NeuroOne's Trigeminal Nerve Ablation System Shows Promise in Initial Clinical Cases
TL;DR
NeuroOne's FDA-cleared OneRF system offers surgeons a competitive edge with its multi-contact probe that reduces procedural time and improves precision in trigeminal neuralgia treatments.
The OneRF system uses a multi-contact RF probe to deliver temperature-controlled energy, ablating trigeminal nerve fibers precisely without repositioning, minimizing complications in pain management procedures.
This technology provides pain relief for chronic facial pain sufferers, improving quality of life for approximately 150,000 Americans annually and advancing neurological care options.
NeuroOne's first pain management application successfully treated two patients with trigeminal neuralgia using thin film ablation technology originally developed for brain procedures.
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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 (AANS), underwent radiofrequency ablations performed by Dr. Michael Staudt, Associate Professor of Neurological Surgery. Both patients reported pain relief without postoperative complications.
The system received 510(k) clearance from the U.S. Food and Drug Administration in August 2025. It represents NeuroOne's first application of its thin-film ablation technology in pain management, distinct from its existing brain ablation system. The procedure utilizes a multi-contact RF probe that allows surgeons to ablate relevant nerve branches without repositioning the instrument, potentially reducing procedural time while enhancing precision under temperature-controlled conditions for improved safety.
Dr. Staudt noted satisfaction with the system's performance in these initial cases, stating it offers meaningful advantages over existing options. NeuroOne CEO Dave Rosa emphasized this milestone validates the company's platform technology for applications beyond neurological disorders. The company now plans to pursue additional pain management opportunities, including targeting lower back pain, which represents an annual market exceeding $1 billion. For more information about the company, visit https://www.nmtc1.com.
The successful cases demonstrate a minimally invasive surgical alternative for treating severe chronic facial pain by delivering targeted RF energy to ablate trigeminal nerve fibers and interrupt pain signaling. This development matters because trigeminal neuralgia causes excruciating pain through the face's main sensory nerve, and current treatment options remain limited for many patients. The technology's expansion into pain management could address significant unmet clinical needs across multiple therapeutic areas.
Curated from NewMediaWire
