Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, MN; Company on track to submit OneRF 510(k) application to the FDA in the second quarter of calendar year 2023
EDEN PRAIRIE, Minn., Dec. 6, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has successfully completed a feasibility study with its OneRF™ ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
The study evaluated the Company’s new RF ablation system in an animal model. The study used NeuroOne’s 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. Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an 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. 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.” said Dave Rosa, CEO of NeuroOne.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.
About NeuroOne
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. For more information, visit https://www.n1mtc.com .
