NeuroOne® Completes FDA Submission for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
NeuroOne Medical Technologies (Nasdaq: NMTC) has submitted a 510(k) application to the FDA for its OneRF® Trigeminal Nerve Ablation System, ahead of schedule. The system aims to treat trigeminal neuralgia, a chronic facial pain condition affecting approximately 100,000 Americans.
The technology features a minimally invasive surgical procedure using radiofrequency energy to destroy abnormal tissue. Key features include multi-point mapping of pain location, stimulation, and temperature-controlled ablation, all using the same electrode. Published data indicates RF ablation achieves ~95% initial pain relief rates with long-term efficacy and low complication rates.
If FDA cleared, NeuroOne anticipates potential revenue generation from trigeminal nerve ablation by late 2025. The system builds upon the company's FDA-cleared OneRF sEEG Ablation System for brain procedures.
NeuroOne Medical Technologies (Nasdaq: NMTC) ha presentato in anticipo alla FDA una domanda 510(k) per il suo OneRF® Trigeminal Nerve Ablation System. Il sistema è progettato per trattare la nevralgia del trigemino, una condizione cronica di dolore facciale che colpisce circa 100.000 americani.
La tecnologia prevede una procedura chirurgica minimamente invasiva che utilizza energia a radiofrequenza per distruggere il tessuto anomalo. Le caratteristiche principali includono la mappatura multipunto della localizzazione del dolore, la stimolazione e l’ablazione a temperatura controllata, tutto tramite lo stesso elettrodo. I dati pubblicati indicano che l’ablazione con RF garantisce circa il 95% di sollievo iniziale dal dolore, con efficacia a lungo termine e basse complicazioni.
In caso di approvazione FDA, NeuroOne prevede di generare ricavi dalla procedura di ablazione del nervo trigemino entro la fine del 2025. Il sistema si basa sull’esperienza del OneRF sEEG Ablation System, già approvato dalla FDA per interventi cerebrali.
NeuroOne Medical Technologies (Nasdaq: NMTC) ha presentado antes de lo previsto una solicitud 510(k) a la FDA para su OneRF® Trigeminal Nerve Ablation System. El sistema está diseñado para tratar la neuralgia del trigémino, una condición crónica de dolor facial que afecta a aproximadamente 100,000 estadounidenses.
La tecnología consiste en un procedimiento quirúrgico mínimamente invasivo que utiliza energía de radiofrecuencia para destruir el tejido anormal. Sus características clave incluyen mapeo multipunto de la localización del dolor, estimulación y ablación controlada por temperatura, todo mediante el mismo electrodo. Datos publicados indican que la ablación por RF logra aproximadamente un 95% de alivio inicial del dolor, con eficacia a largo plazo y bajas tasas de complicaciones.
Si la FDA lo aprueba, NeuroOne anticipa generar ingresos por la ablación del nervio trigémino a finales de 2025. El sistema se basa en el OneRF sEEG Ablation System de la compañía, ya aprobado por la FDA para procedimientos cerebrales.
NeuroOne Medical Technologies (나스닥: NMTC)는 예정보다 앞서 OneRF® 삼차신경 절제 시스템에 대해 FDA에 510(k) 신청서를 제출했습니다. 이 시스템은 약 10만 명의 미국인이 겪고 있는 만성 안면 통증 질환인 삼차신경통 치료를 목표로 합니다.
이 기술은 비침습적 수술 절차로, 이상 조직을 파괴하기 위해 고주파 에너지를 사용합니다. 주요 기능으로는 동일 전극을 사용한 다중 지점 통증 위치 매핑, 자극, 온도 제어 절제가 포함됩니다. 발표된 데이터에 따르면 고주파 절제술은 약 95%의 초기 통증 완화율과 장기적 효능, 낮은 합병증 발생률을 보여줍니다.
FDA 승인이 이루어질 경우, NeuroOne은 2025년 말까지 삼차신경 절제술을 통한 수익 창출을 기대하고 있습니다. 이 시스템은 뇌 수술용으로 FDA 승인을 받은 OneRF sEEG Ablation System을 기반으로 개발되었습니다.
NeuroOne Medical Technologies (Nasdaq : NMTC) a soumis en avance une demande 510(k) à la FDA pour son Système d'Ablation du Nerf Trijumeau OneRF®. Ce système vise à traiter la névralgie du trijumeau, une douleur faciale chronique qui touche environ 100 000 Américains.
La technologie repose sur une procédure chirurgicale peu invasive utilisant l’énergie radiofréquence pour détruire les tissus anormaux. Ses principales caractéristiques incluent une cartographie multipoint de la localisation de la douleur, une stimulation et une ablation contrôlée en température, le tout avec la même électrode. Les données publiées montrent que l’ablation par RF offre environ 95 % de soulagement initial de la douleur, avec une efficacité à long terme et un faible taux de complications.
