NeuroOne Medical Technologies, a company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its OneRF Ablation System.
hxdbzxy Shutterstock
2277765967
Application submission
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 utilises a customised 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 $100 million worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs.
Dave Rosa, CEO of NeuroOne, said: “This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF probe to ablate nervous tissue. In addition, it marks the company’s first complete system combining hardware, software, and our novel electrode technology. Over the past few years, we have been excited with the feedback we have received from our advisory board as well as the performance of the system in animal feasibility studies. We also believe this system has applications beyond ablation of nervous tissue in the brain, offering a larger opportunity than we initially envisioned. I am proud of our entire team and their efforts which allowed us to complete this before the end of June as planned.”
NeuroOne anticipates receiving initial feedback from the FDA no later than 7th August 2023.
