Elutia Confirms No Material Impact from Global Tariffs
Elutia (Nasdaq: ELUT) has announced that global tariffs have not materially impacted its operations or commercial performance. The company's business model, centered on 100% U.S.-based sourcing, manufacturing, and distribution, primarily through its Roswell, Georgia facility, has effectively insulated it from international trade uncertainties.
The company's product portfolio, including EluPro™, CanGaroo®, SimpliDerm®, and its Cardiovascular line, is entirely produced and sold within the United States. The FDA-registered Roswell facility has maintained normal operations without experiencing tariff-related delays, cost increases, or supplier issues. Elutia reports that its pricing and margins remain unaffected by the current global tariff environment.
Elutia (Nasdaq: ELUT) ha annunciato che le tariffe globali non hanno avuto un impatto significativo sulle sue operazioni o sulle sue performance commerciali. Il modello di business dell'azienda, incentrato su un approvvigionamento, produzione e distribuzione interamente basati negli Stati Uniti, principalmente attraverso il suo stabilimento di Roswell, Georgia, l'ha effettivamente protetta dalle incertezze del commercio internazionale.
Il portafoglio prodotti dell'azienda, che include EluPro™, CanGaroo®, SimpliDerm® e la sua linea Cardiovascolare, è completamente prodotto e venduto all'interno degli Stati Uniti. Lo stabilimento di Roswell, registrato presso la FDA, ha mantenuto operazioni normali senza subire ritardi, aumenti di costi o problemi con i fornitori legati alle tariffe. Elutia riporta che i suoi prezzi e margini rimangono inalterati dall'attuale contesto tariffario globale.
Elutia (Nasdaq: ELUT) ha anunciado que las tarifas globales no han impactado materialmente sus operaciones ni su rendimiento comercial. El modelo de negocio de la empresa, centrado en un abastecimiento, fabricación y distribución 100% basado en EE. UU., principalmente a través de su instalación en Roswell, Georgia, la ha protegido eficazmente de las incertidumbres del comercio internacional.
El portafolio de productos de la empresa, que incluye EluPro™, CanGaroo®, SimpliDerm® y su línea Cardiovascular, se produce y vende completamente dentro de los Estados Unidos. La instalación de Roswell, registrada en la FDA, ha mantenido operaciones normales sin experimentar retrasos, aumentos de costos o problemas con proveedores relacionados con las tarifas. Elutia informa que sus precios y márgenes permanecen sin cambios ante el actual entorno tarifario global.
Elutia (Nasdaq: ELUT)는 글로벌 관세가 자사의 운영이나 상업적 성과에 실질적인 영향을 미치지 않았다고 발표했습니다. 회사의 비즈니스 모델은 100% 미국 내에서 조달, 제조 및 유통을 중심으로 하며, 주로 조지아주 로즈웰 시설을 통해 이루어져 있어 국제 무역의 불확실성으로부터 효과적으로 보호받고 있습니다.
회사의 제품 포트폴리오는 EluPro™, CanGaroo®, SimpliDerm® 및 심혈관 라인을 포함하여 전적으로 미국 내에서 생산 및 판매됩니다. FDA에 등록된 로즈웰 시설은 관세와 관련된 지연, 비용 증가 또는 공급업체 문제 없이 정상 운영을 유지하고 있습니다. Elutia는 현재의 글로벌 관세 환경에 의해 가격과 마진이 영향을 받지 않고 있다고 보고하고 있습니다.
Elutia (Nasdaq: ELUT) a annoncé que les tarifs mondiaux n'ont pas eu d'impact significatif sur ses opérations ou ses performances commerciales. Le modèle commercial de l'entreprise, centré sur un approvisionnement, une fabrication et une distribution entièrement basés aux États-Unis, principalement via son site de Roswell, en Géorgie, l'a efficacement protégée des incertitudes du commerce international.
Le portefeuille de produits de l'entreprise, comprenant EluPro™, CanGaroo®, SimpliDerm® et sa ligne cardiovasculaire, est entièrement produit et vendu aux États-Unis. L'établissement de Roswell, enregistré auprès de la FDA, a maintenu des opérations normales sans connaître de retards, d'augmentations de coûts ou de problèmes de fournisseurs liés aux tarifs. Elutia rapporte que ses prix et marges restent inchangés dans l'environnement tarifaire mondial actuel.
Elutia (Nasdaq: ELUT) hat angekündigt, dass globale Zölle ihre Geschäftstätigkeit oder kommerzielle Leistung nicht wesentlich beeinträchtigt haben. Das Geschäftsmodell des Unternehmens, das sich auf 100% in den USA basierende Beschaffung, Herstellung und Distribution konzentriert, hauptsächlich über seine Einrichtung in Roswell, Georgia, hat es effektiv vor internationalen Handelsunsicherheiten geschützt.
Das Produktportfolio des Unternehmens, einschließlich EluPro™, CanGaroo®, SimpliDerm® und seiner kardiovaskulären Produktlinie, wird vollständig in den Vereinigten Staaten produziert und verkauft. Die von der FDA registrierte Einrichtung in Roswell hat den normalen Betrieb aufrechterhalten, ohne dass es zu verzögerungen, Kostensteigerungen oder Lieferantenproblemen aufgrund von Zöllen gekommen ist. Elutia berichtet, dass ihre Preise und Margen von der aktuellen globalen Zollumgebung unberührt bleiben.
- 100% U.S.-based operations provide immunity from global tariff impacts
- No cost increases or margin pressure from tariffs
- Vertically integrated manufacturing ensures supply chain stability
- FDA-registered facility maintains normal operations without disruptions
- international market presence and growth potential due to U.S.-only focus
SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance.
Elutia sources, manufactures, and distributes
“We are proud to be a U.S.-based company with all operations and sales occurring domestically,” said Dr. Randy Mills, CEO of Elutia. “Thanks to our vertically integrated manufacturing and U.S.-focused commercial strategy, we remain insulated from the uncertainties surrounding the current tariff landscape and continue to reliably produce and deliver our advanced medical products so patients can thrive without compromise.”
Elutia’s Roswell facility is FDA-registered as a medical device manufacturing establishment and has not experienced any delays, cost increases, or supplier issues related to the tariffs. The Company believes it is well-positioned to continue serving the U.S. market without impacts to its pricing or margins.
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. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding any future impacts on Elutia’s performance of current or new and/or increased global tariffs, and any resulting future difficulties, delays or cost increases in securing necessary suppliers or materials for Elutia’s products. 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: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our 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; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; 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 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; 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, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, 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
This press release was published by a CLEAR® Verified individual.
FAQ
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