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

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NMTC - proprietary assets


$NMTC
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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 $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
4. Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** NMTC ***NMTC

NMTC - Technical opinion

$NMTC ****
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INDICATOR:

Composite Indicator
Trend Seeker®
BUY
Short Term Indicators
20 Day Moving Average
BUY
20 - 50 Day MACD Oscillator
BUY
20 - 100 Day MACD Oscillator
SELL
20 - 200 Day MACD Oscillator
SELL
20 - Day Average Volume: 201,310 Average: HOLD
source: BarChart.COM --- https://www.barchart.com/stocks/quotes/NMTC/opinion11/08/2023
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$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC ***

$NMTC - PR 11/07/2023

$NMTC
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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 $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC. *** $NMTC *** $NMTC *** $NMTC

8K Out - filed 11/07/2023


$NMTC
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discussion:
Dave Rosa, CEO of NeuroOne, commented, “We remain bullish on the potential for this technology to cause a paradigm shift in how patients are treated in ablation procedures. The potential to reduce hospital stays, additional procedures, complications and cost gives us confidence that this will have a meaningful impact in the market. We hope to complete discussions with the FDA in the near future as we prepare for a targeted commercial launch in the first half of 2024.”[/I]
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Current:
Float: 7,976,291 shares available to trade
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** NMTC *** NMTC ***

***News out NMTC

$NMTC - news out FDA response

_news today_____________________________
NeuroOne® Provides Progress Update on FDA 510(k) Submission for OneRF™ Ablation System
November 07 2023 - 08:00AM
GlobeNewswire Inc.

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Current shares -
Float: 7,976,291 shares available to trade
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** NMTC. *** NMTC

$NMTC - up 5% from bottom


$NMTC - feature

$NMTC - MACD rising above 9D-MA
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Total shares outstanding ****** 23,919,184 (11/03/2023)
$NMTC



NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode in Robotic #Neurosurgery: Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brain during procedure at @ClevelandClinic.

Read here: https://t.co/5hLL0U97Od$NMTC #N1MTC pic.twitter.com/Rj21O8388A
— NeuroOne Medical Technologies Corporation (@N1MTC) May 17, 2023

--- Full Profile Here: https://insiderfinancial.com/newalert
[Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023].
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

$NMTC - feature

$NMTC - accumulation
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current float: ****** 7,976,291 (11/03/2023)
$NMTC

Full Profile Here: https://insiderfinancial.com/newalert
[Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023].
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

$NMTC - re 'Going Higher'
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$NMTC

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

Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023.
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

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 $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

NMTC - Debt to equity


$NMTC
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Current: debt/equity: 0.31
Total Assets: *** $5,758,124 - per latest 10K (08/14/2023)
Total Liabilities * $1,836,826 - " - " - " - " - " - (08/14/2023)
https://www.otcmarkets.com/stock/NMTC/disclosure
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

NMTC - low floater - structure

$NMTC
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Current:
Float: 7,976,291 shares available to trade
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$NMTC *** $NMTC *** $NMTC *** $NMTC *** $NMTC

NMTC - low floater - structure

$NMTC
_______________________________
Current:
Float: 7,976,291 shares available to trade
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$NMTC *** $NMTC *** $NMTC *** $NMTC ***

NMTC share structure

$NMTC
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Current:
Held at DTC: 13,732,171 shares
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$NMTC *** $NMTC *** $NMTC *** $NMTC ***

NMTC share structure

NMTC
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current:
O/S: 23,919,184 shares
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$NMTC *** $NMTC *** $NMTC *** $NMTC

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

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$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC

NMTC ratings

NMTC
________________________________
Barchart Opinion
INDICATOR
Opinion Strength & Direction ***BUY
Composite Indicator
Trend Seeker® ***BUY
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Short Term Indicators
20 Day Moving Average ***BUY
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$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC

$NMTC treats

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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

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

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$NMTC *** NMTC *** NMTC *** NMTC *** NMTC *** NMTC

$NMTC - Monday 10/30/2023 mention

NMTC ________________
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$NMTC *** $NMTC *** $NMTC *** NMTC *** $NMTC *** $NMTC

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

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 $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023.
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$NMTC *** $NMTC *** $NMTC *** $NMTC

NMTC recent profile

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NMTC HAS NO DEBT OUTSTANDING AS OF JUNE 30, 2023
PRODUCT REVENUE OF $630,000 IN Q3 2023, COMPARED TO $32,000 IN Q3 2022
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$NMTC

I bought 900 shares right before closing and it didn’t show them in trades.

NMTC.......................https://stockcharts.com/h-sc/ui?s=NMTC&p=W&b=5&g=0&id=p86431144783;

2.10 right around the corner

Tapped this baby again

$NMTC loading up this week! :)

Up 8% on 2X average daily volume. I like it.

Nice green start here.

$NMTC

it seems this this has become a trading stock. I'm holding

Impressive run over the short term. Better than expected.

Highlights from the Neuralink presentation yesterday.

Quarter-sized implant with 64 "hairs".
Drill holes.
Remove quarter-sized section of skull.
Insert 64 "hairs" / electrodes into the brain.
Insert quarter-size implant into the section of removed skull bone.
Seal of skin and viola, you're brain now has blue tooth.

Up 12% early. Let's see if it holds.

Elon's Neuralink is now "ready" for humans. Elon tweeted the news last night. Didn't get any "pin action" from Neuralink's yearly presentation last year. Maybe this year is different? 20% bump today, perhaps?

anyone out there???

Huge coverage on Fox Business this AM - love what the company does. just took a small position today.

FDA 501(k) clearance for 30 day use of the EVO sEEG system is huge news, and takes the shackles off of Zimmer Biomet to market this product.

The share price drop, in the face of this great news, is perplexing, but will likely be followed by a sharp rebound once this news is fully processed by the market.

Yep

And hopefully you sold them today right after opening bell

Going higher

Loaded 15000 shares

Ok nice

10K/A is out and a PR.

Looks good I’m in

Just saw the CEO on Fox Business. Didn't even know about NMTC until now. I'm in.

Strong close!

It's trading 80% over its 10-day average volume in the last 30 minutes of the day, UP 11% and just under the high of the day.

Definitely HUGE News and as things develop, $NMTC will rocket.