NeuroOne Medical Technologies Corporation has successfully used its OneRF Trigeminal Nerve Ablation System to treat two patients with facial pain suffering from trigeminal neuralgia at University Hospitals in Cleveland, Ohio. The procedures mark the first clinical application of the company's technology in pain management following FDA clearance in August 2025.
The trigeminal neuralgia condition affects approximately 150,000 people in the United States annually according to the American Association of Neurological Surgeons (AANS) - April 2024. This chronic pain condition involves the trigeminal nerve, the main sensory nerve in the face associated with triggering excruciating pain. Dr. Michael Staudt, the Lincoln Endowed Chair in Brain Health and an Associate Professor of Neurological Surgery at University Hospitals, performed radiofrequency ablations on both patients using NeuroOne's system.
Both patients reported pain relief without complications following the procedures performed in the operating room. The system's multi-contact probe allowed the surgeon to ablate relevant nerve branches without repositioning the probe each time, potentially reducing procedural time while improving patient comfort and safety. Dr. Staudt commented that the system performed well in these cases and that University Hospitals looks forward to adopting this tool in clinical practice, believing it offers meaningful advantages over other available systems.
The OneRF Trigeminal Nerve Ablation System represents NeuroOne's expansion beyond brain procedures into pain management therapies. The system features a minimally invasive surgical technology that delivers targeted RF energy to ablate trigeminal nerve fibers, interrupting pain signaling. Differentiated features include what the company describes as a "first-of-its-kind" multi-contact RF probe that allows for both precise localization and targeted ablation of pain-conducting nerve tissue using the same probe under temperature-controlled conditions.
Dave Rosa, CEO of NeuroOne, stated that this milestone successfully showcases the platform technology's unique ability to be adopted for both brain ablation procedures and pain management. The company expects to pursue additional opportunities leveraging its technology platform in pain management and other therapeutic applications, including lower back pain, which represents an annual market of over $1 billion. NeuroOne is targeting a limited commercial launch for its pain management applications.
The successful cases at University Hospitals validate NeuroOne's patented platform technology for both brain ablation and pain management procedures. The company's technology platform includes four FDA-cleared product families: Evo Cortical Electrodes, Evo sEEG Electrodes, OneRF Ablation System for brain procedures, and now the OneRF Trigeminal Nerve Ablation System. These solutions offer the potential to reduce hospitalizations and surgical procedures while lowering costs and improving patient outcomes through combination diagnostic and therapeutic functions. For more information about the company, visit https://www.nmtc1.com.
