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NeuroOne(R) Announces Initial Successful Cases Completed With OneRF(R) Trigeminal Nerve Ablation System at the University Hospitals in Cleveland

Patients Reported Pain Relief Without Postoperative Complications

Further Validates NeuroOne’s Patented Platform Technology for Both Brain Ablation and Pain Management Procedures

In August 2025, the Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its OneRF® Trigeminal Nerve Ablation System, which leverages the Company’s proprietary OneRF® Ablation platform technology for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually(1). The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.

Dr. Michael Staudt, the Lincoln Endowed Chair in Brain Health and an Associate Professor of Neurological Surgery at University Hospitals, performed radiofrequency (“RF”) ablations on two patients suffering from trigeminal neuralgia. The ablations were performed in the operating room and both patients reported pain relief, without complications. With NeuroOne’s multi-contact probe, the surgeon was able to ablate the relevant nerve branches without repositioning the probe each time.   

Dr. Staudt commented, “We are pleased with how NeuroOne’s OneRF Trigeminal Nerve Ablation System performed ablations in these cases, and we look forward to adopting this tool in our clinical practice. We believe it offers patients and physicians meaningful advantages over other systems available today.”

Dave Rosa, CEO of NeuroOne, added, “This is our first foray into pain management therapies with our thin film ablation technology. Importantly, this milestone successfully showcases our platform technology’s unique ability to be adopted for both brain ablation procedures as well as pain management. To that end, we expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, including lower back pain, with an annual market of over $1 billion as we target a limited commercial launch. On behalf of the entire NeuroOne team, we would like to thank Dr. Staudt and his staff for their support.”

The OneRF® Trigeminal Nerve Ablation System features a minimally invasive surgical technology to treat severe, chronic facial pain. The system delivers targeted RF energy to ablate trigeminal nerve fibers, interrupting pain signaling. Differentiated features of this system include a “first-of-its-kind” multi-contact RF probe that allows for both precise localization and targeted ablation of the pain-conducting nerve tissue - using the same RF probe - and under temperature-controlled conditions, which enhances safety and accuracy. This system may also allow for reduced procedural time, as well as improved patient comfort and safety.

1American Association of Neurological Surgeons (AANS) - April 2024

About NeuroOne

NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System (for brain), and OneRF® Trigeminal Nerve Ablation System. These solutions 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. The Company is engaged in research and development for drug delivery and spinal cord stimulation (SCS) programs. For more information, visit www.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," "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 additional procedures to be performed, the potential for NeuroOne to pursue additional opportunities in pain management and other therapeutic applications, including lower back pain, and the business strategy, market size, potential growth opportunities, and future operations. 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 our partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, 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 related to our ability 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.

Company Contact:
800-631-4030
ir@nmtc1.com

Investor Relations:
MZ Group - MZ North America
949-491-8235
NMTC@mzgroup.us   

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