(Nasdaq: NMTC) Profile
OUR NEW PROFILE IS: (NASDAQ: 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
NMTC HAS NO DEBT OUTSTANDING AS OF JUNE 30, 2023
NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION
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
CHECK OUT THE INVESTOR PRESENTATION HERE
CHECK OUT THE COMPANY FACT SHEET HERE
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Hello Everyone,
It has been quite a while since we sent out a special full profile on a company like this.
This next company has several important catalysts in play that are worth researching.
The company had incredible success last month and could be ready for the next let up as we get ready to close out 2023.
Pull up NMTC Immediately.
NMTC is a medical technology company focused on the development and commercialization of a minimally invasive and high-definition/high-precision electrode technology platform used for acute diagnostics and chronic treatment across a wide range of neurologic conditions including epilepsy, Parkinson’s disease, dystonia, essential tremors, and chronic pain due to failed back surgeries. NeuroOne’s electrodes offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions such as EEG recording and tissue ablation and/or chronic stimulation. In addition to NeuroOne’s FDA-cleared EVO® diagnostic electrodes, a combination recording and radiofrequency (RF) ablation technology, OneRF®, is currently under development as the Company’s first therapeutic device. Other research and development programs include revolutionary new thin-film-based (chronic) electrodes for spinal cord stimulation (SCS) and deep brain stimulation (DBS), and the potential application of the Company’s technology for artificial intelligence and machine learning.
AS YOU CAN SEE NOVEMBER HAS BEEN AN INCREDIBLE MONTH FOR NMTC, CRACKING NEW 5 MONTH HIGHS AND HOLDING IT’S RECENT GAINS FAIRLY WELL AFTER FINDING A NEW RANGE HERE ABOVE $1.25.
THIS ONE STARTED TAKING OFF ON NOVEMBER 7TH WHEN THE COMPANY RELEASED THE NEWS BELOW. IN THE NEWS ANNOUNCEMENT THEY ANNOUNCED THEY ANTICIPATED FEEDBACK FROM THE FDA WITHIN 30 DAYS WHICH MEANS THE COMPANY COULD HAVE SOMETHING TO REPORT ANY DAY NOW.
NEUROONE® PROVIDES PROGRESS UPDATE ON FDA 510(K) SUBMISSION FOR ONERF™ ABLATION SYSTEM
Feedback from responses to FDA anticipated in 30 days
Commercialization remains on track in first half of 2024 pending FDA clearance
Product potential for transformative improvement in neurosurgery as first known sEEG-guided RF system that records and ablates nervous tissue with the added benefit of temperature control
EDEN PRAIRIE, Minn., Nov. 07, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today that it has responded to the Food and Drug Administration’s (FDA) questions regarding the Company’s previous submission of a 510(k) for its OneRF™ Ablation System. The Company expects to receive additional communication back from the FDA in thirty days or less.
The OneRF system uses the already implanted sEEG electrodes to record brain activity and allow for ablation of nervous tissue when connected to the Company’s proprietary radio frequency (RF) generator. If cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents the first step in bringing to market an innovative RF ablation system in the field of neurology and neurosurgery.
As the Company’s first therapeutic device, OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays for patients. NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs.
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.”
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE IN ROBOTIC NEUROSURGERY
Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brain duringprocedure at Cleveland Clinic
EDEN PRAIRIE, Minn., May 17, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the first clinical case using the Evo® sEEG electrode in robotic neurosurgery. Performed by Dr. William Bingaman at Cleveland Clinic, the procedure was the first to utilize NeuroOne’s Evo sEEG electrode, exclusively marketed in the U.S. by Zimmer Biomet, with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex minimally invasive neurosurgical procedures.
Dave Rosa, CEO of NeuroOne, commented, “This clinical case utilizing our minimally invasive and high-definition electrode technology with ROSA One Brain is a major milestone in NeuroOne’s partnership with Zimmer Biomet. Now that Zimmer Biomet has commenced U.S. distribution of our Evo sEEG electrodes, this case study confirms the synergistic use of our product with Zimmer Biomet’s robotics platform which was the foundation of our interest to partner with Zimmer Biomet.”
