NeuroOne® to Host Fiscal Fourth Quarter Corporate Update
EDEN PRAIRIE, Minn., Dec. 13, 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, to host fiscal Fourth Quarter Corporate Update for the period ended September 30, 2022.
Fourth Quarter and Recent Business Highlights
- Received a $3.5 million accelerated payment from distribution partner Zimmer Biomet related to certain milestone events; Zimmer Biomet received a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share
- Received FDA 510(k) clearance to market the Evo® sEEG Electrode technology for temporary (less than 30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, enabling NeuroOne to fully address the approximately $100M diagnostic electrode market
- Shipped initial stocking order to Zimmer Biomet for Evo sEEG Electrodes
- Completed hardware and software prototypes for preliminary design verification tests on a proprietary radiofrequency (RF) generator for use with the NeuroOne OneRF™ ablation system that is being developed to record brain activity and ablate brain tissue using the same electrode
- Successfully completed an animal feasibility study with the OneRF combination recording and ablation technology at the Mayo Clinic
- Successfully tested complete OneRF ablation system with nine leading Neurosurgeons, with encouraging initial feedback
- Implemented physician advisory board comprised of leading neurosurgeons and pain specialists for our Spinal Cord Stimulation electrode platform
- Developed electrode designs for spinal cord stimulation to treat chronic back pain
- CEO Dave Rosa featured on Fox Business Network's 'Mornings with Maria'
- Included in an NIH grant submission with the University of Minnesota to develop a chronic cortical electrode capable of both recording and stimulation, that would, with potential assistance from Medtronic, plug directly into a Medtronic pulse generator. We believe this device will provide new opportunities for clinical studies in many areas, including chronic pain, substance use disorder, obsessive compulsive disorder, and other mental health conditions
- Presented our data to the scientific community at the Neuroelectronic Interfaces Gordon Research Conference, Congress of Neurological Surgeons, Society for Neuroscience, and American Epilepsy Society meetings
- Exhibited our Evo electrode product family with Zimmer Biomet at Congress of Neurological Surgeons annual meeting and American Epilepsy Society annual meeting
- Evo sEEG implantation accuracy study featured in a podium presentation at the Biennial Meeting of the World Society for Stereotactic & Functional Neurosurgery, held in South Korea September 4-7, 2022
- Rang Nasdaq Stock Market closing bell to commemorate FDA clearance milestone for Evo sEEG Electrode technology
Dave Rosa, CEO of NeuroOne, commented, "During and subsequent to our fiscal fourth quarter, we made significant progress across a number of key initiatives. We were excited to receive FDA 510(k) clearance for our second diagnostic product, the Evo sEEG Depth Electrode, for less than 30 day use. We are now preparing for the commercial launch of this product in the first calendar quarter of 2023 with our distribution partner Zimmer Biomet. Additionally, we made notable progress on our OneRF ablation system, completing hardware and software prototypes for design verification testing of the accompanying RF generator, completing the design of the OneRF system accessories, and completing an animal feasibility study at the Mayo Clinic. This system will potentially be our first therapeutic device, representing the next major phase in the Company's development. In addition, we strengthened our balance sheet with the receipt of $3.5 million from Zimmer Biomet. Taken altogether, we begin fiscal 2023 with several commercial and development catalysts and a product pipeline targeting multi-billion-dollar markets, underpinning our unwavering commitment to driving shareholder value."
Upcoming Targeted Milestones
- Evo sEEG Depth Diagnostic Electrode
- Commercial launch in the first calendar quarter of 2023
- OneRF Ablation therapeutic electrode and generator system
- Complete design verification and validation of the full OneRF ablation system
- Begin production of final RF Generator design
- Submit application for FDA 510(k) clearance by mid calendar year 2023
- Chronic Use Electrode
- Engage firm to design percutaneous delivery system
- Complete prototypes for development of surgical techniques and in-vivo validation of thin film technology performance in the spinal cord
- Complete and initiate testing of electrode prototypes to demonstrate chronic stability of thin film devices
We have not yet filed our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, and we will provide financial results when our independent registered public accounting firm completes its audit procedures.
As of September 30, 2022, the Company had cash, cash equivalents, and short-term investments of $11.1 million. The Company had no debt outstanding as of September 30, 2022.
Tuesday, December 13, 2022 – 4:30 PM Eastern Time
Participant Dial-In:
877-407-8293 / +1 201-689-8349
Live Webcast:
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Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13734879; available through December 27, 2022
Webcast Replay:
Available for 12 months
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit https://www.n1mtc.com .
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward–looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "upcoming," "target," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the development of the Company's ablation electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch and commercialization of our technology, clinical and pre-clinical testing, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds; the risk that the COVID-19 pandemic will continue to adversely impact our business; the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.
"Caution: Federal law restricts this device to sale by or on the order of a physician"
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