NeuroOne Announces First Implant of OneRF Ablation Electrodes

First to market FDA-cleared thin-film, sEEG-guided RF system capable of both recording electrical activity and ablating nervous tissue with the added benefit of temperature control

EDEN PRAIRIE, Minn., April 09, 2024 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the first implant of its OneRF Ablation electrode by doctors at a top ranked hospital in the US, as ranked by the US News & World Best Hospital Report in its 2023-2024 publication. The OneRF Ablation system has FDA 510(k) clearance for creation of radiofrequency (“RF”) lesions in nervous tissue for functional neurosurgical procedures.

“We are excited to announce that yesterday, doctors implanted Evo sEEG-RF electrodes in a patient suffering from epilepsy. Once the monitoring identifies the areas of the brain that are causing seizures, the surgical team now has the option to use the same electrodes to perform an ablation utilizing NeuroOne’s RF generator. This capability provides the neurosurgeon an entirely new option for use in the appropriate patients and situation. Being first to market with this technology positions the Company as a market leader in offering multi-functional diagnostic and therapeutic thin-film electrode technology,” said Dave Rosa, CEO of NeuroOne. “As stated previously, we believe the technology has the potential to reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety.”

The OneRF Ablation System is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of thin film 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 stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.