The Evo sEEG electrode technology offers stereoelectroencephalography recording, brain stimulation and future development of ablation solutions targeted for patients suffering from multiple neurological conditions. In October 2022, NeuroOne received FDA clearance to market its Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
NEUROONE® REPORTS THIRD QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
EDEN PRAIRIE, Minn., Aug. 14, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces its operating results for the fiscal third quarter 2023 ended June 30, 2023.
Fiscal Third Quarter 2023 and Recent Business Updates
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
Dave Rosa, CEO of NeuroOne, commented, “The Company continues to execute on a number of commercial, development and financing objectives. We are now beginning to expand the commercial launch of our Evo sEEG electrode with Zimmer Biomet after a successful limited launch. In addition, we received encouraging feedback from the FDA regarding the Company’s recent 510(k) FDA submission of the OneRF Ablation System and believe our previous timelines remain on track. We are excited by the potential of our drug delivery system currently in development after recent testing at the Mayo Clinic in Rochester Minnesota. We also recently raised gross proceeds of $6.0 million through a public offering which included new fundamental institutional investors without having to offer warrants and $2.5 million through the use of an ATM (at-the-market) facility. I am pleased with the Company’s continued execution on our strategic plan and I look forward to our future progress in the areas outlined.”
Upcoming Targeted Milestones
Evo sEEG:
- Full market launch of Evo sEEG system with Zimmer Biomet
- Expand sales training of the sEEG product line to Zimmer personnel
OneRF Ablation:
- Poster presentation planned for the Congress of Neurological Surgeons (CNS) Meeting in September
- Initiate component orders for OneRF ablation system for future commercialization
SCS Program:
- Complete testing of an implantable pulse generator (IPG) for fluid ingress
- Perform percutaneous placement of a paddle electrode in a human cadaver model
Drug Delivery Program:
- Define product requirements for drug delivery system for both clinical and research use in the biotech and pharma industry
- Complete large animal feasibility studies for drug delivery system into the brain.
Fiscal Third Quarter 2023 Financial Results
Product revenue was $630,000 in the fiscal third quarter 2023, compared to product revenue of $32,000 in the fiscal third quarter 2022. For the first nine months of fiscal 2023, product revenue was $1.2 million, compared to $102,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first nine months of fiscal 2023, compared to collaboration revenue of $6,000 in the first nine months of fiscal 2022. Collaboration revenue was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the respective periods.
Total operating expenses in the fiscal third quarter 2023 were $3.8 million, compared with $2.8 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.2 million in the same period of fiscal 2022. Selling, General and Administrative (SG&A) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.5 million in the prior year period. For the first nine months of fiscal 2023, total operating expenses were $10.5 million, compared with $8.6 million in the same period of the prior fiscal year. R&D expense in the first nine months of fiscal 2023 was $5.2 million compared with $3.5 million in the same period of fiscal 2022. SG&A expense in the first nine months of fiscal 2023 was $5.3 million compared with $5.1 million in the prior year period.
Net loss was $3.5 million for the fiscal third quarter 2023, compared to a net loss of $2.8 million in the prior year period. Net loss for the first nine months of fiscal 2023 was $8.7 million compared with $8.6 million in the same period of fiscal 2022.
As of June 30, 2023, the Company had cash and cash equivalents of $3.1 million, compared to $8.1 million in cash and cash equivalents and $3.0 million in short term investments as of September 30, 2022. The Company had working capital of $3.1 million as of June 30, 2023, compared to working capital of $9.1 million as of September 30, 2022.
On July 27, 2023, the Company consummated an underwritten public offering of its common stock from which the Company received $5.2 million in net proceeds. In addition, the Company sold common stock under the ATM program from which the Company received net proceeds of $2.5 million.
The Company had no debt outstanding as of June 30, 2023.
NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION
Company is also developing a percutaneous (through a needle) delivery system for paddle leads
EDEN PRAIRIE, Minn., March 16, 2023 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the successful completion of an initial animal implant of its novel thin film paddle leads for spinal cord stimulation. The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back and leg pain.
The study evaluated the feasibility of implanting a variety of sizes and shapes of ultra-thin paddle leads in a sheep model. A mini laminectomy surgical approach was used to gain access to the epidural space for device placement. All devices were easily advanced to the target location in under one minute. A competitive silicone-based lead was also placed for comparison purposes. The NeuroOne lead fit comfortably in the epidural space and the veterinary surgeon reported no concerns regarding the placement of the lead.
