NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced today the completion of the limited market release of its OneRF® Trigeminal Nerve Ablation System, following FDA 510(k) clearance in August 2025. A total of 12 patients were successfully treated across three leading centers, with all patients reporting freedom from pain after treatment. Physicians also reported short procedural times, with the fastest procedure completed in 16 minutes.
Trigeminal neuralgia is a severely debilitating chronic pain condition affecting approximately 150,000 patients in the United States. Often referred to as the “suicide disease,” it causes extreme, intractable facial pain that disrupts basic 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 to treat different nerve segments. 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,” explained 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, including epilepsy and trigeminal neuralgia, 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.”
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.
