08:56 AM EDT, 08/18/2025 (MT Newswires) -- NeuroOne Medical Technologies ( NMTC ) said Monday that the US Food and Drug Administration has cleared its OneRF Trigeminal Nerve Ablation System for procedures treating chronic pain and for functional neurosurgery.

The device targets trigeminal neuralgia, a severe facial pain condition affecting about 150,000 people annually in the US.

NeuroOne said the clearance builds on its proprietary RF generator platform and allows the company to move forward with a limited commercial launch in Q4, ahead of earlier expectations.

Shares of NeuroOne were up more than 18% in Monday's premarket activity.