These results demonstrated feasibility for placement of a thin film paddle lead intended to treat chronic back pain due to multiple failed back surgeries. More testing will be completed to optimize the design and placement. The Company is also developing a percutaneous (through a needle) paddle lead placement system which would eliminate the need for an incision in the patient’s back. The preliminary bench top testing for this percutaneous approach has also been successfully completed.
Dave Rosa, CEO of NeuroOne, commented, “This represents a major milestone for the Company as we continue our development of innovative devices that provide therapeutic properties coupled with recording capabilities. The market opportunity for spinal cord stimulation is large and growing. We believe our technology can fill a market need for improved patient outcomes due in part to its potential ability to place a paddle device through a needle, provide a larger stimulation surface area of the spinal cord, better conformability with the tissue and improve battery life of devices, reducing the frequency of patient’s need to recharge or replace the battery.”
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Evo® Cortical ElectrodeNeuroOne offers a breakthrough thin-film electrode for the diagnosis of various neurological conditions. Evo’s high- definition, minimally invasive technology delivers major advantages over the limitations of legacy silicone-based electrodes, hampered by the lack of innovation and progress in electrode technology, that are still widely used today.o Over 7 times thinner and 8 times lighter than comparable silicone electrodes used in legacy products. o Flexibility, thinness, and reduced weight facilitates potential for minimally invasive placement.o Reduced inflammation as compared to silicon-based legacy electrodes based on published testing by Mayo.Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for up to 30 days.
Evo® sEEG Electrode
The Evo sEEG electrode technology offers stereoelectrocencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was recently performed by Dr. Robert Gross at Emory University for intraoperative brain mapping at the subsurface level of the brain.
The sEEG electrode has received FDA 510(k) clearance from the FDA for use of less than 24 hours. A 510(k) for Evo sEEG electrode technology for up to 30 day use has been submitted to the FDA.
Brain Monitoring – Understanding What Allows Us To Sense, Move, Think And Feel
Neurons
86 BILLION NEURONS
Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, movement).
Monitoring Neural Activity
THEY CAN RECORD ELECTRICAL SIGNALS
There are different ways to record and monitor neural activity. Their solution is to provide electrodes that are placed on top of or within the brain and capture the activity of a group of neurons located underneath/around each contact. The signals recorded are called intracranial electroencephalogram (iEEG) or electrocorticography (ECoG) signals. The shape, amplitude and frequency of these electrical signals provide a readout of the activity of that brain area.
Monitoring Neurological Disorders
Neurological diseases may be associated with disturbances in neural activity and connectivity between brain areas. The changes in the shape, amplitude and frequency of recorded electrical signals may be used to identify areas with altered activity.
Epilepsy
Epilepsy is the disease associated with spontaneously recurring seizures. A seizure is a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in behavior, movements or feelings, and in levels of consciousness. There are different types of seizures and their characterization and classification helps guide the treatment.
There are more than twenty seven FDA-approved drugs for the treatment of seizures. However, in ~1/3 of the patient’s medication fails to control their seizures. These patients are candidates for surgical options.
Evo® Cortical Electrode
Cortical or subdural electrodes are used in electrocorticography (ECoG) or intracranial electroencephalography (iEEG) surgeries to monitor, record and stimulate the surface of the brain for up to 30 days. The company’s Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes. (Rx only)
The Evo Advantage
Decreased Immunological Response – The Evo Electrode is over 7 times thinner than a silicone electrode. The flexibility and reduced volume should reduce pain and edema.
The Evo’s polyimide substrate has properties like increased flexibility, reduced volume, and decreased immunological response, which should reduce signal artifacts.
Single Tail Design – The single thin tail design allows the implanted electrode tail to be tunneled through one incision which should reduce infection risk and procedure time.
Reduced Cable Management – A disposable cable assembly is sent with each Evo Electrode as an electrode kit, removing the need to source the correct cables for each electrode being used in surgery. Also, hospital resources are freed from the management of sterilizing and storing individual electrode cable assemblies.
How NeuroOne’s Thin Film Electrode Technology is Different
In comparison to currently available technologies, our electrodes are manufactured with polyimide thin film. Our electrodes are designed to reduce trauma to the brain by allowing a less invasive implant due to the flexibility, thinness and reduced weight of the electrode.
