NeuroOne® Completes FDA Submission for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain

Core Viewpoint - NeuroOne Medical Technologies Corporation has submitted its 510(k) application to the FDA for its OneRF® Trigeminal Nerve Ablation technology, aimed at treating trigeminal neuralgia, ahead of schedule, indicating progress in its product development timeline [2][3]. Company Overview - NeuroOne is focused on developing minimally invasive medical technologies to improve surgical care for patients with neurological disorders, including epilepsy and chronic pain conditions [6]. - The company’s OneRF® Ablation System utilizes radiofrequency energy to treat trigeminal neuralgia, a condition affecting approximately 100,000 individuals in the U.S. [3][4]. Product Details - The OneRF® Trigeminal Nerve Ablation technology is designed to provide a minimally invasive option for patients, using a multi-contact probe that allows for multi-point mapping, stimulation, and ablation with temperature control [3]. - Previous studies indicate that radiofrequency ablation has a high initial pain relief rate of around 95% and long-term efficacy, making it a preferred choice for patients seeking less invasive treatment options [4]. Market Potential - If the FDA grants clearance, the company anticipates potential revenue generation from the trigeminal nerve ablation procedure by late 2025 [5]. - The technology has received significant media attention, which may enhance its market visibility and acceptance [5]. Future Applications - NeuroOne is exploring additional applications for its technology in treating various neurological disorders, including depression, mood disorders, and high blood pressure, which could further expand its market reach [6].