PRAIRIE, Minn., May 12, 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 second quarter of fiscal year 2022 ended
March 31, 2022.
Second Quarter and Recent Business
- Evo® sEEG electrode first commercial order is in inventory and
ready to ship pending FDA clearance for less than 30 day duration
of use. The Evo sEEG electrode was already 510(k) cleared for
temporary (less than 24 hours) use.
- Filed appeal with the FDA regarding their decision related to
the Company's request for clearance for less than 30 day use of
NeuroOne's Evo® sEEG Electrode. Appeal meeting between NeuroOne and
the FDA was held on April
- Participated in Zimmer Biomet's physician advisory board
meeting with prominent neurosurgeons to perform usability testing
of Evo sEEG implant accessories.
- Initiated the process to qualify a second source to manufacture
electrodes for Evo® Cortical and sEEG product lines to increase
manufacturing capacity and reduce supply risk for both product
- Initiated cost reduction program for cable assembly.
- Exhibited our Evo Cortical electrode product family at the
University of Minnesota Neuromodulation
Symposium and presented at the Gordon Research Conference 2022
Neuroelectronic Interfaces Meeting.
- Announced positive five-year bench top results in stimulation
testing of electrodes designed for use in spinal cord stimulation
for patients suffering with chronic back pain.
- Completed prototypes for RF ablation system as well as planning
phase with our hardware partner RBC Medical Systems which remains
on schedule to submit to FDA in the first quarter of calendar year
2023 for commercial clearance.
- Appointed Maria Vomero, PhD., a
prominent scientist and expert in thin film electrode technology to
drive the Company's spinal cord stimulation program, further
strengthening the development team.
- NeuroOne featured on "The Claman Countdown," an American
financial program airing on the Fox Business Network.
- Presented at the 34th Annual Roth Capital Partners
Conference and the Oppenheimer 32nd Annual Virtual
Dave Rosa, CEO of NeuroOne
commented, "In September 2021,
NeuroOne received FDA 510(k) clearance for our Evo sEEG product
line for less than 24 hour use. Although the FDA did not
provide clearance for longer term use for our sEEG product line,
the Company remains confident that the product met ISO 10993
"Biological Evaluation of Medical Devices - Part 12 and Part
18" requirements for biocompatibility which was the basis
of the Company appealing the FDA decision. We appreciated the FDA's
willingness to hear our appeal which occurred on April 14th, 2022. We continue to
remain ready to fulfill our initial stocking order to Zimmer Biomet
upon an FDA clearance for less than 30 day use. Additionally,
the development of our RF ablation electrode and hardware remains
on schedule as we expect to complete system prototypes by the end
of the third calendar quarter of 2022. We are still targeting
submitting for 510(k) clearance for RF ablation in early calendar
year 2023. Cost reduction programs are underway for our cable
assembly line, next generation connector and validation of a new
electrode supplier in order to ensure the ability to meet supply
requirements to Zimmer Biomet. Our team remains enthusiastic and
determined as we make progress across a number of key commercial
and product development objectives for 2022."
- Evo sEEG Depth Diagnostic Electrode
- FDA decision on Company's appeal regarding the FDA's denial for
clearance of the Evo sEEG product line for less than 30 day
- Qualification of second source for manufacturing of the Evo
Cortical and sEEG electrode product lines.
- Completion of validation of new cable assembly providing
significant cost reduction for the specific component.
- Completion of design verification to extend the shelf life for
cortical electrode product line to 3 years and sEEG product line to
- RF Ablation system
- Generator prototype expected by the end of the third
calendar quarter of 2022.
- Completion of additional feasibility testing planned on sEEG RF
probe, temperature accessory, and RF connection box expected in
- Submit 510(k) application to the FDA in early calendar year
- Completion of physician advisory board for spinal cord
- Partner with research organization to develop electrode for new
- Chronic Use Electrode
- Report additional accelerated aging test results for chronic
Second Quarter of Fiscal 2022
Product revenue was $37,000 in the second quarter of
fiscal 2022, compared to product revenue of $18,000 in the second quarter of fiscal
2021. Collaboration revenue was delayed in the second
quarter of fiscal 2022 due to the FDA decision, compared to
collaboration revenue of $20,000 in the second 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 March 31, 2022.
Total operating expenses in the second quarter of fiscal 2022
were $3.0 million, compared with $2.4 million in the same
period of the prior year. R&D expense in the second
quarter was $1.8 million, compared with $1.3 million in
the same period of fiscal 2021. SG&A expense in the
second quarter of fiscal 2022 was $1.2 million, compared
with $1.1 million in the prior year period.
Net loss was $3.1 million for the second quarter of
fiscal 2022, compared to a net loss of $2.4 million in the
second quarter of fiscal 2021.
As of March 31, 2022, the Company had cash of $12.9
million, compared to $16.2 million at December 31, 2021 and $6.9
million at September 30, 2021,
our fiscal year end.
The Company had no debt outstanding at March 31, 2022.
May 12, 2022 - 4:30 PM Eastern Time
Participant Dial In:
Toll Free: 877 407 8293/ +1 201 689 8349
877-660-6853 / +1 201-612-7415, Access ID: 13729644; available
through May 26, 2022
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
more information, visit https://www.n1mtc.com.
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 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
"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