NeuroOne receives FDA clearance to market its OneRF ablation system

NeuroOne has announced that it has received U.S. Food and Drug Administration 510(k) clearance to market its OneRF Ablation System for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

“When NeuroOne was founded, one of our ambitious goals was to be the first to develop and commercialise thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions,” said Dave Rosa, CEO of NeuroOne. “We believe we have the potential to dramatically change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures. This may also reduce hospital stays, number of surgeries, and adverse events, while offering significant benefits from a clinical perspective. The addition of temperature control at the point of ablation also may enhance patient safety. Our team’s achievement in reaching this milestone was the culmination of years of perseverance, and I could not be more excited for our future. We are now preparing for a commercial launch either directly or through a strategic partner in the first half of calendar 2024.”

Robert E. Gross, MD, PhD, chair of the Department of Neurosurgery at New Jersey Medical School and Robert Wood Johnson Medical School said "The FDA clearance of NeuroOne's OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG. This may lead to improved outcomes for patients with potential for fewer interventions, and an improved therapeutic window."

The OneRF Ablation System is the Company’s first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF Ablation System, NeuroOne’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines which are used primarily for recording electrical activity in the brain for less than 30 days.