NeuroOne Medical Technologies Corporation has announced the completion of the limited market release of its OneRF Trigeminal Nerve Ablation System. The system, which received FDA 510(k) clearance in August 2025, is designed for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 patients in the United States.
A total of 12 patients were successfully treated across three centers during the release. All patients reported freedom from pain following treatment. Physicians noted short procedural times, with the fastest procedure completed in 16 minutes. These early results highlight potential advantages of NeuroOne's multi-contact probe technology.
A key limitation addressed by the new system is the need for multiple sleep-wake cycles during conventional radiofrequency ablation procedures. Current systems often require patients to be awakened repeatedly to confirm pain localization before being re-anesthetized for probe repositioning. NeuroOne's probe is designed to enable precise mapping and ablation in a single cycle without repositioning. Neurosurgeon Michael Staudt, MD, noted that the multi-contact probe represents a step forward, as it is designed to test and treat multiple nerve distributions without repositioning.
The OneRF Trigeminal Nerve Ablation Kit utilizes the same NeuroOne Radiofrequency Generator already employed in epilepsy ablation procedures. This compatibility allows existing customers to add trigeminal neuralgia treatment without additional capital investment, as each procedure uses a disposable kit. The ability to support multiple clinical applications with a single system may enhance the platform's appeal to hospitals evaluating new technology. For more information on the company, visit https://nmtc1.com.
Dave Rosa, President and CEO of NeuroOne, stated that the results highlight clinical and procedural advantages, including improved patient comfort. The company is expanding access to additional centers while evaluating strategic partnership opportunities. The system is indicated for creating radiofrequency lesions to treat pain or lesion nerve tissue for functional neurosurgical procedures. It received clearance under FDA K251243.
The development could impact the standard of care for a condition often called the "suicide disease" due to its severe, intractable pain. By potentially reducing procedure complexity and improving patient experience, the technology may offer a more efficient surgical option where medications provide only temporary relief. The business implications include leveraging an existing platform for new applications, potentially reducing hospital costs and improving outcomes for patients suffering from neurological disorders.
