NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain

Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025 

EDEN PRAIRIE, Minn., March 11, 2025 (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, has accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the Company’s patented OneRF^® Technology Platform. The Company had previously projected a submission by the end of June 2025.

Trigeminal nerve ablation is a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face caused by trigeminal neuralgia. The trigeminal nerve is the main sensory nerve in the face and NeuroOne’s procedure is designed to provide pain relief for this condition. According to the October 2024 Research and Markets report titled Trigeminal Neuralgia Therapeutics Market, the trigeminal neuralgia therapeutics market, comprised of pharmacologic and surgical technologies, is expected to grow from $262 million in 2024 to over $416 million by 2030, primarily due to an aging population.

“Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation System, approximately two months ahead of schedule,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “If cleared by the FDA—we believe there is a potential to generate revenues from trigeminal nerve ablation in late 2025, which was not previously expected in calendar year 2025.

“Importantly, trigeminal nerve ablation would be the second radiofrequency ablation technology in our portfolio leveraging our patented OneRF^® Technology Platform. As we move ahead, we believe there are several additional ablation applications we can introduce and look forward to updating you on our progress as we move throughout the year.”

About NeuroOne

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing 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 press release 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,” “forecasts,” “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 plan to submit a 510(k) application with the FDA in May 2025 for our trigeminal nerve ablation program, the potential to receive revenue from the commercialization of our trigeminal nerve ablation program in 2025 or at all, our 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 for 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 related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages 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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