NeuroOne Medical Technologies Corporation today announced the first clinical case using the Evo sEEG electrode was performed by Dr. Robert Gross at Emory University. Dr. Gross selected the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the brain.
Dave Rosa, Chief Executive Officer of NeuroOne, states, “This first clinical case use represents a major milestone achievement of one of our primary objectives for the Company.”
Rosa added, “We are grateful to Dr. Gross and his staff and were excited to hear of the positive experience he had using the electrode. We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA in August for clearance to commercialize the product for less than 30 days use.”
In September 2021, the Company received U.S. Food and Drug Administration 510(k) clearance to market its Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
The Evo sEEG electrode represents the Company’s second FDA 510(k) cleared product, providing a full line of electrode technology to address an estimated worldwide market of $100M for patients requiring diagnostic brain mapping procedures. In comparison with cortical electrodes, sEEG electrodes provide a similar function at the subsurface level of the brain by using a much less invasive process that does not require removal of the top portion of the patient’s skull. sEEG has become the predominant technology used in these procedures due to its less invasive placement and subsurface location.