Case performed at Emory
University for intraoperative brain mapping
EDEN
PRAIRIE, Minn., July 12,
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 the first clinical case using the Evo sEEG electrode was
performed by Dr. Robert Gross at
Emory University. Dr. Gross selected
the Evo sEEG electrode for intraoperative brain mapping at the
subsurface level of the brain.
Dave Rosa, Chief Executive
Officer of NeuroOne, states, "This first clinical case use
represents a major milestone achievement of one of our primary
objectives for the Company. We are grateful to Dr. Gross and his
staff and were excited to hear of the positive experience he had
using the electrode. We look forward to continuing to gain clinical
experience with the electrode as we prepare to submit a special
510(k) to FDA in August for clearance to commercialize the product
for less than 30 days use."
In September 2021, the Company
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. In comparison with 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 has
become the predominant technology used in these procedures due to
its less invasive placement and subsurface location.
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
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"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.
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"
Dr. Robert Gross is a paid
consultant for NeuroOne Medical Technologies Corporation.
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SOURCE NeuroOne Medical Technologies Corporation