Si la FDA donne son feu vert, NeuroOne prévoit de générer des revenus grâce à l’ablation du nerf trijumeau d’ici fin 2025. Ce système s’appuie sur le OneRF sEEG Ablation System, déjà approuvé par la FDA pour les interventions cérébrales.
NeuroOne Medical Technologies (Nasdaq: NMTC) hat vorzeitig einen 510(k)-Antrag bei der FDA für sein OneRF® Trigeminal Nerve Ablation System eingereicht. Das System soll die Trigeminusneuralgie behandeln, eine chronische Gesichtsschmerz-Erkrankung, die etwa 100.000 Amerikaner betrifft.
Die Technologie umfasst ein minimalinvasives chirurgisches Verfahren, das Radiofrequenzenergie nutzt, um abnormes Gewebe zu zerstören. Zu den wichtigsten Merkmalen zählen die multipunkte Schmerzlokalisierung, Stimulation und temperaturkontrollierte Ablation – alles mit derselben Elektrode. Veröffentlichten Daten zufolge erzielt die RF-Ablation eine anfängliche Schmerzlinderung von etwa 95 % mit langfristiger Wirksamkeit und niedrigen Komplikationsraten.
Bei FDA-Zulassung rechnet NeuroOne damit, bis Ende 2025 Einnahmen aus der Trigeminusnerv-Ablation zu generieren. Das System baut auf dem bereits von der FDA zugelassenen OneRF sEEG Ablation System für Hirnprozeduren auf.
- 510(k) submission completed ahead of schedule
- Technology addresses large market of 100,000 U.S. patients
- Published data shows ~95% initial pain relief rates with low complications
- Potential revenue generation expected by late 2025 if cleared
- Builds on existing FDA-cleared OneRF platform
- FDA clearance still pending and not guaranteed
- Revenue generation dependent on regulatory approval
- Faces competition from established treatment methods
Insights
NeuroOne's early FDA submission for facial pain treatment demonstrates regulatory execution and potential market expansion.
NeuroOne's 510(k) submission for the OneRF® Trigeminal Nerve Ablation System ahead of schedule represents positive execution against internal timelines. This regulatory strategy intelligently leverages their existing cleared OneRF® platform, which typically streamlines the FDA review process since the agency has familiarity with the core technology.
The submission targets treatment of trigeminal neuralgia, affecting approximately 100,000 patients in the U.S. who currently rely on pharmaceutical interventions or more invasive surgical procedures. The referenced literature indicates RF ablation generally provides ~95% initial pain relief rates with long-term efficacy through repeat treatments, while maintaining low complication rates.
The technology features multi-point mapping of pain location, stimulation and ablation using the same electrode, and temperature-controlled ablation for enhanced safety. These capabilities mirror the company's FDA-cleared brain ablation system, demonstrating a cohesive technology platform approach that expands clinical applications.
From a regulatory perspective, this submission represents a logical extension of their technology into an adjacent therapeutic area. The CEO's projection of potential commercialization in late 2025 (contingent on FDA clearance) aligns with typical timeframes for devices following this regulatory pathway.
NeuroOne's expansion into facial pain treatment broadens addressable market with minimal additional regulatory risk.
This FDA submission represents a strategic market expansion for NeuroOne beyond their current focus on epilepsy treatment. By leveraging their existing OneRF® technology platform for a new clinical indication, the company demonstrates platform versatility while potentially creating operational efficiencies in manufacturing and regulatory processes.
The trigeminal neuralgia treatment landscape currently includes medications and invasive surgical approaches like microvascular decompression, radiosurgery, or other percutaneous techniques. NeuroOne's approach offers a minimally invasive alternative that may reduce procedural time and improve patient comfort, positioning it between pharmaceutical and more invasive surgical options.
With 100,000 affected patients in the U.S., this represents a meaningful addressable market. The multi-contact probe design allowing physicians to map, stimulate, and ablate using a single device addresses clinical needs for more precise intervention with potentially fewer complications.
The company's ahead-of-schedule regulatory submission demonstrates operational efficiency. With potential revenue generation targeted for late 2025 (conditional on FDA clearance), this product expansion represents a logical growth avenue. The media coverage on major networks indicates growing awareness that could support future commercialization efforts if the product receives clearance.
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 (~
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 Fox News and Good Morning America. For more interviews and information on the company, please visit www.nmtc1.com.
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 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
MZ Group – MZ North America
NMTC@mzgroup.us
1 American Association of Neurological Surgeons (AANS) - April 2024
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.
FAQ
What is the expected FDA approval timeline for NeuroOne's OneRF Trigeminal Nerve Ablation System (NMTC)?
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