Company focused on manufacturing and commercialization in
partnership with Zimmer Biomet
EDEN
PRAIRIE, Minn., Nov. 30,
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 shipped the first commercial
order to Zimmer Biomet for 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. Zimmer Biomet is the exclusive worldwide distribution
partner for the NeuroOne Evo Cortical and sEEG electrode product
lines.
"This shipment represents a monumental accomplishment for the
Company. Without the persistence of our staff and manufacturing
partners, we could not have reached this point. We look forward to
commercialization of this exciting technology in the future in
partnership with Zimmer Biomet," 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, potential
advantages of the technology, 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