OneRF platform expands into trigeminal neuralgia treatment
NeuroOne has submitted its 510(k) application ahead of schedule for FDA clearance to use its OneRF radiofrequency ablation system in treating trigeminal neuralgia—a debilitating facial pain condition.
The minimally invasive procedure targets abnormal tissue on the trigeminal nerve using a multi-contact probe that enables precise mapping, stimulation, and ablation through a single electrode. The system features temperature-controlled safety and was previously cleared by the FDA in December 2023 for functional neurosurgical procedures.
Key Points:
- OneRF system targets chronic facial pain via nerve ablation
- Earlier-than-expected submission supports 2025 commercialization timeline
- Builds on success in epilepsy-related ablations
- Part of a distribution agreement with Zimmer Biomet
“If cleared, this would broaden our clinical impact and validate the scalability of our technology,” said NeuroOne CEO Dave Rosa, projecting potential revenue from this new indication by late 2025.
Follow MEDWIRE.AI for updates in neuromodulation and RF ablation technologies.
