Patient's Seizure-Free Streak Hit One-Year Mark Post Treatment with NeuroOne
In a significant stride for medical technology, NeuroOne Medical Technologies Corporation has filed a 510(k) submission to the Food and Drug Administration (FDA) in April 2025 for its innovative OneRF Trigeminal Nerve Ablation System. The system, designed to treat facial pain, is currently under regulatory review, with no public indication of FDA clearance or approval as of mid-2025 [1][2][3][5].
The OneRF System, already cleared for certain epilepsy-related diagnostic and therapeutic applications, has shown promising clinical results. One patient, for instance, has enjoyed over a year of seizure freedom following treatment [1][2][3]. NeuroOne aims to expand the use of this technology platform to address trigeminal nerve-related facial pain with the new ablation system.
The OneRF Ablation System offers monitoring, mapping, ablation, and bedside ablation procedures, making it a comprehensive solution for neurological disorders. The system's potential for treating various neurological disorders, including facial pain, could significantly expand its market reach and impact in the medical field.
The system's effectiveness in treating neurological disorders is supported by medical professionals. Dr. Brin Freund, Clara's treating physician, has expressed positive feedback about the OneRF Ablation System, stating excellent results [4]. Clara, a patient treated with NeuroOne's OneRF Ablation System, has been seizure-free for over a year [6][7]. Her life has improved significantly since the treatment, allowing her to engage in activities like college, fishing, and peaceful dinners with her family [8].
Dave Rosa, CEO of NeuroOne, emphasised the one-year seizure-free milestone as validating the benefits of the OneRF platform [9]. Dr. Freund also believes there is a strong case for further clinical and research opportunities using the OneRF Ablation System to expand treatment capabilities [10].
NeuroOne Medical Technologies Corporation is a medtech company dedicated to improving surgical care for neurological disorder patients. The company plans to pursue FDA approval for the OneRF Trigeminal Nerve Ablation System, following their successful 510(k) submission in April 2025. Dr. Freund's endorsement of the OneRF Ablation System suggests potential for its adoption in a wider range of medical applications [11].
The OneRF Ablation System, being the first and only FDA 510(k)-cleared device for both diagnostic and therapeutic applications, marks a significant advancement in the field of neurological disorder treatments [12]. As the regulatory review process continues, the medical community eagerly awaits the FDA's decision on the OneRF Trigeminal Nerve Ablation System.
- The OneRF Ablation System, designed for neurological disorders such as facial pain, could potentially extend its impact in the health-and-wellness sector, particularly in managing mental-health conditions linked to neurological disorders.
- NeuroOne Medical Technologies Corporation, a medtech company specializing in neurological disorders, aims to leverage the OneRF Ablation System's technology platform for treating various medical-conditions, not just trigeminal nerve-related facial pain, using advancements in science and technology.
- With the OneRF Ablation System's demonstrated effectiveness in treating epilepsy-related conditions and its potential for addressing other neurological disorders, this medical technology may contribute significantly to the ongoing research and treatment of neurological disorders and mental-health issues, thereby improving health-and-wellness outcomes.
