NeuroOne® Initiates Limited Commercial Launch of OneRF™ Ablation System
26 Mars 2024 - 2:00PM
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
initiated a limited commercial launch of its OneRF™ Ablation
System, which has FDA 510(k) clearance for creation of
radiofrequency (“RF”) lesions in nervous tissue for functional
neurosurgical procedures.
“Today is an exciting day for NeuroOne as we
begin the limited commercial launch of our OneRF™ Ablation System.
We are proud to be the first to market with a thin-film electrode
technology capable of performing both diagnostic and therapeutic
functions utilizing the same electrode,” said Dave Rosa, CEO of
NeuroOne. “We expect to start shipping systems this week to centers
participating in our limited launch with cases already scheduled
starting in April. We believe physicians and patients will benefit
from our technology given it may reduce hospital stays, number of
surgeries, and adverse events, while offering significant clinical
benefits including temperature control to enhance patient safety.
Looking ahead, we plan to leverage the system for other targeted
ablation indications by submitting additional FDA 510(k)
applications.”
The OneRF™ Ablation System is NeuroOne’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
reduce hospital stays, reduce the number of surgeries, or reduce
adverse events, the timing and extent of product launch and
commercialization of our technology, our intent to submit
additional 510(k) applications for new indications, business
strategy, market size, potential growth opportunities, and future
operations. 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 related to 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 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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