Elutia Announces Full Launch of EluPro™ Following Strong Initial Demand
Elutia Inc. (ELUT) has announced the full U.S. commercial launch of EluPro™, the first FDA-cleared antibiotic-eluting biomatrix for cardiac implantable electronic devices and neurostimulators. Following a successful pilot program, EluPro has gained strong physician adoption, with submissions to 136 hospital value analysis committees and sales initiated at 70 institutions. The company has established partnerships with four major group purchasing organizations, including Premier and S3P.
The product addresses a significant market opportunity, as over 600,000 cardiac implantable electronic devices are implanted annually in the U.S., with complication rates of 5-7%. EluPro combines rifampin and minocycline antibiotics with a regenerative biomatrix to prevent infections and promote healing. Early results show over 50% increase in envelope orders following VAC approval. The U.S. CIED protection market is valued at $600 million.
Elutia Inc. (ELUT) ha annunciato il lancio commerciale completo negli Stati Uniti di EluPro™, il primo biomatrice a rilascio di antibiotici approvato dalla FDA per dispositivi elettronici impiantabili cardiaci e neurostimolatori. Dopo un programma pilota di successo, EluPro ha ottenuto una forte adozione da parte dei medici, con presentazioni a 136 comitati di analisi del valore ospedaliero e vendite avviate in 70 istituzioni. L'azienda ha stabilito collaborazioni con quattro importanti organizzazioni di acquisto di gruppo, tra cui Premier e S3P.
Il prodotto affronta una significativa opportunità di mercato, poiché oltre 600.000 dispositivi elettronici impiantabili cardiaci vengono impiantati annualmente negli Stati Uniti, con tassi di complicazione del 5-7%. EluPro combina gli antibiotici rifampicina e minociclina con una biomatrice rigenerativa per prevenire le infezioni e promuovere la guarigione. I risultati iniziali mostrano un aumento di oltre il 50% negli ordini di involucri dopo l'approvazione VAC. Il mercato della protezione dei CIED negli Stati Uniti è valutato a 600 milioni di dollari.
Elutia Inc. (ELUT) ha anunciado el lanzamiento comercial completo en EE. UU. de EluPro™, la primera biomatriz liberadora de antibióticos aprobada por la FDA para dispositivos electrónicos implantables cardíacos y neuroestimuladores. Tras un exitoso programa piloto, EluPro ha logrado una fuerte adopción por parte de los médicos, con presentaciones a 136 comités de análisis de valor hospitalario y ventas iniciadas en 70 instituciones. La compañía ha establecido asociaciones con cuatro importantes organizaciones de compras, incluyendo Premier y S3P.
El producto aborda una oportunidad de mercado significativa, ya que más de 600,000 dispositivos electrónicos implantables cardíacos se implantan anualmente en EE. UU., con tasas de complicaciones del 5-7%. EluPro combina los antibióticos rifampicina y minociclina con una biomatriz regenerativa para prevenir infecciones y promover la curación. Los resultados iniciales muestran un aumento de más del 50% en los pedidos de sobre cuando se obtuvo la aprobación de VAC. El mercado de protección de CIED en EE. UU. tiene un valor de 600 millones de dólares.
Elutia Inc. (ELUT)는 심장 이식형 전자 장치 및 신경 자극기를 위한 FDA 승인 항생제 방출 바이오 매트릭스인 EluPro™의 미국 상용 런칭을 공식 발표했습니다. 성공적인 파일럿 프로그램을 거쳐 EluPro는 136개의 병원 가치 분석 위원회에 제출되었고 70개 기관에서 판매가 시작되며 강력한 의사 채택을 얻었습니다. 이 회사는 Premier 및 S3P를 포함한 네 개의 주요 그룹 구매 조직과 파트너십을 구축했습니다.
이 제품은 매년 미국에서 600,000개 이상의 심장 이식형 전자 장치가 이식되고 5-7%의 합병증 발생률을 기록하는 중요한 시장 기회를 다루고 있습니다. EluPro는 감염 예방 및 치유 촉진을 위해 리팜피신 및 미노사이클린 항생제를 재생 바이오 매트릭스와 결합합니다. 초기 결과에 따르면 VAC 승인 이후 봉투 주문이 50% 이상 증가했습니다. 미국 CIED 보호 시장은 6억 달러로 평가됩니다.
Elutia Inc. (ELUT) a annoncé le lancement commercial complet de EluPro™ aux États-Unis, la première biomatrice libérant des antibiotiques ayant reçu l'agrément de la FDA pour les dispositifs électroniques implantables cardiaques et les neurostimulateurs. Suite à un programme pilote réussi, EluPro a connu une forte adoption par les médecins, avec des soumissions à 136 comités d'analyse de valeur hospitalière et des ventes initiées dans 70 établissements. L'entreprise a établi des partenariats avec quatre grandes organisations d'achats groupés, dont Premier et S3P.
