NeuroOne Medical today announced it completed a feasibility study of its OneRF ablation system.
The feasibility study evaluated the OneRF ablation system that uses existing sEEG diagnostic electrodes for brain tissue lesioning. Researchers completed the study in an animal model. The research combined the sEEG electrodes with a proprietary RF generator. In addition, there was a unique temperature control accessory that monitored and maintained ablation temperatures. The temperature control accessory allows doctors to set the temperature and time for each ablation procedure.
Dr. Van Gompel and his team implanted five sEEG electrodes. They performed electrophysiological records and completed a total of 10 RF ablations using different settings for temperature and time. An MRI scan confirmed all ablations in the feasibility study.
“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation. The addition of this feature may improve the safety of the procedure. We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful. We look forward to the FDA submission of the device in the second calendar quarter of 2023,” NeuroOne CEO Dave Rosa said in a news release.
Last week, the company began shipping its 30-day sEEG electrodes to Zimmer Biomet following NeuroOne’s FDA clearance to market its Evo sEEG electrode technology for temporary use with brain recording, monitoring and stimulation equipment.