NeuroOne® Receives FDA 510(k) Clearance to Market its OneRF™ Ablation System
December 11 2023 - 8:00AM
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 received U.S.
Food and Drug Administration (“FDA”) 510(k) clearance to market its
OneRF™ Ablation System for creation of radiofrequency (“RF”)
lesions in nervous tissue for functional neurosurgical procedures.
“When NeuroOne was founded, one of our ambitious
goals was to be the first to develop and commercialize thin-film
electrodes capable of performing both diagnostic and therapeutic
functions and offer a better methodology to treat patients
suffering from a variety of neurological conditions,” said Dave
Rosa, CEO of NeuroOne. “We believe we have the potential to
dramatically change the way these surgeries are performed so that
patients may only need to go through surgery once for both
diagnostic and therapeutic procedures. This may also reduce
hospital stays, number of surgeries, and adverse events, while
offering significant benefits from a clinical perspective. The
addition of temperature control at the point of ablation also may
enhance patient safety. Our team’s achievement in reaching this
milestone was the culmination of years of perseverance, and I could
not be more excited for our future. We are now preparing for a
commercial launch either directly or through a strategic partner in
the first half of calendar 2024.”
Robert E. Gross, MD, PhD, chair of the
Department of Neurosurgery at New Jersey Medical School and Robert
Wood Johnson Medical School said "The FDA clearance of NeuroOne's
OneRF system will provide neurosurgeons with an important new tool
in the surgical management of epilepsy, with the ability to provide
ablative therapy using already implanted depth electrodes used for
diagnosing the epileptic focus as part of stereoEEG. This may lead
to improved outcomes for patients with potential for fewer
interventions, and an improved therapeutic window."
The OneRF Ablation System is the Company’s first
device with a therapeutic indication and its third FDA
510(k)-cleared device. NeuroOne now boasts a full line of electrode
technology to address patients requiring diagnostic brain mapping
procedures as well as RF ablation using the same sEEG electrode. In
addition to the OneRF Ablation System, NeuroOne’s other FDA-cleared
devices include the Evo® cortical and sEEG electrode product lines
which are used primarily for recording electrical activity in the
brain for less than 30 days.
NeuroOne estimates the current brain ablation
market to be at least $100M worldwide and growing rapidly, with the
potential to grow multifold based on large addressable patient
populations with unmet clinical needs.
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 www.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 press release 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, 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 our partnerships may not facilitate the
commercialization or market acceptance of our technology; whether
due to supply chain disruptions, labor shortages, 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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