NeuroOne® Receives FDA 510(k) Clearance for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain

Core Viewpoint - NeuroOne Medical Technologies Corporation has received FDA clearance for its OneRF Trigeminal Nerve Ablation System, which offers a minimally invasive alternative for treating trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people annually in the U.S. [1][2] Group 1: Product and Technology - The OneRF Trigeminal Nerve Ablation System utilizes a proprietary RF generator platform to create radiofrequency lesions for pain treatment and functional neurosurgical procedures [1][2] - This system features a unique multi-contact RF probe that allows for precise localization and tailored ablation of nerve tissue, enhancing safety and accuracy during procedures [3] - The technology aims to reduce procedural time, improve patient comfort, and enhance overall patient safety [3] Group 2: Market Potential and Strategy - The company plans a limited commercial launch of the OneRF system in the fourth quarter of 2025, with expectations to generate revenues from trigeminal nerve ablation by late 2025 [1][4] - NeuroOne's technology platform has potential applications across various neurological disorders and pain management functions, including lower back pain [4] - Current users of the OneRF brain ablation system may also adopt the nerve ablation procedures, justifying further investment in the technology [4] Group 3: Company Overview - NeuroOne Medical Technologies Corporation focuses on developing minimally invasive solutions for various neurological disorders, including epilepsy and chronic pain [5] - The company is exploring additional therapeutic applications, such as treatments for depression, mood disorders, and high blood pressure [5]