. Notwithstanding the foregoing, the Board may act prior to January 1st of a given year to provide that there will be
no January 1st increase in shares for such year or that the increase in shares for such year will be a lesser number of shares of
Common Stock than would otherwise occur pursuant to the preceding sentence.
As of the year ended December 31, 2023, the aggregate
number of our shares of common stock that may be issued or used for reference purposes under the 2022 Plan was 2,470,814 (154,426 post-split).
On January 1, 2024, the 2022 Plan had an automatic increase of 660,311 (41,270 post-split) shares which was 5% of the total number of shares
of Capital Stock outstanding on December 31, 2023.
Options granted under the 2022 Plan may be incentive
stock options or non-statutory stock options, as determined by the administrator at the time of grant of an option. Restricted stock
may also be granted under the 2022 Plan. The options vest in accordance with the grant terms and are exercisable for a period of up to
10 years from grant date.
The Company did not grant any stock options for
the twelve months ended December 31, 2023. The fair value of the options granted for the twelve months ended December 31, 2022 were
estimated at the date of grant using the Black-Scholes-Merton option pricing model with the following assumptions:
| Schedule of assumptions used for valuation | |
| |
| Risk-free interest rate (4/2022 – 8/2022) | |
| 1.99% | |
| Risk-free interest rate (9/2022 – 12/2022) | |
| 3.67% | |
| Dividend yield | |
| – | |
| Expected term | |
| 6-8 years | |
| Expected volatility | |
| 66.35% | |
Nocimed, Inc. 2015 Stock Plan
The Company maintains the Nocimed, Inc. 2015 Stock
Plan, or the “Existing Plan”, under which the Company could grant 152,558 shares (after giving effect to the 2024 Stock Split)
or options of the Company to our employees, consultants, and other service providers. The Company suspended the Existing Plan in connection
with the April 2022, initial public offering. The Company did not grant any stock options under the Existing Plan for the twelve months
ended December 31, 2022. No further awards will be granted under the Existing Plan, but awards granted prior to the suspension date will
continue in accordance with their terms and the terms of the Existing Plan.
Determining Fair Value of Stock Options
The fair value of each grant of stock options
was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires
significant judgment to determine.
Valuation and Amortization Method —The
Company estimates the fair value of its stock options using the Black-Scholes-Merton option-pricing model. This fair value is then amortized
over the requisite service periods of the awards.
Expected Term—The Company estimates
the expected term of stock option by taking the average of the vesting term and the contractual term of the option, as illustrated by
the simplified method.
Expected Volatility—The expected
volatility is derived from the Company’s expectations of future market volatility over the expected term of the options.
Risk-Free Interest Rate—The risk-free
interest rate is based on the U.S. Treasury yield curve on the date of grant.
Dividend Yield—The dividend yield
assumption is based on the Company’s history and expectation of no dividend payouts.
Stock Award Activity
A post-split summary of option activity under
the Company’s equity incentive plans is as follows:
| Schedule of option activity |
|
| | |
| | |
| |
| |
|
Options
Outstanding | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Life (In Years) | |
| Balance at December 31, 2021 |
|
| 140,980 | | |
$ | 29.47 | | |
| 9.2 | |
| Options granted |
|
| 33,334 | | |
$ | 36.80 | | |
| 9.6 | |
| Options exercised |
|
| – | | |
| | | |
| | |
| Options forfeited/expired |
|
| (3,138 | ) | |
$ | 20.32 | | |
| 5.6 | |
| Balance at December 31, 2022 |
|
| 171,176 | | |
| 31.07 | | |
| 8.4 | |
| Options granted |
|
| – | | |
| | | |
| | |
| Options exercised |
|
| – | | |
| | | |
| | |
| Options forfeited/expired |
|
| (1,720 | ) | |
$ | 23.64 | | |
| 6.0 | |
| Balance at December 31, 2023 |
|
| 169,456 | | |
$ | 31.15 | | |
| 7.5 | |
| |
|
| | | |
| | | |
| | |
| Exercisable at December 31, 2023 |
|
| 147,977 | | |
$ | 30.57 | | |
| 7.4 | |
The aggregate intrinsic value in the table above
of the unexercised options reflects the total pre-tax intrinsic value (the difference between the Nasdaq closing price on December 30,
2023, and the exercise price of the options that would have been received by option holders if all options exercisable had been exercised.
The aggregate intrinsic value of options outstanding
at December 31, 2023 is $0. The aggregate intrinsic value of vested and exercisable options at December 31, 2022 is $0.
