NeuroOne® Completes FDA Submission for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Multi-Contact Probe Provides Alternative to Pharmaceutical and Invasive Surgical Treatments
Submission Completed Earlier Than Anticipated
EDEN PRAIRIE, Minn., April 23, 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 filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.
This submission leverages the Company’s proprietary OneRF® Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the U.S.1. 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 (MCD), radiosurgery, or other percutaneous techniques. The OneRF® Trigeminal Nerve Ablation technology features a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face. Differentiated features of this multi-contact probe are designed to use multi-point mapping of pain location, stimulation and ablation, all using the same electrode and with the safety of temperature-controlled ablation. These features are also present in the FDA 510(k) cleared OneRF sEEG (brain) Ablation System. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.
Previously published data have shown that RF ablation offers high initial pain relief rates (~95%) and long-term efficacy, especially with repeat treatments, while maintaining a low complication rate2,3, These characteristics make it a preferred option for patients who are not candidates for major surgery or who are looking for less invasive approaches4.
Dave Rosa, President and CEO of NeuroOne, stated: “Our OneRF® ablation technology platform has already achieved successful commercialization and patient outcomes in lesioning nerve tissue for functional neurosurgical procedures, such as the treatment of epilepsy. Expanding into facial pain broadens the clinical impact of our technology and further validates the versatility and scalability of our platform.”
“If cleared by the FDA, we believe there is a potential to generate revenues from trigeminal nerve ablation in late calendar year 2025.”
NeuroOne’s OneRF® ablation technology has garnered significant media interest, including recent features on and . For more interviews and information on the company, please visit .
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 .
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 potential to receive 510(k) clearance for our trigeminal nerve ablation system, 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.
IR Contact
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2 Kanpolat Y et al. Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia: 25-year experience with 1,600 patients. Neurosurgery. 2001 Mar;48(3):524-32;. doi: 10.1097/00006123-200103000-00013.
3 Wang Z et al. Radiofrequency thermocoagulation for the treatment of trigeminal neuralgia. Exp Ther Med. 2022 Jan;23(1):17. doi: 10.3892/etm.2021.10939.
4 Emril DR, Ho KY. Treatment of trigeminal neuralgia: role of radiofrequency ablation. J Pain Res. 2010 Dec 12;3:249-54.doi: 10.2147/JPR.S14455.
