First NeuroOne OneRF Ablation Electrode Implanted

NeuroOne has achieved the first implantation of its OneRF ablation electrode at a top-ranked U.S. hospital.
 
OneRF earned U.S. Food and Drug Administration (FDA) clearance late last year and the company began a limited launch of OneRF last month.
 
The ablation electrode creates radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. OneRF is the company’s first device with a therapeutic indication and is its third FDA-cleared device.
 
NeuroOne has a full line of thin-film electrode technology for patients needing diagnostic brain mapping as well as RF ablation using the same sEEG electrode. The company’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines. These are mainly used for stimulation, recording, and monitoring of the brain’s electrical activity for under 30 days.
 
“We are excited to announce that yesterday, doctors implanted Evo sEEG-RF electrodes in a patient suffering from epilepsy,” said NeuroOne CEO Dave Rosa. “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,” Rosa went on. “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. 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.”