NeuroOne Medical, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has initiated a limited commercial launch of its OneRF Ablation System, which has FDA 510(k) clearance for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.
“Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF™ Ablation System. We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilizing the same electrode,” said Dave Rosa, CEO of NeuroOne. “We expect to start shipping systems this week to centers participating in our limited launch with cases already scheduled starting in April. We believe physicians and patients will benefit from our technology given it may reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety. Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”
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 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.
NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.
