NeuroOne's OneRF Trigeminal Nerve Ablation System Shows Promise in Limited Market Release

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 addresses trigeminal neuralgia, a severely debilitating chronic pain condition affecting approximately 150,000 patients in the United States that is often referred to as the "suicide disease" due to the extreme, intractable pain it causes. While medications may provide temporary relief, many patients ultimately require surgical intervention.

A total of 12 patients were successfully treated across three centers during the limited market release, with all 12 patients reporting freedom from pain following treatment. Physicians reported that the majority of cases had short procedural times, with the fastest procedure completed in 16 minutes. These results highlight the advantages of NeuroOne's multi-contact probe, which is designed to address a key limitation of current ablative systems that require multiple sleep-wake cycles as patients are repeatedly awakened to confirm pain localization then re-anesthetized while the probe is repositioned.

"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, allowing existing OneRF Ablation System customers to quickly add trigeminal neuralgia treatment without additional capital investment. Each procedure utilizes a disposable kit, and 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 system received FDA 510(k) clearance under K251243.

"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. The company is 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.