NeuroOne® Receives FDA 510(k) Clearance for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
FDA Clearance Further Validates Technology Platform and Offers Alternatives to Pharmaceutical and Invasive Surgical Treatments
EDEN PRAIRIE, Minn., Aug. 18, 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 received U.S. Food and Drug Administration ("FDA") clearance to market its OneRF® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. As previously announced, the company completed the FDA submission earlier than anticipated and now targets a limited commercial launch in the fourth quarter of calendar 2025.
This clearance leverages the Company's proprietary OneRF® Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually1. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.
Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression (MVD), radiosurgery, or other percutaneous techniques. The OneRF® Trigeminal Nerve Ablation System features a minimally invasive surgical technology to treat severe, chronic facial pain. The system delivers targeted radiofrequency (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 tailored ablation of the pain-conducting nerve tissue – using the same RF probe, and under temperature-controlled conditions which enhance safety and accuracy. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.
"One of the key aspects of the OneRF® technology platform is its potential to be effective across multiple neurological disorders and pain management functions," said Dave Rosa, Chief Executive Officer of NeuroOne. "This is our first venture in pain management therapies and this newest technology aligns well with current commercial efforts with our OneRF® brain ablation system. Some of the current users for the OneRF® brain ablation system also perform nerve ablation procedures for facial pain, which may allow current medical practices to further justify the investment. Furthermore, we expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, such as treatment of lower back pain. With this clearance, we will continue our ongoing discussions with strategic partners and have the potential to begin generating revenues from trigeminal nerve ablation as soon as late calendar year 2025."
About NeuroOne
NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, monitoring, ablation, drug delivery and stimulation 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 timing and success of our commercial launch of the OneRF® Trigeminal Nerve Ablation System, our ability to obtain revenues from such launch in calendar 2025, the ability for our product to allow for reduced procedural time, improved patient comfort and improved patient safety, our ability to leverage our platform to pursue additional opportunities in pain management and other therapeutic applications, and our business strategy, market size, and other potential growth opportunities. 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.
IR Contact
MZ Group – MZ North America
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1 American Association of Neurological Surgeons (AANS) - April 2024
