Notes
to Consolidated Financial Statements
1.
BUSINESS OF THE COMPANY AND GOING CONCERN
Business
Description
Vycor
Medical, Inc. (the “Company”) designs, develops and markets neurological medical devices and therapies through two
operating divisions: Vycor Medical and NovaVision. Vycor Medical focuses on brain and cervical surgical access systems for sale
to hospitals and medical professionals; NovaVision focuses on neuro-stimulation therapies and diagnostic devices for the treatment
and screening of vision field loss resulting from neurological damage.
Ability
to continue as a Going Concern
The accompanying consolidated financial
statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred losses since
its inception, including a net loss of $796,202 and $1,379,356 for the years ending December 31, 2019 and 2018,
respectively, and has not generated sufficient cash flows from operations. As at December 31, 2019 the Company had a working
capital deficiency of $541,070, excluding related party liabilities of $1,248,904. These conditions, among others, raise substantial
doubt regarding our ability to continue as a going concern. The financial statements do not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities
that may result from the outcome of this uncertainty.
The
Company is executing on a plan to achieve a reduction in cash operating losses for both the Vycor Medical and NovaVision divisions.
Included within the working capital deficiency above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”),
together with accrued interest of $280,765, which has a maturity date of June 30, 2020, having been extended on a number of occasions
from its initial due date of June 11, 2011. At this time, it is not known whether any further extension of the note beyond
June 30, 2020 will be available. However, the Company believes it may not have sufficient cash to meet its various cash needs
through March 31, 2021 unless the Company is able to obtain additional cash from the issuance of debt or equity securities. Fountainhead,
the Company’s largest shareholder, has provided working capital funding to the Company on an as-needed basis, although there
is no guarantee that this will continue to be the case. The Company may consider seeking additional equity or debt funding, although
there is no assurance that this would be available on acceptable terms or at all. If adequate funds are not available, the Company
may have to delay or curtail development or commercialization of products, or cease some of its operations
2.
SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation and Basis of Presentation
The
consolidated financial statements include the accounts of Vycor Medical, Inc., and its wholly-owned subsidiaries, NovaVision,
Inc. (a Delaware corporation), NovaVision GmbH (a German corporation) and Sight Science Limited (a UK corporation), both wholly
owned subsidiaries of NovaVision, Inc. The Company is headquartered in Boca Raton, FL. All material inter-company accounts, transactions,
and balances have been eliminated in consolidation.
Revenue
Recognition
On
January 1, 2018, the Company adopted the new accounting standard, ASC 606, Revenue from Contracts with Customers and all the related
amendments (new revenue standard) to all contracts. The adoption of the new accounting standard had no impact on company’s
consolidated financial statements.
Vycor
Medical generates revenue from the sale of its surgical access system to hospitals and other medical professionals. Vycor Medical
records revenue from product sales when obligations under the terms of a contract with customers are satisfied. Generally, this
occurs with the transfer of control of the goods to customers. Vycor Medical does not provide for product returns or warranty
costs.
Vycor
determines revenue recognition through the following steps:
|
|
●
|
Identification
of the contract, or contracts, with a customer
|
|
|
|
|
|
|
●
|
Identification
of the performance obligations in the contract
|
|
|
|
|
|
|
●
|
Determination
of the transaction price
|
|
|
|
|
|
|
●
|
Allocation
of the transaction price to the performance obligations in the contract
|
|
|
|
|
|
|
●
|
Recognition
of revenue when Vycor satisfy a performance obligation
|
NovaVision
generates revenues from various programs, therapy services and other sources such as software license sales. Therapy services
revenues represent fees from NovaVision’s vision restoration therapy software, eye movement training software, diagnostic
software, clinic set up and training fees, and the professional and support services associated with the therapy. NovaVision provides
vision restoration therapy directly to patients. The typical therapy program consists of NeuroEyeCoach, performed over 2-4 weeks,
and six modules of Vision Restoration Therapy, performed over 6 months. A patient contract comprises set-up fees and monthly therapy
fees. Set-up fees are recognized at the outset of the contract and therapy revenue is recognized ratably over the therapy period.
Patient therapy is restricted to being completed by a patient within a specified time frame.
Deferred
revenue results from patients paying for the therapy in advance of receiving the therapy.
As
part of the adoption of ASC 606, see Note 6 to the Consolidated Financial Statements for further disaggregation of revenue.
Cash
and cash equivalents
The
Company maintains cash balances at various financial institutions. Accounts at each institution in the U.S. are insured by the
Federal Deposit Insurance Corporation up to $250,000. Cash balances may at times exceed the FDIC insured limits. Cash also includes
a US investment account in a money market backed by government securities up to 105% of the account balance. The Company considers
all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Included within cash
are deposits paid by patients, held by the Company until the patient returns the VRT device or chinrest at the end of therapy.
At December 31, 2019 and 2018 patient deposits amounted to $46,191 and $44,605, respectively, and are included in Accrued Liabilities.
Accounts
Receivable and Allowance for Doubtful Accounts Receivable
The
Company’s accounts receivable are due from the hospitals and distributors in the case of Vycor Medical, and from patients
directly for therapy or physicians for diagnostic products in the case of NovaVision. Accounts receivable are due once products
have been delivered or at the time the therapy is initiated; however, for NovaVision therapy patients sometimes credit is extended
through various payment plans based on individual financial conditions, generally not to exceed the therapy period. The outstanding
balances are stated net of an allowance for doubtful accounts.
