NeuroOne庐 Receives FDA 510(k) Clearance for OneRF庐 Trigeminal Nerve Ablation System to Treat Facial Pain
NeuroOne Medical Technologies (NASDAQ: NMTC) has received FDA 510(k) clearance for its OneRF庐 Trigeminal Nerve Ablation System, designed to treat facial pain through radiofrequency lesioning. The system features a pioneering multi-contact RF probe that enables both precise localization and targeted ablation of pain-conducting nerve tissue.
The technology targets trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people annually in the United States. NeuroOne plans a limited commercial launch in Q4 2025, with potential revenue generation beginning in late 2025. The company aims to expand the OneRF庐 technology platform to address additional pain management applications, including lower back pain treatment.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha ottenuto la clearance 510(k) della FDA per il suo OneRF庐 Trigeminal Nerve Ablation System, concepito per trattare il dolore facciale mediante lesioni a radiofrequenza. Il sistema presenta una sonda RF multi-contatto innovativa che consente una localizzazione precisa e l'ablazione mirata del tessuto nervoso responsabile del dolore.
La tecnologia 猫 rivolta alla nevralgia del trigemino, una condizione dolorosa cronica che colpisce circa 150.000 persone all'anno negli Stati Uniti. NeuroOne prevede un lancio commerciale limitato nel IV trimestre 2025, con possibili ricavi a partire dalla fine del 2025. L'azienda intende inoltre ampliare la piattaforma OneRF庐 per applicazioni aggiuntive nella gestione del dolore, inclusi trattamenti per il dolore lombare.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha obtenido la autorizaci贸n 510(k) de la FDA para su OneRF庐 Trigeminal Nerve Ablation System, dise帽ado para tratar el dolor facial mediante lesiones por radiofrecuencia. El sistema incorpora una sonda RF multi-contacto pionera que permite localizar con precisi贸n y ablacionar de forma dirigida el tejido nervioso que transmite el dolor.
La tecnolog铆a est谩 dirigida a la neuralgia del trig茅mino, una dolencia cr贸nica que afecta a aproximadamente 150.000 personas al a帽o en Estados Unidos. NeuroOne planea un lanzamiento comercial limitado en el cuarto trimestre de 2025, con potencial generaci贸n de ingresos a finales de 2025. La compa帽铆a tambi茅n pretende ampliar la plataforma OneRF庐 para otras aplicaciones de manejo del dolor, incluido el tratamiento del dolor lumbar.
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鞚� 旮办垹鞚� 氙戈淡鞐愳劀 鞐瓣皠 鞎� 150,000氇�鞐愱矊 鞓來枼鞚� 氙胳箻電� 毵岇劚 韱奠 歆堩櫂鞚� 靷检皑鞁犼步韱�鞚� 響滌爜鞙茧 頃╇媹雼�. NeuroOne鞚� 2025雲� 4攵勱赴 鞝滍暅鞝� 靸侅梾 於滌嫓毳� 瓿勴殟頃橁碃 鞛堨溂氅�, 2025雲� 毵愲秬韯� 靾橃澋 彀届稖鞚� 臧�電ロ暊 瓴冹溂搿� 氤搓碃 鞛堨姷雼堧嫟. 須岇偓電� 霕愴暅 OneRF庐 頂岆灚韽检潉 鞖旐喌 旃橂 霌� 於旉皜 韱奠 甏�毽� 攵勳暭搿� 頇曥灔頃橂牑電� 氇╉憸毳� 臧�歆�瓿� 鞛堨姷雼堧嫟.
NeuroOne Medical Technologies (NASDAQ: NMTC) a obtenu l'autorisation 510(k) de la FDA pour son OneRF庐 Trigeminal Nerve Ablation System, con莽u pour traiter les douleurs faciales par ablation par radiofr茅quence. Le syst猫me int猫gre une sonde RF multi-contact novatrice permettant une localisation pr茅cise et une ablation cibl茅e des tissus nerveux transmettant la douleur.
La technologie vise la n茅vralgie du trijumeau, une affection douloureuse chronique touchant environ 150 000 personnes par an aux 脡tats-Unis. NeuroOne pr茅voit un lancement commercial limit茅 au 4e trimestre 2025, avec un d茅but potentiel de g茅n茅ration de revenus fin 2025. La soci茅t茅 entend 茅galement 茅tendre la plateforme OneRF庐 脿 d'autres applications de prise en charge de la douleur, notamment le traitement des lombalgies.
NeuroOne Medical Technologies (NASDAQ: NMTC) hat f眉r sein OneRF庐 Trigeminal Nerve Ablation System die FDA-510(k)-Zulassung erhalten. Das System ist zur Behandlung von Gesichtsschmerzen durch Radiofrequenz-L盲sionen konzipiert und verf眉gt 眉ber eine neuartige Multi-Contact-RF-Sonde, die eine pr盲zise Lokalisierung und gezielte Ablation schmerzleitenden Nervengewebes erm枚glicht.
