NeuroOne Probe Delivers 100% Pain Relief in 12 Patients at Three Centers in 16-Minute Procedures
NeuroOne completed a limited market release of its OneRF Trigeminal Nerve Ablation System, treating 12 patients at three centers who all reported pain relief in procedures as fast as 16 minutes. The FDA 510(k)-cleared multi-contact probe enables mapping and ablation without repositioning, integrating with existing OneRF generators to support expansion.
1. Limited Market Release and Clinical Outcomes
NeuroOne completed limited releases of its OneRF Trigeminal Nerve Ablation System across three centers, treating 12 patients with trigeminal neuralgia. All 12 patients reported complete pain freedom following treatment, with cases achieving procedural times as brief as 16 minutes.
2. Multi-Contact Probe Design and Efficiency
The system’s multi-contact radiofrequency probe allows simultaneous testing and treatment of multiple nerve distributions in a single sleep–wake cycle. This design eliminates the need for multiple anesthesia cycles and probe repositioning, reducing procedure duration and improving patient comfort.
3. FDA Clearance and Platform Integration
The OneRF Trigeminal Nerve Ablation Kit received FDA 510(k) clearance under K251243. It uses the same NeuroOne generator employed in epilepsy ablation procedures, enabling existing customers to add trigeminal neuralgia treatment without new capital investment.
4. Commercial Expansion and Go-To-Market Strategy
NeuroOne is expanding access to additional centers while evaluating strategic partnerships and broader market strategies. The platform’s ability to support both epilepsy and trigeminal neuralgia with a single system may enhance hospital adoption by lowering costs and offering combined diagnostic and therapeutic functions.