NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the completion of the limited market release of its OneRF® Trigeminal Nerve Ablation System, following FDA 510(k) clearance in August 2025. The system is designed for radiofrequency ablation to treat trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 patients in the United States, often referred to as the “suicide disease” due to the severity of pain.
During the limited market release, 12 patients were successfully treated across three leading centers. All patients reported freedom from pain after the procedure, according to the company. Physicians also noted short procedural times, with the fastest completed in 16 minutes. These results underscore the advantages of NeuroOne’s multi-contact probe, which enables precise mapping and ablation without the need for repositioning.
A key limitation of current ablative systems is the requirement for multiple sleep–wake cycles—often three or more—as patients are repeatedly awakened to confirm pain localization and then re-anesthetized while the probe is repositioned. NeuroOne’s multi-contact probe addresses this inefficiency by allowing mapping and ablation in a single cycle. “This new ablation probe is a step forward for our patients. It is a multi-contact probe designed to test and treat multiple nerve distributions without the need for repositioning,” said neurosurgeon Michael Staudt, MD, the Lincoln Endowed Chair in Brain Health at University Hospitals and an Associate Professor at Case Western Reserve University School of Medicine.
The OneRF® Trigeminal Nerve Ablation Kit uses the same NeuroOne Radiofrequency Generator already employed in epilepsy ablation procedures, allowing existing customers to add trigeminal neuralgia treatment without additional capital investment. Each procedure uses a disposable kit, and the ability to support multiple clinical applications with a single system may enhance the platform's appeal to hospitals evaluating new technology purchases.
“The results from our limited market release highlight the clinical and procedural advantages of our multi-contact probe, including the ability to perform mapping and ablation without repositioning, which may significantly improve patient comfort,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “To build on this momentum, we are expanding access to additional centers while simultaneously evaluating strategic partnership opportunities and broader go-to-market strategies.”
The OneRF® Trigeminal Nerve Ablation System is indicated for creating radiofrequency lesions to treat pain or for lesioning nerve tissue in functional neurosurgical procedures. The system received FDA 510(k) clearance under K251243.
