NeuroOne Speeds Timeline for FDA Submission of Trigeminal Nerve Ablation Tech

NeuroOne Medical Technologies announced that it has accelerated the anticipated timeline of 510(k) submission to the U.S. Food and Drug Administration (FDA) for trigeminal nerve ablation to May 2025. The technology leverages the company’s OneRF tech platform.

Trigeminal nerve ablation uses radiofrequency (RF) energy to destroy abnormal tissue to relieve chronic pain in the face caused by trigeminal neuralgia. The trigeminal nerve is the main sensory nerve in the face.

“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 CEO 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,” Rosa went on. “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.”

In October 2024, NeuroOne executed an amendment to its existing distribution agreement with Zimmer Biomet.