NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first implant of its OneRF Ablation electrode.
The OneRF Ablation system is FDA 510(k) cleared to create radiofrequency nervous tissue lesions for functional neurosurgical procedures. The electrodes are a thin-film, sEEG-guided RF system that records the electrical activity and ablates nervous tissue with the added benefit of temperature control.
“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,” CEO Dave Rosa said in a news release.
NeuroOne’s OneRF Ablation system is the company’s first device with a therapeutic indication. It is the company’s third FDA cleared device, and the company now has a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures.
The company’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines, which are primarily used for stimulating, recording and monitoring electrical activity in the brain for less than 30 days.
“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,” Rosa said.