EDEN PRAIRIE, Minn.,
Sept. 23, 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 successfully
completed an animal feasibility study of its combination recording
and ablation technology at T3 Labs and Georgia
State/Georgia Tech Center for Advanced Brain Imaging in
Atlanta Georgia under the guidance
of Dr. Robert Gross of Emory
University. The study evaluated the ability of the NeuroOne
Evo® sEEG electrodes to record brain activity and then
ablate brain tissue using radiofrequency thermocoagulation in a
porcine model.
The Evo ablation electrode represents the Company's first
development effort for therapeutic technology and is expected to be
the next product offering in its portfolio pending FDA clearance.
The product is designed to provide the ability to both identify
problematic areas of the brain causing seizures as well as ablate
brain tissue to alleviate these symptoms. This would represent a
major advancement in neurosurgery,
given that patients must first undergo the diagnostic surgery and
then schedule a future second surgery to ablate the problematic
tissue.
Dr. Robert Gross of Emory says,
"This pilot study will provide important data to inform the
development of this technological solution that has the potential
to improve treatment efficacy and patient comfort."
"We are encouraged and excited by the results of this animal
feasibility study. This technology offers the potential to
perform two separate procedures using the same device during one
hospital stay which we believe is a safer and more cost-effective
approach for both the patient, health care provider and health care
facility. Today, a patient often needs to have two separate
hospitalizations for two separate surgeries typically with months
between both procedures. Coupled with our recent partnership with
RBC Medical to develop the radio frequency hardware, we are excited
about the potential to offer a complete system for our customers"
says Dave Rosa, CEO of NeuroOne.
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. The Company recently announced an FDA
clearance for 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, and
expects to be launch ready by the end of calendar year 2021,
pending additional regulatory clearance of sEEG labeling for longer
term use.
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 ablation electrode ,
commercialization of the Evo ablation 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