NeuroOne® Reports Third Quarter Fiscal Year 2025 Financial Results; Revenue Increases 105% YoY and Gross Margin Expands to 53.9%
NeuroOne Medical Technologies (NASDAQ: NMTC) reported strong Q3 FY2025 financial results, with product revenue surging 105% year-over-year to $1.7 million and gross margin expanding to 53.9%. The company successfully completed an oversubscribed $8.2 million capital raise, securing funding through FY2026.
Key operational highlights include the first OneRF® Ablation System patient achieving one-year seizure freedom, FDA submission for the OneRF® Trigeminal Nerve Ablation System, and receipt of the first order for their sEEG-based drug delivery system from a major biopharmaceutical company. The company strengthened its IP portfolio with 17 patents and received USPTO allowance for a key manufacturing patent.
NeuroOne maintains its FY2025 product revenue guidance of $8.0-$10.0 million, representing 132-190% growth, and increased gross margin expectations to 50-53%.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha riportato solidi risultati finanziari nel terzo trimestre dell'anno fiscale 2025, con ricavi da prodotti in crescita del 105% su base annua, a 1,7 milioni di dollari, e un margine lordo salito al 53,9%. La società ha completato con successo un aumento di capitale da 8,2 milioni di dollari, sovrasottoscritto, assicurandosi finanziamenti fino al FY2026.
I principali risultati operativi includono il primo paziente trattato con il sistema di ablazione OneRF® che ha raggiunto un anno di assenza di crisi epilettiche, la sottomissione alla FDA per il sistema di ablazione del nervo trigemino OneRF® e il ricevimento del primo ordine per il loro sistema di somministrazione di farmaci basato su sEEG da parte di una grande azienda biofarmaceutica. La società ha rafforzato il proprio portafoglio di proprietà intellettuale con 17 brevetti e ha ricevuto l'accettazione da parte dell'USPTO per un brevetto chiave nel processo produttivo.
NeuroOne conferma le previsioni di ricavi da prodotti per il FY2025 di 8,0-10,0 milioni di dollari (corrispondenti a una crescita del 132-190%) e ha aumentato le aspettative sul margine lordo al 50-53%.
NeuroOne Medical Technologies (NASDAQ: NMTC) informó sólidos resultados financieros en el tercer trimestre del ejercicio fiscal 2025, con ingresos por productos que se dispararon un 105% interanual hasta 1,7 millones de dólares y un margen bruto que se amplió hasta el 53,9%. La compañía completó con éxito una ampliación de capital de 8,2 millones de dólares, sobresuscrita, asegurando financiación hasta el FY2026.
Los principales hitos operativos incluyen que el primer paciente tratado con el sistema de ablación OneRF® alcanzó un año sin convulsiones, la presentación a la FDA del sistema de ablación del nervio trigémino OneRF®, y la recepción del primer pedido de su sistema de liberación de fármacos basado en sEEG por parte de una importante compañía biofarmacéutica. La empresa reforzó su cartera de propiedad intelectual con 17 patentes y obtuvo la aceptación por parte del USPTO de una patente clave de fabricación.
NeuroOne mantiene su previsión de ingresos por productos para FY2025 de 8,0-10,0 millones de dólares, lo que representa un crecimiento del 132-190%, y elevó sus expectativas de margen bruto al 50-53%.
NeuroOne Medical Technologies (NASDAQ: NMTC)는 2025 회계연도 3분기에 강력한 재무 실적을 보고했으며, 제품 매출이 전년 대비 105% 증가한 170만 달러를 기록했고, 총이익률은 53.9%로 확대되었습니다. 회사는 초과청약된 820만 달러 규모의 자본 조달을 성공적으로 마무리해 FY2026까지 자금 확보에 성공했습니다.
주요 운영 성과로는 OneRF® Ablation System으로 치료받은 첫 환자가 1년간 발작 없이 지냈고, OneRF® 삼차신경(Trigeminal) 절제 시스템에 대한 FDA 제출, 그리고 주요 바이오제약사로부터 sEEG 기반 약물 전달 시스템에 대한 첫 수주를 받은 점이 포함됩니다. 또한 회사는 17건의 특허로 지식재산 포트폴리오를 강화했으며, 핵심 제조 특허에 대해 USPTO 승인도 받았습니다.
