Company resubmits 510(k) regarding cortical electrode technology directly to the FDA for review
MINNETONKA, MN / ACCESSWIRE / October 1, 2019 / NeuroOne Medical Technologies Corporation (NMTC), a medical device company focused on the development and commercialization of thin-film electrode technology for recording brain activity, stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson's Disease, and back pain, today announced that it has re-submitted its 510(k) submission to the United States Food and Drug Administration (FDA) for its cortical electrode technology.
On August 14, 2019, the Company announced that it had withdrawn its initial 510(k) submission for its cortical electrode technology after the FDA requested additional sterilization data related to the cable assembly that could not be provided within the time period specified by the FDA. The Company also reported that it planned to submit the sterilization information in a subsequent 510(k) submission directly to the FDA once it had successfully obtained the additional data. On September 28, 2019, the Company sent the 510(k) submission to the FDA and receipt was confirmed on September 30, 2019.
"I am very pleased and grateful at how quickly the team was able to respond to the FDA's request given that just last month we informed the market that we needed to perform additional sterilization testing," stated Dave Rosa, NeuroOne's President and CEO. "We look forward to an interactive process with FDA to conclude this process in as expeditious a manner as possible."
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, Essential Tremors and other related neurological disorders that may improve patient outcomes and reduce procedural costs.
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 the Company'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 "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" 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 Company's regulatory submissions, potential regulatory approval including the timing and approval of the Company's 510(k) submission, commercialization of the technology, business strategy, market size, potential growth opportunities, plans for product applications and product development, future operations, future efficiencies, and other financial and operating information. Although the Company 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 our ability to raise additional funds, uncertainties inherent in the development process of our technology, changes in regulatory requirements or decisions of regulatory authorities, the size and growth potential of the markets for our technology, our ability to serve those markets, the rate and degree of market acceptance of our products, clinical trial patient enrollment, the results of clinical trials, future competition, the actions of third-party clinical research organizations, suppliers and manufacturers, our ability 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 the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future.
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SOURCE: NeuroOne Medical Technologies Corporation
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