Elutia Announces First Patient Implant of EluPro™, the World’s First Drug-Eluting BioEnvelope for Cardiac Pacemakers and Neurostimulators
Elutia Inc. (Nasdaq: ELUT) has announced the first patient implant of EluPro™, the world's first FDA-cleared antibiotic-eluting biologic envelope for cardiac pacemakers and neurostimulators. The procedure was performed by Dr. John Catanzaro at East Carolina University Health Medical Center. EluPro is designed to prevent post-operative complications in patients with implantable devices.
Cleared by the FDA in June 2024, EluPro targets the $600 million U.S. implantable electronic device protection market. Elutia aims to establish a presence in the $8 billion cardiac rhythm management market and adjacent $8 billion neurostimulation sectors. The full commercial launch of EluPro is scheduled for January 2025.
Elutia Inc. (Nasdaq: ELUT) ha annunciato il primo impianto su un paziente di EluPro™, il primo involucro biologico ad rilascio di antibiotico approvato dalla FDA per pacemaker e neurostimolatori. La procedura è stata eseguita dal Dr. John Catanzaro presso il Centro Medico dell'Università della Carolina Orientale. EluPro è progettato per prevenire le complicazioni post-operatorie nei pazienti con dispositivi impiantabili.
Approvato dalla FDA a giugno 2024, EluPro si rivolge al mercato della protezione dei dispositivi elettronici impiantabili negli Stati Uniti, del valore di 600 milioni di dollari. Elutia mira a stabilire una presenza nel mercato della gestione del ritmo cardiaco da 8 miliardi di dollari e nei settori adiacenti della neurostimolazione, anch'essi da 8 miliardi di dollari. Il lancio commerciale completo di EluPro è previsto per gennaio 2025.
Elutia Inc. (Nasdaq: ELUT) ha anunciado el primer implante en un paciente de EluPro™, el primer sobre biológico con liberación de antibióticos aprobado por la FDA para marcapasos y neuroestimuladores. El procedimiento fue realizado por el Dr. John Catanzaro en el Centro Médico de la Universidad de Carolina del Este. EluPro está diseñado para prevenir complicaciones postoperatorias en pacientes con dispositivos implantables.
Aprobado por la FDA en junio de 2024, EluPro está dirigido al mercado de protección de dispositivos electrónicos implantables en Estados Unidos, que tiene un valor de 600 millones de dólares. Elutia busca establecer una presencia en el mercado de manejo del ritmo cardíaco de 8 mil millones de dólares y en los sectores adyacentes de neuroestimulación, también de 8 mil millones de dólares. El lanzamiento comercial completo de EluPro está programado para enero de 2025.
Elutia Inc. (Nasdaq: ELUT)는 최초의 FDA 승인 항생제 방출 생물학적 인벨로프인 EluPro™ 를 환자에게 이식했다고 발표했습니다. 이 시술은 존 카탄자로 박사에 의해 동부 카롤라이나 대학교 의료 센터에서 진행되었습니다. EluPro는 이식 가능한 장치를 가진 환자의 수술 후 합병증을 예방하도록 설계되었습니다.
2024년 6월 FDA의 승인을 받은 EluPro는 6억 달러 규모의 미국 이식 전자 장치 보호 시장을 목표로 하고 있습니다. Elutia는 80억 달러 규모의 심장 리듬 관리 시장과 인접한 80억 달러 규모의 신경 자극 분야에서 입지를 다질 계획입니다. EluPro의 상업적 출시는 2025년 1월로 예정되어 있습니다.
Elutia Inc. (Nasdaq: ELUT) a annoncé le premier implant chez un patient de EluPro™, le premier enveloppe biologique libérant des antibiotiques approuvé par la FDA pour les stimulateurs cardiaques et les neurostimulateurs. La procédure a été réalisée par le Dr John Catanzaro au Centre Médical de l'Université de Caroline de l'Est. EluPro est conçu pour prévenir les complications postopératoires chez les patients porteurs de dispositifs implantables.
Approuvé par la FDA en juin 2024, EluPro cible le marché de la protection des dispositifs électroniques implantables aux États-Unis, d'une valeur de 600 millions de dollars. Elutia vise à établir une présence sur le marché de la gestion du rythme cardiaque de 8 milliards de dollars et dans les secteurs adjacents de la neurostimulation également de 8 milliards de dollars. Le lancement commercial complet de EluPro est prévu pour janvier 2025.