NeuroOne는 FY2025 제품 매출 가이던스를 800만~1,000만 달러로 유지하며(성장률 132~190%), 총이익률 예상치를 50~53%로 상향했습니다.
NeuroOne Medical Technologies (NASDAQ: NMTC) a publié de solides résultats pour le troisième trimestre de l'exercice 2025 : les revenus produits ont bondi de 105% en glissement annuel pour atteindre 1,7 million de dollars et la marge brute s'est élargie à 53,9%. La société a mené à bien une levée de capitaux sursouscrite de 8,2 millions de dollars, garantissant des financements jusqu'au FY2026.
Les principaux faits marquants opérationnels incluent le premier patient traité avec le système d'ablation OneRF® ayant obtenu une année sans crises, le dépôt auprès de la FDA pour le système d'ablation du nerf trijumeau OneRF®, ainsi que la réception de la première commande pour leur système d'administration de médicaments basé sur le sEEG de la part d'une grande société biopharmaceutique. L'entreprise a renforcé son portefeuille de PI avec 17 brevets et a reçu l'acceptation par le USPTO d'un brevet clé de fabrication.
NeuroOne maintient ses prévisions de revenus produits pour FY2025 à 8,0–10,0 millions de dollars (soit une croissance de 132–190%) et a relevé ses attentes de marge brute à 50–53%.
NeuroOne Medical Technologies (NASDAQ: NMTC) meldete starke Finanzergebnisse für Q3 des Geschäftsjahrs 2025: Die Produktumsätze stiegen um 105% im Jahresvergleich auf 1,7 Mio. USD, und die Bruttomarge weitete sich auf 53,9% aus. Das Unternehmen schloss erfolgreich eine überzeichnete Kapitalaufnahme in Höhe von 8,2 Mio. USD ab und sicherte damit die Finanzierung bis FY2026.
Wesentliche operative Höhepunkte sind, dass der erste Patient mit dem OneRF® Ablation System ein Jahr anfallsfrei war, die Einreichung bei der FDA für das OneRF® Trigeminus-Nerven-Ablationssystem sowie der Eingang der ersten Bestellung für ihr auf sEEG basierendes Wirkstoffabgabesystem von einem großen biopharmazeutischen Unternehmen. Das Unternehmen hat sein IP-Portfolio mit 17 Patenten gestärkt und eine USPTO-Zulassung für ein wichtiges Fertigungs-Patent erhalten.
NeuroOne bestätigt die Umsatzprognose für Produkte im FY2025 von 8,0–10,0 Mio. USD (entsprechend einem Wachstum von 132–190%) und hat die Erwartungen an die Bruttomarge auf 50–53% angehoben.
- Product revenue increased 105% YoY to $1.7 million in Q3 FY2025
- Gross margin expanded significantly to 53.9% from 34.1% YoY
- Successfully raised $8.2 million in oversubscribed capital funding
- Operating expenses decreased 9% to $2.8 million
- First OneRF® patient achieved one-year seizure freedom
- Strengthened IP portfolio with 17 patents and new USPTO allowance
- Zero debt on balance sheet as of June 30, 2025
- Net loss of $1.5 million in Q3 FY2025
- Still awaiting FDA clearance for OneRF® Trigeminal Nerve Ablation System
- No international market presence yet, pending ISO 13485 certification
Insights
NeuroOne shows impressive 105% revenue growth with expanding margins and product diversification, positioning for potential profitability with solid cash runway.
NeuroOne's Q3 results demonstrate remarkable financial momentum. Product revenue surged 105% year-over-year to
The company has simultaneously achieved a
The successful
Importantly, NeuroOne maintains its full-year product revenue guidance of
The combination of accelerating revenue growth, expanding margins, controlled expenses, and stronger cash position creates a compelling financial trajectory toward potential profitability. The ongoing partnership with Zimmer Biomet provides strategic market access while new products await FDA clearance could further diversify revenue streams in late 2025.
