The Evo® sEEG electrode 510(k) cleared for
temporary (less than 24 hours) use remains in effect and the
Company will explore the opportunity to market the device for
intraoperative use.
EDEN
PRAIRIE, Minn., May 16, 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 announces
that the U.S. Food and Drug Administration (the "FDA") has
completed its review of the Company's appeal for 510(k) clearance
for its Evo® sEEG Electrode for less than 30-day use. In a
letter to the Company dated May 13,
2022, the FDA stated that they were upholding their decision
that the device is not substantially equivalent for extended
use based on their analysis of the methodology used for exhaustive
extraction testing.
The FDA also stated that the Company may
submit a new 510(k)
with new evidence, specifically as it
relates to the subacute toxicity endpoint, to support a finding of
substantial equivalence. The Company is in the
process of collecting such data and intends to submit a Special
510(k) which according to FDA guidance is processed within 30 days
of receipt, rather than the 90 days for a traditional 510(k). The
Company expects to resubmit the application to the FDA in
August 2022.
"While the appeal decision is disappointing, we remain
optimistic that the current product design and materials will
successfully demonstrate substantial equivalence at the conclusion
on the ongoing subacute toxicity test," said Dave Rosa, Chief Executive Officer of
NeuroOne. "Once completed, we intend to submit the new test
data results to the FDA while referencing the previous 510(k)
submission. In addition, the Company will immediately explore the
opportunity to market the device through Zimmer Biomet for
intraoperative use to gain product clinical experience while we
progress with the re-submission to the FDA."
In September 2021 the Company
received FDA clearance to market the Evo® sEEG Electrode for
temporary (less than 24 hours) use with equipment for the
recording, monitoring, and stimulation of electrical signals at the
subsurface level of the brain.
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 Company's submission of its revised 510(k) clearance
request for its Evo® sEEG Electrode for less than 30-day use,
applications for, or receipt of, regulatory clearance, the
Company's ability to submit a special 510(k) clearance request, the
timing and extent of product launch and commercialization of our
technology, expected negotiations with Zimmer Biomet regarding the
opportunity to market the device for intraoperative use, clinical
and pre-clinical testing, what the future may hold for electrical
stimulation and NeuroOne's potential role. 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