NeuroOne Medical Technologies Corporation announced its submission of a 510(k) application to the U.S. Food and Drug Administration for its OneRF™ Ablation System. This technology uses the already implanted sEEG electrodes to record brain activity and allow for ablation of nervous tissue when connected to a proprietary radio frequency (RF) generator. If cleared by the FDA, NeuroOne's OneRF 510(k) submission represents the first step in bringing to market an innovative RF ablation system in the field of neurology and neurosurgery.

As the Company's first therapeutic device, OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays for patients.

NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs. NeuroOne anticipates receiving initial feedback from the FDA no later than August 7th, 2023.