NeuroOne® Submits 510(k) Application to FDA for OneRF™ Ablation System
12 Junio 2023 - 7:35AM
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, announced today its
submission of a 510(k) application to the U.S. Food and Drug
Administration (FDA) for its OneRF™ Ablation System. This
technology uses the already implanted sEEG electrodes to record
brain activity and allow for ablation of nervous tissue when
connected to a proprietary radio frequency (RF) generator. If
cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents
the first step in bringing to market an innovative RF ablation
system in the field of neurology and neurosurgery.
As the Company’s first therapeutic device, OneRF
is a combination system that includes both diagnostic and
therapeutic capabilities. The system utilizes a customized RF
generator with real-time temperature monitoring capabilities,
allowing clinicians to have greater control over temperature
management during the ablation. Designed to both record brain
activity and ablate nervous tissue using the same electrode, the
system is designed to offer the potential for a safer clinical
option for patients as well as lower costs by reducing the number
of invasive procedures and hospital stays for patients. NeuroOne
estimates the current brain ablation market to be at least $100M
worldwide and growing rapidly, with the potential to grow multiple
fold based on large addressable patient populations with unmet
clinical needs.
Dave Rosa, CEO of NeuroOne, commented, “This is
a monumental day for NeuroOne as it represents the first known FDA
510(k) submission of an sEEG electrode intended to record brain
activity and also be used as an RF probe to ablate nervous tissue.
In addition, it marks the Company’s first complete system combining
hardware, software, and our novel electrode technology. Over the
past few years, we have been excited with the feedback we have
received from our advisory board as well as the performance of the
system in animal feasibility studies. We also believe this system
has applications beyond ablation of nervous tissue in the brain,
offering a larger opportunity than we initially envisioned. I am
proud of our entire team and their efforts which allowed us to
complete this before the end of June as planned.”
NeuroOne anticipates receiving initial feedback
from the FDA no later than August 7th, 2023.
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. The Company may also pursue applications for other areas
such as depression, mood disorders, pain, incontinence, high blood
pressure, and artificial intelligence. For more information, visit
nmtc1.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 development of the Company's electrode technology
program, applications for, or receipt of, regulatory clearance, the
receipt and/or timing of any feedback from the FDA relating to the
Company’s OneRF ablation system, the ability of the OneRF ablation
system to offer a safer option for patients, the timing and extent
of product launch and commercialization of our technology, clinical
and pre-clinical testing, what the future may hold for electrical
stimulation and NeuroOne's potential role, business strategy,
market size, potential growth opportunities, future operations,
future efficiencies, and other financial and operating information.
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; 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 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.
Contact:
800-631-4030 ir@nmtc1.com
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