NeuroOne® Announces First in Human Ablations Completed with OneRF™ Ablation System
June 25 2024 - 9:00AM
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 the
OneRF Ablation System was recently used at a prestigious hospital
located in Jacksonville, Florida to successfully complete five
ablations in one patient.
The patient was suffering from multifocal
epilepsy, a condition whereby seizures are triggered from multiple
areas of the brain. In this procedure, ten Evo® sEEG electrodes,
were placed in various locations of the patient’s brain. Four
electrodes identified problematic areas of the brain that were
triggering seizures. Ablations were performed at the targeted areas
using the temperature control safety feature, and two of these
ablations occurred at different contacts on one electrode. Using
the same electrodes, the successful ablations were confirmed by
post ablation sEEG recordings demonstrating lack of brain activity
at the point of tissue ablation. The procedure was performed at the
patient’s bedside saving both the time and cost of having to
conduct the procedure in an operating room.
“It was exciting for the Company to witness the
first clinical ablations performed using the OneRF Ablation System.
The ability to safely perform these procedures at the patient’s
bedside will reduce operating room time and cost, freeing up the
operating room to conduct additional procedures,” said Dave Rosa,
CEO of NeuroOne. “We look forward to additional procedures
utilizing the system with the goal of providing a safe therapy for
patients to both monitor and ablate problematic brain tissue. In
the future, the Company intends to leverage the OneRF generator
with future FDA submissions for additional ablation
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 thin film
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 stimulation,
recording and monitoring of 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 additional procedures to be performed, the
potential for future FDA submissions for additional ablation
applications, and the ability of the OneRF Ablation System to
reduce hospital stays, reduce the number of surgeries, or reduce
adverse events, 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:
800-631-4030ir@nmtc1.com
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