NeuroOne® Announces Expansion of Existing Distribution Agreement with Zimmer Biomet for Commercialization of OneRF™ Ablation System
NeuroOne Medical Technologies (NASDAQ: NMTC) has expanded its distribution agreement with Zimmer Biomet for the OneRF™ Ablation System. The amendment grants Zimmer Biomet exclusive rights to distribute the system for brain use. NeuroOne will receive a $3 million upfront payment with potential additional milestone payments. The OneRF system is the only FDA-cleared radiofrequency ablation system in the US for both diagnostic and therapeutic use, having demonstrated success in identifying and ablating brain tissue causing seizures. The system allows for bedside procedures, reducing hospital stays and operating costs while enabling diagnosis and treatment in a single hospitalization.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha ampliato il suo accordo di distribuzione con Zimmer Biomet per il OneRF™ Ablation System. L'emendamento conferisce a Zimmer Biomet diritti esclusivi per distribuire il sistema per uso cerebrale. NeuroOne riceverà un pagamento iniziale di 3 milioni di dollari con ulteriori potenziali pagamenti legati a traguardi. Il sistema OneRF è l'unico sistema di ablazione a radiofrequenza approvato dalla FDA negli Stati Uniti sia per uso diagnostico che terapeutico, avendo dimostrato successo nell'identificazione e nell'ablazione del tessuto cerebrale responsabile delle crisi epilettiche. Il sistema consente procedure al letto del paziente, riducendo i tempi di ricovero e i costi operativi, consentendo diagnosi e trattamento durante un'unica ospedalizzazione.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha ampliado su acuerdo de distribución con Zimmer Biomet para el OneRF™ Ablation System. La enmienda otorga a Zimmer Biomet derechos exclusivos para distribuir el sistema para el uso cerebral. NeuroOne recibirá un pago inicial de 3 millones de dólares con posibles pagos adicionales por hitos. El sistema OneRF es el único sistema de ablación por radiofrecuencia aprobado por la FDA en EE.UU. tanto para uso diagnóstico como terapéutico, habiendo demostrado éxito en la identificación y ablación de tejido cerebral que causa convulsiones. El sistema permite procedimientos al lado de la cama, reduciendo las estancias hospitalarias y los costos operativos, permitiendo el diagnóstico y tratamiento en una única hospitalización.
NeuroOne Medical Technologies (NASDAQ: NMTC)는 Zimmer Biomet와의 OneRF™ Ablation System 배급 계약을 확대했습니다. 이번 수정안은 Zimmer Biomet에 뇌 사용을 위한 시스템의 독점 배급 권리를 부여합니다. NeuroOne은 300만 달러의 선불 지급을 받으며, 추가적인 이정표 지급이 가능할 수 있습니다. OneRF 시스템은 미국에서 진단 및 치료 용도로 FDA의 승인을 받은 유일한 라디오 주파수 절제 시스템으로, 발작을 유발하는 뇌 조직을 식별하고 절제하는 데 성공을 보여주었습니다. 이 시스템은 병상에서 절제를 허용하여 병원 입원 기간과 운영 비용을 줄이고, 단일 입원으로 진단과 치료를 가능하게 합니다.
NeuroOne Medical Technologies (NASDAQ: NMTC) a élargi son contrat de distribution avec Zimmer Biomet pour le OneRF™ Ablation System. L'amendement accorde à Zimmer Biomet des droits exclusifs pour distribuer le système à des fins cérébrales. NeuroOne recevra un paiement initial de 3 millions de dollars avec des paiements supplémentaires potentiels liés à des jalons. Le système OneRF est le seul système d'ablation par radiofréquence autorisé par la FDA aux États-Unis pour des usages diagnostiques et thérapeutiques, ayant démontré son efficacité dans l'identification et l'ablation du tissu cérébral provoquant des crises. Le système permet des procédures au chevet du patient, réduisant les séjours à l'hôpital et les coûts d'exploitation tout en permettant le diagnostic et le traitement au cours d'une seule hospitalisation.
