Humacyte announces Symvess™ ECAT Approval from U.S. Defense Logistics Agency
Humacyte (Nasdaq: HUMA) has received Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency for its Symvess product. This approval enables healthcare professionals at Department of Defense (DOD) and Veterans Affairs facilities to access Symvess for treating military service members, veterans, and other patients.
Symvess, an acellular tissue engineered vessel, received FDA approval in December 2024 for extremity vascular trauma indication. The ECAT system integration represents a significant milestone in making the product accessible to military healthcare providers. However, for uses beyond the FDA-approved indication, Symvess remains investigational and requires further regulatory approval.
Humacyte (Nasdaq: HUMA) ha ottenuto l'approvazione per l'inserimento nel Catalogo Elettronico (ECAT) dall'Agenzia Logistica della Difesa degli Stati Uniti per il suo prodotto Symvess. Questa approvazione consente ai professionisti sanitari delle strutture del Dipartimento della Difesa (DOD) e degli Affari dei Veterani di accedere a Symvess per trattare militari, veterani e altri pazienti.
Symvess, un vaso ingegnerizzato a base di tessuto acellulare, ha ricevuto l'approvazione FDA a dicembre 2024 per l'indicazione di trauma vascolare agli arti. L'integrazione nel sistema ECAT rappresenta un traguardo importante per rendere il prodotto accessibile ai fornitori di assistenza sanitaria militare. Tuttavia, per usi oltre l'indicazione approvata dalla FDA, Symvess rimane sperimentale e necessita di ulteriori approvazioni regolatorie.
Humacyte (Nasdaq: HUMA) ha recibido la aprobación para su inclusión en el Catálogo Electrónico (ECAT) por parte de la Agencia de Logística de Defensa de EE.UU. para su producto Symvess. Esta aprobación permite a los profesionales de la salud en las instalaciones del Departamento de Defensa (DOD) y de Asuntos de Veteranos acceder a Symvess para tratar a miembros del servicio militar, veteranos y otros pacientes.
Symvess, un vaso tejido acellular, obtuvo la aprobación de la FDA en diciembre de 2024 para la indicación de trauma vascular en extremidades. La integración al sistema ECAT representa un hito importante para facilitar el acceso del producto a los proveedores de atención médica militar. Sin embargo, para usos fuera de la indicación aprobada por la FDA, Symvess sigue siendo experimental y requiere aprobaciones regulatorias adicionales.
Humacyte (나스닥: HUMA)가 미국 국방물류청(Defense Logistics Agency)으로부터 전자 카탈로그(ECAT) 등재 승인을 Symvess 제품에 대해 받았습니다. 이 승인으로 국방부(DOD) 및 재향군인청 시설의 의료진이 군 복무자, 재향군인 및 기타 환자를 치료하기 위해 Symvess를 이용할 수 있게 되었습니다.
Symvess는 세포가 제거된 조직 공학 혈관으로, 2024년 12월에 FDA 승인을 받았으며 말초 혈관 외상 치료 적응증을 획득했습니다. ECAT 시스템 통합은 군 의료 제공자들이 제품에 접근할 수 있도록 하는 중요한 이정표입니다. 그러나 FDA 승인 적응증 외의 용도에 대해서는 Symvess가 아직 연구 단계에 있으며 추가 규제 승인이 필요합니다.
Humacyte (Nasdaq : HUMA) a obtenu l'approbation pour l'inscription au catalogue électronique (ECAT) de l'Agence logistique de la Défense américaine pour son produit Symvess. Cette approbation permet aux professionnels de santé des établissements du Département de la Défense (DOD) et des Anciens Combattants d'accéder à Symvess pour traiter les militaires, les vétérans et d'autres patients.
Symvess, un vaisseau tissulaire acellulaire conçu par ingénierie, a reçu l'approbation de la FDA en décembre 2024 pour l'indication de traumatisme vasculaire des extrémités. L'intégration au système ECAT représente une étape importante pour rendre ce produit accessible aux prestataires de soins militaires. Cependant, pour des usages au-delà de l'indication approuvée par la FDA, Symvess reste expérimental et nécessite des autorisations réglementaires supplémentaires.
Humacyte (Nasdaq: HUMA) hat von der US-Verteidigungslogistikagentur die Zulassung für die Aufnahme in den Elektronischen Katalog (ECAT) für sein Produkt Symvess erhalten. Diese Zulassung ermöglicht es medizinischem Fachpersonal in Einrichtungen des Verteidigungsministeriums (DOD) und der Veteranenverwaltung, Symvess zur Behandlung von Militärangehörigen, Veteranen und anderen Patienten zu verwenden.
Symvess, ein zellfreies, gewebetechnisch hergestelltes Gefäß, erhielt im Dezember 2024 die FDA-Zulassung für die Indikation bei peripherem Gefäßtrauma. Die Integration in das ECAT-System stellt einen wichtigen Meilenstein dar, um das Produkt militärischen Gesundheitsdienstleistern zugänglich zu machen. Für Anwendungen über die FDA-zugelassene Indikation hinaus bleibt Symvess jedoch experimentell und benötigt weitere behördliche Genehmigungen.
- Secured ECAT listing approval, expanding access to DOD and VA facilities
- Previously obtained FDA approval for extremity vascular trauma indication
- Positive feedback reported from DOD hospitals
- Product remains investigational for uses beyond extremity vascular trauma indication
Electronic Catalog listing approval makes Symvess available to healthcare professionals at U.S. Department of Defense and U.S. Department of Veterans Affairs facilities
DURHAM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced today that Symvess has been awarded Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency. ECAT is an internet system that provides the Department of Defense (DOD) and other federal agencies with access to manufacturers’ and distributors’ products. The approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at DOD and U.S. Department of Veterans Affairs facilities.
Symvess (acellular tissue engineered vessel-tyod) was approved in the extremity vascular trauma indication by the Food and Drug Administration (FDA) in December 2024.
“We are pleased that Symvess is now listed in the ECAT system, making the product more readily available to healthcare professionals treating military personnel and their families,” said Dr. Laura Niklason, President and CEO of Humacyte, Inc. “We have received positive feedback in our interactions with a number of DOD hospitals, and we look forward to making Symvess available to more patients in need.”
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for use or sale by the FDA or any other regulatory agency.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing an innovative biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues designed to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,�� “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize our ATEV in the United States under the brand name Symvess in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and the Form 10-Q for the quarter ended March 31, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
FAQ
What is the significance of Humacyte's ECAT approval for Symvess (HUMA)?
When did Humacyte's Symvess receive FDA approval and for what indication?
What is Symvess and what is it used for?
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