NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
NeuroOne Medical Technologies (Nasdaq: NMTC) has accelerated its FDA 510(k) submission timeline for the OneRF® Trigeminal Nerve Ablation System to May 2025, approximately two months ahead of the original schedule. The system aims to treat facial pain caused by trigeminal neuralgia through minimally invasive radiofrequency ablation.
This represents the company's second radiofrequency ablation technology utilizing their patented OneRF® Technology Platform. According to Research and Markets, the trigeminal neuralgia therapeutics market is projected to grow from $262 million in 2024 to $416 million by 2030, driven by an aging population.
If FDA cleared, NeuroOne anticipates potential revenue generation from trigeminal nerve ablation in late 2025, which wasn't previously expected within the 2025 calendar year. This would add to their portfolio of three FDA-cleared product families.
NeuroOne Medical Technologies (Nasdaq: NMTC) ha accelerato la sua tempistica di presentazione per il 510(k) della FDA per il OneRF® Trigeminal Nerve Ablation System a maggio 2025, circa due mesi prima del programma originale. Il sistema mira a trattare il dolore facciale causato dalla nevralgia del trigemino attraverso un'ablazione a radiofrequenza minimamente invasiva.
Questo rappresenta la seconda tecnologia di ablazione a radiofrequenza dell'azienda che utilizza la loro piattaforma tecnologica brevettata OneRF®. Secondo Research and Markets, il mercato dei trattamenti per la nevralgia del trigemino è previsto crescere da 262 milioni di dollari nel 2024 a 416 milioni di dollari entro il 2030, sostenuto da una popolazione in invecchiamento.
Se approvato dalla FDA, NeuroOne prevede una potenziale generazione di entrate dall'ablazione del nervo trigeminale entro la fine del 2025, cosa che non era stata precedentemente prevista per l'anno solare 2025. Questo si aggiungerebbe al loro portafoglio di tre famiglie di prodotti approvati dalla FDA.
NeuroOne Medical Technologies (Nasdaq: NMTC) ha acelerado su cronograma de presentación del 510(k) ante la FDA para el OneRF® Trigeminal Nerve Ablation System a mayo de 2025, aproximadamente dos meses antes de lo previsto originalmente. El sistema tiene como objetivo tratar el dolor facial causado por la neuralgia del trigémino a través de una ablación por radiofrecuencia mínimamente invasiva.
Esto representa la segunda tecnología de ablación por radiofrecuencia de la compañía que utiliza su plataforma tecnológica patentada OneRF®. Según Research and Markets, se proyecta que el mercado de terapias para la neuralgia del trigémino crecerá de 262 millones de dólares en 2024 a 416 millones de dólares para 2030, impulsado por una población envejecida.
Si es aprobado por la FDA, NeuroOne anticipa una posible generación de ingresos por ablación del nervio trigémino a finales de 2025, lo cual no se esperaba anteriormente dentro del año calendario 2025. Esto se sumaría a su cartera de tres familias de productos aprobados por la FDA.
NeuroOne Medical Technologies (Nasdaq: NMTC)는 OneRF® 삼차신경 절제 시스템에 대한 FDA 510(k) 제출 일정을 2025년 5월로 앞당겼습니다. 이는 원래 예정된 일정보다 약 두 달 빠른 것입니다. 이 시스템은 최소 침습적인 고주파 절제를 통해 삼차신경통으로 인한 얼굴 통증을 치료하는 것을 목표로 합니다.
이는 회사의 두 번째 고주파 절제 기술로, 그들의 특허받은 OneRF® 기술 플랫폼을 활용합니다. Research and Markets에 따르면, 삼차신경통 치료 시장은 2024년 2억 6200만 달러에서 2030년까지 4억 1600만 달러로 성장할 것으로 예상되며, 이는 노인 인구 증가에 의해 촉진됩니다.
FDA 승인이 이루어질 경우, NeuroOne은 2025년 말 삼차신경 절제에서 잠재적인 수익 창출을 기대하고 있으며, 이는 2025년 캘린더 연도 내에는 예상되지 않았던 것입니다. 이는 FDA 승인을 받은 세 가지 제품군의 포트폴리오에 추가될 것입니다.
NeuroOne Medical Technologies (Nasdaq: NMTC) a accéléré son calendrier de soumission du 510(k) à la FDA pour le OneRF® Trigeminal Nerve Ablation System à mai 2025, soit environ deux mois avant le calendrier initial. Le système vise à traiter la douleur faciale causée par la névralgie du trigème par une ablation par radiofréquence peu invasive.
