PRAIRIE, Minn., Aug. 11,
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 third quarter of fiscal
year 2022 ended June 30, 2022.
Third Quarter and Recent Business Updates
- Zimmer Biomet agreed to an accelerated $3.5M milestone payment for Evo® sEEG electrode;
Zimmer received a warrant to purchase 350,000 shares of NeuroOne's
common stock at $3.00 per share.
- Re-submitted special 510(k) to FDA for <30 day use for the
Evo sEEG electrode.
- Completed ablation system prototypes, including RF generator
from RBC Medical and NeuroOne's electrodes and accessories, ahead
of schedule and successfully tested the first fully integrated
sEEG/RF ablation system.
- Achieved major milestone with first sEEG electrode case for
intraoperative brain mapping at the subsurface level of the brain
performed at Emory University.
- Qualified second source for manufacturing for both the Evo
cortical and sEEG electrodes.
- Completed validation and placed orders for a new cable assembly
which will provide significant cost reduction.
- Established advisory board of leading anesthesiologists and
neurosurgeons for spinal cord stimulation program.
- Completed design verification to extend shelf life for Evo
cortical electrodes to three years.
- Presented at the HC Wainwright Global Investment Conference and
the NobleCon 18 Investor Conference.
- Exhibited the Evo Cortical electrode family in partnership with
Zimmer Biomet at the American Association of Neurological Surgeons
Annual Scientific Meeting and the American Society for Stereotactic
and Functional Neurosurgery Biennial Meeting.
- The first peered-reviewed paper presenting the biocompatibility
results for NeuroOne subdural thin film electrodes was
published in the Frontiers of Neuroscience journal on
- The Company's Evo sEEG implantation accuracy study was accepted
as a podium presentation at the Biennial Meeting of the World
Society for Stereotactic & Functional Neurosurgery, to be held
in South Korea September 4-7 2022.
Dave Rosa, CEO of NeuroOne
commented, "The Company made great strides in the third fiscal
quarter of 2022 and subsequent six weeks. Significant progress was
made in testing our Evo sEEG electrode and on August 9th we re-submitted to the FDA
a special 510(k) seeking clearance for <30 day use. In addition,
we were excited to have the first Evo sEEG case performed by Dr.
Robert Gross of Emory University for less than 24 hour use. We were
also successful in reducing costs by completing validation of a new
cable assembly and extending shelf life of the Evo Cortical
electrode product lines. A backup supplier for our electrodes was
also qualified providing additional insurance for our supply chain.
Regarding our ablation system which we have named OneRF™ we
successfully completed bench top testing for the entire system.
Finally, we are excited that Zimmer Biomet agreed to an
accelerated $3.5M milestone payment
for the Evo® sEEG electrode." Rosa continued, "This amendment to
our agreement provides NeuroOne with near term capital without the
need for a highly dilutive financing and reinforces our ongoing
partnership with Zimmer Biomet."
Upcoming Targeted Milestones
- Evo sEEG Depth Diagnostic Electrode
- FDA decision on Re-submission of 510(k) for <30 day use for
the Evo sEEG electrode.
- Complete additional cases for sEEG electrode intraoperative use
(<24 hour) at select sites.
- OneRF(RF ablation system)
- Continue additional feasibility testing of the full responsive
SEEG/RF ablation system in September
- Submit 510(k) application to the FDA in early calendar year
- Partner with a research organization to develop electrode for
new clinical indication.
- Chronic Use Electrode
- Continue development and testing of disruptive new chronic
electrode for Spinal Cord Stimulation.
- Host first multi-specialty advisory board meeting for spinal
cord stimulation program.
Third Quarter of Fiscal 2022 Financial Results
Product revenue was $32,000 in the third quarter of
fiscal 2022, compared to product revenue of $40,000 in the third quarter of fiscal
2021. Collaboration revenue was delayed in the third
quarter of fiscal 2022 due to the FDA decision, compared to
collaboration revenue of $17,000 in the third quarter of
fiscal 2021. Collaboration revenue is derived from the Zimmer
Development Agreement and represents the portion of the upfront
initial development fee payment eligible for revenue recognition as
of June 30, 2022.
Total operating expenses in the third quarter of fiscal 2022
were $2.8 million, compared with $3.0 million in the
prior year third quarter. R&D expense in the third
quarter of fiscal 2022 was $1.2 million, compared
with $0.9 million in the same period of fiscal 2021.
SG&A expense in the third quarter of fiscal 2022 was $1.5
million, compared with $2.1 million in the prior year third
Net loss for the third quarter of fiscal 2022 was $2.8
million, compared to a net loss of $3.0 million in the third
quarter of fiscal 2021.
As of June 30, 2022, the Company
had cash of approximately $10.2
million, compared to $6.9
million as of September 30,
2021, the end of the Company's most recent fiscal
year. The Company had no debt outstanding as of June 30, 2022.
Conference Call and Webcast Information
Thursday, August 11, 2022 –
5:30 PM Eastern Time
877-407-8293 / +1 201-689-8349
877-660-6853 / 201-612-7415, Access ID: 13732116; available through
August 25, 2022
Webcast Replay: Available for 12 months
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
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, cost reduction of our new cable assembly, shelf life
for Evo cortical electrodes, expected negotiations with Zimmer
Biomet, 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