NeuroOne Medical Technologies (NASDAQ: NMTC) hat sein Vertriebsabkommen mit Zimmer Biomet für das OneRF™ Ablation System erweitert. Die Änderung gewährt Zimmer Biomet exklusive Rechte zur Verteilung des Systems für den Einsatz im Gehirn. NeuroOne wird eine Vorauszahlung von 3 Millionen Dollar erhalten, mit potenziellen zusätzlichen Meilensteinzahlungen. Das OneRF-System ist das einzige in den USA von der FDA zugelassene Radiofrequenz-Ablationssystem für diagnostische und therapeutische Anwendungen und hat nachgewiesen, dass es erfolgreich das Gewebe im Gehirn, das Anfälle verursacht, identifiziert und ablatiert. Das System ermöglicht Eingriffe am Patientenbett, reduziert Krankenhausaufenthalte und Betriebskosten und ermöglicht Diagnose und Behandlung während eines einzigen Krankenhausaufenthalts.
- Secured $3 million upfront payment with potential additional milestone payments
- Exclusive distribution agreement with major medical device company Zimmer Biomet
- Only FDA-cleared system for both diagnostic and therapeutic use in the US
- Potential for reduced hospital costs through bedside procedures
- Expected to generate meaningful revenue and improve profitability
- None.
Insights
This expanded distribution agreement marks a significant financial milestone for NeuroOne. The
- Reduced hospital stays and operating costs through bedside procedures
- Potential for increased procedure volumes through simplified workflows
- Access to Zimmer Biomet's extensive distribution network both domestically and internationally
- Additional revenue streams from milestone payments based on performance
For a company with a
The OneRF™ Ablation System represents a technological breakthrough in neurological treatment. Its unique FDA clearance for both diagnostic and therapeutic applications in a single device streamlines the treatment workflow significantly. The system's ability to identify seizure-triggering tissue and perform ablation in one procedure reduces patient risk and improves care efficiency. The temperature control feature enhances safety protocols, addressing a critical concern in neural ablation procedures. The bedside treatment capability eliminates the need for multiple operating room visits, representing both cost savings and improved patient experience. This technology platform shows potential for expanded indications beyond current applications, suggesting strong future growth opportunities in neurological treatment markets.
License Provides Exclusive Commercialization Rights for US Distribution and Certain OUS Markets
Agreement expected to boost NeuroOne sales revenue and profitability
EDEN PRAIRIE, Minn., Oct. 31, 2024 (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, today announced the execution of an amendment to its existing distribution agreement with Zimmer Biomet that will provide Zimmer Biomet with certain exclusive rights to distribute NeuroOne’s OneRF™ Ablation System for use in the brain.
NeuroOne will receive an upfront payment of
The OneRF Ablation System is the only FDA cleared radiofrequency ablation system in the United States for both diagnostic and therapeutic use. It has been used in a number of ablation cases since its limited launch in April. Cases were reported as being successful using the same device to identify the brain tissue triggering seizure activity and ablate the targeted tissue to reduce or eliminate brain-related seizure activity. In addition, the technology has the potential to reduce hospital stays, number of surgeries and adverse events while offering temperature control to enhance patient safety. The devices are initially placed in the operating room. To date, all the ablations have been performed at the patient’s bedside saving additional operating costs while allowing the patient to be diagnosed and treated in one hospitalization instead of multiple visits.
“The expanded agreement with Zimmer Biomet to include distribution of our OneRF Ablation System is a significant catalyst for the Company,” says Dave Rosa, president and CEO of NeuroOne. “We are confident that the partnership will allow NeuroOne to leverage Zimmer Biomet’s leadership position in robotic technology and extensive distribution channel both in the United States and abroad. As the world’s first FDA cleared system for both diagnostic and therapeutic procedures, our ablation system provides clear advantages over existing competitive electrode technologies. We look forward to continuing to expand the indications for use in the future.”
Brian Hatcher, President, SET and CMFT at Zimmer Biomet said, “We are excited to expand the relationship with NeuroOne to include the OneRF Ablation System, which builds on our existing agreement to distribute NeuroOne’s Cortical and sEEG diagnostic electrode technology, and we look forward to launching this product in the near future.”
About NeuroOne
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. 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 www.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," "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 potential for the expanded distribution agreement to increase revenues and profitability, the potential to receive any milestone payment, the potential for future FDA submissions for additional ablation applications, business strategy, market size, potential growth opportunities, and future operations. 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 our partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, 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 our ability 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”
Contact:
800-631-4030
ir@nmtc1.com
FAQ
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