Dive Brief:
- NeuroOne Medical Technologies received Food and Drug Administration clearance for a minimally invasive nerve ablation system to treat trigeminal neuralgia, a condition that causes severe, chronic facial pain.
- Trigeminal neuralgia is typically treated with medication or invasive procedures. NeuroOne’s OneRF ablation system uses radiofrequency energy to create lesions to interrupt pain signals.
- NeuroOne filed its FDA submission in April, earlier than previously anticipated. The Eden Prairie, Minnesota-based company said Monday it now expects to launch the device on a limited basis in the fourth quarter of this year.
Dive Insight:
About 150,000 people a year are diagnosed with trigeminal neuralgia, according to the American Association of Neurological Surgeons. The pain is caused by irritation of the trigeminal nerve that provides sensation to the face, though the exact cause is not known. The condition is most common in people over the age of 50 and in women. A form of trigeminal neuralgia is associated with multiple sclerosis.
NeuroOne’s radiofrequency electrode targets and ablates the pain-conducting nerve fibers. The treatment may reduce procedure times and improve patient comfort and safety, the company said.
FDA clearance of the OneRF device for trigeminal neuralgia marks the company’s first expansion into the treatment of chronic pain. NeuroOne also sells its FDA-cleared OneRF sEEG brain ablation system used in neurosurgery and has a distribution agreement with Zimmer Biomet.
“We expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, such as treatment of lower back pain,” CEO Dave Rosa said in a statement.
In May, NeuroOne said FDA clearance of the trigeminal neuralgia treatment could begin to generate revenue for the company in late 2025.
