NeuroOne Medical completes FDA submission for OneRF Ablation System RF

NeuroOne Medical (NMTC) Technologies has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance. This submission leverages the Company’s proprietary OneRF Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the U.S. 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, MCD, radiosurgery, or other percutaneous techniques. The OneRF Trigeminal Nerve Ablation technology features a minimally invasive surgical procedure that uses radiofrequency energy to destroy abnormal tissue to relieve severe, chronic pain in the face. Differentiated features of this multi-contact probe are designed to use multi-point mapping of pain location, stimulation and ablation, all using the same electrode and with the safety of temperature-controlled ablation. These features are also present in the FDA 510(k) cleared OneRF sEEG Ablation System. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.