As of December 31, 2023, there was approximately
$327,853 of total unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over the next
21 months.
The Company adjusts expense for actual forfeitures
in the periods they occur.
Restricted Stock Units
During the twelve month period ending
December 31, 2023, the Company granted RSUs under the 2022 Plan that have a combination of time-based and performance-based vesting,
contingent upon continued service with the Company. The Company granted certain consultants an aggregate of RSUs for 26,506
common shares (after giving effect to the 2024 Stock Split).
Post-split RSU activity under the 2022 Plan was
as follows for the year ended December 31, 2023:
| Schedule of RSU activity |
|
|
|
|
|
|
|
|
| |
|
RSU’s
Outstanding |
|
|
Weighted-Average Grant-Date Fair value per Unit |
|
| Nonvested as of December 31, 2021 |
|
|
– |
|
|
$ |
– |
|
| Granted |
|
|
30,120 |
|
|
|
13.12 |
|
| Vested |
|
|
(3,864 |
) |
|
|
13.92 |
|
| Forfeited |
|
|
– |
|
|
|
– |
|
| Nonvested as of December 31, 2022 |
|
|
26,256 |
|
|
|
13.12 |
|
| Granted |
|
|
26,506 |
|
|
|
8.52 |
|
| Vested |
|
|
(22,936 |
) |
|
|
10.40 |
|
| Forfeited |
|
|
(14,077 |
) |
|
|
10.11 |
|
| Nonvested as of December 31, 2023 |
|
|
15,749 |
|
|
$ |
10.72 |
|
The grant date fair value for a RSU is
the market price of the common stock on the date of grant. The total fair value of RSUs vested during 2023 was $226,918.
As of December 31, 2023, there was approximately
$43,468 total unrecognized compensation cost related to non-vested RSUs, which is expected to be recognized over the next nine months.
Common Stock Subject to Vesting
The Company entered into a contract for consulting
services shortly after the completion of the IPO in April 2022. The contract included a fee payable in the form of 40,000 (2,500 after
giving effect to the 2024 Stock Split) restricted common shares that vested over six months. The shares were issued in November 2022
after the shares vested. Stock-based vendor payments of $102,000 were recognized on the date of grant and recorded as general and administrative
expense.
Stock-based Compensation Expense
The following table summarizes the total stock-based
compensation expense included in the Company’s statements of operations for the periods presented:
| Schedule of stock-based compensation expense | |
| | |
| |
| | |
December 31, | |
| | |
| | |
2022 | |
| | |
2023 | | |
(restated) | |
| Sales and marketing | |
$ | 228,437 | | |
$ | 57,298 | |
| Research and development | |
| 9,725 | | |
| (259 | ) |
| General and administrative | |
| 217,839 | | |
| 1,129,619 | |
| Total stock-based compensation | |
$ | 456,001 | | |
$ | 1,186,658 | |
NOTE 16. INCOME TAXES
The Company accounts for income taxes under ASC
740-10, which provides for an asset and liability approach of accounting for income taxes. Under this approach, deferred tax assets and
liabilities are recognized based on anticipated future tax consequences, using currently enacted tax laws, attributed to temporary differences
between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts calculated for income tax purposes.
A reconciliation
of the federal income tax rates to the Company’s effective tax rates for the year ended December 31, 2023 consist of
the following:
| Schedule of reconciliation
of the federal income tax rates | |
| | | |
| | |
2023 | | |
| U.S. federal statutory rate | |
| 21.0 | % | |
| Effects of: | |
| | | |
| State taxes, net of federal benefit | |
| 7.0 | % | |
| Stock based compensation | |
| (0.6 | )% | |
| Permanent differences | |
| (0.3 | )% | |
| Other | |
| (0.3 | )% | |
| Change in valuation allowance | |
| (26.8 | )% | |
| Effective rate | |
| – | % | |
Significant
components of the Company’s deferred tax assets as of December 31, 2023 are summarized below.
| Schedule of deferred tax assets | |
| | | |
| | |
2023 | | |
| Deferred tax asset: | |
| | | |
| Net operating losses | |
$ | 9,235,000 | | |
| Stock based compensation | |
| 479,000 | | |
| Total deferred tax asset | |
| 9,714,000 | | |
| Less valuation allowance | |
| (9,714,000 | ) | |
| Net deferred income tax liability | |
$ | – | | |
The Company
recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making
such a determination, the Company considers all available positive and negative evidence, including future reversals of existing
taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. The
Company assessed the need for a valuation allowance of $9,714,000
required as of December 31, 2023, as the Company determined it is more likely than not the deferred tax assets will not be realized.