We
have a policy of reserving for uncollectible accounts based on our best estimate of the amount of probable credit losses in our
existing accounts receivable. We extend credit to our customers based on an evaluation of their financial condition and other
factors. We generally do not require collateral or other security to support accounts receivable. We perform ongoing credit evaluations
of our customers and maintain an allowance for potential bad debts if required. We determine whether an allowance for doubtful
accounts is required by evaluating specific accounts where information indicates the customers may have an inability to meet financial
obligations. In these cases, we use assumptions and judgment, based on the best available facts and circumstances, to record a
specific allowance for those customers against amounts due to reduce the receivable to the amount expected to be collected. These
specific allowances are re-evaluated and adjusted as additional information is received. The amounts calculated are analyzed to
determine the total amount of the allowance. We may also record a general allowance as necessary. Direct write-offs are taken
in the period when we have exhausted our efforts to collect overdue and unpaid receivables or otherwise evaluate other circumstances
that indicate that we should abandon such efforts.
Inventories
Inventories
consist of raw materials, work in process and finished goods that are stated at the lower of cost determined using the weighted
average cost method, or net realizable value. Net realizable value is the estimated selling price, in the ordinary course of business,
less estimated costs to complete and dispose of the product. If the Company identifies excess, obsolete or unsalable items, its
inventories are written down to their realizable value in the period in which the impairment is first identified. The provision
for inventory obsolescence for the years ended December 31, 2019 and 2018 was $12,558 and $6,279, respectively. Shipping and handling
costs incurred for inventory purchases and product shipments are recorded in cost of sales in the Company’s consolidated
statements of comprehensive loss.
Leases
The
Company has one leased building in Boca Raton, Florida that is classified as operating lease right-of use (“ROU”)
assets and operating lease liabilities in the Company’s consolidated balance sheet as per ASC 842. ROU assets and
lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement
date for leases exceeding 12 months. Minimum lease payments include only the fixed lease component of the agreement. Operating
lease expense is recognized on a straight-line basis over the lease term and is included in cost of Selling, General and Administrative
expenses.
The
standard was effective for us beginning January 1, 2019. The Company elected the available practical expedients on adoption. The
adoption had a material impact on our consolidated balance sheets, but did not have a material impact on our consolidated statements
of comprehensive loss. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases.
Foreign
Currency
The
Euro is the local currency of the country in which NovaVision GmbH conducts its operations and is considered the functional currency
of this entity; the GB Pound is the local currency of the country in which Sight Science Limited conducts its operations and is
considered the functional currency of this entity. All balance sheet amounts are translated to U.S. dollars using the U.S. exchange
rate at the balance sheet date except for the equity section which is translated at historical rates. Operating statement amounts
are translated using an average exchange rate for the period of operations. Foreign currency translation effects are accumulated
as part of the accumulated other comprehensive income (loss) and included in stockholders’ equity (deficiency) in the accompanying
Consolidated Balance Sheets.
Educational
marketing and advertising expenses
The
Company may incur costs for the education of customers on the uses and benefits of its products. The Company will include education,
marketing and advertising expense as a component of selling, general and administrative costs as such costs are incurred.
Income
taxes
We
use the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.”
Under this method, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and
(ii) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s
financial statements or tax returns. 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 the results of operations in the period that includes the
enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available
positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized.
ASC
Topic 740.10.30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements
and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. ASC Topic 740.10.40 provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure, and transition. We have no material uncertain tax positions
for any of the reporting periods presented.
Fixed
assets
Fixed
assets are stated at cost less accumulated depreciation. Depreciation is provided for on a straight-line basis over the useful
lives of the assets. Expenditures for additions and improvements are capitalized; repairs and maintenance are expensed as incurred.
Patents
and Other Intangible Assets
The
Company capitalizes legal and related costs associated with the establishment and enhancement of patents for its products once
patents have been applied for. Costs associated with the development of the patented item or processes are charged to research
and development costs as incurred. The capitalized costs are amortized over the life of the patent. The Company reviews intangible
assets on an annual in accordance with the authoritative guidance. Trademarks have an indefinite life and are reviewed annually
by management for impairment in accordance with the authoritative guidance.
Impairment
of long-lived assets
Long-lived
assets are reviewed for impairment when circumstances indicate the carrying value of an asset may not be recoverable. For assets
that are to be held and used, impairment is recognized when the estimated undiscounted cash flows associated with the asset or
group of assets is less than their carrying value. If impairment exists, an adjustment is made to write the asset down to its
fair value, and a loss is recorded as the difference between the carrying value and fair value. Fair values are determined based
on quoted market values, discounted cash flows or internal and external appraisals, as applicable. Assets to be disposed of are
carried at the lower of carrying value or estimated net realizable value.
During
the year ended December 31, 2018, and following the applicable guidance, the Company made a full provision of $307,576 against
the NovaVision intangible assets and capitalized software, of which $256,790 was in respect of Trademarks and Website and $50,786
was in respect of unamortized software development costs.
Research
and Development
The
Company expenses all research and development costs as incurred. For the years ended December 31, 2019 and 2018, the amounts charged
to research and development expenses were $0 for both years, respectively.
Software
Development Costs
The
Company accounts for software development costs in accordance with ASC 350-40, whereby all costs incurred during the preliminary
stage of a development project should be charged to expense as incurred. Capitalization of costs begins after the preliminary
stage has been completed, management commits to funding the project, it is probable that the project will be completed, and the
software will be used for its intended function. All post-implementation costs are charged to expense as incurred. Accordingly,
direct internal and external costs associated with the development of the features and functionality of the Company’s software,
incurred during the application development stage, are capitalized and amortized using the straight-line method of the estimated
life of five years. There was no capitalized for software development during the years ended December 31, 2019 and 2018. As part
of the impairment review referred to above, software development costs were written down by $50,786 to $0 during the year ended
December 31, 2018.
