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. Twelve patients were successfully treated across three leading centers, with all patients reporting freedom from pain after treatment. Physicians noted that the majority of cases had short procedural times, with the fastest completed in 16 minutes.
Trigeminal neuralgia is a severely debilitating chronic pain condition affecting approximately 150,000 patients in the United States and is often referred to as the "suicide disease" due to the extreme, intractable pain it can cause. Patients experience sudden, intense facial pain that disrupts daily functions. While medications may provide temporary relief, many patients ultimately require surgical intervention.
A key limitation of current ablative systems is the need for multiple sleep–wake cycles—often three or more—as patients are repeatedly awakened to confirm pain localization, then re-anesthetized while the probe is repositioned. NeuroOne’s multi-contact probe is designed to address this inefficiency by enabling precise mapping and ablation in a single cycle without repositioning.
“This type of surgery has been performed for many decades with a radiofrequency probe, although this requires waking the patient up multiple times during the surgery and is only capable of testing and treating one pain distribution at a time,” said neurosurgeon Michael Staudt, MD, the Lincoln Endowed Chair in Brain Health at University Hospitals and an Associate Professor of Neurological Surgery at Case Western Reserve University School of Medicine. “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.”
The OneRF Trigeminal Nerve Ablation Kit uses the same NeuroOne Radiofrequency Generator already used in epilepsy ablation procedures. This allows existing OneRF Ablation System customers to quickly add trigeminal neuralgia treatment without additional capital investment, with each procedure utilizing a disposable kit. The ability to support multiple clinical applications with a single system may also make the NeuroOne platform more attractive 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.”