Furthermore, the potential to significantly increase the resolution of brain recordings may enable the usage of powerful computing techniques, such as machine learning and artificial intelligence.
Caution: US Federal law restricts this device to sell by or on the order of a physician
Two FDA-Cleared Devices and Counting
Are you beginning to understand that NeuroOne is not just “another” MedTech company? In fact, their Evo Cortical and sEEG Electrodes are both FDA approved!
What they are doing right now has incredible implications for the future of the medical industry.
So much so that the technologies below could be commonplace and in wide use across the globe.
Evo® Cortical Electrode* (less than 30-day use)
NeuroOne offers a thin-film electrode for the diagnosis of various neurological conditions. Evo’s high- definition, minimally invasive technology delivers major advantages over the limitations of legacy silicone-based electrodes, hampered by the lack of innovation and progress in electrode technology, that are still widely used today.
• 7 times thinner and 8 times lighter than typical silicone electrodes1 • Reduced artifact and improved signal quality2
• Reduced inflammation based on published testing by Mayo Clinic3
Evo® sEEG Electrode* (less than 30-day use)
The Evo sEEG electrode technology offers stereoelectroencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was performed intraoperatively by Dr. Robert Gross at Emory University for brain mapping at the subsurface level of the brain.
• Designed to be less invasive – reduced risk of brain plunge, may require fewer brain insertions • Improved signal quality vs. other devices1
• Proven implant accuracy1
• Automated manufacturing, precise and consistent quality1
*Caution U.S. Federal law restricts this device to sale by, or on the order of, a physician.
1NeuroOne data on file 2Bower R., et al. December 2017. Multi-Resolution intracranial EEG rodent recording system. (Abst. 2.062) 2017. American Epilepsy Society 3Worrell, G. et. al. December 2019. Commercial Scale Production of Thin-Film electrode arrays for Clinical Intracranial EEG. (Abst. 1.154), 2019. American Epilepsy Society)
OneRFTM Therapeutic Ablation Electrode System
OneRF is a developing technology that utilizes existing implanted sEEG diagnostic electrodes for RF ablation in nervous (brain) tissue to create tissue lesion(s). It is designed to be a safer and less expensive combination electrode, intended to improve patient outcomes, reduce procedures and overall treatment cost.
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE
Evo sEEG electrodes used for brain mapping in epilepsy surgery
EDEN PRAIRIE, Minn., May 10, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that its first clinical case using the Evo® sEEG electrode was performed by Dr. Jamie Van Gompel at Mayo Clinic. Using a non-robotic stereotactic frame system, Evo electrodes were implanted successfully and met the Company’s product performance objectives.
Dave Rosa, CEO of NeuroOne, commented, “We would like to thank Dr. Van Gompel and his surgical team at Mayo for this ‘first in the world’ opportunity. We are ecstatic with the initial performance of our Evo sEEG electrodes which confirmed the results of many years of testing on the device. While we previously used the device intraoperatively, this was the first clinical case that was cleared by the FDA for less than 30 day use. We look forward to continued success with the launch of the technology as we continue the roll out of the technology through our distribution partner, Zimmer Biomet.”
NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. Epilepsy mapping procedures primarily utilize sEEG electrodes due to their less invasive insertion procedure, but less than 5% of people with drug-resistant epilepsy who are surgical candidates receive diagnostic procedures using sEEGs. NeuroOne believes there is a significant opportunity to expand market adoption of sEEG technology with broad U.S. distribution of its Evo product line.
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
MAJOR 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.
NEUROONE® ANNOUNCES $3.5 MILLION ACCELERATED MILESTONE PAYMENT FROM ZIMMER BIOMET FOR EVO® SEEG ELECTRODE
Amendment provides Zimmer Biomet with 350,000 warrants with exercise price of $3.00 per share
EDEN PRAIRIE, Minn., Aug. 3, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. (“Zimmer”) that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments. In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company’s common stock, with an exercise price of $3.00 per share.
Dave Rosa, Chief Executive Officer of NeuroOne, states, “I want to thank Zimmer for all their support to date and their confidence in our business, technology and future endeavors. This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for a highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer.”
Brian Hatcher, President of the Trauma, CMFT, Foot and Ankle Division of Zimmer said, “We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world.” Under the Exclusive Development and Distribution Agreement signed by both parties in July 2020, Zimmer Biomet has exclusive global distribution rights to distribute the Company’s Cortical and sEEG diagnostic electrode technology.
