NeuroOne® Announces Expansion of Existing Distribution Agreement with Zimmer Biomet for Commercialization of OneRF™ Ablation System
October 31 2024 - 4:01PM
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 the
execution of an amendment to its existing distribution agreement
with Zimmer Biomet that will provide Zimmer Biomet with certain
exclusive rights to distribute NeuroOne’s OneRF™ Ablation System
for use in the brain.
NeuroOne will receive an upfront payment of $3
million with the potential to earn an additional milestone payment
if certain performance criteria is achieved. NeuroOne expects that
the agreement will generate meaningful revenue and drive improved
profitability for the Company.
The OneRF Ablation System is the only FDA
cleared radiofrequency ablation system in the United States for
both diagnostic and therapeutic use. It has been used in a number
of ablation cases since its limited launch in April. Cases were
reported as being successful using the same device to identify the
brain tissue triggering seizure activity and ablate the targeted
tissue to reduce or eliminate brain-related seizure activity. In
addition, the technology has the potential to reduce hospital
stays, number of surgeries and adverse events while offering
temperature control to enhance patient safety. The devices are
initially placed in the operating room. To date, all the ablations
have been performed at the patient’s bedside saving additional
operating costs while allowing the patient to be diagnosed and
treated in one hospitalization instead of multiple visits.
“The expanded agreement with Zimmer Biomet to
include distribution of our OneRF Ablation System is a significant
catalyst for the Company,” says Dave Rosa, president and CEO of
NeuroOne. “We are confident that the partnership will allow
NeuroOne to leverage Zimmer Biomet’s leadership position in robotic
technology and extensive distribution channel both in the United
States and abroad. As the world’s first FDA cleared system for both
diagnostic and therapeutic procedures, our ablation system provides
clear advantages over existing competitive electrode technologies.
We look forward to continuing to expand the indications for use in
the future.”
Brian Hatcher, President, SET and CMFT at Zimmer
Biomet said, “We are excited to expand the relationship with
NeuroOne to include the OneRF Ablation System, which builds on our
existing agreement to distribute NeuroOne’s Cortical and sEEG
diagnostic electrode technology, and we look forward to launching
this product in the near future.”
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 potential for the expanded distribution
agreement to increase revenues and profitability, the potential to
receive any milestone payment, the potential for future FDA
submissions for additional ablation applications, 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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