Uses
of estimates in the preparation of financial statements
The
preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ
from those estimated. To the extent management’s estimates prove to be incorrect, financial results for future periods may
be adversely affected. Significant estimates and assumptions contained in the accompanying consolidated financial statements include
management’s estimate of the allowance for uncollectible accounts receivable, provision for inventory obsolescence, useful
life of intangible assets, and the fair values of options and warrants included in the determination of debt discounts and share
based compensation.
Stock
Compensation
The
Company recognizes the cost of all share-based payments under the relevant authoritative accounting guidance. Share-based payments
include any remuneration paid by the Company in shares of the Company’s common stock or financial instruments that grant
the recipient the right to acquire shares of the Company’s common stock. For share-based payments to employees, which consist
only of awards made under the stock option plan described below, the Company accounts for the payments in accordance with the
provisions of ASC Topic 718, “Stock Compensation”. Share-based payments to consultants, service providers and other
non-employees are accounted for under in accordance with ASC Topic 718, ASC Topic 505, “Equity Payments to Non-Employees”
or other applicable authoritative guidance.
Convertible
Instruments
We
evaluate and account for conversion options embedded in convertible instruments in accordance with ASC 815 “Derivatives
and Hedging Activities”.
Applicable
GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative
financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics
and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks
of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is
not re-measured at fair value under other GAAP with changes in fair value reported in earnings as they occur and (c) a separate
instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument.
We
account for convertible instruments (when we have determined that the embedded conversion options should not be bifurcated from
their host instruments) as follows: We record when necessary, discounts to convertible notes for the intrinsic value of conversion
options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment
date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements
are amortized over the term of the related debt to their stated date of redemption. The embedded conversion option in connection
with our convertible debt could not be exercised unless and until we completed a Qualifying Financing transaction. Accordingly,
we determined based on authoritative guidance that the embedded conversion option is deemed to be a contingent conversion rather
than active conversion option that did not require accounting recognition at the commitment dates of the issuances of the Notes.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our
own stock as defined in ASC 815-40 (“Contracts in Entity’s Own Equity”). We classify as assets or liabilities
any contracts that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and
if that event is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical
settlement or net-share settlement). We assess classification of our common stock purchase warrants and other free-standing derivatives
at each reporting date to determine whether a change in classification between assets and liabilities is required.
Fair
Value Measurements
We
adopted the provisions of ASC Topic 820, “Fair Value Measurements and Disclosures”, which defines fair value as used
in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.
The
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable
and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature
of these instruments. The carrying amounts of our short and long-term credit obligations approximate fair value because the effective
yields on these obligations, which include contractual interest rates taken together with other features such as concurrent issuances
of warrants and/or embedded conversion options, are comparable to rates of returns for instruments of similar credit risk.
ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price)
in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable
inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may
be used to measure fair value:
Level
1 — quoted prices in active markets for identical assets or liabilities
Level
2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable
Level
3 — inputs that are unobservable (for example cash flow modeling inputs based on assumptions)
The
Company has no Financial instruments measured at Fair value on a recurring basis.
Net
Loss Per Share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period.
Diluted net loss per share is computed giving effect to all dilutive potential common shares that were outstanding during the
period. Dilutive potential common shares consist of incremental shares issuable upon exercise of stock options and warrants and
conversion of preferred stock and convertible debt. Such potentially dilutive shares are excluded when the effect would be to
reduce a net loss per share. No dilution adjustment has been made to the weighted average outstanding common shares in the periods
presented because the assumed exercise of outstanding options and warrants and the conversion of preferred stock and debt would
be anti-dilutive.
The
following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per
share:
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Stock options outstanding
|
|
|
700,000
|
|
|
|
1,380,000
|
|
|
Warrants to purchase common stock
|
|
|
3,717,826
|
|
|
|
3,717,826
|
|
|
Debentures convertible into common stock
|
|
|
2,765,548
|
|
|
|
2,652,568
|
|
|
Preferred shares convertible into common
stock
|
|
|
1,272,052
|
|
|
|
1,272,052
|
|
|
Directors Deferred
Compensation Plan
|
|
|
1,175,907
|
|
|
|
775,911
|
|
|
Total
|
|
|
9,631,333
|
|
|
|
9,798,357
|
|
Recent
Accounting Pronouncements
From
time to time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies
that may have an impact on the Company’s accounting and reporting. The Company believes that other recently issued accounting
pronouncements and other authoritative guidance for which the effective date is in the future will not have an impact on its accounting
or reporting or that such impact will not be material to its financial position, results of operations and cash flows when implemented.
3.
INVENTORY
|
|
|
December
31, 2019
|
|
|
December
31, 2018
|
|
|
|
|
|
|
|
|
|
|
Raw materials and work in
process
|
|
$
|
82,142
|
|
|
$
|
59,325
|
|
|
Finished goods
|
|
|
128,386
|
|
|
|
143,797
|
|
|
Total
Inventory
|
|
$
|
210,528
|
|
|
$
|
203,122
|
|
4.
LEASE
The
Company recognized the following related to a lease in its consolidated balance sheet at December 31, 2019:
|
|
|
Year Ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Operating Lease ROU Assets
|
|
$
|
31,658
|
|
|
$
|
-
|
|
|
|
|
$
|
31,658
|
|
|
$
|
-
|
|
|
Operating Lease Liabilities
|
|
|
|
|
|
|
|
|
|
Current portion
|
|
$
|
28,010
|
|
|
$
|
-
|
|
|
|
|
$
|
28,010
|
|
|
$
|
-
|
|
5.
