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Thursday, May 19, 2022

NeuroOne Medical Technologies Corporation (NMTC) stock plunged in the Current market; here is why?

NeuroOne Medical Technologies Corporation (NMTC) stock declined in the current market after announcing that FDA has declined its 510(k) application. NMTC’s stock price is $1.29, losing more than 43% from the previous closing price. NMTC stock closed at $2.22 at the end of the last trading session. NMTC stock volume traded in the previous trading session was around 68.41K shares. The current market cap of the company is about $19.91 million.


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NMTC: SEC Filing

Evo sEEG electrodes were cleared by the FDA in September 2021 for temporary use with recording, monitoring, and stimulation devices to capture electrical impulses at a subsurface level of the brain. NeuroOne Medical Technologies originally announced this.

According to a company filing with the FDA in November 2021, it requested approval to utilize its Evo sEEG electrode technology for no more than 30 days. The FDA refused the Company’s 510(k) application on March 11, 2022, citing a lack of substantial equivalency in the technique utilized for thorough extraction testing. According to the FDA letter, this sEEG Electrode for less than 30 days is not substantially identical to the predicate device. If the company possesses biocompatibility data that shows its device is substantially identical, the FDA said the company might resubmit a 510(k).

NMTC: What Next?

Following the FDA’s request for more information, the Company’s independent subject matter experts concluded that the thorough extraction approach employed for chemical characterization was legitimate and satisfied the requisite subacute toxicity biocompatibility endpoints for extended usage (less than 30 days). Due to this delay in decision making, the Company will appeal the decision to a higher level of FDA. The FDA may take up to 60 days to respond to an appeal.

The Evo sEEG electrode is planned to be commercially available in the first quarter of 2022, pending FDA approval. The Company anticipates additional time and will continue to work with the FDA to get 510(k) approval. Additional talks are taking place between the Company and Zimmer Biomet to obtain a mutually advantageous agreement on previously agreed upon milestone payments.

Conclusion

The decline of the anticipated approval from the FDA has caused a severe blow to its share price. The company is looking forward to submitting an appeal to the higher authority of the FDA. However, FDA has also stated that the company may resubmit the application if they believe their provided data is correct.

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