Die Technologie richtet sich gegen die Trigeminusneuralgie, eine chronische Schmerzerkrankung, die in den USA j盲hrlich etwa 150.000 Menschen betrifft. NeuroOne plant einen begrenzten kommerziellen Start im vierten Quartal 2025, mit m枚glicher Umsatzentstehung Ende 2025. Das Unternehmen beabsichtigt zudem, die OneRF庐-Plattform auf weitere Anwendungen im Schmerzmanagement zu erweitern, einschlie脽lich der Behandlung von R眉ckenschmerzen.
- FDA 510(k) clearance received ahead of schedule for OneRF庐 Trigeminal Nerve Ablation System
- Technology addresses a significant market of 150,000 annual U.S. patients with trigeminal neuralgia
- Potential revenue generation starting late 2025
- System offers advantages including reduced procedure time and improved patient safety
- Platform technology can be expanded to additional pain management applications
- Limited initial commercial launch indicates restricted revenue potential in early stages
Insights
FDA clearance for NeuroOne's trigeminal pain device enables Q4 2025 commercialization, expanding their neurological treatment portfolio.
NeuroOne has secured a significant regulatory milestone with FDA 510(k) clearance for its OneRF庐 Trigeminal Nerve Ablation System. This clearance authorizes the company to market the device specifically for creating radiofrequency lesions to treat pain and for lesioning nerve tissue in functional neurosurgical procedures. The approval validates their technology platform while providing a clear path to commercialization.
This device targets trigeminal neuralgia, a debilitating condition affecting approximately 150,000 people annually in the US. The condition is characterized by severe facial pain triggered by the trigeminal nerve. Traditional treatments include medications and more invasive surgical interventions like microvascular decompression.
The OneRF庐 system offers several technical advantages over existing treatments. It features a novel multi-contact RF probe that enables both precise localization and tailored ablation using a single instrument. The temperature-controlled conditions enhance safety and accuracy compared to alternative approaches. These features potentially translate to reduced procedure time and improved patient outcomes.
From a commercial perspective, NeuroOne plans a limited market launch in Q4 2025. The company's strategy appears to leverage existing relationships with medical practices already using their OneRF庐 brain ablation system, creating potential cross-selling opportunities. Management has indicated ongoing discussions with strategic partners and the possibility of generating revenue from this new indication by late 2025.
This clearance represents NeuroOne's expansion into pain management therapies beyond their existing neurological applications, demonstrating the versatility of their technology platform and opening potential new market opportunities including lower back pain treatment.
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 (鈥淔DA鈥�) clearance to market its OneRF庐 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听 and now targets a limited commercial launch in the fourth quarter of calendar 2025.
This clearance leverages the Company鈥檚 proprietary OneRF庐 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庐 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 鈥渇irst-of-its-kind鈥� multi-contact RF probe that allows for both precise localization and tailored ablation of the pain-conducting nerve tissue 鈥� 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.
鈥淥ne of the key aspects of the OneRF庐 technology platform is its potential to be effective across multiple neurological disorders and pain management functions,鈥� said Dave Rosa, Chief Executive Officer of NeuroOne. 鈥淭his is our first venture in pain management therapies and this newest technology aligns well with current commercial efforts with our OneRF庐 brain ablation system. Some of the current users for the OneRF庐 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.鈥�
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鈥檚 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听.
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鈥搇ooking statement that reflects NeuroOne鈥檚 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鈥搇ooking statements by the words or phrases 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥渨ill,鈥� 鈥渃ould,鈥� 鈥渨ould,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥渇orecasts,鈥� 鈥渙bjective,鈥� 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥減otential,鈥� 鈥渢arget,鈥� 鈥渟eek,鈥� 鈥渃ontemplate,鈥� 鈥渃ontinue, 鈥渇ocused on,鈥� 鈥渃ommitted to鈥� and 鈥渙ngoing,鈥� or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward鈥搇ooking statements may include statements regarding the timing and success of our commercial launch of the OneRF庐 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途 whether due to supply chain disruptions, labor shortages or otherwise途 risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials途 risks related to uncertainties associated with the Company鈥檚 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途 uncertainties inherent in the development process of our technology途 risks related to changes in regulatory requirements or decisions of regulatory authorities途 that we may not have accurately estimated the size and growth potential of the markets for our technology途 risks relate to clinical trial patient enrollment and the results of clinical trials途 that we may be unable to protect our intellectual property rights途 and other risks, uncertainties and assumptions, including those described under the heading 鈥淩isk Factors鈥� in our filings with the Securities and Exchange Commission. These forward鈥搇ooking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward鈥搇ooking 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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FAQ
What FDA clearance did NeuroOne (NMTC) receive in August 2025?
How many people are affected by trigeminal neuralgia in the United States?
When will NeuroOne launch the OneRF庐 Trigeminal Nerve Ablation System commercially?
What are the key features of NeuroOne's OneRF庐 Trigeminal Nerve Ablation System?
What other applications is NeuroOne pursuing for the OneRF庐 technology platform?
