NeuroOne® Issues Letter to Shareholders
NeuroOne Medical Technologies (NMTC) has issued a shareholder letter highlighting recent achievements and future outlook. The company expanded its partnership with Zimmer Biomet, securing exclusive distribution rights for the OneRF® Ablation System with a $3.0 million upfront payment in November 2024.
The company recently raised $8.3 million from institutional investors, ensuring funding through fiscal 2026. NeuroOne confirmed no material impact from global tariffs due to its US-based supply chain. They plan to submit a 510(k) filing to FDA in May 2025 for trigeminal nerve ablation treatment.
For fiscal year 2025, NeuroOne projects product revenues of $8.0-$10.0 million (132%-190% increase from $3.5 million in FY2024) and improved gross margins of 47%-51% (up from 31% in FY2024). The company is also advancing its Spinal Cord Stimulation Program and sEEG-Based Drug Delivery Program, with strategic partnership discussions underway.
NeuroOne Medical Technologies (NMTC) ha pubblicato una lettera agli azionisti evidenziando i recenti risultati e le prospettive future. L'azienda ha ampliato la partnership con Zimmer Biomet, assicurandosi i diritti esclusivi di distribuzione per il OneRF® Ablation System con un pagamento iniziale di 3,0 milioni di dollari previsto per novembre 2024.
Recentemente la società ha raccolto 8,3 milioni di dollari da investitori istituzionali, garantendo finanziamenti fino all’esercizio fiscale 2026. NeuroOne ha confermato che non vi sono impatti significativi dai dazi globali grazie alla sua catena di approvvigionamento basata negli Stati Uniti. È previsto il deposito di una domanda 510(k) alla FDA a maggio 2025 per il trattamento di ablazione del nervo trigemino.
Per l’esercizio fiscale 2025, NeuroOne prevede ricavi da prodotti tra 8,0 e 10,0 milioni di dollari (un incremento del 132%-190% rispetto ai 3,5 milioni del 2024) e un miglioramento del margine lordo tra il 47% e il 51% (in aumento rispetto al 31% del 2024). La società sta inoltre portando avanti il Programma di Stimolazione del Midollo Spinale e il Programma di Somministrazione di Farmaci basato su sEEG, con discussioni strategiche in corso per partnership.
NeuroOne Medical Technologies (NMTC) ha emitido una carta a los accionistas destacando logros recientes y perspectivas futuras. La empresa amplió su asociación con Zimmer Biomet, asegurando los derechos exclusivos de distribución para el OneRF® Ablation System con un pago inicial de 3,0 millones de dólares en noviembre de 2024.
Recientemente, la compañía recaudó 8,3 millones de dólares de inversores institucionales, asegurando financiamiento hasta el año fiscal 2026. NeuroOne confirmó que no hay un impacto material por aranceles globales debido a su cadena de suministro basada en EE.UU. Planean presentar una solicitud 510(k) a la FDA en mayo de 2025 para el tratamiento de ablación del nervio trigémino.
Para el año fiscal 2025, NeuroOne proyecta ingresos por productos de 8,0 a 10,0 millones de dólares (un aumento del 132%-190% respecto a los 3,5 millones del 2024) y un margen bruto mejorado del 47%-51% (frente al 31% del 2024). La compañía también avanza en su Programa de Estimulación de la Médula Espinal y en el Programa de Administración de Medicamentos basado en sEEG, con discusiones estratégicas para alianzas en curso.
NeuroOne Medical Technologies (NMTC)는 최근 성과와 향후 전망을 강조하는 주주 서한을 발행했습니다. 회사는 Zimmer Biomet와의 파트너십을 확장하여 OneRF® Ablation System의 독점 유통 권한을 확보했으며, 2024년 11월에 300만 달러의 선불금을 받았습니다.
최근 기관 투자자로부터 830만 달러를 조달하여 2026 회계연도까지 자금 확보를 보장했습니다. NeuroOne은 미국 기반 공급망 덕분에 글로벌 관세로 인한 실질적인 영향이 없음을 확인했습니다. 2025년 5월에 삼차신경 절제 치료를 위한 510(k) FDA 제출을 계획하고 있습니다.
2025 회계연도에는 제품 매출이 800만~1000만 달러(2024년 350만 달러 대비 132%-190% 증가)로 예상되며, 총이익률은 47%-51%(2024년 31%에서 상승)로 개선될 전망입니다. 또한 척수 자극 프로그램과 sEEG 기반 약물 전달 프로그램을 진행 중이며, 전략적 파트너십 논의도 진행되고 있습니다.
