Emerging Markets Report - NeuroOne Medical Technologies Receives FDA 510(k) Clearance - Seite 2

In limited trials, the Mayo Clinic was able to successfully document pre-seizure activity in epileptic patients using NeuroOne’s technology. The Mayo Clinic tests were conducted as part of a licensing and development agreement between the two companies--a partnership that constitutes a significant first step toward NeuroOne’s commercial adoption.

NeuroOne’s Receives FDA 510(k) Clearance for Its Evo Cortical Electrode Device

On December 2, NeuroOne announced that it received 510(k) clearance from the US Food and Drug Administration (FDA) to begin marketing its Evo Cortical Electrode device for the purpose of short-term brain stimulation, monitoring, and recording.

For those of you who might not be familiar with this term, a 510(k) is a technical document detailing technical, performance, and safety information for a given product. The FDA must review a company’s 501(k) submission and “clear” its product prior to a company commercializing the technology.

NeuroOne’s now-cleared Evo Cortical Electrode product line is the culminating result of the company’s collaboration with the Mayo Foundation and the Wisconsin Alumni Research Foundation, another institution to which the company has an exclusive licensing agreement.

"This is certainly a monumental achievement for the Company," says Dave Rosa, NeuroOne's President and CEO. "This 510(k) clearance is a critical step in executing our corporate strategy, and we look forward to working towards our goal of applying this platform to a variety of other devices for recording, monitoring and stimulation for various therapeutic applications such as epilepsy, Parkinson's Disease, spinal cord stimulation and artificial intelligence."

NMTC Currently at Market Lows
Having been granted the regulatory green light to begin bringing its product line to market, NeuroOne’s stock is still ranging within its lows (currently at around $2.45 per share). This shouldn’t come as a surprise, as the emerging healthcare space is often too specialized a sub-industry for most mainstream investors to monitor let alone understand.

But for the few who can grasp both the relevance and growth potential of NeuroOne’s product line, the company offers early investors an opportunity to get in on a much-needed medical product that, to date, sees neither comparable solutions nor formidable competition.

About NeuroOne:
NeuroOne Medical Technologies Corporation is a medical technology company focused on providing minimally invasive and high-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, essential tremors, dystonia, back pain and other related neurological disorders that may improve patient outcomes and reduce procedural costs.