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 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 severe, intractable pain it causes.
During the limited market release, 12 patients were successfully treated across three leading centers. All 12 patients reported freedom from pain after treatment, and physicians noted that the majority of procedures were completed in short times, with the fastest procedure taking just 16 minutes. The results underscore the advantages of NeuroOne’s multi-contact probe, which allows precise mapping and ablation in a single cycle without requiring multiple sleep-wake cycles—a limitation of current ablative systems that often require three or more cycles as patients are repeatedly awakened to confirm pain localization.
“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, allowing existing customers to add trigeminal neuralgia treatment without additional capital investment. Each procedure utilizes a disposable kit. The ability to support multiple clinical applications with a single system may 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.”
The NeuroOne OneRF Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The system received FDA 510(k) clearance under K251243.
