NeuroOne Medical receives FDA 510k clearance for OneRF

NeuroOne Medical (NMTC) Technologies has received U.S. Food and Drug Administration, 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.