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 under K251243, was used to treat 12 patients across three medical centers. All patients reported freedom from pain following the procedure, according to the company's announcement.
This development is significant for the approximately 150,000 patients in the United States suffering from trigeminal neuralgia, a chronic pain condition so severe it is often called the "suicide disease." The condition causes sudden, intense facial pain that disrupts basic daily functions, and while medications may offer temporary relief, many patients eventually require surgical intervention. The potential impact of a more effective and efficient surgical option could substantially improve quality of life for this patient population.
A key advantage reported by physicians involved in the limited release was the system's procedural efficiency. The majority of cases had short procedural times, with the fastest completed in 16 minutes. This efficiency stems from the design of NeuroOne's multi-contact probe, which addresses a major limitation of current ablative systems. Traditional methods often require multiple sleep-wake cycles, where patients are repeatedly awakened to confirm pain localization and then re-anesthetized while the probe is repositioned. NeuroOne's probe is designed to enable precise mapping and ablation in a single cycle without repositioning.
"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 improved patient comfort and reduced procedural complexity highlighted in this early experience could influence hospital adoption and treatment protocols.
From a healthcare systems perspective, the OneRF® system uses the same NeuroOne Radiofrequency Generator already employed in epilepsy ablation procedures. This compatibility allows existing customers to add trigeminal neuralgia treatment without significant additional capital investment, as each procedure utilizes a disposable kit. The ability of a single platform to support multiple clinical applications, including epilepsy and now trigeminal neuralgia, may make the NeuroOne technology more attractive to hospitals evaluating new purchases, potentially affecting market dynamics in neurological treatment devices.
Dave Rosa, President and Chief Executive Officer of NeuroOne, stated that the results highlight the clinical and procedural advantages of the multi-contact probe. The company is now expanding access to additional centers while evaluating strategic partnership opportunities and broader go-to-market strategies. The system is indicated for creating radiofrequency lesions for pain treatment or for lesioning nerve tissue for functional neurosurgical procedures. For more information on the company, visit https://nmtc1.com.
The limited market release results, while promising, represent early clinical experience. The company's press release includes standard disclaimers noting that the recounted patient experiences may not be representative of all outcomes and contains forward-looking statements subject to risks and uncertainties. The full press release was originally published on https://www.newmediawire.com.
