Company focused on manufacturing ramp for
commercialization in partnership with Zimmer Biomet
EDEN
PRAIRIE, Minn., Oct. 25,
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 it has received U.S. Food and Drug Administration
(FDA) 510(k) clearance to market its Evo sEEG Electrode technology
for temporary (less than 30 days) use with recording, monitoring,
and stimulation equipment for the recording, monitoring, and
stimulation of electrical signals at the subsurface level of the
brain.
On August 9, 2022, the Company
announced it had resubmitted its 510(k) application to the FDA for
less than 30 day use, which included additional biocompatibility
testing as requested by the FDA. On October
20, 2022, the Company received an FDA clearance letter
stating that the Evo sEEG System is substantially equivalent to the
predicate device and may be marketed in the United States.
"I am extremely proud of the entire NeuroOne team and their
relentless pursuit of this clearance. Despite the challenges we
faced, our team remained focused and persistent in driving this
successful conclusion. This is clearly our most exciting and
important accomplishment to date. We are now able to advance our
commercialization efforts in partnership with Zimmer Biomet, our
distribution and development partner. We look forward to continuing
to execute our strategic plan, which next up includes our RF
ablation system, the Company's first therapeutic electrode
technology," said Dave Rosa, CEO of
NeuroOne.
The Evo sEEG System represents the Company's second FDA 510(k)
cleared product. NeuroOne now provides a full line of electrode
technology to address an estimated worldwide market of $100 million for patients requiring diagnostic
brain mapping procedures. As opposed to cortical electrodes, sEEG
electrodes provide a similar function at the subsurface level of
the brain by using a much less invasive process that does not
require removal of the top portion of the patient's skull. sEEG
electrodes are the predominant technology used in these procedures
due to their less invasive placement and subsurface location.
The Company's Evo Cortical and sEEG Electrodes are a portfolio
of hi-definition thin film electrodes. Potential advantages include
increased signal clarity and reduced noise; better tactile feedback
during insertion into brain tissue; and faster order fulfillment
due to an automated manufacturing process.
As previously reported, NeuroOne is also advancing a pipeline of
therapeutic electrode technologies for brain tissue ablation and
chronic stimulation use for DBS (deep brain stimulation) and spinal
cord stimulation for chronic back pain. These therapeutic
electrode technologies represent addressable markets valued between
$500 million and $6 billion.
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
potential market size, commercialization activities, and potential
regulatory clearance/approval of brain tissue ablation and chronic
stimulation use for DBS and spinal cord stimulation for chronic
back pain. 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