NeuroOne Medical, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has received FDA clearance to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. As previously announced, the company completed the FDA submission earlier than anticipated and now targets a limited commercial launch in the fourth quarter of calendar 2025.
This clearance leverages the company’s proprietary OneRF Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.
Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression (MVD), radiosurgery, or other percutaneous techniques. The OneRF Trigeminal Nerve Ablation System features a minimally invasive surgical technology to treat severe, chronic facial pain. The system delivers targeted radiofrequency (RF) energy to ablate trigeminal nerve fibers, interrupting pain signaling.
Differentiated features of this system include a “first-of-its-kind” multi-contact RF probe that allows for both precise localization and tailored ablation of the pain-conducting nerve tissue – using the same RF probe, and under temperature-controlled conditions which enhance safety and accuracy. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.
