EDEN
PRAIRIE, Minn., Dec. 13,
2022 /PRNewswire/ -- 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, to
host fiscal Fourth Quarter Corporate Update for the period
ended September 30, 2022.
Fourth Quarter and Recent Business Highlights
- Received a $3.5 million
accelerated payment from distribution partner Zimmer Biomet related
to certain milestone events; Zimmer Biomet received a Warrant to
purchase 350,000 shares of the Company's common stock, with an
exercise price of $3.00 per share
- Received FDA 510(k) clearance to market the Evo® sEEG Electrode
technology for temporary (less than 30 day) use with recording,
monitoring, and stimulation equipment for the recording,
monitoring, and stimulation of electrical signals at the subsurface
level of the brain, enabling NeuroOne to fully address the
approximately $100M diagnostic
electrode market
- Shipped initial stocking order to Zimmer Biomet for Evo sEEG
Electrodes
- Completed hardware and software prototypes for preliminary
design verification tests on a proprietary radiofrequency (RF)
generator for use with the NeuroOne OneRF™ ablation system that is
being developed to record brain activity and ablate brain tissue
using the same electrode
- Successfully completed an animal feasibility study with the
OneRF combination recording and ablation technology at the Mayo
Clinic
- Successfully tested complete OneRF ablation system with nine
leading Neurosurgeons, with encouraging initial feedback
- Implemented physician advisory board comprised of leading
neurosurgeons and pain specialists for our Spinal Cord Stimulation
electrode platform
- Developed electrode designs for spinal cord stimulation to
treat chronic back pain
- CEO Dave Rosa featured on Fox
Business Network's 'Mornings with Maria'
- Included in an NIH grant submission with the University of Minnesota to develop a chronic
cortical electrode capable of both recording and stimulation, that
would, with potential assistance from Medtronic, plug
directly into a Medtronic pulse generator. We believe
this device will provide new opportunities for clinical studies in
many areas, including chronic pain, substance use disorder,
obsessive compulsive disorder, and other mental health
conditions
- Presented our data to the scientific community at the
Neuroelectronic Interfaces Gordon Research Conference,
Congress of Neurological Surgeons, Society for Neuroscience, and
American Epilepsy Society meetings
- Exhibited our Evo electrode product family with
Zimmer Biomet at Congress of Neurological Surgeons annual
meeting and American Epilepsy Society annual meeting
- Evo sEEG implantation accuracy study featured in a podium
presentation at the Biennial Meeting of the World Society
for Stereotactic & Functional
Neurosurgery, held in South
Korea September 4-7, 2022
- Rang Nasdaq Stock Market closing bell to commemorate FDA
clearance milestone for Evo sEEG Electrode
technology
Dave Rosa, CEO of NeuroOne,
commented, "During and subsequent to our fiscal fourth quarter, we
made significant progress across a number of key initiatives. We
were excited to receive FDA 510(k) clearance for our second
diagnostic product, the Evo sEEG Depth Electrode, for less than 30
day use. We are now preparing for the commercial launch of this
product in the first calendar quarter of 2023 with our distribution
partner Zimmer Biomet. Additionally, we made notable progress on
our OneRF ablation system, completing hardware and software
prototypes for design verification testing of the accompanying RF
generator, completing the design of the OneRF system accessories,
and completing an animal feasibility study at the Mayo Clinic. This
system will potentially be our first therapeutic device,
representing the next major phase in the Company's development. In
addition, we strengthened our balance sheet with the receipt of
$3.5 million from Zimmer Biomet.
Taken altogether, we begin fiscal 2023 with several commercial and
development catalysts and a product pipeline targeting
multi-billion-dollar markets, underpinning our unwavering
commitment to driving shareholder value."
Upcoming Targeted Milestones
- Evo sEEG Depth Diagnostic Electrode
-
- Commercial launch in the first calendar quarter of 2023
- OneRF Ablation therapeutic electrode and generator system
-
- Complete design verification and validation of the full OneRF
ablation system
- Begin production of final RF Generator design
- Submit application for FDA 510(k) clearance by mid calendar
year 2023
- Chronic Use Electrode
-
- Engage firm to design percutaneous delivery system
- Complete prototypes for development of surgical techniques and
in-vivo validation of thin film technology performance in the
spinal cord
- Complete and initiate testing of electrode prototypes to
demonstrate chronic stability of thin film devices
We have not yet filed our Annual Report on Form 10-K for the
fiscal year ended September 30, 2022,
and we will provide financial results when our independent
registered public accounting firm completes its audit
procedures.
As of September 30, 2022, the Company had cash, cash
equivalents, and short-term investments of $11.1
million. The Company had no debt outstanding as
of September 30, 2022.
Conference Call and Webcast
Information
Tuesday, December 13,
2022 – 4:30 PM Eastern Time
Participant Dial-In:
877-407-8293 / +1 201-689-8349
Live Webcast:
Join here
Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13734879; available
through December 27, 2022
Webcast Replay:
Available for 12 months
About NeuroOne Medical
Technologies Corporation
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 https://www.n1mtc.com .
Forward Looking
Statements
This press release contains 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
"may," "might," "will," "could," "would," "should," "expect,"
"intend," "plan," "upcoming," "target," "objective," "anticipate,"
"believe," "estimate," "predict," "project," "potential," "target,"
"seek," "contemplate," "continue" 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 ablation
electrode technology program, applications for, or receipt of,
regulatory clearance, the timing and extent of product launch and
commercialization of our technology, clinical and pre-clinical
testing, 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; risks that our sEEG electrodes
may not be ready for commercialization in a timely manner or at
all, whether due to supply chain disruptions 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 the COVID-19 pandemic will continue to
adversely impact our business; 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"
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SOURCE NeuroOne Medical Technologies Corporation