- NeuroOne Medical Technologies (NMTC, Financial) has submitted its 510(k) application to the FDA for the OneRF® Trigeminal Nerve Ablation System ahead of schedule.
- The system targets trigeminal neuralgia, a chronic facial pain condition affecting around 100,000 Americans, and shows approximately 95% initial pain relief rates.
- Pending FDA clearance, potential revenue generation from the system is anticipated by late 2025.
NeuroOne Medical Technologies Corporation (NMTC) has taken a significant step forward in the management of chronic facial pain by submitting a 510(k) application to the U.S. Food and Drug Administration (FDA) for its OneRF® Trigeminal Nerve Ablation System, well ahead of their internal timeline. This advanced medical technology is designed to treat trigeminal neuralgia, a severe facial pain condition affecting approximately 100,000 patients in the United States.
The OneRF® system employs a minimally invasive surgical procedure using radiofrequency (RF) energy to ablate abnormal tissue, potentially providing substantial relief for patients. Its innovative features include multi-point mapping of pain sites, stimulation, and temperature-controlled ablation using a singular electrode. Published clinical data indicates RF ablation achieves about 95% initial pain relief, with sustained long-term effectiveness and a low risk of complications.
NeuroOne anticipates that FDA clearance could enable revenue generation by late 2025. This development marks an extension of their existing FDA-cleared OneRF sEEG Ablation System, highlighting the platform's versatility and potential for broader clinical applications. If successful, this innovation will broaden NeuroOne's impact on the treatment of neurological disorders, providing a less invasive alternative to traditional surgical interventions.
