NeuroOne’s OneRF Nerve Ablation Wins FDA Nod for Facial Pain

NeuroOne Medical Technologies has received U.S. Food and Drug Administration (FDA) clearance of its OneRF trigeminal nerve ablation system to create radiofrequency (RF) lesions to treat pain or for lesioning nerve tissue for functional neurosurgical procedures.

The company had completed FDA submission earlier than expected and plans a limited commercial launch in Q4 of this year.

The FDA nod leverages the company’s OneRF ablation system RF generator platform to treat trigeminal neuralgia, a chronic pain condition that affects about 150,000 people in the U.S. annually. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.

The system delivers targeted RF energy to ablate trigeminal nerve fibers, interrupting pain signaling. It includes a multi-contact RF probe that allows precise localization and tailored ablation of the pain-conducting nerve tissue using the same probe.

OneRF can allow for less procedural time, improved comfort, and improved patient safety, NeuroOne said.

“One of the key aspects of the OneRF technology platform is its potential to be effective across multiple neurological disorders and pain management functions,” said Dave Rosa, CEO of NeuroOne. “This is our first venture in pain management therapies and this newest technology aligns well with current commercial efforts with our OneRF brain ablation system. Some of the current users for the OneRF brain ablation system also perform nerve ablation procedures for facial pain, which may allow current medical practices to further justify the investment. Furthermore, we expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, such as treatment of lower back pain. With this clearance, we will continue our ongoing discussions with strategic partners and have the potential to begin generating revenues from trigeminal nerve ablation as soon as late calendar year 2025.”