Why NeuroOne Medical (NMTC) Shares Are Trading Lower Today - NeuroOne Medical Tech (NASDAQ:NMTC)

NeuroOne Medical Technologies Corporation NMTC has submitted a special 510(k) to the FDA for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 days use.
According to FDA guidance, a special 510(k) is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).
NeuroOne Medical is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation, and ablation solutions.
In May, the FDA stated that they upheld their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.
Today, the agency informed the company that it could submit a new 510(k) with new evidence, specifically regarding the subacute toxicity biocompatibility endpoint.
Last week, NeuroOne announced a $3.5 million accelerated milestone payment from Zimmer Biomet Holdings Inc ZBH. The amendment will also give Zimmer 350,000 warrants with an exercise price of $3.00 per share.
Price Action: NMTC shares are down 5.80% at $1.79 during the market session on the last check Tuesday.

NeuroOne Medical Shares Fall After EEG Electrode Regulatory Update