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FAQ: NeuroOne's OneRF® Trigeminal Nerve Ablation System and Initial Successful 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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The announcement covers the initial successful use of NeuroOne's OneRF® Trigeminal Nerve Ablation System to treat two patients with trigeminal neuralgia (facial pain) at University Hospitals in Cleveland, Ohio.
It is a minimally invasive surgical system that uses targeted radiofrequency (RF) energy to ablate trigeminal nerve fibers, interrupting pain signaling to treat trigeminal neuralgia, a chronic facial pain condition affecting approximately 150,000 people in the U.S. annually.
It successfully showcases NeuroOne's platform technology's unique ability to be adopted for both brain ablation procedures and pain management, marking the company's first entry into pain management therapies and validating its patented technology.
The system delivers targeted RF energy to ablate pain-conducting nerve tissue. Its differentiated features include a 'first-of-its-kind' multi-contact RF probe that allows precise localization and targeted ablation using the same probe under temperature-controlled conditions, which may reduce procedural time and improve patient comfort and safety.
Dr. Michael Staudt, the Lincoln Endowed Chair in Brain Health and an Associate Professor of Neurological Surgery at University Hospitals, performed the RF ablations. Both patients reported pain relief without complications.
NeuroOne received 510(k) clearance from the FDA in August 2025 to market the system. The two successful cases at University Hospitals in Cleveland were completed and announced on December 9, 2025.
The system may offer reduced procedural time, improved patient comfort and safety, and meaningful advantages over other available systems. The multi-contact probe allows ablation of relevant nerve branches without repositioning each time.
NeuroOne expects to pursue additional opportunities in pain management and other therapeutic applications, including lower back pain, which has an annual market of over $1 billion, targeting a limited commercial launch.
According to the content, you can find more information about the 510(k) clearance at https://ir.nmtc1.com/press-release-details?newsId=3135019.
Curated from NewMediaWire