NOTES PAYABLE
Related
Party Notes Payable consists of:
|
|
|
December 31,
2019
|
|
|
December 31,
2018
|
|
|
On June 25, 2018 the
Company issued promissory notes to Peter Zachariou for $30,000. The notes bear interest at 10% per annum and are payable on
the earlier of one year or five days following the delivery of written demand for payment by the Payee. The note was extended
for another twelve months on its due date to June 25, 2020 or on demand by the Payee
|
|
|
30,000
|
|
|
|
30,000
|
|
|
Between March 26, 2018 and December
31, 2019 the Company issued various promissory notes to Fountainhead Capital Management Limited for $200,873. The notes bear interest
at 10% per annum and are payable on the earlier of one year or five days following the delivery of written demand for payment
by the Payee. Five notes were extended for another twelve months on their due dates which will be due between April 2020 and March
2021 or on demand by the Payee.
|
|
|
200,873
|
|
|
|
163,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Related Party Notes Payable
|
|
$
|
230,873
|
|
|
$
|
193,000
|
|
Other
Notes Payable consists of:
|
|
|
December 31,
2019
|
|
|
December 31,
2018
|
|
|
On March 25, 2011 the Company
issued a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”). The term note bears interest
at 16% per annum and was due June 25, 2011, and has been extended on a number of occasions. On the note’s most recent
due date, the note was amended and extended to June 30, 2020. The note is personally guaranteed by certain officers and
directors of the Company See further note below.
|
|
$
|
300,000
|
|
|
$
|
300,000
|
|
|
Insurance policy finance agreements.
|
|
|
28,032
|
|
|
|
25,814
|
|
|
Total Other Notes Payable
|
|
$
|
328,032
|
|
|
$
|
325,814
|
|
On
January 24, 2018 the Company entered into an amendment agreement (the “Amendment”) with EuroAmerican Investments (“EuroAmerican”)
regarding its $300,000 loan note (the “Note”). Under the Amendment, the Note was extended and the conversion terms
of the Note reduced to $0.21, the same as the offering price of the 2018 Offering. Conversion of the Note and accrued interest
would result in the issuance of 2,765,548 shares of Common Stock. Notwithstanding, EuroAmerican agreed that the Note could not
be converted without first offering the Company the right to redeem the Note at principal and accrued interest, and secondly Fountainhead
the right to purchase the Note, which cannot be converted prior to such offer and the failure of the Company and Fountainhead
to exercise such option in accordance with the amendment terms. In addition, the Company agreed to issue warrants to purchase
2,308,405 shares of Common Stock at $0.27, the same terms as the 2018 Offering, exercisable for three years from January 1, 2018,
if and when the conversion option is exercised. The amendment was recognized as a modification, based on the guidance in ASC 470-50.
The
Company routinely finances all their insurance policies through a third party finance company which requires a down payment and
subsequent monthly payments, the time periods vary from 10 months to 12 equal monthly payments.
6.
SEGMENT REPORTING, GEOGRAPHICAL INFORMATION
(a)
Business segments
The
Company operates in two business segments: Vycor Medical, which focuses on devices for neurosurgery; and NovaVision, which focuses
on neuro stimulation therapies and diagnostic devices for the treatment and screening of vision field loss. Set out below are
the revenues, gross profits and total assets for each segment.
|
|
|
Twelve
Months Ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Vycor
Medical
|
|
$
|
1,299,830
|
|
|
$
|
1,311,311
|
|
|
NovaVision
|
|
$
|
181,921
|
|
|
$
|
198,019
|
|
|
|
|
$
|
1,481,751
|
|
|
$
|
1,509,330
|
|
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
1,171,149
|
|
|
$
|
1,160,118
|
|
|
NovaVision
|
|
$
|
163,946
|
|
|
$
|
179,614
|
|
|
|
|
$
|
1,335,095
|
|
|
$
|
1,339,732
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
|
2019
|
|
|
|
2018
|
|
|
Total Assets:
|
|
|
|
|
|
|
|
|
|
Vycor
Medical
|
|
$
|
1,036,857
|
|
|
$
|
981,553
|
|
|
NovaVision
|
|
|
55,086
|
|
|
|
62,224
|
|
|
Total
Assets
|
|
$
|
1,091,943
|
|
|
$
|
1,043,777
|
|
(b)
Geographic information. The Company operates in two geographic segments, the United States and Europe. Set out below are the revenues,
gross profits and total assets for each segment.
|
|
|
Twelve
Months Ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
1,380,209
|
|
|
$
|
1,406,101
|
|
|
Europe
|
|
$
|
101,542
|
|
|
$
|
103,229
|
|
|
|
|
$
|
1,481,751
|
|
|
$
|
1,509,330
|
|
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
1,246,464
|
|
|
$
|
1,248,257
|
|
|
Europe
|
|
$
|
88,631
|
|
|
$
|
91,475
|
|
|
|
|
$
|
1,335,095
|
|
|
$
|
1,339,732
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
|
2019
|
|
|
|
2018
|
|
|
Total Assets:
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
1,055,312
|
|
|
$
|
981,553
|
|
|
Europe
|
|
|
36,631
|
|
|
|
62,224
|
|
|
Total Assets
|
|
$
|
1,091,943
|
|
|
$
|
1,043,777
|
|
7.