Ceci représente la deuxième technologie d'ablation par radiofréquence de l'entreprise utilisant leur plateforme technologique brevetée OneRF®. Selon Research and Markets, le marché des traitements pour la névralgie du trigème devrait passer de 262 millions de dollars en 2024 à 416 millions de dollars d'ici 2030, soutenu par une population vieillissante.
Si la FDA l'approuve, NeuroOne prévoit une génération de revenus potentiels grâce à l'ablation du nerf trigéminal d'ici fin 2025, ce qui n'était pas prévu auparavant pour l'année civile 2025. Cela viendrait s'ajouter à leur portefeuille de trois familles de produits approuvés par la FDA.
NeuroOne Medical Technologies (Nasdaq: NMTC) hat den Zeitrahmen für die Einreichung des FDA 510(k) für das OneRF® Trigeminal Nerve Ablation System auf Mai 2025 beschleunigt, etwa zwei Monate früher als ursprünglich geplant. Das System zielt darauf ab, Gesichtsschmerzen, die durch trigeminale Neuralgie verursacht werden, durch minimalinvasive Radiofrequenzablation zu behandeln.
Dies stellt die zweite Radiofrequenzablationstechnologie des Unternehmens dar, die ihre patentierte OneRF®-Technologieplattform nutzt. Laut Research and Markets wird der Markt für Therapeutika der trigeminalen Neuralgie voraussichtlich von 262 Millionen US-Dollar im Jahr 2024 auf 416 Millionen US-Dollar bis 2030 wachsen, was durch eine alternde Bevölkerung vorangetrieben wird.
Wenn die FDA genehmigt, erwartet NeuroOne eine potenzielle Einnahmengenerierung aus der trigeminalen Nervenablation Ende 2025, was zuvor nicht innerhalb des Kalenderjahres 2025 erwartet wurde. Dies würde ihr Portfolio von drei FDA-zugelassenen Produktfamilien erweitern.
- Accelerated FDA submission timeline by 2 months
- Potential revenue generation in late 2025, earlier than previously expected
- Growing market opportunity: $262M in 2024 to $416M by 2030
- Expanding product portfolio with second RF ablation technology
- FDA clearance still pending and not guaranteed
- Revenue generation dependent on successful FDA clearance
Insights
NeuroOne's accelerated FDA submission timeline for its OneRF® Trigeminal Nerve Ablation System demonstrates positive operational momentum. Moving the 510(k) submission up to May 2025 from the originally planned June timeline potentially positions the company to generate revenue in late 2025 from this product, which wasn't previously expected within this calendar year.
This submission targets the treatment of trigeminal neuralgia, a condition causing severe chronic facial pain. The targeted market is projected to grow from
Strategically, this represents the second application of NeuroOne's OneRF® Technology Platform, validating their approach of leveraging proprietary technology across multiple clinical indications. For a company with a market cap of approximately
While the ultimate impact depends on FDA clearance, this accelerated timeline represents tangible progress in expanding their neurological intervention portfolio beyond their three already-cleared product families.
Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025
EDEN PRAIRIE, Minn., March 11, 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 accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the Company’s patented OneRF® Technology Platform. The Company had previously projected a submission by the end of June 2025.
Trigeminal nerve ablation is a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face caused by trigeminal neuralgia. The trigeminal nerve is the main sensory nerve in the face and NeuroOne’s procedure is designed to provide pain relief for this condition. According to the October 2024 Research and Markets report titled Trigeminal Neuralgia Therapeutics Market, the trigeminal neuralgia therapeutics market, comprised of pharmacologic and surgical technologies, is expected to grow from
“Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation System, approximately two months ahead of schedule,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “If cleared by the FDA—we believe there is a potential to generate revenues from trigeminal nerve ablation in late 2025, which was not previously expected in calendar year 2025.
“Importantly, trigeminal nerve ablation would be the second radiofrequency ablation technology in our portfolio leveraging our patented OneRF® Technology Platform. As we move ahead, we believe there are several additional ablation applications we can introduce and look forward to updating you on our progress as we move throughout the year.”
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 plan to submit a 510(k) application with the FDA in May 2025 for our trigeminal nerve ablation program, 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
FAQ
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