NeuroOne® Submits Special 510(k) to FDA for Evo® sEEG Electrode

Rhea-AI Summary

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) has re-submitted a special 510(k) application to the FDA on August 8, 2022, to extend the usage duration of its sEEG electrode from less than 24 hours to less than 30 days. This expedited review is expected to be completed within 30 days. Following a previous setback in May, where the FDA upheld a decision of not substantially equivalent, NeuroOne has addressed biocompatibility concerns. CEO Dave Rosa expressed optimism about the submission and continued discussions with the FDA.

Positive

• Resubmission of the 510(k) application for extended sEEG electrode usage duration is a strategic move.
• Expedited review process may lead to quicker market access for the device.

Negative

• FDA previously deemed the application not substantially equivalent.
• Uncertainties remain regarding the approval timeline and commercialization.

Company re-submits application to gain FDA clearance for less than 30 day use

EDEN PRAIRIE, Minn., Aug. 9, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company submitted a special 510(k) to the U.S. Food and Drug Administration ("FDA") on August 8^th for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use. A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).

Dave Rosa, Chief Executive Officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion."

On May 16^th, the Company issued a press release stating the FDA's decision to uphold the not substantially equivalent decision after the Company had appealed the ruling. The FDA also informed the Company it could submit a new 510(k) with new evidence specifically as it relates to the subacute toxicity biocompatibility endpoint.

About NeuroOne

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. For more information, visit https://www.n1mtc.com.

Forward Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward–looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the timing of the FDA's review of the Company's special 510(k) submission; and the ability to obtain FDA clearance of the Company's sEEG electrode for <30 day use on a timely basis, or at all. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions, labor shortages, the impact of COVID-19 or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds; the risk that the COVID-19 pandemic will continue to adversely impact our business; the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.

"Caution: Federal law restricts this device to sale by or on the order of a physician"

 

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SOURCE NeuroOne Medical Technologies Corporation

FAQ

What is NeuroOne Medical Technologies Corporation's latest FDA submission?

NeuroOne has submitted a special 510(k) application for its sEEG electrode to extend its usage from less than 24 hours to less than 30 days.

When was the 510(k) application submitted?

The application was submitted on August 8, 2022.

What are the implications of the FDA's expedited review?

The FDA's expedited review for the special 510(k) application is expected to take approximately 30 days, potentially speeding up the approval process.

What challenges did NeuroOne face with the FDA previously?

Previously, the FDA upheld a not substantially equivalent decision regarding NeuroOne's application.

What is the significance of the sEEG electrode for NeuroOne?

The sEEG electrode is crucial for extending patient monitoring durations, potentially improving patient outcomes in neurological procedures.