FIXED ASSETS
Fixed
Assets and the estimated lives used in the computation of depreciation are as follows:
|
|
|
Estimated
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
Useful
Lives
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Machinery and equipment
|
|
3 years
|
|
$
|
137,566
|
|
|
$
|
137,503
|
|
|
Leasehold Improvements
|
|
3 years
|
|
|
8,063
|
|
|
|
7,989
|
|
|
Purchased Software
|
|
3 years
|
|
|
27,706
|
|
|
|
27,706
|
|
|
Molds and Tooling
|
|
5 years
|
|
|
715,463
|
|
|
|
660,798
|
|
|
Furniture and fixtures
|
|
7 years
|
|
|
26,120
|
|
|
|
26,120
|
|
|
Therapy Devices
|
|
3 years
|
|
|
134,002
|
|
|
|
130,415
|
|
|
Internally Developed
Software
|
|
5
years
|
|
|
379,782
|
|
|
|
379,782
|
|
|
|
|
|
|
|
1,428,702
|
|
|
|
1,370,313
|
|
|
Less: Accumulated depreciation and amortization
|
|
|
|
|
(1,054,175
|
)
|
|
|
(997,670
|
)
|
|
Property and Equipment, net
|
|
|
|
|
374,527
|
|
|
|
372,643
|
|
Depreciation
expense for the years ended December 31, 2019 and 2018 was $57,274 and $127,020 respectively, including $9,454 and $10,965 respectively
for Therapy Devices which is allocated to Cost of Sales.
As
part of the impairment review referred to in Note 8, software development costs were written down by $50,786 to $0 during the
year ended December 31, 2018.
8.
INTANGIBLE ASSETS
Intangible
Assets consists of:
|
|
|
December
31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Amortized intangible assets: Patent
(8 years useful life)
|
|
|
|
|
|
|
|
|
|
Gross
carrying Amount
|
|
$
|
865,639
|
|
|
$
|
865,639
|
|
|
Accumulated
Amortization
|
|
|
(842,313
|
)
|
|
|
(830,336
|
)
|
|
|
|
$
|
23,326
|
|
|
$
|
35,303
|
|
|
Amortized intangible assets: Website
(5 years useful life)
|
|
|
|
|
|
|
|
|
|
Gross carrying Amount
|
|
$
|
20,382
|
|
|
$
|
20,382
|
|
|
Accumulated
Amortization
|
|
$
|
(20,382
|
)
|
|
$
|
(20,195
|
)
|
|
|
|
$
|
0
|
|
|
$
|
187
|
|
Intangible
asset amortization expense for the periods ended December 31, 2019 and 2018 was $12,164 and $50,331, respectively.
During
the year ended December 31, 2018, and following the applicable guidance, the Company made a full provision of $307,576 against
the NovaVision intangible assets and capitalized software, of which $256,790 was in respect of Trademarks and Website and $50,786
was in respect of unamortized software development costs.
9.
EQUITY
Equity
Transactions
From
January to December 2019 and 2018, the Company granted 399,996 and 265,384 shares, respectively) of Common Stock (valued at $84,000
during each period) to non-employee Directors. Under the terms of the Directors Deferred Compensation Plan, the receipt of these
shares is deferred until January 15th of the year following termination of their services as a director. As of December 31, 2019
these shares have yet to be issued.
During
January to December 2019 and 2018, under the terms of the Consultancy Agreement referred to in Note 13, the Company issued 2,142,856
and 2,204,770 shares, respectively, of Common Stock to Fountainhead for fees of $450,000 and $675,000, respectively, of which
$225,000 in 2018 was in respect of fees accrued at December 31, 2017.
On
April 4, 2019 the Company issued 5,000 shares of Common Stock to Robert Anderson in accordance with the terms of a consulting
agreement.
On
April 20, 2018, the Company issued an aggregate of 1,113,936 shares of Company Common Stock on the cashless exercise of an aggregate
of Warrants to purchase 3,111,560 shares of Common Stock.
Increase
in Authorized Share Capital
On
February 9, 2018, the Board of Directors of the Company unanimously adopted a resolution seeking stockholder approval to (a) amend
the Company’s Certificate of Incorporation to increase the number of authorized Company Common Shares from 25,000,000 to
55,000,000 and (b) to adopt the Company’s 2018 Stock Incentive Plan. Thereafter, on February 9, 2018, pursuant to the By-Laws
of the Company and applicable Delaware law, stockholders holding in excess of fifty percent (50%) of the votes entitled to be
cast on the aforementioned two matters (identified in the section entitled “Voting Securities and Principal Holders Thereof”)
adopted a resolution to authorize the Board of Directors, in its sole discretion, to increase the number of authorized shares
of Company Common Stock from 25,000,000 to 55,000,000 and adopt the Company’s 2018 Stock Incentive Plan.
Warrants
and Options
The
details of the outstanding rights, options and warrants and value of such rights, options and warrants are as follows:
STOCK
WARRANTS:
|
|
|
|
|
|
Weighted
average
|
|
|
|
|
|
|
|
exercise
price
|
|
|
|
|
Number
of shares
|
|
|
per
share
|
|
|
Outstanding at December 31, 2017
|
|
|
6,929,386
|
|
|
$
|
0.31
|
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
|
Exercised
|
|
|
(3,111,560
|
)
|
|
$
|
0.28
|
|
|
Cancelled or expired
|
|
|
(100,000
|
)
|
|
$
|
2.56
|
|
|
Outstanding at December 31, 2018
|
|
|
3,717,826
|
|
|
$
|
0.27
|
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
|
Cancelled or expired
|
|
|
-
|
|
|
|
-
|
|
|
Outstanding at December 31, 2019
|
|
|
3,717,826
|
|
|
$
|
0.27
|
|
STOCK
OPTIONS:
|
|
|
|
|
|
Weighted
average
|
|
|
|
|
|
|
|
exercise
price
|
|
|
|
|
Number of shares
|
|
|
per
share
|
|
|
Outstanding at December 31, 2017
|
|
|
725,557
|
|
|
$
|
0.95
|
|
|
Granted
|
|
|
680,000
|
|
|
$
|
0.28
|
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
|
Cancelled or
expired
|
|
|
(25,557
|
)
|
|
|
5.97
|
|
|
Outstanding at December 31, 2018
|
|
|
1,380,000
|
|
|
$
|
0.53
|
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
|
Cancelled or
expired
|
|
|
(680,000
|
)
|
|
|
0.79
|
|
|
Outstanding at December 31,
2019
|
|
|
700,000
|
|
|
$
|
0.28
|
|
As
of December 31, 2019, the weighted-average remaining contractual life of outstanding warrants and options is 0.11 and 1.45 years,
respectively.