NeuroOne's OneRF platform shows clinical success with seizure-free patients and expansion into new neurological applications with strategic partnership momentum.
The clinical outcomes data emerging from NeuroOne's OneRF® Ablation System represents a significant validation of the technology's therapeutic potential. The first patient reaching one year of seizure freedom provides compelling real-world evidence of durable efficacy, while additional patients showing either complete seizure freedom or substantial reduction reinforces the technology's consistent performance. These outcomes suggest the platform is delivering on its promise to transform neurological treatment.
The company's strategic expansion of its technology platform into multiple neurological applications demonstrates impressive platform versatility. The FDA submission for the OneRF® Trigeminal Nerve Ablation System was completed ahead of schedule, targeting the large facial pain market with potential revenue contribution by late 2025. Simultaneously, development programs for basivertebral nerve ablation for lower back pain and a percutaneous paddle lead for spinal cord stimulation show NeuroOne is leveraging its core technology across multiple high-value neurological disorders.
Particularly noteworthy is NeuroOne's entry into the drug delivery space with its sEEG-based system, evidenced by the first order from a large biopharmaceutical company for preclinical research. This represents an entirely new market vertical beyond the company's diagnostic and ablation applications, potentially opening collaboration opportunities in the growing field of targeted neurological therapeutics.
The strengthened intellectual property position with 17 issued and pending patents, including the recent notice of allowance for a key manufacturing patent, provides crucial competitive barriers in the neuromodulation space. With ongoing development of international market access through ISO 13485 certification efforts, NeuroOne is systematically building a comprehensive commercial foundation for sustained growth across multiple neurological applications and global markets.
Completed Oversubscribed
EDEN PRAIRIE, Minn., Aug. 14, 2025 (GLOBE NEWSWIRE) -- 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 third quarter of fiscal year 2025 ended June 30, 2025.
Recent Company Highlights
- Product revenue increased
105% to$1.7 million in the third quarter of fiscal year 2025, compared to$0.8 million in the third quarter of fiscal year 2024. - Product gross margin expanded significantly to
53.9% in the third quarter of fiscal year 2025, compared to34.1% in the third quarter of fiscal year 2024. - Operating expenses decreased
9% to$2.8 million in the third quarter of fiscal year 2025, compared to$3.1 million in the same quarter of the prior year. - Successfully completed an oversubscribed capital raise with institutional investors in April 2025, totaling
$8.2 million in net proceeds. - Achieved milestone with first OneRF® Ablation System patient surpassing the one-year mark of seizure freedom. * Other early patients are also showing significant improvement with reduced or eliminated seizures and symptoms.
- Successfully filed FDA submission ahead of schedule for the OneRF® Trigeminal Nerve Ablation System to treat facial pain. An FDA response is expected in the near term.
- Received first order for NeuroOne’s sEEG-based drug delivery system (currently in development) from a large biopharmaceutical company planning to test NeuroOne’s system in preclinical research, representing a completely new market for NeuroOne.
- Received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) that a key patent will be issued surrounding how the Company’s neural and spinal cord stimulation electrodes are manufactured, representing a significant competitive deterrent for NeuroOne’s platform technology. Today, NeuroOne has 13 issued and pending patents in the U.S., as well as 4 internationally.
- Strengthened management team with the additions of Dr. Parag Patil as Chief Medical Advisor, Emily Johns as General Counsel and Corporate Secretary, and Evan Goulet, PhD as Sr. Director of Quality Assurance and Regulatory Affairs.
Management Commentary
“The third quarter of fiscal 2025 was highlighted by significantly improved year-over-year financial results, as well as several operational milestones that improve our competitive positioning and market potential,” said Dave Rosa, CEO of NeuroOne. “On the heels of our continued successful launch of the OneRF® Ablation system, we showed dramatic improvements in revenue—which increased
“We’ve also continued to make progress in expanding our market opportunity by leveraging the same NeuroOne electrode technology platform. To that end, we submitted our 510(k) application to the FDA for our OneRF® Trigeminal Nerve Ablation System ahead of schedule and expect to receive a response shortly. Conditional to receiving FDA 510(k) clearance, we have the ability to generate revenues from trigeminal nerve ablation in calendar year 2025. In addition, we are excited to have received the first order for our sEEG-based drug delivery system, which is in development, from a biopharmaceutical company planning to test our system in preclinical research. Discussions are ongoing with a number of top-tier strategic partners for other potential applications, including basivertebral nerve ablation (BVNA) and spinal cord stimulation for lower back pain management.
