NeuroOne Medical Technologies has announced that it has successfully completed a feasibility study with its OneRF ablation system—a developing technology that utilises existing implanted stereoelectroencephalography (sEEG) diagnostic electrodes for brain tissue lesioning.
The study evaluated the company’s new radiofrequency (RF) ablation system in an animal model. It used NeuroOne’s US Food and Drug Administration (FDA)-cleared sEEG electrodes combined with a proprietary RF generator, and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed. This allows clinicians to set temperature and time for each ablation, the company claims.
Jamie Van Gompel and his team at the Mayo Clinic in Rochester, USA implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of 10 RF ablations using different settings for temperature and time. All ablations were confirmed by a magnetic resonance imaging (MRI) scan.
“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,” said NeuroOne CEO Dave Rosa. “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.”
As previously reported, NeuroOne is also currently advancing a pipeline of therapeutic electrode technologies in deep brain stimulation (DBS) and spinal cord stimulation (SCS) for chronic back pain.