10.
SHARE-BASED COMPENSATION
The
Company from time to time issues common stock, stock options or common stock warrants to acquire services or goods from non-employees.
Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of
their fair value, which is measured as of the “measurement date” using an option pricing model. The “measurement
date” for options and warrants related to contracts that have substantial disincentives to non-performance is the date of
the contract, and for all other contracts is the vesting date. Expense related to the options and warrants is recognized on a
straight-line basis over the shorter of the period over which services are to be received or the life of the option or warrant.
Stock
Option Plan
Under
ASC Topic 718, the Company estimates the fair value of option awards on the date of grant using an option pricing model. The grant
date fair value is recognized over the option vesting period, the period during which an employee is required to provide service
in exchange for the award. No compensation cost is recognized for equity instruments for which employees do not render the requisite
service. Under these standards, compensation cost for employee cost for employee stock-based awards is based on the estimated
grant-date fair value and recognized over the vesting period of the applicable award on a straight-line basis.
For
the years ended December 31, 2019 and 2018, the Company recognized share-based compensation of $0 and $4,871, respectively for
the issuance of stock options to management and employees.
Stock
appreciation rights may be granted either on a stand-alone basis or in conjunction with all or part of any other stock options
granted under the plan. As of December 31, 2019 there were no awards of any stock appreciation rights.
Non-Employee
Stock Compensation
Aggregate
stock-based compensation for stock and warrants granted to non-employees for the years ended December 31, 2019 and 2018 was $534,940
and $620,754. The expense related to stock not issued during the years ended December 31, 2019 and 2018 comprise: $84,000, respectively
for both years, related to stock granted but not issued to directors under the Directors Deferred Compensation Plan; and $0 and
$86,754 related to the issuance of 660,000 options in the year ended December 31, 2018 discussed below. As of December 31, 2019,
there was $0 of total unrecognized compensation costs related to warrant and stock awards and non-vested options.
During
the year ended December 31, 2019 and 2018, options with a value of $0 and $86,754, respectively, were granted to Fountainhead
with performance vesting conditions, (see Note 13). The performance conditions of the options granted during 2018 were met and
these options became fully vested in June 2018 and recognized as stock compensation during the period.
Stock-based
Compensation Valuation Methodology
Stock-based
compensation resulting from the issuance of Common Stock is calculated by reference to the valuation of the Stock on the date
of issuance, the expense being recognized as the compensation is earned. Stock-based compensation expenses related to employee
options and warrants granted to non-employees are recognized as the stock options and warrants are earned. The fair value of the
stock options or warrants granted is estimated at the grant date, using the Black-Scholes option pricing model, and the expense
is recognized on a straight-line basis over the shorter of the period over which services are to be received or the life of the
option or warrant. The grant date fair value of employee share options and similar instruments is estimated using the Black-Scholes
option pricing model on the basis of the fair value of the underlying common stock on the measurement date, adjusted for the unique
characteristics of those equity instruments, using the assumptions noted in the table below. The fair value of the common stock
is determined by the then-prevailing private placement purchase price. Expected volatility was based on the historical volatility
of a peer group of publicly traded companies. The expected term of options and warrants was based upon the life of the option,
and the risk-free rate used was based on the U.S. Treasury Constant Maturity rate.
The
stock compensation expensed during the year ended December 31, 2019 resulted from the issuance of Common Stock on the date of
vesting, valued on the date of issuance and options. The following assumptions were used in calculations of the Black-Scholes
option pricing model for option-based stock compensation in year ended December 31, 2018:
|
|
|
Year
ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Risk-free interest rates
|
|
|
-
|
%
|
|
|
1.72-2.41
|
%
|
|
Expected life
|
|
|
-
|
|
|
|
1.5
– 4.0 years
|
|
|
Expected dividends
|
|
|
-
|
%
|
|
|
0
|
%
|
|
Expected volatility
|
|
|
-
|
%
|
|
|
102-107
|
%
|
|
Vycor Common Stock fair value
|
|
$
|
-
|
|
|
|
$
0.20 - 0.49
|
|
11.
INCOME TAXES
Loss
Before Taxes
|
|
|
December
31, 2019
|
|
|
December
31, 2018
|
|
|
Domestic
|
|
$
|
675,687
|
|
|
$
|
1,077,557
|
|
|
Foreign
|
|
|
120,515
|
|
|
|
301,799
|
|
|
|
|
$
|
796,202
|
|
|
$
|
1,379,356
|
|
The
reconciliation of income tax expense at the U.S. statutory rate of 21%, to the Company’s effective tax rate is as follows:
|
|
|
Year
Ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
US statutory rate
|
|
$
|
(167,235
|
)
|
|
$
|
(289,665
|
)
|
|
Tax difference between foreign and U.S.
|
|
|
(13,341
|
)
|
|
|
(12,732
|
)
|
|
Change in Valuation
Allowance
|
|
|
(180,576
|
)
|
|
|
(302,396
|
)
|
|
Tax Provision
|
|
$
|
-
|
|
|
$
|
-
|
|
Deferred
Income Taxes
The
Company has incurred net operating losses since inception. The Company has not reflected any tax benefit related to such net operating
losses in the financial statements. Prior to August 15, 2007 the Company was a limited liability company and losses were passed
through to the individual members, therefore the Company only has potential tax benefits from the date it became a ‘C’
corporation.
