EDEN PRAIRIE, Minn.,
Feb. 14, 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 today announces its operating
results for the first quarter of fiscal year 2022 ended
December 31, 2021.
First Quarter and Recent Business Updates
- Submitted clearance request to FDA for less than 30-day use of
NeuroOne's Evo® sEEG Electrode, which has already been 510(k)
cleared for temporary (less than 24 hours) use
- Exhibited our Evo cortical electrode product family at the
American Epilepsy Society Meeting in Zimmer Biomet's booth
- Presented poster with the following title at American Epilepsy
Society (AES) annual meeting in December
2021: "First FDA-cleared thin film electrode for
intracranial recording and monitoring of brain activity – device
testing and initial clinical use."
- Surpassed five years of accelerated aging testing for recording
electrodes
- Received initial stocking orders from Zimmer Biomet for EVO
sEEG electrodes
- Appointed Chad Wilhelmy as Vice
President of Quality Control and Regulatory Affairs
- NeuroOne featured on "The Medical Alley" Podcast in
December 2021
- Closed on an underwritten registered public offering of
4,172,057 shares of its common stock at a price
of $3.20 per share with gross proceeds of $13.35
million
Dave Rosa, CEO of NeuroOne
commented, "During and subsequent to our fiscal first quarter, we
made significant advancements across our product portfolio. We
submitted a request to the FDA for additional regulatory clearance
of our Evo sEEG labeling for longer term use. We submitted
responses on February 9, 2022, to
questions from the FDA regarding our submission and the FDA
acknowledged receipt of our response on February 10, 2022. We remain ready to fulfill our
initial stocking order to Zimmer Biomet upon an FDA
clearance. Product shipment following FDA clearance of our
sEEG product family also qualifies the Company for an additional
milestone payment from our distribution partner, Zimmer
Biomet. Additionally, we advanced development of our ablation
electrode, and are focused on having complete system prototypes by
the end of the third calendar quarter of 2022 and submitting for
510(k) clearance in early 2023. We also reported progress with our
advanced aging testing to support our next generation electrodes
for chronic use, which we believe will address multi-billion-dollar
markets. Furthermore, we bolstered our balance sheet with
a $13.35 million public offering. In summary, we have
strengthened our financial position with several commercial and
development value catalysts."
Upcoming Targeted Milestones
- Evo sEEG Depth Diagnostic Electrode
-
- Commercial ready in early 2022, pending additional regulatory
clearance of sEEG labeling for less than 30-day use, which will
allow for product shipment and trigger a milestone payment from
Zimmer Biomet for the licensing fee
- RF Ablation Therapeutic system
-
- Generator prototype expected by the end of the third
calendar quarter of 2022
- Completion of additional feasibility testing planned
- Submit application for FDA 510(k) clearance in early calendar
2023
- Commercialize the RF System with RF Ablation capable SEEG
Electrode in the first half of 2023 following FDA approval, if
received
- Chronic Use Electrode
-
- Report additional accelerated aging test results for chronic
stimulation electrodes before the end of March 2022
First Quarter of Fiscal 2022 Financial Results
Product revenue was $34,000 in the first quarter of
fiscal 2022 compared to product revenue of $71,000 in the first quarter of fiscal
2021. Collaboration revenue was $6,000 in the first
quarter of fiscal 2022, compared to collaboration revenue
of $22,000 in the first quarter of fiscal 2021.
Collaboration revenue was derived from the Zimmer Development
Agreement and represented the portion of the upfront initial
development fee payment eligible for revenue recognition as
of December 30, 2021.
Total operating expenses in the first quarter of fiscal 2022
were $2.8 million, compared with $2.1 million in the same
period of the prior year. R&D expense in the first quarter of
fiscal 2022 was $1.1 million, compared with $0.9 million
in the same period of fiscal 2021. SG&A expense in the first
quarter of fiscal 2022 was $1.7 million, compared
with $1.2 million in the prior year period.
Net loss was $2.8 million for the first quarter of
fiscal 2022, compared to a net loss of $2.0 million in the
first quarter of fiscal 2021.
As of December 31, 2021, the Company had cash of $16.2
million, compared to $6.9 million at September 30, 2021. The cash balance
at December 31, 2021 includes proceeds from an underwritten
registered public offering of 4,172,057 shares of common stock at a
price of $3.20 per share, resulting in gross proceeds of
approximately $13.35 million.
The Company had no debt outstanding at December 31, 2021.
Conference Call Information
Event Date:
February 14, 2022 - 4:30 PM Eastern Time
Participant Numbers:
Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 502618
Event Webcast URL:
https://www.webcaster4.com/Webcast/Page/2821/44395
Replay Number: Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 44395
Event Webcast Replay URL:
https://www.webcaster4.com/Webcast/Page/2821/44395
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. For
more information,
visit https://www.n1mtc.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 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 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 ablation electrode technology program,
applications for, or receipt of, regulatory clearance, the timing
and extent of product launch and commercialization of our
technology, expected milestone payments, 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 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, labor shortages, the impact of COVID-19
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