NeuroOne Medical Technologies Corporation has 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 that causes severe facial pain and is sometimes called the "suicide disease" due to its intensity.
During the limited market release, 12 patients were successfully treated across three medical centers. All 12 patients reported freedom from pain following treatment, according to the company's announcement. Physicians involved in the procedures reported that most cases had short procedural times, with the fastest procedure completed in 16 minutes.
The system addresses a key limitation of current ablative treatments, which typically require multiple sleep-wake cycles during surgery. 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 enable precise mapping and ablation in a single cycle without repositioning, potentially improving patient comfort and procedural efficiency.
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, noted that traditional radiofrequency probes require waking patients multiple times during surgery and can only test and treat one pain distribution at a time. "This new ablation probe is a step forward for our patients," Staudt said. "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 employed in epilepsy ablation procedures. This compatibility allows existing OneRF Ablation System customers to 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 make the NeuroOne platform more attractive to hospitals evaluating new technology purchases.
Dave Rosa, President and Chief Executive Officer of NeuroOne, stated that the results highlight the clinical and procedural advantages of the multi-contact probe. "To build on this momentum, we are expanding access to additional centers while simultaneously evaluating strategic partnership opportunities and broader go-to-market strategies," Rosa said.
The NeuroOne OneRF Trigeminal Nerve Ablation System received FDA 510(k) clearance under K251243 and 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's early success suggests potential for improving treatment outcomes for patients suffering from trigeminal neuralgia, a condition that often requires surgical intervention when medications provide only temporary relief.
