NeuroOne® Receives FDA 510(k) Clearance for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain

FDA Clearance Further Validates Technology Platform and Offers Alternatives to Pharmaceutical and Invasive Surgical Treatments

EDEN PRAIRIE, Minn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, 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.

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