Following gaining permission, NeuroOne Medical Technologies Corporation (NASD: NMTC) increased 11.84% to $1.70 in after-hours trading on the previous check Tuesday.
Which endorsement has NMTC obtained?
The U.S. Food and Drug Administration (FDA) has given NeuroOne (NMTC) permission to commercialize its Evo sEEG Electrode technology for short-term (less than 30 days) use with equipment for recording, monitoring, and stimulating electrical impulses at the brain’s subsurface level.
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On August 9, 2022, NeuroOne declared it had resubmitted its 510(k) application to the FDA for shorter than 30-day of usage. This time, the FDA requested further biocompatibility testing, and NeuroOne complied. An FDA clearance letter declaring that the Evo sEEG System is essentially comparable to the predicate device and may be sold in the United States was given to the company on October 20, 2022.
NMTC had difficulties, but its staff never wavered in their will to see the project through to a successful completion. NMTC’s most exciting and significant achievement to date is without a doubt this. As a result of its agreement with Zimmer Biomet, its distribution and development partner, NeuroOne is now able to accelerate its commercialization activities. The Company’s initial therapeutic electrode technology, the RF ablation system, will be the next step in NMTC’s continued execution of our strategic plan.
What’s in it for NMTC?
The Evo sEEG System is the second FDA 510(k) certified device for the company. With a comprehensive range of electrode technologies now available, NeuroOne can serve the projected $100 million global market for patients who need diagnostic brain mapping operations. Unlike cortical electrodes, which need the top of the patient’s skull to be removed, sEEG electrodes provide a comparable function at the subsurface level of the brain utilizing a far less intrusive technique.
Due to its subsurface insertion and less intrusive usage, sEEG electrodes are the most common technique employed in these treatments. Evo Cortical and sEEG Electrodes from the company are a selection of high-definition thin film electrodes. Potential benefits include improved tactile feedback during insertion into brain tissue, less noise, higher signal clarity, and quicker order fulfillment owing to automated production.
What NMTC remained up to?
In addition, NeuroOne (NMTC) is developing a pipeline of therapeutic electrode technologies for brain tissue ablation, continuous stimulation, deep brain stimulation (DBS), and spinal cord stimulation for persistent back pain. These therapeutic electrode technologies from NMTC represent addressable markets with an estimated value of $500 million to $6 billion.