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 the OneRF Ablation System was recently used in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient.
In mid-July, led by Dr. Michael Staudt, Neurosurgeon, a patient benefitted from forty-four ablations through six different implanted OneRF electrodes over a two-day period. These ablations were performed based on guidance provided by the sEEG recordings that confirmed the focal epileptic zone in the patient. The ablation sessions were performed at the patient’s bedside and were well-tolerated by the patient. Immediate and short-term clinical evaluation suggests a positive outcome of the ablation procedure. At two months follow-up, the patient is seizure-free with self-reported improvements in mood and memory. Long term outcomes will be evaluated over time.
Dr. Staudt commented “We are very pleased with how NeuroOne’s OneRF system performed in this case, and we look forward to adopting this capability in our clinical practice. We think many patients could benefit from this technology in the near future.”
“We are extremely pleased that the OneRF system had a positive impact for the patient. 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,” said Dave Rosa, CEO of NeuroOne.
The OneRF™ Ablation System is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF™ Ablation System, NeuroOne’s other FDA-cleared devices include the Evo® cortical and sEEG electrode product lines which are used primarily for stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.
NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.