NeuroOne® Announces U.S. Commercial Launch of Evo® sEEG Electrodes
Evo sEEGs complementary to Zimmer Biomet’s robotic neurosurgery platform; strong market opportunity for paired technologies
EDEN PRAIRIE, Minn., May 02, 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 commercial launch of the Evo® sEEG electrode product line in the United States. Zimmer Biomet holds exclusive worldwide distribution rights to NeuroOne’s Evo Cortical and sEEG product lines, and the Evo product line is expected to utilize 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, “The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our Company’s history. Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the Company is well positioned in the market given the synergies that exist between our novel thin film electrode platform and Zimmer Biomet’s robotic platform. Importantly, this new technology potentially provides NeuroOne with a steady and predictable new revenue stream. We expect to complete our initial case within the next 30 days.”
NeuroOne provides a full line of electrode technology to address an estimated U.S. 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.
NeuroOne’s Evo sEEG electrode technology offers stereoelectroencephalography recording, brain stimulation and future capabilities for spinal cord stimulation, and ablation solutions targeted for patients suffering from epilepsy, chronic back pain, and Parkinson’s disease. The Evo® sEEG is the Company’s most advanced diagnostic electrode designed to be secure, precise, and less invasive, with proven placement accuracy and signal quality, and made in a mostly automated manufacturing process.
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.
About NeuroOne
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 nmtc1.com.
Forward Looking Statements
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 development of the Company’s electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of the product launch and commercialization of our technology, synergies and marketing strategies with Zimmer Biomet, clinical and pre-clinical testing, what the future may hold for electrodes and NeuroOne’s potential role, business strategy, market size, potential growth opportunities, future operations, future efficiencies, future revenue streams 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; 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 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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