Bluewater2023
4 months ago
NeuroOne signs distro deal for neuroablation system, brings in more than $5M
AUGUST 5, 2024 BY SEAN WHOOLEY
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NeuroOne_Logo (1)NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it signed a distribution deal for its OneRF ablation system.
The Eden Prairie, Minnesota-based company signed a non-binding term sheet with an undisclosed global medical technology company. The partnership remains subject to the negotiation and execution of definitive documentation, due diligence and other closing conditions.
NeuroOne’s latest partnership could mirror the one it has with Zimmer Biomet for its Evo sEEG electrodes.
The company’s OneRF system picked up FDA 510(k) clearance in December 2023. Indications cover the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes.
NeuroOne also closed a $2.65 million private placement and added $3 million in an additional credit facility.
“Today’s financings, $3 million of which is minimally dilutive to our shareholders, puts our company in a strong position to operate our business and move forward with a potential partnership for our OneRF Ablation System, which we anticipate will close by the end of the third calendar quarter,” Dave Rosa, CEO of NeuroOne, said in a news release.
More about the NeuroOne financings
NeuroOne’s private placement consisted of an aggregate of nearly 3 million shares of common stock, plus warrants to purchase 2.2 million shares of common stock at a purchase price of 90¢ per unit. Each unit consisted of one share of common stock and a warrant to purchase 0.75 shares of common stock.
Warrants have an exercise price of $1.19 per share of common stock. They’re exercisable for a period of three years from the date of issuance. Investors in this placement included current institutional investors and insiders.
The company also secured its $3 million credit line from Growth Opportunity Funding, LLC.
NeuroOne plans to use proceeds from its offering to fund operations, working capital and general corporate purposes. That could include expanding commercialization efforts for the limited OneRF launch. It could also extend to product development for a new ablation indication and completion of the diligence process with a potential strategic partners.
LessIsMore
1 year ago
NMTC Neuroone receives FDA 510(k) clearance for the OneRF Ablation System. Stock is low-float and a prospectus was filed in early December so trade appropriately.
Device Classification Name generator, lesion, radiofrequency
510(k) Number K231675
Device Name OneRF Ablation System
Applicant
NeuroOne Medical Technologies Corp.
7599 Anagram Drive
Eden Prairie, MN 55344
Applicant Contact Debra Kridner
Correspondent
Mcra, LLC
803 7th St., NW, 3rd Floor
Washington, DC 20001
Correspondent Contact John Doucet
Regulation Number 882.4400
Classification Product Code
GXD
Subsequent Product Code
GXI
Date Received 06/08/2023
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
4gh1rx
1 year ago
NMTC - proprietary assets
$NMTC
_______________________________
Financial Highlights:
Product revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022
Collaboration revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023
Evo® sEEG:
Completed limited launch at target centers by end of July; full launch with Zimmer Biomet expected by end of fiscal fourth quarter
Positive user feedback received on product evaluation forms
Initiation of new sites expected to ramp in fiscal fourth quarter
Received first order for calendar 2024 product supply from Zimmer Biomet
OneRF™Ablation:
Submitted 510(k) to FDA on June 8th
Poster presentation on OneRF Ablation System preclinical study at the Neurological Disorders Summit (NDS 2023) in Italy
Received feedback from FDA regarding 510(k) submission for OneRF Ablation System
Spinal Cord Stimulation Program:
Completed 28 day animal implants of the Company’s thin film spinal cord stimulation paddle electrodes without any adverse events or neurological complications
Filed a non-provisional patent for a novel conformable thin film paddle lead for spinal cord placement
Drug Delivery Program:
Successfully completed proof of concept testing of drug delivery into the brain in a small animal model at the Mayo Clinic in Rochester, Minnesota
OTHER CATALYSTS
1. Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
2. Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
3. Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
4. Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
______________________________________________________________________________________
$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** NMTC ***NMTC
4gh1rx
1 year ago
$NMTC - PR 11/07/2023
$NMTC
__________________________________________________
Projection -
Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
____________________________________________________
$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC. *** $NMTC *** $NMTC *** $NMTC
4gh1rx
1 year ago
8K Out - filed 11/07/2023
$NMTC
_______________________________
discussion:
Dave Rosa, CEO of NeuroOne, commented, “We remain bullish on the potential for this technology to cause a paradigm shift in how patients are treated in ablation procedures. The potential to reduce hospital stays, additional procedures, complications and cost gives us confidence that this will have a meaningful impact in the market. We hope to complete discussions with the FDA in the near future as we prepare for a targeted commercial launch in the first half of 2024.”[/I]
