NeuroOne Medical Technologies (Nasdaq:NMTC) announced the first human uses of its OneRF neuroablation system in Florida.
Surgeons at a hospital in Jacksonville, Florida, successfully completed five ablations in one patient suffering from multifocal epilepsy. In the procedure, surgeons placed 10 Evo sEEG electrodes in various locations of the patient’s brain. Four electrodes identified problematic areas of the brain triggering seizuers.
Using OneRF’s temperature control safety, surgeons performed ablations, with two occurring at different contacts on one electrode. The same electrodes confirmed the successful ablations with post-ablation sEEG recordings demonstrating lack of brain activity at the point of tissue ablation.
The procedure took place at the patient’s bedside, saving time and costs related to operating room procedures.
“It was exciting for the company to witness the first clinical ablations performed using the OneRF ablation system. The ability to safely perform these procedures at the patient’s bedside will reduce operating room time and cost, freeing up the operating room to conduct additional procedures,” said Dave Rosa, NeuroOne CEO. “We look forward to additional procedures utilizing the system with the goal of providing a safe therapy for patients to both monitor and ablate problematic brain tissue. In the future, the company intends to leverage the OneRF generator with future FDA submissions for additional ablation applications.”
More about the NeuroOne OneRF ablation system
OneRF picked up FDA 510(k) clearance for the OneRF system in December 2023. Indications cover the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.
NeuroOne’s first-to-market thin-film, sEEG-guided RF ablation system can both record electrical activity and ablate nervous tissue. The system, which also features temperature control, is the third FDA-cleared device at NeuroOne and the first therapeutic device made by the company. The company says the system could reduce hospital stays, total surgeries and adverse events while offering significant clinical benefits.
This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. They utilize a much less invasive process that eliminates the need to remove the top portion of the skull, though.
In March, NeuroOne initiated a limited commercial launch for its OneRF ablation system. The company announced the first implant of the OneRF Ablation electrode in April.
NeuroOne estimates the current neuroablation market to be a $100 million opportunity that’s still growing.
