NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) has received FDA 510(k) clearance to market its OneRF® Trigeminal Nerve Ablation System, marking its first FDA-approved treatment for trigeminal neuralgia—a debilitating facial pain condition impacting over 150,000 Americans annually.
This advanced system utilizes a multi-contact radiofrequency (RF) probe capable of both pain localization and precise lesioning in a temperature-controlled, minimally invasive procedure. NeuroOne expects this innovation to shorten procedure times, enhance patient comfort, and improve safety outcomes.
CEO Dave Rosa highlighted that this clearance expands NeuroOne’s therapeutic reach beyond brain ablation and opens doors to new pain management applications, such as lower back pain, leveraging their OneRF® platform. The company plans a limited commercial launch in Q4 2025, targeting early revenue generation from this novel offering.
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