Elutia Inc. (Nasdaq: ELUT) hat die erste Patientenimplantation von EluPro™ bekannt gegeben, dem weltweit ersten von der FDA zugelassenen biologischen Umschlag mit antibiotischen Wirkstoffen für Herzschrittmacher und Neurostimulatoren. Der Eingriff wurde von Dr. John Catanzaro im East Carolina University Health Medical Center durchgeführt. EluPro wurde entwickelt, um post-operative Komplikationen bei Patienten mit implantierbaren Geräten zu verhindern.
Von der FDA im Juni 2024 zugelassen, zielt EluPro auf den US-Markt für Schutz von implantierbaren elektronischen Geräten im Wert von 600 Millionen Dollar. Elutia strebt an, sich im 8 Milliarden Dollar schweren Markt für Herzrhythmusmanagement und im benachbarten 8 Milliarden Dollar schweren Neurostimulationssektor zu positionieren. Die vollständige Markteinführung von EluPro ist für Januar 2025 geplant.
- First-ever patient implant of EluPro, a novel antibiotic-eluting biologic envelope
- FDA clearance for EluPro obtained in June 2024
- Targeting a $600 million U.S. market for implantable electronic device protection
- Potential expansion into $16 billion combined cardiac and neurostimulation markets
- Full commercial launch of EluPro planned for January 2025
- None.
Insights
The first implant of EluPro™ marks a significant advancement in medical device technology. This antibiotic-eluting biologic envelope addresses a critical need in cardiac and neurostimulation implants by potentially reducing post-operative complications. The product's FDA clearance and successful first implant demonstrate its readiness for clinical use, which could lead to improved patient outcomes and reduced healthcare costs.
EluPro's market potential is substantial, targeting a
Investors should note the planned commercial launch in January 2025, which provides a clear timeline for potential revenue generation. The successful first implant and positive physician feedback are encouraging signs for future adoption and market penetration.
Elutia's EluPro™ launch represents a pivotal moment for the company's financial outlook. Entering a
Investors should consider the following financial implications:
- Potential for rapid market share gain due to competition
- Diversified revenue streams from multiple medical device applications
- Possible premium pricing due to the product's unique biologic and antibiotic-eluting properties
However, it's important to monitor the adoption rate post-launch and any reimbursement challenges that may arise. The January 2025 commercial launch provides a clear milestone for assessing initial market traction and revenue impact. This news is likely to positively influence Elutia's stock performance in the near term, subject to successful commercialization execution.
SILVER SPRING, Md., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a pioneer in drug-eluting biomatrix products, today announced a landmark achievement with the first-ever patient implant of EluPro®, the world’s first antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration (FDA). The groundbreaking procedure was performed by John Catanzaro, MD, MBA, Chief, Division of Cardiology, Director, Cardiology Services, and Program Director of Clinical Cardiac Electrophysiology Fellowship at East Carolina University Health Medical Center in Greenville, North Carolina.
“We are honored to be the first facility to implant EluPro,” said Dr. Catanzaro. “With its combination of proven antibiotics and biomatrix with demonstrated regenerative benefits, EluPro offers a more natural solution to reduce post-operative complications. This is a significant advancement in patient care, providing enhanced protection and peace of mind for patients needing a pacemaker or defibrillator.”
Achieving this milestone demonstrates Elutia’s ability to deliver on its commitment to advancing healthcare with innovative solutions that address device complications.
“Our mission is to humanize medicine so patients can thrive without compromise, and today, we made significant progress toward fulfilling that promise,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “Today’s milestone is a testament to the team’s relentless pursuit of better patient outcomes and I want to thank the entire Elutia CRU. With EluPro, physicians finally have a biologic antibiotic-eluting envelope to protect their patients, and we look forward to its full commercial launch in January 2025.”
EluPro is designed to prevent post-operative complications in patients with cardiac implantable devices such as pacemakers and internal defibrillators. Cleared by the FDA in June 2024, it is also approved for use with additional devices, including neuromodulators and neurostimulators for pain management, epilepsy, incontinence, and sleep apnea.
The launch of EluPro presents a major opportunity in the
For more information about EluPro, visit https://elutia.com/products/elupro/.
About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.
Forward-Looking Statements
This press release contains “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. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration (“FDA”); preparations for the launch of EluPro, including the timing and anticipated success thereof; the size of the pacemaker and implantable defibrillator protection market and the potential of EluPro to compete in that market; and the potential for applying our drug-eluting biomatrix technology into adjacent markets. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/53c6e902-d58d-4689-9f3b-b56c761abe1a
FAQ
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