NeuroOne Medical Technologies Corporation has announced the completion of the limited market release of its OneRF Trigeminal Nerve Ablation System following FDA 510(k) clearance in August 2025. The system is designed to treat trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 patients in the United States that is often referred to as the "suicide disease" due to the extreme, intractable pain it causes.
During the limited market release, 12 patients were successfully treated across three medical centers, with all patients reporting freedom from pain following treatment. Physicians reported that the majority of cases had short procedural times, with the fastest procedure completed in 16 minutes. These early results suggest potential improvements in both patient outcomes and procedural efficiency compared to existing treatments.
The significance of this development lies in addressing a key limitation of current ablative systems, which typically require multiple sleep-wake cycles during procedures. Patients are repeatedly awakened to confirm pain localization and then re-anesthetized while the probe is repositioned to treat different nerve segments. NeuroOne's multi-contact probe is designed to enable precise mapping and ablation in a single cycle without repositioning, potentially reducing procedure time and improving patient comfort.
"This new ablation probe is a step forward for our patients," explained neurosurgeon Michael Staudt, MD, the Lincoln Endowed Chair in Brain Health at University Hospitals and an Associate Professor of Neurological Surgery at Case Western Reserve University School of Medicine. "It is a multi-contact probe designed to test and treat multiple nerve distributions without the need for repositioning."
The OneRF Trigeminal Nerve Ablation Kit uses the same NeuroOne Radiofrequency Generator already employed in epilepsy ablation procedures. This compatibility allows existing OneRF Ablation System customers to add trigeminal neuralgia treatment capabilities without additional capital investment, with each procedure utilizing a disposable kit. The ability to support multiple clinical applications with a single system may make the NeuroOne platform more attractive to hospitals evaluating new technology purchases.
Dave Rosa, President and Chief Executive Officer of NeuroOne, stated, "The results from our limited market release highlight the clinical and procedural advantages of our multi-contact probe, including the ability to perform mapping and ablation without repositioning, which may significantly improve patient comfort." The company is now expanding access to additional centers while evaluating strategic partnership opportunities and broader go-to-market strategies.
The potential impact of this technology extends beyond individual patient outcomes to healthcare system efficiency. By potentially reducing procedure times and eliminating the need for multiple anesthesia cycles, the system could decrease operating room utilization and associated costs. For patients suffering from trigeminal neuralgia, who often experience sudden, intense facial pain that disrupts basic daily functions, this technology represents a potential advancement in treatment options beyond medications that may provide only temporary relief.
