The OneRF ablation system uses existing implanted sEEG diagnostic electrodes for brain tissue lesioning
NeuroOne has completed a feasibility study with its OneRF ablation system in an animal model. (Credit: Milad Fakurian on Unsplash)
NeuroOne Medical Technologies, a US-based developmental stage company, has announced the completion of a feasibility study with its OneRF ablation system in an animal model.
According to the company, the OneRF ablation system uses existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
In the animal model, NeuroOne’s US Food and Drug Administration (FDA)-cleared sEEG electrodes were combined with a proprietary RF generator to evaluate the new RF ablation system.
Additionally, the study used a new temperature control accessory that monitored and maintained the temperatures at which the ablation was carried out. These allowed clinicians to set the temperature and time for the ablations, said NeuroOne.
The study saw the implantation of five sEEG electrodes, followed by electrophysiological recordings before ten RF ablations using different settings for temperature and time were undertaken. All the ablations in the study were confirmed by an MRI scan.
NeuroOne CEO Dave Rosa said: “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.”
In addition, NeuroOne is developing a pipeline of therapeutic electrode technologies for spinal cord stimulation and deep brain stimulation (DBS) for the treatment of chronic back pain.
The firm is also said to be on track to file a 510(k) application with the FDA in Q2 2023 for its OneRF ablation system.
In October this year, NeuroOne secured FDA 510(k) clearance to market its Evo sEEG Electrode technology.