NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) has announced its first clinical case using the Evo sEEG electrode at Emory University, performed by Dr. Robert Gross. This milestone supports the company's goal of improving surgical options for neurological disorders. NeuroOne plans to submit a 510(k) application to the FDA in August for commercial clearance of the electrode for less than 30 days of use. The Evo sEEG electrode has a market potential of $100 million and offers a less invasive alternative for brain mapping compared to traditional methods.
- First clinical case using the Evo sEEG electrode has been successfully performed.
- Evo sEEG electrode has potential to capture a $100M market for diagnostic brain mapping.
- Company is preparing to submit a 510(k) application to the FDA for product commercialization.
- Potential delays in commercialization due to supply chain issues and labor shortages.
- Risks associated with the performance of technology based on clinical trial results.
Case performed at Emory University for intraoperative brain mapping
EDEN PRAIRIE, Minn., July 12, 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 the first clinical case using the Evo sEEG electrode was performed by Dr. Robert Gross at Emory University. Dr. Gross selected the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the brain.
Dave Rosa, Chief Executive Officer of NeuroOne, states, "This first clinical case use represents a major milestone achievement of one of our primary objectives for the Company. We are grateful to Dr. Gross and his staff and were excited to hear of the positive experience he had using the electrode. We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA in August for clearance to commercialize the product for less than 30 days use."
In September 2021, the Company received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
The Evo sEEG electrode represents the Company's second FDA 510(k) cleared product, providing a full line of electrode technology to address an estimated worldwide market of
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. For more information, visit https://www.n1mtc.com .
This press release may include 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 or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" 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 timing of the Company's submission of its revised 510(k) clearance request for its Evo® sEEG electrode for less than 30-day use. 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, labor shortages, the impact of COVID-19 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"
Dr. Robert Gross is a paid consultant for NeuroOne Medical Technologies Corporation.
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SOURCE NeuroOne Medical Technologies Corporation
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