Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in
Rochester, MN
Company on track to submit OneRF 510(k) application to the
FDA in the second quarter of calendar year 2023
EDEN
PRAIRIE, Minn., Dec. 6, 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 successfully completed a feasibility study with its
OneRF™ ablation system, a developing technology that utilizes
existing implanted sEEG diagnostic electrodes for brain tissue
lesioning.
The study evaluated the Company's new RF ablation system in an
animal model. The study used NeuroOne's FDA cleared sEEG electrodes
combined with a proprietary RF generator and a unique temperature
control accessory that monitors and maintains the temperature at
which the ablation is performed. This allows clinicians to set
temperature and time for each ablation. Dr. Van Gompel and his team implanted five sEEG
electrodes, performed electrophysiological recordings, and then
completed a total of ten RF ablations using different settings for
temperature and time. All ablations were confirmed by an MRI
scan.
"This technology potentially represents a major improvement in
the field, as it is the first known sEEG-guided RF system to
monitor and adjust settings based on temperature throughout the
ablation. The addition of this feature may improve the safety of
the procedure. We are extremely excited regarding the
continued progress with the OneRF ablation system and believe it
could have a significant impact in setting a new gold standard for
these procedures, if successful. We look forward to the FDA
submission of the device in the second calendar quarter of 2023."
said Dave Rosa, CEO of NeuroOne.
As previously reported, NeuroOne is also advancing a
pipeline of therapeutic electrode technologies for 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 for NeuroOne's technology to be a major improvement in
the field, the potential for NeuroOne's technology to improve
safety of procedures, the timing and success of any FDA regulatory
submissions, 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