NEWS
NOV 16, 2023 08:00AM
NEUROONE® ANNOUNCES PATENT ALLOWANCE FOR DRUG DELIVERY UTILIZING A NOVEL NEURAL PROBE
NOV 14, 2023 05:15PM
NEUROONE® APPOINTS MEDTECH EXECUTIVE CHRISTOPHER R. VOLKER AS CHIEF OPERATING OFFICER AND REPORTS INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)
NOV 07, 2023 08:00AM
NEUROONE® PROVIDES PROGRESS UPDATE ON FDA 510(K) SUBMISSION FOR ONERF™ ABLATION SYSTEM
OCT 13, 2023 09:30AM
NEUROONE® TO PRESENT AT THE THINKEQUITY CONFERENCE ON OCTOBER 19, 2023
SEP 06, 2023 04:00PM
NEUROONE® TO PRESENT AT THE H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE
AUG 14, 2023 04:00PM
NEUROONE® REPORTS THIRD QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
AUG 08, 2023 04:00PM
NEUROONE® TO REPORT THIRD QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON AUGUST 14
JUL 25, 2023 08:00AM
NEUROONE MEDICAL TECHNOLOGIES CORPORATION ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK
JUL 24, 2023 04:03PM
NEUROONE MEDICAL TECHNOLOGIES CORPORATION ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK
JUN 12, 2023 08:35AM
NEUROONE® SUBMITS 510(K) APPLICATION TO FDA FOR ONERF™ ABLATION SYSTEM
MAY 17, 2023 09:00AM
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE IN ROBOTIC NEUROSURGERY
MAY 11, 2023 04:00PM
NEUROONE® REPORTS SECOND QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
MAY 11, 2023 12:17PM
NEUROONE® TO REPORT SECOND QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON MAY 11
MAY 10, 2023 09:00AM
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE
MAY 05, 2023 03:08PM
NEUROONE REPORTS INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)
MAY 05, 2023 09:00AM
NEUROONE® TO PRESENT AT THE SIDOTI MICRO-CAP VIRTUAL CONFERENCE ON MAY 10
MAY 02, 2023 09:00AM
NEUROONE® ANNOUNCES U.S. COMMERCIAL LAUNCH OF EVO® SEEG ELECTRODES
APR 27, 2023 04:00PM
NEUROONE REPORTS INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)
MAR 16, 2023 07:30AM
NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION
MAR 09, 2023 09:00AM
NEUROONE® TO PARTICIPATE IN THE 35TH ANNUAL ROTH CONFERENCE
MAR 07, 2023 07:30AM
NEUROONE® AWARDED U.S. PATENT COVERING NOVEL AND PROPRIETARY THIN FILM ELECTRODE PLATFORM
FEB 14, 2023 04:00PM
NEUROONE® REPORTS FIRST QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
FEB 09, 2023 09:00AM
NEUROONE® TO REPORT FIRST QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON FEBRUARY 14
JAN 30, 2023 09:00AM
NEUROONE® ISSUES LETTER TO SHAREHOLDERS
DEC 22, 2022 09:00AM
NEUROONE® REPORTS FISCAL FOURTH QUARTER AND FULL FISCAL YEAR 2022 FINANCIAL RESULTS
DEC 13, 2022 04:00PM
NEUROONE® TO HOST FISCAL FOURTH QUARTER CORPORATE UPDATE
DEC 08, 2022 09:00AM
NEUROONE® TO REPORT FOURTH QUARTER AND FISCAL YEAR 2022 FINANCIAL RESULTS AND PROVIDE CORPORATE UPDATE ON DECEMBER 13
DEC 06, 2022 09:00AM
NEUROONE® SUCCESSFULLY COMPLETES FEASIBILITY STUDY WITH ITS ONERF™ ABLATION SYSTEM
NOV 30, 2022 09:00AM
NEUROONE® SHIPS INITIAL ZIMMER BIOMET ORDER FOR ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE
NOV 22, 2022 09:00AM
NEUROONE® TO RING NASDAQ STOCK MARKET CLOSING BELL ON NOVEMBER 22
NOV 21, 2022 11:00AM
NEUROONE® CEO DAVE ROSA FEATURED ON FOX BUSINESS NETWORKS MORNINGS WITH MARIA
OCT 25, 2022 09:00AM
NEUROONE® RECEIVES FDA 510(K) CLEARANCE TO MARKET ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE
SEP 22, 2022 09:00AM
NEUROONE REPORTS INDUCEMENT GRANTS UNDER NASDAQ LISTING RULE 5635(C)(4)
MANAGMENT
DAVE ROSA
President & Chief Executive Officer
Mr. Rosa is an entrepreneur with three decades of experience in the medical device industry spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa’s background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised $200M in the capital markets. Mr. Rosa holds an MBA from Duquesne University and a BS in Commerce and Engineering from Drexel University.
