Core Viewpoint - NeuroOne Medical Technologies Corporation has accelerated its timeline for the 510(k) submission to the FDA for trigeminal nerve ablation, now expected in May 2025, utilizing its patented OneRF® Technology Platform, ahead of the previously projected June 2025 submission [1][3] Company Summary - NeuroOne is focused on developing minimally invasive medical technologies aimed at improving surgical care for patients with neurological disorders, including epilepsy, Parkinson's disease, and chronic pain [4] - The company has already achieved 510(k) FDA clearance for three product families and is now advancing its OneRF Trigeminal Nerve Ablation System [3] - If FDA clearance is obtained, the company anticipates potential revenue generation from trigeminal nerve ablation by late 2025, which was not previously expected within that calendar year [3] Industry Summary - Trigeminal nerve ablation is a minimally invasive procedure that uses radiofrequency energy to alleviate severe chronic facial pain caused by trigeminal neuralgia [2] - The market for trigeminal neuralgia therapeutics, which includes both pharmacologic and surgical technologies, is projected to grow from 416 million by 2030, driven primarily by an aging population [2]
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain