NeuroOne Medical Technologies Corporation has reported successful initial clinical use of its OneRF Trigeminal Nerve Ablation System at University Hospitals in Cleveland, Ohio. Two patients suffering from trigeminal neuralgia, a chronic facial pain condition affecting approximately 150,000 people in the United States annually according to the American Association of Neurological Surgeons (https://www.aans.org), underwent radiofrequency ablations performed by Dr. Michael Staudt, Associate Professor of Neurological Surgery. Both patients experienced pain relief without postoperative complications.
The significance of these cases extends beyond individual patient outcomes. NeuroOne received FDA 510(k) clearance for the system in August 2025, marking the company's expansion into pain management therapies using its proprietary thin-film ablation technology. The system represents a strategic diversification from NeuroOne's existing brain ablation applications, potentially opening access to broader therapeutic markets. Dave Rosa, NeuroOne's CEO, indicated the company expects to pursue additional opportunities in pain management, specifically mentioning lower back pain as a target application with an annual market exceeding $1 billion.
From a clinical perspective, the system's technical features may offer procedural advantages. The multi-contact RF probe allows surgeons to perform both precise nerve localization and targeted ablation using the same instrument without repositioning, potentially reducing procedural time while maintaining temperature-controlled conditions for enhanced safety. Dr. Staudt noted the system performed well in these initial cases and expressed anticipation for adopting the tool into regular clinical practice, suggesting it offers meaningful advantages over existing alternatives.
The implications for patients with trigeminal neuralgia are substantial. This condition involves the trigeminal nerve, the main sensory nerve in the face, and can cause excruciating pain that significantly impacts quality of life. A minimally invasive treatment option that demonstrates early success without complications could provide relief for patients who may have limited alternatives. The system's design aims to interrupt pain signaling by delivering targeted RF energy to ablate specific nerve fibers.
For the medical device industry, this development highlights the growing intersection of neurological and pain management technologies. NeuroOne's platform approach, leveraging core technology across multiple applications, demonstrates how specialized medical innovations can expand into adjacent therapeutic areas. The company's existing FDA-cleared product families include Evo Cortical Electrodes, Evo sEEG Electrodes, and the OneRF Ablation System for brain procedures, with the trigeminal nerve system representing a new direction. As NeuroOne targets a limited commercial launch and explores additional applications, this initial clinical validation provides important momentum for both the company and the evolving field of precision ablation therapies.