NeuroOne Medical Technologies (NMTC) a publié une lettre aux actionnaires mettant en avant ses récentes réalisations et ses perspectives d’avenir. La société a renforcé son partenariat avec Zimmer Biomet, obtenant les droits exclusifs de distribution pour le OneRF® Ablation System avec un paiement initial de 3,0 millions de dollars prévu en novembre 2024.
Récemment, l’entreprise a levé 8,3 millions de dollars auprès d’investisseurs institutionnels, assurant un financement jusqu’à l’exercice 2026. NeuroOne a confirmé qu’il n’y a pas d’impact significatif des tarifs mondiaux grâce à sa chaîne d’approvisionnement basée aux États-Unis. Elle prévoit de soumettre un dossier 510(k) à la FDA en mai 2025 pour le traitement par ablation du nerf trijumeau.
Pour l’exercice 2025, NeuroOne prévoit des revenus produits entre 8,0 et 10,0 millions de dollars (soit une augmentation de 132 % à 190 % par rapport aux 3,5 millions de 2024) et une amélioration des marges brutes entre 47 % et 51 % (contre 31 % en 2024). La société fait également progresser son programme de stimulation de la moelle épinière et son programme de délivrance de médicaments basé sur sEEG, avec des discussions stratégiques de partenariat en cours.
NeuroOne Medical Technologies (NMTC) hat einen Aktionärsbrief veröffentlicht, der jüngste Erfolge und zukünftige Aussichten hervorhebt. Das Unternehmen hat seine Partnerschaft mit Zimmer Biomet erweitert und exklusive Vertriebsrechte für das OneRF® Ablation System mit einer Vorauszahlung von 3,0 Millionen US-Dollar im November 2024 gesichert.
Kürzlich hat das Unternehmen 8,3 Millionen US-Dollar von institutionellen Investoren eingeworben und damit die Finanzierung bis zum Geschäftsjahr 2026 gesichert. NeuroOne bestätigte, dass globale Zölle aufgrund der in den USA ansässigen Lieferkette keine wesentlichen Auswirkungen haben. Im Mai 2025 soll eine 510(k)-Einreichung bei der FDA für die Behandlung der Trigeminusnerv-Ablation erfolgen.
Für das Geschäftsjahr 2025 prognostiziert NeuroOne Produktumsätze von 8,0 bis 10,0 Millionen US-Dollar (ein Anstieg von 132 % bis 190 % gegenüber 3,5 Millionen im Geschäftsjahr 2024) sowie verbesserte Bruttomargen von 47 % bis 51 % (gegenüber 31 % im Geschäftsjahr 2024). Das Unternehmen entwickelt außerdem sein Programm zur Rückenmarkstimulation und das sEEG-basierte Arzneimittelabgabeprogramm weiter, wobei strategische Partnerschaftsgespräche im Gange sind.
- Secured $8.3 million funding, ensuring operations through fiscal 2026
- Expanded Zimmer Biomet partnership with $3.0 million upfront payment
- Projected 132%-190% revenue growth to $8.0-$10.0 million in FY2025
- Expected gross margin improvement from 31% to 47%-51% in FY2025
- US-based supply chain eliminates tariff impact risks
- Recent share offering resulted in shareholder dilution
Insights
NeuroOne is making substantial progress in multiple areas that strengthen its competitive position. The OneRF® Ablation System represents a significant advancement as the first FDA-cleared product combining diagnostic and therapeutic capabilities in a single electrode. This dual functionality creates a compelling value proposition that likely factored into Zimmer Biomet's decision to expand their partnership and secure exclusive distribution rights.
The accelerated 510(k) submission for trigeminal nerve ablation targets a sizable market of 100,000-200,000 patients with facial pain in the U.S. This application leverages their existing technology platform, demonstrating efficient R&D resource allocation through platform expansion rather than developing entirely new technologies.
The company's U.S.-based supply chain provides a strategic advantage amid global trade uncertainties. While many medical device companies face potential disruptions from tariffs, NeuroOne's domestic manufacturing approach insulates them from these risks and potential component shortages.
The ongoing development of the Spinal Cord Stimulation Paddle Lead and sEEG-Based Drug Delivery Program demonstrates a clear technology roadmap. The mention of advanced discussions with strategic partners suggests additional validation of their technology is forthcoming. The company is effectively expanding their addressable market across multiple neurological applications while maintaining focus on their core technology platform.
NeuroOne's financial picture has strengthened considerably with several positive developments. The $8.3 million capital raise provides runway through at least fiscal 2026, eliminating near-term financing concerns. Importantly, the offering was oversubscribed and structured without toxic financing mechanisms that would create future dilution pressure.
