FDA Clears NeuroOne’s Nerve Ablation System for Trigeminal Neuralgia

NeuroOne Medical Technologies has received US Food and Drug Administration (FDA) clearance for its OneRF ablation system, a minimally invasive device designed to treat trigeminal neuralgia — a chronic condition that causes severe, stabbing facial pain.

The radiofrequency-based system creates targeted lesions in nerve fibers to disrupt pain signals. The company says the approach may shorten procedure times while improving patient comfort and safety, offering an alternative to medication or more invasive surgical procedures.

NeuroOne submitted the application in April 2025, earlier than anticipated, and now expects a limited US launch in Q4 2025.

Trigeminal neuralgia affects about 150,000 people annually in the US, most commonly women over 50. In some cases, it is linked to multiple sclerosis.

FDA clearance of the OneRF device marks NeuroOne’s first entry into chronic pain treatment. The company also markets its FDA-cleared OneRF sEEG brain ablation system for neurosurgery and maintains a distribution partnership with Zimmer Biomet.

In May, NeuroOne projected that this new indication could begin generating revenue in late 2025.

24-08-2025