NeuroOne Medical Technologies Corporation has completed the limited market release of its OneRF® Trigeminal Nerve Ablation System following FDA 510(k) clearance in August 2025. The system was used to treat 12 patients across three medical centers, with all patients reporting freedom from pain following treatment. This development is significant for addressing trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 patients in the United States that is sometimes called the "suicide disease" due to its severity.
Physicians reported that most procedures had short completion times, with the fastest taking just 16 minutes. These results highlight potential advantages of NeuroOne's multi-contact probe design. Current ablative systems typically require multiple sleep-wake cycles during surgery, where patients are awakened to confirm pain localization and then re-anesthetized while the probe is repositioned. This process may require three or more cycles. NeuroOne's system is designed to enable 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. "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 system uses the same NeuroOne Radiofrequency Generator already employed in epilepsy ablation procedures, allowing existing customers to add trigeminal neuralgia treatment without additional capital investment.
Dave Rosa, President and Chief Executive Officer of NeuroOne, stated that the results highlight 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 company's technology platform, which includes the OneRF® Ablation System, received FDA 510(k) clearance under K251243. More information about the company is available at https://nmtc1.com.
The ability to support multiple clinical applications, including epilepsy and trigeminal neuralgia, with a single system may make the NeuroOne platform more attractive to hospitals evaluating new technology purchases. Each procedure utilizes a disposable kit, and the system is indicated for creating radiofrequency lesions for pain treatment or lesioning nerve tissue for functional neurosurgical procedures. The early experience suggests the approach may improve patient comfort while maintaining treatment effectiveness for this challenging neurological condition.