“We also began efforts this quarter to prepare the company to enter international markets by launching a program to apply for ISO 13485 certification. We expect that obtaining ISO 13485 certification will allow for additional growth that is not factored in our current operational plan.
“With 17 issued and outstanding patents in the U.S. and internationally, we have made steadfast progress on growing our IP portfolio. In July, we received notice of allowance from USPTO that a key patent will be issued surrounding how our neural and spinal cord stimulation electrodes are manufactured, representing a significant competitive advantage for NeuroOne.”
“Today, we stand in a stronger position than ever, given our expanding IP portfolio, ramping of revenues and solidified financial position following our
Operational Updates
OneRF® Ablation System:
- The first patient treated with NeuroOne’s OneRF Ablation System reached one year of seizure freedom in June 2025.*
- Additional patients are showing similar results with either seizure freedom or a significantly reduced number of seizures.*
- The Company continues to work closely with Zimmer Biomet and physician advisors on advanced training and education for this novel combination diagnostic and therapeutic procedure.
- Product exhibited by Zimmer Biomet at the American Association of Neurological Surgeons (AANS) in April 2025.
- Planning post-market registry to collect outcomes data.
OneRF® Trigeminal Nerve Ablation System:
- Filed 510(k) submission with the FDA in April 2025, ahead of schedule.
- NeuroOne expects to receive a response from the FDA in the near term.
- Subject to 510(k) clearance by the FDA, the OneRF® Trigeminal Nerve Ablation System could contribute to revenue in late calendar year 2025.
OneRF® BVNA Nerve Ablation System
- Initiated program to develop a product offering leveraging the OneRF system for basivertebral nerve radiofrequency ablation (BVNA) for the treatment of lower back pain.
- Formed an advisory board of key opinion leaders for this application.
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
- Initiated implants for chronic animal study.
- Continuing discussions with potential strategic partners to further develop and commercialize the Company’s Percutaneous Paddle Lead.
sEEG-Based Drug Delivery Program:
- Received first order for NeuroOne’s sEEG-based drug delivery system (currently in development) from a large biopharmaceutical company planning to test NeuroOne’s system in preclinical research, representing a completely new market for NeuroOne.
- Completed animal study with miniaturized sEEG-based drug delivery system designed for research use in small animals.
- Presentations at the American Society for Gene and Cell Therapy annual meeting in New Orleans in May 2025 and the Neurological Disorders Summit in Germany in April 2025.
Outside the U.S. (OUS) Distribution
- Initiated process to secure ISO13485 certification, which is a requisite for device registration and commercialization in many regions outside of the United States. Additional requirements may also need to be met prior to achieving regulatory approval in OUS markets.
- The Company has not sold or commercialized any products in international markets to-date, representing a potentially significant revenue opportunity.
Third Quarter Financial Results
Product revenue increased
Product gross profit increased significantly to
Total operating expenses decreased
Net loss in the third quarter of fiscal year 2025 improved to
As of June 30, 2025, the Company had cash and cash equivalents of
In April 2025, the Company completed an oversubscribed capital raise with institutional investors totaling
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue for fiscal year 2025 to range between
Conference Call and Webcast
Management will host an investor conference call and webcast today, Thursday, August 14, 2025, at 8:30 a.m. Eastern time to discuss the Company’s third quarter fiscal year 2025 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Thursday, August 14, 2025
Time: 8:30 a.m. Eastern time
U.S. Dial-In (Toll Free): 888-506-0062
International Dial-In: 973-528-0011
Participant Access Code: 939482
Webcast: 3Q Webcast Link
Please join at least five minutes before the start of the call to ensure timely participation.
A playback of the call will be available through Thursday, August 28, 2025. To listen, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 52598. A webcast replay will also be available using the webcast link above through August 28, 2025.