Our net deferred tax asset and valuation allowance increased by $1,315,000 for
the year ended December 31, 2023. The ultimate realization of deferred tax assets is dependent upon the
generation of future taxable income during the periods in which those temporary differences become deductible.
The Company has evaluated
its income tax positions and has determined that it does not have any uncertain tax positions. The Company will recognize interest and
penalties related to any uncertain tax positions through its income tax expense.
The Company files income
tax returns in the U.S., Colorado, and California jurisdictions and is subject to examination by the various taxing authorities.
NOTE 17. SUBSEQUENT EVENTS
Reverse
Stock Split
In March 2023 the Company’s stockholders
approved a reverse stock split proposal at a ratio in the range of one-for-five to one-for-fifty, with the final ratio to be determined
by the Company's board in its discretion without further approval from the Company's stockholders. In January 2024, the Company's board
approved the final reverse stock split ratio of one-for-sixteen, which resulted in a reduction in the number of outstanding shares of
common stock and a proportionate increase in the value of each share. The common stock began trading on a reverse split-adjusted basis
on the NASDAQ on January 4, 2024.
The following table presents selected share
information reflecting on a retroactive basis the reverse stock splits for the years ended December 31, 2023 and 2022:
| |
|
Year
ended December 31, |
|
| |
|
2023 |
|
|
2022 |
|
| Weighted average shares
outstanding, basic and diluted - pre-2024 split |
|
|
8,908,934 |
|
|
|
6,105,569 |
|
| Weighted average shares outstanding, basic and diluted
- post-2024 split |
|
|
556,808 |
|
|
|
381,598 |
|
| Basic and diluted net loss per shares attributable to
common stockholders - pre-2024 split |
|
$ |
(0.55 |
) |
|
$ |
(1.23 |
) |
| Basic and diluted net loss per shares attributable to
common stockholders - post-2024 split |
|
$ |
(8.82 |
) |
|
$ |
(19.61 |
) |
White Lion Equity
Line Agreement
On October 9, 2023, the
Company entered into an equity line common stock purchase agreement (the “Equity Line Purchase Agreement”) and a related registration
rights agreement with White Lion Capital, LLC (“White Lion”). Pursuant to the Equity Line Agreement, the Company has the right,
but not the obligation to require White Lion to purchase, from time to time, up to $10,000,000 in aggregate gross purchase price of newly
issued shares of the Company’s common stock, subject to certain limitations and conditions set forth in the Equity Line Purchase
Agreement.
Pursuant to the Equity
Line Purchase Agreement (see Note 13: Stockholders Equity), the Company issued to White Lion 452,343 newly issued post-split common shares
for proceeds of $1,449,532, between January 4, 2024 and January 8, 2024. Through February 26, 2024, the Company has issued 750,000 shares
(after giving effect to the 2024 Stock Split) to White Lion for total proceeds of $2,912,481.
Exchange Agreements
In May, September and November 2023 the Company issued $2,550,000 aggregate
principal amount of unsecured non-convertible notes to certain accredited investors.
Between January 22 and
January 29, 2024, the Company entered into a series of exchange agreements (the “Exchange Agreements”) with the accredited
investors to exchange principal and accrued interest on these notes for shares of common stock. Pursuant to the Exchange Agreements, the
Company issued an aggregate of 644,142 post-split shares of common stock in exchange for $1,519,779 principal and accrued interest on
the notes. Following these exchanges, the remaining outstanding balance of principal and interest on the notes is $1,145,037.
The Company and the accredited
investors may elect in the future to effect additional exchanges of the notes for common stock. Any such future exchanges would be negotiated
and agreed to among the parties.
5,175,000 UNITS, EACH UNIT CONSISTING OF
ONE SHARE OF COMMON
STOCK
OR PRE-FUNDED WARRANTS
TO PURCHASE SHARES
OF COMMON STOCK AND
TWO WARRANTS EACH
TO PURCHASE ONE SHARE
OF COMMON STOCK
ACLARION, INC.
PROSPECTUS
February 26, 2024
Maxim Group LLC
Aclarion (NASDAQ:ACON)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aclarion (NASDAQ:ACON)
Historical Stock Chart
From Apr 2023 to Apr 2024