Revenue projections are compelling, with product revenues expected to reach $8.0-$10.0 million in FY2025, representing 132%-190% growth compared to FY2024's $3.5 million. This substantial growth reflects the expanded Zimmer Biomet partnership, which included a $3.0 million upfront payment and established minimum purchase requirements.
Gross margin expansion from 31% to 47%-51% indicates improving operational efficiency and scale benefits. This margin improvement, combined with the revenue growth trajectory, supports management's assertion that they may reach cash flow breakeven without additional dilutive financing if key milestones are achieved.
The company's partnership with Zimmer Biomet provides both capital and commercial validation. The established minimum purchase requirements create predictable baseline revenue, while the exclusive distribution rights leverage Zimmer's extensive sales network. This combination of improved capital position, expanding margins, and commercial partnership significantly de-risks NeuroOne's execution path and strengthens their path toward profitability.
Company Now Fully Funded Through at least Fiscal 2026; Company Confirms No Material Impact from Global Tariffs
EDEN PRAIRIE, Minn., April 16, 2025 (GLOBE NEWSWIRE) -- 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, has issued a letter to shareholders from CEO, Dave Rosa.
Dear Shareholders,
In recent months, NeuroOne has achieved several significant milestones, including the expansion of our commercial partnership with Zimmer Biomet, progress towards the submission of a 510(k) filing to treat facial pain, and continued product development momentum in areas of back pain management and drug delivery.
Most notably, the expansion of our partnership with Zimmer Biomet included exclusive distribution rights in the United States and certain additional countries for the OneRF® Ablation System, which is the first and only FDA-cleared product that uses the same sEEG electrode for both diagnostic and therapeutic applications. The agreement included an upfront license payment of
Given the recent discussions around tariffs and global trade policy, we have also received questions regarding potential impacts on our supply chain. Investors should know that all of our key components are sourced and manufactured within the United States. Having a domestic-focused supply chain has been an intentional part of our operational strategy, and we do not anticipate any meaningful impact from current or proposed tariffs.
To execute on the opportunities in front of us, last week we successfully completed a capital raise with institutional investors totaling
With the proceeds from this offering, we believe the Company is now fully funded to operate through at least the end of fiscal year 2026, based on Zimmer making the minimum purchase requirements set forth in our expanded agreement. While our near-term focus remains on disciplined execution, if we achieve some of the key milestones currently in progress, we believe this capital could bring us to cash flow breakeven and support our long-term growth plans with no need for additional dilutive financing.
For instance, in March 2025, we accelerated the anticipated timeline of our 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the OneRF® Technology Platform and will be used to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. With an estimated 100,000-200,000 patients suffering from facial pain in the U.S. alone, this market represents a significant opportunity for NeuroOne.
Other areas of growth include the Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program and the sEEG-Based Drug Delivery Program. Both are solutions that utilize the OneRF® platform for pain management and drug delivery, respectively. We are in advanced discussions with strategic partners which would further validate our technology, provide significant reach, and potentially, include upfront payments.
Today, we stand as a larger, more mature company than ever before as we ramp revenues and product margins. We have a world class strategic partner, the necessary capital to execute on our strategic growth initiatives and several upcoming milestones that present significant opportunities to grow shareholder value.
As we look ahead, we are reiterating our fiscal year 2025 guidance, with product revenues expected to increase to between
Thank you for your unwavering support and being part of the NeuroOne story as we work to drive significant shareholder value and execute on the opportunities ahead of us.
Sincerely,
Dave Rosa
President & CEO
About NeuroOne
NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing 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. 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 fully-funded through 2026; the continued development of the Company’s electrode technology program (including its drug delivery program and spinal cord stimulation program); the ability to achieve cash-flow break-even without additional dilutive financing; fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion; the plan to submit a 510(k) application with the FDA in May 2025 for the Company’s 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 it has a reasonable basis for each forward-looking statement, the Company cautions you that these statements are based on a combination of facts and factors currently known by the Company and its expectations of the future, about which the Company cannot be certain. Actual future results may be materially different from what the Company expects due to factors largely outside of its control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements; risks that Zimmer may not purchase the minimum purchase requirements; risks that the Company’s strategic partnerships may not facilitate the commercialization or market acceptance of its technology; whether due to supply chain disruptions, labor shortages or otherwise; risks that the Company’s technology will not perform as expected; 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 Company may not be able to secure or retain coverage or adequate reimbursement for its technology; uncertainties inherent in the development process of the Company’s technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that the Company may not have accurately estimated the size and growth potential of the markets for its technology; risks that the Company may be unable to protect its intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in the Company’s 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.
IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us
FAQ
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