About NeuroOne
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, monitoring, ablation, drug delivery and stimulation 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 nmtc1.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 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); fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion, the potential to receive FDA clearance for our trigeminal nerve ablation program, the potential to receive revenues from our trigeminal nerve ablation program in calendar 2025, the potential to receive any revenues from our trigeminal nerve ablation 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.
Caution: Federal law restricts this device to sale by or on the order of a physician.
*Disclaimer: This recounts one patient’s experience and may not be representative of all patient outcomes.
IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us
NeuroOne Medical Technologies Corporation
Balance Sheets
(unaudited)
| As of | ||||||||
| June 30, | September 30, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,039,683 | $ | 1,460,042 | ||||
| Accounts receivable | — | 176,636 | ||||||
| Inventory | 1,897,701 | 2,635,153 | ||||||
| Deferred offering costs | — | 142,633 | ||||||
| Prepaid expenses | 233,363 | 216,461 | ||||||
| Total current assets | 10,170,747 | 4,630,925 | ||||||
| Intangible assets, net | 50,525 | 67,262 | ||||||
| Right-of-use asset | 283,621 | 254,910 | ||||||
| Property and equipment, net | 314,588 | 416,843 | ||||||
| Total assets | $ | 10,819,481 | $ | 5,369,940 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 467,734 | $ | 1,029,206 | ||||
| Accrued expenses and other liabilities | 958,056 | 1,184,014 | ||||||
| Total current liabilities | 1,425,790 | 2,213,220 | ||||||
| Warrant liability | 1,040,894 | 2,140,315 | ||||||
| Operating lease liability, long term | 175,344 | 194,392 | ||||||
| Total liabilities | 2,642,028 | 4,547,927 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 49,825 | 30,816 | ||||||
| Additional paid–in capital | 85,118,194 | 75,795,610 | ||||||
| Accumulated deficit | (76,990,566 | ) | (75,004,413 | ) | ||||
| Total stockholders’ equity | 8,177,453 | 822,013 | ||||||
| Total liabilities and stockholders’ equity | $ | 10,819,481 | $ | 5,369,940 | ||||
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product revenue | $ | 1,696,050 | $ | 825,776 | $ | 6,356,767 | $ | 3,180,719 | ||||||||
| Cost of product revenue | 781,215 | 543,904 | 2,743,982 | 2,242,114 | ||||||||||||
| Product gross profit | 914,835 | 281,872 | 3,612,785 | 938,605 | ||||||||||||
| License revenue | — | — | 3,000,000 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 1,618,950 | 1,881,099 | 5,602,818 | 6,057,520 | ||||||||||||
| Research and development | 1,182,485 | 1,194,674 | 3,865,376 | 3,951,559 | ||||||||||||
| Total operating expenses | 2,801,435 | 3,075,773 | 9,468,194 | 10,009,079 | ||||||||||||
| Loss from operations | (1,886,600 | ) | (2,793,901 | ) | (2,855,409 | ) | (9,070,474 | ) | ||||||||
| Fair value change in warrant liability | 319,625 | — | 1,099,421 | — | ||||||||||||
| Financing costs | (9,325 | ) | — | (334,063 | ) | — | ||||||||||
| Other income | 75,432 | 26,376 | 103,898 | 102,959 | ||||||||||||
| Loss before income taxes | (1,500,868 | ) | (2,767,525 | ) | (1,986,153 | ) | (8,967,515 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (1,500,868 | ) | $ | (2,767,525 | ) | $ | (1,986,153 | ) | $ | (8,967,515 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.03 | ) | $ | (0.10 | ) | $ | (0.05 | ) | $ | (0.35 | ) | ||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic and diluted | 48,604,996 | 27,352,660 | 36,850,431 | 25,746,503 | ||||||||||||
FAQ
What were NeuroOne's (NMTC) Q3 2025 revenue and growth numbers?
How much capital did NeuroOne raise in its 2025 funding round?
What is NeuroOne's revenue guidance for fiscal year 2025?
What clinical success has NeuroOne's OneRF® Ablation System shown?
What is the status of NeuroOne's FDA submission for the OneRF® Trigeminal Nerve Ablation System?
