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
8th 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 16th, 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