Deferred
income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Significant components of the Company and its subsidiaries’
deferred tax assets at December 31, 2019 and December 31, 2018 are as follows:
|
|
|
December
31, 2019
|
|
|
December
31, 2018
|
|
|
Operating loss carry-forward
|
|
$
|
18,600,000
|
|
|
$
|
18,600,000
|
|
|
Deferred tax asset before Valuation
allowance
|
|
|
3,906,000
|
|
|
|
3,906,000
|
|
|
Valuation allowance
|
|
|
(3,906,000
|
)
|
|
|
(3906,000
|
)
|
|
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
In
assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or
all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation
of future taxable income.
The
authoritative guidance requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of the
evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Based on the level
of historical taxable losses and projections of future taxable income (losses) over the periods in which the deferred tax assets
can be realized, management currently believes that it is more likely than not that the Company will not realize the benefits
of these deductible differences. Accordingly, management has determined that a 100% valuation allowance is appropriate at December
31, 2019 and December 31, 2018.
The
U.S. Tax Cuts and Jobs Act (Tax Act) was enacted on December 22, 2017 and introduces significant changes to U.S. income tax law.
Effective in 2018, the Tax Act reduces the U.S. statutory tax rate from 35% to 21% and creates new taxes on certain foreign-sourced
earnings and certain related-party payments, which are referred to as the global intangible low-taxed income tax and the base
erosion tax, respectively. The Tax Act requires us to pay U.S. income taxes on accumulated foreign subsidiary earnings not previously
subject to U.S. income tax at a rate of 15.5% to the extent of foreign cash and certain other net current assets and 8% on the
remaining earnings. Since the Company’s foreign subsidiaries have not generated income and have no accumulated earnings,
the Company believes that the Tax Act will not have a significant impact on the Company’s consolidated financial statements.
Net
Operating Loss Carry-Forwards
Under
the Tax Act, net operating loss carryforwards generated for tax years beginning after December 31, 2018, will have an indefinite
carryforward period.
As
of December 31, 2019 and 2018, the Company had U.S. accumulated losses for tax purposes of approximately $18,600,000 and $18,600,000
respectively, which may be carried forward and offset against U.S. taxable income. $18,320,000 expires during the tax
years 2027 through 2037 and $280,000 can be carryforward indefinitely.
Federal
tax laws impose significant restrictions on the utilization of net operating loss carry-forwards and in the event of a change
in ownership of the Company, as defined by the Internal Revenue Code Section 382. The Company’s net operating loss carry-forwards
may be subject to the above limitations.
As
of December 31, 2019 and 2018, the Company had German accumulated losses for tax purposes of approximately $1,435,763 and $1,195,915
respectively, which may be carried forward and offset against German taxable income subject to certain restrictions and limitations
in the event of changes in the NovaVision GmbH’s ownership.
As
of December 31, 2019 and 2018, the Company had UK accumulated losses for tax purposes of approximately $200,010 and $234,000 respectively,
which may be carried forward and offset against UK taxable income subject to certain restrictions and limitations.
Tax
Rates
The
applicable US income tax rate for the Company for both of the years ended December 31, 2019 and 2018 was 21% and 21%, respectively.
Non-US subsidiaries are taxed according to the tax laws in their respective country of residence. The German applicable rate for
both of the years ended December 31, 2019 and 2018 was 31.58%; the UK applicable rate for both the years ended December 31, 2019
and 2018 was 19%.
US
income taxes and foreign withholding taxes were not provided for on undistributed earnings of the Company’s foreign subsidiaries.
The Company intends to reinvest these earnings indefinitely in its foreign subsidiaries. If these earnings were distributed to
US in the form of dividends or otherwise, after the repayment of intercompany debt, the Company would be subject to additional
US income taxes (subject to an adjustment for foreign tax credits) and foreign withholding taxes.
Uncertain
Tax Position
The
Company has recorded no liability for income taxes associated with unrecognized tax benefits at the date of adoption and has not
recorded any liability associated with unrecognized tax benefits during 2019 and 2018. Accordingly, the Company has not recorded
any interest or penalty in regard to any unrecognized benefit.
12.
COMMITMENTS AND CONTINGENCIES
Lease
Effective
August 1, 2017 the Company leased office space located at 951 Broken Sound Parkway, Suite 320, Boca Raton, FL 33487 from WPT Land
2L.P., for a gross rent of approximately $5,700 plus sales tax per month. The lease terminates September 30, 2020. The Company’s
subsidiary in Germany occupies premises on a short-term lease agreement. Rent expense for the year ended December 31, 2019 and
2018 was $98,682 and $99,458 respectively.
Potential
German tax liability
In
June 2012 the Company’s NovaVision German subsidiary received a preliminary assessment for Magdeburg City trade tax of €75,000 (approximately $82,000), with an additional interest
charge of €12,000 (approximately $13,200). This assessment is for the 2010 fiscal year and relates to the Company’s
acquisition of the assets of the former NovaVision, Inc. An initial assessment for corporate tax for the same period
was preliminarily reduced to zero. The Company did not accept this trade tax assessment and appealed against it to the relevant
tax authorities with a view to its reduction. The relevant tax authorities agreed to suspend the assessment pending the outcome
of certain court hearings and proposed tax legislation, and the Company agreed to make monthly payments on account totaling €75,000
(approximately $82,000) which were completed in October 2016 and fully expensed. At that time the Company appealed against the
interest charge of €12,000 (approximately $13,200) which the tax authorities did not accept but also agreed to suspend pending
the outcome of the hearings and proposed legislation outlined above. Accordingly, the Company has made no provision for this liability
in the year ended December 31, 2019 and 2018 respectively.
