NeuroOne Medical Technologies (Nasdaq:NMTC) today announced a breakthrough patient procedure using its OneRF ablation system.

The OneRF system picked up FDA 510(k) clearance in December 2023 for the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue.

OneRF 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.

Last month, the Eden Prairie, Minnesota-based company signed a distribution deal with an undisclosed global medical technology company for OneRF. It could mirror the deal it has with Zimmer Biomet for its Evo sEEG electrodes.

NeuroOne reports that clinicians at the University Hospitals in Cleveland used OneRF to successfully complete 44 ablations in one patient. Neurosurgeon Dr. Michael Staudt led the ablations, which took place through six different OneRF electrodes over a two-day period. Guidance provided by sEEG recordings confirming the focal epileptic zone in the patient enabled the ablations.

The ablations took place at the patient’s bedside and the company reported them as well-tolerated. Immediate and short-term clinical evaluation suggest positive outcomes. At two months follow-up, the patient is seizure-free with self-reported improvements in mood and memory. NeuroOne plans to evaluate long-term outcomes over time.

“We are extremely pleased that the OneRF system had a positive impact for the patient,” said NeuroOne CEO Dave Rosa. “This case was unique in that it far exceeded the range of ablations found in clinical literature. It was exciting to see the system safely perform forty-four ablations and yield a positive outcome to date. We appreciate Dr. Staudt and his staff’s support during the case and look forward to future cases.”