Le produit répond à une opportunité de marché significative, car plus de 600 000 dispositifs électroniques implantables cardiaques sont implantés chaque année aux États-Unis, avec des taux de complications de 5 à 7%. EluPro combine les antibiotiques rifampicine et minocycline avec une biomatrice régénérative pour prévenir les infections et favoriser la guérison. Les premiers résultats montrent une augmentation de plus de 50% des commandes d'enveloppes suite à l'approbation de la VAC. Le marché de la protection des CIED aux États-Unis est évalué à 600 millions de dollars.
Elutia Inc. (ELUT) hat die vollständige Markteinführung von EluPro™ in den USA bekannt gegeben, der ersten von der FDA zugelassenen antibiotikafreisetzenden Biomatrix für herzimplantierbare elektronische Geräte und Neurostimulatoren. Nach einem erfolgreichen Pilotprogramm hat EluPro eine starke Akzeptanz bei Ärzten gewonnen, mit Einreichungen bei 136 Krankenhauswertanalysekommissionen und Verkaufsstart an 70 Einrichtungen. Das Unternehmen hat Partnerschaften mit vier großen Einkaufsorganisationen, darunter Premier und S3P, etabliert.
Das Produkt spricht eine bedeutende Marktchance an, da jährlich über 600.000 herzimplantierbare elektronische Geräte in den USA implantiert werden, mit Komplikationsraten von 5-7%. EluPro kombiniert Rifampicin und Minocyclin-Antibiotika mit einer regenerativen Biomatrix, um Infektionen vorzubeugen und die Heilung zu fördern. Erste Ergebnisse zeigen einen Anstieg von über 50% bei den Umschlagbestellungen nach der VAC-Zulassung. Der Markt für CIED-Schutz in den USA wird auf 600 Millionen US-Dollar geschätzt.
- First-to-market FDA-cleared antibiotic-eluting biomatrix for CIEDs
- Strong initial adoption with sales at 70 institutions
- 50% increase in orders post-VAC approval
- Partnerships established with 4 major GPOs
- Addresses large market of 600,000 annual CIED implants
- Target market valued at $600 million in U.S.
- None.
Insights
The EluPro launch represents a major commercial milestone in the
The technology's dual mechanism - antibiotic elution plus biomatrix healing support - provides a unique competitive advantage over existing synthetic options. With 600,000 annual CIED implants and
The early GPO contracts, particularly with industry leaders Premier and S3P, will accelerate market access and reduce barriers to hospital adoption. This comprehensive commercialization strategy positions Elutia to capture meaningful market share in this underserved segment.
This product launch carries significant revenue implications. The combination of strong initial demand metrics, broad FDA clearance and strategic GPO partnerships creates multiple growth catalysts. The
The total addressable market of
For investors, the comprehensive market access strategy through VACs and GPOs reduces execution risk. The broad device compatibility and unique technological advantages position Elutia to potentially become a standard of care, which could drive sustained market penetration and revenue growth.
First FDA-Cleared Antibiotic-Eluting BioEnvelope Now Available in U.S. for Implantable Pacemakers, Defibrillators, and Neurostimulators
SILVER SPRING, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT), a pioneer in drug-eluting biomatrix technologies, announced the U.S. commercial launch of EluPro™, the first and only FDA-cleared antibiotic-eluting biomatrix designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators.
“EluPro is an exciting innovation that addresses two critical challenges for patients with implantable devices: preventing infection and promoting healthy healing of the surgical pocket,” said Sunil Kapur, M.D., Cardiac Electrophysiologist at Brigham and Women’s Hospital. “The unique combination of powerful antibiotic protection and natural biomatrix technology represents a significant step forward in improving outcomes for patients. I am eager to see this technology benefit the field of electrophysiology.”
This full launch follows a successful pilot program in which EluPro was introduced at select hospitals, demonstrating strong physician adoption and positive patient outcomes. During this initial phase, Elutia has submitted EluPro for approval with 136 hospital value analysis committees (VACs), initiated sales at 70 institutions and established key relationships with four prominent group purchasing organizations (GPOs), including Premier and S3P. In an early indication of positive customer reception, envelope orders have increased over
"The launch of EluPro represents a significant advance in care for patients with CIEDs and neurostimulators," announced Dr. Randy Mills, CEO of Elutia. "Our successful pilot program confirmed EluPro’s substantial potential, marked by expeditious navigation of GPO and value analysis committee approvals and strong initial demand by physicians. I am proud of the Elutia CRU for their relentless efforts as we expand EluPro’s reach to benefit all patients in need of our groundbreaking technology."
Each year, more than 600,000 CIEDs are implanted in the U.S., with complication rates of 5
To learn more, visit www.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 the launch of EluPro, including the timing and anticipated success thereof. 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 successfully commercialize, market and sell our newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; 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; the continued and future acceptance of our products by the medical community; 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; 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; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; 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
FAQ
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