Full Press Release Details
Reports Strong Fourth Quarter Fiscal 2025 Financial Results with Product Revenue Growth of 907% to $2.7 Million and 55.8% Gross Margin
& Total Revenue Growth of 163% to $9.1 Million for Fiscal Year 2025
Growth Fueled by Sales of the OneRF Ablation System
510(k) Clearance for OneRF Trigeminal Nerve Ablation System with First Two Facial Pain Patients Successfully Treated
Balance Sheet Funds Growth Through Fiscal Year 2026
to Host Conference Call Today at 8:30 a.m. Eastern Time
PRAIRIE, Minn., December 17, 2025 -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"),
a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial
results for the fourth quarter and fiscal year ended September 30, 2025.
Quarter and Fiscal Year 2025 Financial Highlights
fourth quarter of fiscal 2025 capped the most successful year in our history," said Dave Rosa, CEO of NeuroOne. "Bolstered
by expansion of our OneRF Ablation System, sales surged in the fiscal fourth quarter to $2.7 million and reached a total of $9.1 million
in fiscal year 2025. In addition, we improved our gross margin to 56.5% while decreasing operating expenses and improving our balance
sheet significantly with a capital raise in April. Operationally, we received FDA 510(k) clearance for the OneRF Trigeminal
Nerve Ablation System and performed the first two cases successfully, advanced the development of our spinal cord stimulation electrode
for lower back pain, initiated a new product development program for basi-vertebral nerve ablation for lower back pain, reported sales
of our first pre-clinical drug delivery devices to a large pharmaceutical company, strengthened our infrastructure with key senior executive
hires, initiated the process to gain ISO 13485 certification for international commercial expansion and, lastly, bolstered our intellectual
continue to remain encouraged that our technology platform can significantly improve the quality of life for people with debilitating
neurological disorders. Our financial condition has improved significantly and continues to advance toward anticipated profitability.
Leveraging our strengthened balance sheet, we believe we are well positioned to expand the use of our technology platform into all three
areas of focus: brain related disorders, pain management, and drug delivery. We believe this is critical to build long-term value for
our shareholders," concluded Rosa.
Highlights and Updates
Drug Delivery Program:
Trigeminal Nerve Ablation System:
Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
Quarter and Full Year Fiscal 2025 Financial Results
revenue increased 907% to $2.7 million in the fourth quarter of fiscal 2025, compared to product revenue of $0.3 million in
the fourth quarter of fiscal 2024. For the full fiscal year 2025, product revenue increased 163% to $9.1 million, compared to $3.5 million
for the same period in fiscal 2024. The Company also had license revenue of $3.0 million in the full fiscal year 2025, which is not included
in product revenue, compared to no license revenue in fiscal 2024. License revenue in fiscal 2025 was derived from the expanded
exclusive distribution agreement with Zimmer Biomet.
gross profit increased significantly to $1.5 million, or 55.8% of revenue, in the fourth quarter of fiscal 2025, compared to product
gross profit of $0.1 million, or 51.8% of revenue, in the same quarter of the prior fiscal year. For the full fiscal year 2025, product
gross profit increased significantly to $5.1 million, or 56.5% of revenue, compared to product gross profit of $1.1 million, or 31.3%
of revenue in the full fiscal year 2024.
operating expenses decreased 2.0% to $2.9 million in the fourth quarter of fiscal 2025, compared to $3.0 million in the same
quarter of the prior year. Research & Development (R&D) expense in the fourth quarter of fiscal 2025 was $1.1 million, the
same as the fourth quarter of fiscal 2024. Selling, General & Administrative (SG&A) expense in the fourth quarter of fiscal 2025
decreased 3.4% to $1.78 million, compared to $1.84 million in the same quarter of the prior year. For the full fiscal
year 2025, total operating expenses decreased 4.6% to $12.4 million, compared to $13.0 million in the full fiscal year
2024. R&D expense in the full fiscal year 2025 decreased to $5.0 million, compared to $5.1 million in fiscal
year 2024. SG&A expense in the full fiscal year 2025 decreased 6.6% to $7.4 million, compared to $7.9 million in
loss in the fourth quarter of fiscal 2025 improved by 52% to $1.6 million, or ($0.03) per share, compared to a net loss of $3.4
million, or ($0.11) per share, in the same quarter of the prior year. Net loss for the full fiscal year 2025 improved significantly
by 71% to $3.6 million, or ($0.09) per share, compared with a net loss of $12.3 million, or ($0.46) per share, in the same period
of September 30, 2025, the Company had cash and cash equivalents of $6.6 million, compared to $1.5 million as of September
30, 2024. Of note, NeuroOne is funded through fiscal 2026, potentially longer if key milestones are hit.
Company had working capital of $7.9 million as of September 30, 2025, compared to working capital of $2.4 million as of September 30,
2024. NeuroOne had no debt outstanding as of September 30, 2025.
will host an investor conference call and webcast today, Wednesday, December 17, 2025, at 8:30 a.m. Eastern time to discuss the Company's
fourth quarter and full fiscal year 2025 financial results, provide a corporate update, and conclude with Q&A from telephone participants.
To participate, please use the following information:
Wednesday, December 17, 2025
8:30 a.m. Eastern Time
Dial-In (Toll Free): 888-506-0062
Dial-In: 973-528-0011
join at least five minutes before the start of the call to ensure timely participation.
playback of the call will be available through Wednesday, December 31, 2025. To listen, please call 877-481-4010 within the United States
or 919-882-2331 when calling internationally, using replay passcode 53302. A webcast replay will also be available using the webcast
link above through Wednesday, December 31, 2025.
Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients
suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology
platform with four FDA-cleared product families: Evo(R) Cortical Electrodes, Evo(R) sEEG Electrodes, OneRF(R) Ablation System (for brain),
and OneRF(R) Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical
procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions. The Company is engaged
in research and development for drug delivery and spinal cord stimulation (SCS) programs. For more information, visit nmtc1.com.
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," "forecasts,"
"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 Company's ability to be funded
through 2026; potential profitability of the Company, the ability to obtain ISO 13485 certification and expand internationally, the continued
development of the Company's electrode technology program (including its drug delivery program and spinal cord stimulation program);
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 related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that
our strategic partnerships may not facilitate the commercialization or market acceptance of our technology whether due to supply
chain disruptions, labor shortages 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 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 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.
Federal law restricts this device to sale by or on the order of a physician.
This recounts one patient's experience and may not be representative of all patient outcomes.
Group - MZ North America