NeuroOne's Evo sEEG Electrode Scores FDA Clearance For Temporary Use

The FDA has granted 510(k) clearance to NeuroOne Medical Technologies Corporation's NMTC Evo sEEG Electrode technology for temporary (less than 24 hours) use.
The system comes with recording, monitoring, and stimulation equipment for electrical signals at the subsurface level of the brain.
"The next steps for the Company are to expand the sEEG labeling for longer-term use, which we believe will be a key part of our commercialization strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for the ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson's disease, and chronic back pain," said Dave Rosa, CEO of NeuroOne.
NeuroOne is also advancing a pipeline of therapeutic electrode technologies for brain tissue ablation and chronic stimulation use for deep brain and spinal cord stimulation for chronic back pain.
Read Next: NeuroOne, RBC Medical Innovations Come Together For Ablation Device Program.
The Company expects to be launch-ready by the end of 2021, pending additional regulatory clearance of sEEG labeling for longer-term use.
Price Action: NMTC stock is down 14.60% at $4.62 during the premarket session on the last check Wednesday.