RON MCCLURG
Chief Financial Officer
Mr. McClurg has over 30 years of financial leadership experience with private and public companies. Prior to joining NeuroOne, Mr. McClurg was VP – Finance & Administration and Chief Financial Officer of Incisive Surgical, Inc., a privately-held medical device manufacturer, and Chief Financial Officer and Treasurer of Wavecrest Corporation, a privately-held manufacturer of electronic test instruments for the semiconductor industry. Mr. McClurg also served as Chief Financial Officer for several publicly-held companies, including Video Sentry Corporation, Insignia Systems, Inc., and Orthomet, Inc. Currently, he serves as a director for a privately held company. He began his career in public accounting with Ernst & Young, where he earned his CPA certificate. He holds a Bachelor of Business Administration degree in accounting from the University of Wisconsin – Eau Claire.
MARK CHRISTIANSON
Co-Founder, Business Development Director, Medical Sales Liaison
In excess of 15 years of executive sales, sales management, marketing, and project management experience with development stage companies. Prior to NeuroOne, Mr. Christianson held the positions of North American Sales Manager for Cortec Corporation, a manufacturer of specialty chemical products, and Regional Sales Manager for PMT Corporation, a leading manufacturer of products for neurosurgery, orthopedics and plastic surgery. He holds an accounting degree from Augsburg College.
STEVE MERTENS
Chief Technology Officer
Prior to joining NeuroOne, Mertens was Sr. Vice President of R&D and Operations at Nuvaira, a privately held lung denervation company developing minimally invasive products for obstructive lung diseases. Before that, Mertens was a Senior Vice President of Research and Development for Boston Scientific, where he guided a wide range of technologies through product development for the cardiology, electrophysiology, and peripheral vascular markets.
Mertens began his medical device career working in engineering, quality control, and manufacturing roles at SciMed Life Sciences. Mertens holds a Bachelor of Science degree in Chemical Engineering from the University of Minnesota and a master’s degree in Business Administration from the University of St. Thomas.
CAMILO DIAZ-BOTIA
Director of Electrode Development
Dr. Camilo Diaz-Botia is a highly experienced neural engineer whose work has focused on the development of technologies for bidirectional communication with the nervous system. He has authored and co-authored multiple peer reviewed scientific articles published in journals including Journal of Neural Engineering, Neuron, and Lab-on-a-Chip.
Most recently, Dr. Diaz-Botia worked for Neuralink where he led and mentored the process engineering team to deliver projects with unique microfabrication processes. Under his direction, the team built and designed novel processes for integration of thin film neural probes with brain machine interface systems.
Dr. Diaz-Botia earned a B.S. in Electrical Engineering from Universidad Nacional de Colombia and a Ph.D. in Bioengineering from the joint program at the University of California Berkeley and the University of California San Francisco. During his graduate studies, he conducted research on microfabricated thin film neural interfaces for chronic implants developing electrocorticography arrays with silicon carbide, a material suitable for long-term performance in harsh environments, and electrode arrays for minimally invasive subcortical recordings.
CHAD WILHELMY
Vice President of Quality Control and Regulatory Affairs
Chad Wilhelmy joined NeuroOne with 20 years of medical device experience developing, implementing, and leading quality management systems. Prior to joining NeuroOne, he held top leadership roles at HLT Medical as the Vice President of Quality and at Sunshine Heart as the Senior Director of Quality. He has driven quality strategies from early-stage development to commercial distribution with both the FDA and Notified Body. Chad earned a Bachelor of Science degree from the University of Wisconsin – Stout in Engineering Technology with an emphasis in Quality.
Sincerely,