___________________________________
Current:
Float: 7,976,291 shares available to trade
_______________________________
$NMTC *** $NMTC *** $NMTC *** $NMTC *** NMTC *** NMTC ***
4gh1rx
1 year ago
NMTC - catalysts
$NMTC
_______________________________
Financial Highlights:
Product revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022
Collaboration revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023
Evo® sEEG:
Completed limited launch at target centers by end of July; full launch with Zimmer Biomet expected by end of fiscal fourth quarter
Positive user feedback received on product evaluation forms
Initiation of new sites expected to ramp in fiscal fourth quarter
Received first order for calendar 2024 product supply from Zimmer Biomet
OneRF™Ablation:
Submitted 510(k) to FDA on June 8th
Poster presentation on OneRF Ablation System preclinical study at the Neurological Disorders Summit (NDS 2023) in Italy
Received feedback from FDA regarding 510(k) submission for OneRF Ablation System
Spinal Cord Stimulation Program:
Completed 28 day animal implants of the Company’s thin film spinal cord stimulation paddle electrodes without any adverse events or neurological complications
Filed a non-provisional patent for a novel conformable thin film paddle lead for spinal cord placement
Drug Delivery Program:
Successfully completed proof of concept testing of drug delivery into the brain in a small animal model at the Mayo Clinic in Rochester, Minnesota
OTHER CATALYSTS
Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
______________________________________________________________________________________
$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC
4gh1rx
1 year ago
NMTC partnership
___________________________
Highlights:
-- STRATEGIC PARTNERSHIP WITH ZIMMER BIOMET (NYSE:ZBH, ~$27B MKT CAP) TO EXCLUSIVELY COMMERCIALIZE AND DISTRIBUTE EVO® DIAGNOSTIC ELECTRODES; ACCELERATED PAYMENT OF $3.5 MILLION RECEIVED IN AUGUST 2022
-- NMTC HAS NO DEBT OUTSTANDING AS OF JUNE 30, 2023
-- PRODUCT REVENUE OF $630,000 IN Q3 2023, COMPARED TO $32,000 IN Q3 2022
_______________________________________________________________________________
$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC
4gh1rx
1 year ago
$NMTC treats
_______________
NMTC
_______________________________
Financial Highlights
Product revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022
Collaboration revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023
Evo® sEEG:
Completed limited launch at target centers by end of July; full launch with Zimmer Biomet expected by end of fiscal fourth quarter
Positive user feedback received on product evaluation forms
Initiation of new sites expected to ramp in fiscal fourth quarter
Received first order for calendar 2024 product supply from Zimmer Biomet
OneRF™Ablation:
Submitted 510(k) to FDA on June 8th
Poster presentation on OneRF Ablation System preclinical study at the Neurological Disorders Summit (NDS 2023) in Italy
Received feedback from FDA regarding 510(k) submission for OneRF Ablation System
Spinal Cord Stimulation Program:
Completed 28 day animal implants of the Company’s thin film spinal cord stimulation paddle electrodes without any adverse events or neurological complications
Filed a non-provisional patent for a novel conformable thin film paddle lead for spinal cord placement
Drug Delivery Program:
Successfully completed proof of concept testing of drug delivery into the brain in a small animal model at the Mayo Clinic in Rochester, Minnesota
_______________________________________________________________________________
$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC
4gh1rx
1 year ago
NMTC partnership
___________________________
Highlights:
-- STRATEGIC PARTNERSHIP WITH ZIMMER BIOMET (NYSE:ZBH, ~$27B MKT CAP) TO EXCLUSIVELY COMMERCIALIZE AND DISTRIBUTE EVO® DIAGNOSTIC ELECTRODES; ACCELERATED PAYMENT OF $3.5 MILLION RECEIVED IN AUGUST 2022
-- NMTC HAS NO DEBT OUTSTANDING AS OF JUNE 30, 2023
-- PRODUCT REVENUE OF $630,000 IN Q3 2023, COMPARED TO $32,000 IN Q3 2022
_______________________________________________________________________________
$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC
4gh1rx
1 year ago
NMTC news ....
$NMTC
___________________________
CATALYSTS:
1. Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
2. Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
3. Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
4. Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
5. Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
6. Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
_______________________________________________________________________________
$NMTC *** $NMTC *** $NMTC *** NMTC *** $NMTC *** $NMTC
4gh1rx
1 year ago
NMTC Update
$NMTC
_____________________
Financial Highlights
Product revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022
Collaboration revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023.
__________________________________________________
$NMTC *** $NMTC *** $NMTC *** $NMTC
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