NeuroOne Reports Successful Initial Cases Using OneRF Trigeminal Nerve Ablation System at University Hospitals Cleveland

NeuroOne Medical Technologies Corporation has announced the successful completion of initial cases using 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, were treated with the system. Both patients reported pain relief without postoperative complications.

The procedures were performed by Dr. Michael Staudt, the Lincoln Endowed Chair in Brain Health and an Associate Professor of Neurological Surgery at University Hospitals. Using radiofrequency ablations with NeuroOne's multi-contact probe, Dr. Staudt was able to ablate the relevant nerve branches without needing to reposition the probe for each ablation. This technical feature is central to the system's design, which aims to enhance precision and potentially reduce procedural time.

The company received 510(k) clearance from the U.S. Food and Drug Administration in August 2025 to market the OneRF Trigeminal Nerve Ablation System. The system leverages NeuroOne's proprietary OneRF Ablation platform technology, originally developed for brain procedures, for the treatment of trigeminal neuralgia. The condition involves the trigeminal nerve, the main sensory nerve in the face, which can trigger severe pain.

Dr. Staudt commented on the system's performance, stating he was pleased with how it performed the ablations and looks forward to adopting the tool in clinical practice. He believes it offers meaningful advantages over other available systems. The system is described as featuring 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, which is intended to enhance safety and accuracy.

Dave Rosa, CEO of NeuroOne, highlighted the significance of this milestone as the company's first entry into pain management therapies using its thin film ablation technology. He stated that it successfully showcases the platform technology's unique ability to be adopted for both brain ablation procedures and pain management. Rosa indicated the company expects to pursue additional opportunities leveraging its technology platform in pain management and other therapeutic applications, including targeting the lower back pain market, which he noted represents an annual market of over $1 billion. The company is targeting a limited commercial launch. For more information on the company, visit https://www.nmtc1.com.

The successful initial cases at a major academic medical center validate the clinical application of NeuroOne's technology beyond its established use in neurological diagnostics and brain ablation. For patients with trigeminal neuralgia, who often face debilitating pain, the development of new, minimally invasive surgical options with reported advantages in precision and safety could represent a significant advancement. For the medical device industry, NeuroOne's expansion into pain management demonstrates the potential for platform technologies to address multiple therapeutic areas, potentially improving efficiency in research and development. The company's mention of targeting the substantial lower back pain market suggests a strategic pivot that could influence competitive dynamics in the neuromodulation and pain management sectors if future developments prove successful.