NeuroOne Medical Technologies Corporation has received FDA 510(k) clearance to market its OneRF® Trigeminal Nerve Ablation System.
The system is designed for procedures that create radiofrequency lesions to treat pain or for lesioning nerve tissue in functional neurosurgery. A limited commercial launch is planned for the fourth quarter of 2025.
The OneRF® system builds on NeuroOne’s proprietary RF generator platform and is intended to treat trigeminal neuralgia, a chronic facial pain condition affecting around 150,000 people in the United States each year.
The system delivers targeted radiofrequency energy to ablate trigeminal nerve fibres, interrupting pain signals while minimising procedural invasiveness.
Key features include a multi-contact RF probe for precise localisation and controlled ablation of the pain-conducting nerve tissue.
The temperature-controlled system aims to improve procedural safety, reduce time, and enhance patient comfort compared with existing treatments such as medication, microvascular decompression, radiosurgery, or other percutaneous techniques.
NeuroOne expects the system to expand opportunities in pain management and other therapeutic areas.
