EDEN PRAIRIE, Minn.,
Sept. 7, 2021 /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 24
hours) use with recording, monitoring, and stimulation equipment
for the recording, monitoring, and stimulation of electrical
signals at the subsurface level of the brain.
The Evo sEEG electrode represents the Company's second FDA
510(k) cleared product, providing a full line of electrode
technology to address an estimated worldwide market of $100M 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 as it does not
require removal of the top portion of the patient's skull. It has
become the predominant technology used in these procedures due to
its 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 between
$500 million and $6 billion.
"This represents yet another critical milestone met by the
Company as we continue to execute our strategy. The next
steps for the Company are to expand the sEEG labeling for longer
term use, which we believe will be a key part of our
commercialization strategy for the Evo sEEG electrode, and complete
development of an sEEG ablation electrode/probe for ablation of
brain tissue and permanently implanted stimulation electrodes for
patients with chronic applications such as epilepsy, Parkinson's
disease and chronic back pain," said Dave
Rosa, CEO of NeuroOne.
As previously reported, the Company expects to be launch ready
by the end of calendar year 2021, pending additional regulatory
clearance of sEEG labeling for longer term use.
Caution: Federal (USA) law
restricts this device to sale by or on the order of a
physician.
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 .
The Company previously announced it had successfully met the
first performance milestone in the distribution and development
agreement signed with Zimmer Biomet on July 20, 2020. In
addition to acquiring exclusive global distribution rights to
NeuroOne's Evo™ (Evo) patented electrode technology, the
partnership also offered the potential for NeuroOne to earn
back-end milestone payments if certain events were met within a
specified time frame.
NeuroOne received FDA clearance for its Evo cortical technology
in November 2019.
In partnership with Mayo Clinic, Wisconsin Alumni Research
Foundation (WARF) and other prominent academic medical centers, the
Company began developing its cortical electrode technology in 2015.
The Company initially focused its efforts on the epilepsy and
intraoperative tumor monitoring markets. NeuroOne intends to
continue to develop the technology for use in therapeutic
applications for Parkinson's disease, epilepsy and pain management
due to failed back surgery procedures.
Forward Looking Statement
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 of the Evo sEEG electrode for longer
term use, commercialization of the Evo sEEG electrode, 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