13.
CONSULTING AND OTHER AGREEMENTS
The
following agreement remained in force during the year ended December 31, 2019:
Consulting
Agreement with Fountainhead
In
March 2017 and effective April 1, 2017, the Company amended the Fountainhead Consulting Agreement (“the Amended Agreement”).
Under the Amended Agreement, fees of $450,000 are payable to Fountainhead, with an option to receive $5,000 per month in cash
and the remainder payable in Company Common Stock issued at the higher of $0.21 and the average price for the 30 days prior to
issuance, and deliverable at the end of each fiscal quarter. The Consulting Agreement also contains provisions for Fountainhead
to receive a higher proportion of its fees in cash subject to certain future liquidity events and Board approval. Under the terms
of the Amended Agreement, Fountainhead provides the executive management team of the Company, including the positions of CEO,
President and CFO, whose employment agreements with the Company stipulate they receive no remuneration from the Company.
14.
RELATED PARTY TRANSACTIONS AND BALANCES
Peter
Zachariou, and David Cantor, directors of the Company, are investment managers of Fountainhead which owned, at December 31, 2019,
57% of the Company’s Common Stock and 95% of the Company’s Series D Preferred Stock. Adrian Liddell, Chairman is a
consultant to Fountainhead.
During
January to December 2019 and 2018, under the terms of the Consultancy Agreement referred to in Note 13, the Company issued 2,142,856
and 2,204,770 shares, respectively, of Common Stock to Fountainhead for fees of $450,000 and $675,000, respectively, of which
$225,000 in 2018 was in respect of fees accrued at December 31, 2017.
During
the year ended December 31, 2019 and 2018, respectively, the Company issued unsecured loan notes to Fountainhead for a total of
$37,873 and $163,000, respectively. The loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary.
During year ended December 31, 2019 and 2018, the Company issued unsecured loan notes to Peter Zachariou for a total of $0 and
$30,000, respectively. The loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary.
During
each of the years ended December 31, 2019 and 2018, the Company accrued an aggregate of $324,370 of Preferred D Stock dividends,
of which $226,037 was in respect of Fountainhead and $83,386 was in respect of Peter Zachariou.
As
referred to in Note 5, on January 24, 2018 the Company entered into the Amendment with EuroAmerican. regarding its $300,000 Note.
Under the Amendment, EuroAmerican granted a right of first refusal prior to converting or selling the Note a) first to Vycor to
redeem the Note and accrued interest at face value and b) if not exercised second to Fountainhead to purchase the Note and accrued
interest at face value on the same terms. The note is personally guaranteed by certain officers and directors of the Company.
There
were no other related party transactions during the years ended December 31, 2019 and 2018.
15.
CONCENTRATION
Vycor
Medical sells its neurosurgical devices in the US primarily direct to hospitals, and internationally through distributors who
in turn sell to hospitals.
|
Sales Concentration
|
|
Year
ended December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Number of customers over
10%
|
|
|
0
|
|
|
|
0
|
|
|
Percentage of sales
|
|
|
0
|
%
|
|
|
0
|
%
|
Accounts
Receivable Concentration
|
|
|
At
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Number of customers over
10%
|
|
|
1
|
|
|
|
2
|
|
|
Percentage of accounts receivable
|
|
|
37
|
%
|
|
|
13%
and 40
|
%
|
We
have three sub-contract manufacturers who both represent over 10% of purchased on an annual basis.
16.
SUBSEQUENT EVENTS
In December 2019, an outbreak of a novel
strain of coronavirus (COVID-19) originated in Wuhan, China, and has since spread to a number of other countries, including the
United States. On March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. In addition, as of the time
of the filing of this Annual Report on Form 10-K, several states in the United States have declared states of emergency, and several
countries around the world, including the United States, have taken steps to restrict travel. While our operations are principally
located in the United States, and our sub-contract manufacturers are located in the United States, we participate in a global
supply chain, and the existence of a worldwide pandemic, the fear associated with COVID-19, or any, pandemic, and the reactions
of governments around the world in response to COVID-19, or any, pandemic, to regulate the flow of labor and products and impede
the travel of personnel, may impact our ability to conduct normal business operations, which could adversely affect our results
of operations and liquidity. Disruptions to our supply chain and business operations, or to our suppliers’ or customers’
supply chains and business operations, could include disruptions from the closure of supplier and manufacturer facilities, interruptions
in the supply of raw materials and components, personnel absences, or restrictions on the shipment of our or our suppliers’
or customers’ products, any of which could have adverse ripple effects on our manufacturing output and delivery schedule.
Although we have implemented business continuity plans for our offices and personnel to enable continuity of service remotely,
if a critical number of our employees become too ill to work, or we are not able to access a sufficient quantity of our inventory
for shipment due to enforced office closures, our production ability could be materially adversely affected in a rapid manner.
Similarly, if our customers experience adverse business consequences due to COVID-19, or any other, pandemic, demand for our products
could also be materially adversely affected in a rapid manner. Although neurosurgery is not generally an elective procedure, general
hospital dislocation and diversion of resources could impact our revenues. Global health concerns, such as COVID-19, could also
result in social, economic, and labor instability in the countries and localities in which we or our suppliers and customers operate.
Any of these uncertainties could have a material adverse effect on our business, financial condition or results of operations.
Other than the above stated Subsequent
Event, the Company has evaluated the existence of events and transactions subsequent to the balance sheet date through
the date the consolidated financial statements were issued and has determined that there were no significant subsequent
events or transactions that would require recognition or disclosure in the financial statements.