The submission comes in ahead of schedule for the Eden Prairie, Minnesota-based company. Just last month, the company earmarked May for the 510(k) clearance submission. Before that, the company projected a submission by the end of June.

Trigeminal nerve ablation is a minimally invasive procedure. It uses radiofrequency (RF) energy to destroy abnormal tissue and relieve severe, chronic pain in the face caused by trigeminal neuralgia. Using the company’s patented OneRF platform, NeuroOne designed its procedure to provide pain relief for this condition.