NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the Company’s patented OneRF Technology Platform. The Company had previously projected a submission by the end of June 2025.
Trigeminal nerve ablation is a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face caused by trigeminal neuralgia. The trigeminal nerve is the main sensory nerve in the face and NeuroOne’s procedure is designed to provide pain relief for this condition.
According to the October 2024 Research and Markets report titled Trigeminal Neuralgia Therapeutics Market, the trigeminal neuralgia therapeutics market, comprised of pharmacologic and surgical technologies, is expected to grow from 262 million USD in 2024 to over 416 million USD by 2030, primarily due to an aging population.
“Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation System, approximately two months ahead of schedule,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “If cleared by the FDA—we believe there is a potential to generate revenues from trigeminal nerve ablation in late 2025, which was not previously expected in calendar year 2025.
“Importantly, trigeminal nerve ablation would be the second radiofrequency ablation technology in our portfolio leveraging our patented OneRF Technology Platform. As we move ahead, we believe there are several additional ablation applications we can introduce and look forward to updating you on our progress as we move throughout the year.”
