Humacyte announced that results from its V007 Pivotal Phase 3 clinical trial for its ATEV (acellular tissue engineered vessel) in arteriovenous access for high-risk dialysis patients will be presented at the Society for Vascular Surgery Vascular Annual Meeting (VAM25). The presentation, titled 'Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis,' suggests positive trial outcomes for HUMA's bioengineered vessel technology. Dr. Mohamad A. Hussain from Brigham and Women's Hospital and Harvard Medical School will present the findings on June 6, 2025, at 10:50 a.m. CT in New Orleans during Plenary Session 6.
Humacyte ha annunciato che i risultati del suo studio clinico pivotale di Fase 3 V007 sull'ATEV (vasi ingegnerizzati tissutali acellulari) per l'accesso artero-venoso in pazienti dializzati ad alto rischio saranno presentati al Society for Vascular Surgery Vascular Annual Meeting (VAM25). La presentazione, intitolata 'Il vaso ingegnerizzato tissutale acellulare supera la fistola artero-venosa nei pazienti ad alto rischio in emodialisi', suggerisce esiti positivi per la tecnologia dei vasi bioingegnerizzati di HUMA. Il dott. Mohamad A. Hussain del Brigham and Women's Hospital e della Harvard Medical School presenter脿 i risultati il 6 giugno 2025 alle 10:50 CT a New Orleans durante la Sessione Plenaria 6.
Humacyte anunci贸 que los resultados de su ensayo cl铆nico pivotal de fase 3 V007 para su ATEV (vaso de tejido acellularmente dise帽ado) en el acceso arteriovenoso para pacientes de di谩lisis de alto riesgo se presentar谩n en la Reuni贸n Anual Vascular de la Sociedad de Cirug铆a Vascular (VAM25). La presentaci贸n, titulada 'El vaso de tejido acellularmente dise帽ado supera a la f铆stula arteriovenosa en pacientes de alto riesgo en hemodi谩lisis', sugiere resultados positivos para la tecnolog铆a de vasos bioingenierizados de HUMA. El Dr. Mohamad A. Hussain del Brigham and Women's Hospital y la Harvard Medical School presentar谩 los hallazgos el 6 de junio de 2025 a las 10:50 a.m. CT en Nueva Orleans durante la Sesi贸n Plenaria 6.
Humacyte a annonc茅 que les r茅sultats de son essai clinique pivot de phase 3 V007 concernant son ATEV (vaisseau tissulaire acellulaire ing茅nier茅) pour l'acc猫s art茅rioveineux chez les patients dialys茅s 脿 haut risque seront pr茅sent茅s lors de la r茅union annuelle de la Society for Vascular Surgery (VAM25). La pr茅sentation, intitul茅e 芦 Le vaisseau tissulaire acellulaire ing茅nier茅 surpasse la fistule art茅rioveineuse chez les patients 脿 haut risque en h茅modialyse 禄, sugg猫re des r茅sultats positifs pour la technologie des vaisseaux bioing茅nier茅s de HUMA. Le Dr Mohamad A. Hussain du Brigham and Women's Hospital et de la Harvard Medical School pr茅sentera les conclusions le 6 juin 2025 脿 10h50 CT 脿 La Nouvelle-Orl茅ans lors de la session pl茅ni猫re 6.
Humacyte gab bekannt, dass die Ergebnisse seiner V007 entscheidenden Phase-3-Studie f眉r sein ATEV (zellfreies, gewebetechnisch hergestelltes Gef盲脽) f眉r arterioven枚sen Zugang bei Hochrisiko-Dialysepatienten auf dem Jahrestreffen der Society for Vascular Surgery (VAM25) pr盲sentiert werden. Die Pr盲sentation mit dem Titel 鈥濧cellular Tissue Engineered Vessel 眉bertrifft arterioven枚se Fistel bei Hochrisikopatienten in der H盲modialyse鈥� deutet auf positive Studienergebnisse f眉r HUMAs bioingenieurtechnische Gef盲脽technologie hin. Dr. Mohamad A. Hussain vom Brigham and Women's Hospital und der Harvard Medical School wird die Ergebnisse am 6. Juni 2025 um 10:50 Uhr CT in New Orleans w盲hrend der Plenarsitzung 6 vorstellen.
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AV Access Study to be Presented at the Vascular Annual Meeting (VAM25)
DURHAM, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV鈩�) in arteriovenous access for high-risk patients with end-stage renal disease was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM25). The abstract titled 鈥淎cellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial鈥� will be presented at the VAM25 meeting in New Orleans this Friday, June 6, 2025.
Details of the presentation are as follows:
Presentation Title: 鈥淎cellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial鈥�
Presenter: Dr. Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women鈥檚 Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School
Session Title: Plenary Session 6
Session Date/Time: Friday, June 6, 2025, 10:50 a.m. CT
For more information on the Society for Vascular Surgery Vascular Annual Meeting (VAM25), please click .
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鈥檚 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鈥檚 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA鈥檚 Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte鈥檚 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 .
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 sale by the FDA or any other regulatory agency.
Humacyte Media Contact: Rich Luchette Precision Strategies +1-202-845-3924
FAQ
What are the Phase 3 trial results for Humacyte's (HUMA) ATEV in dialysis patients?
The specific trial results will be presented at VAM25 on June 6, 2025. The presentation title suggests the ATEV outperformed arteriovenous fistula in high-risk hemodialysis patients.
Who will present Humacyte's clinical trial results at VAM25?
Dr. Mohamad A. Hussain, a Vascular and Endovascular Surgeon-Scientist at Brigham and Women's Hospital and Assistant Professor at Harvard Medical School, will present the results.
When and where will Humacyte (HUMA) present its V007 Phase 3 trial results?
The results will be presented on Friday, June 6, 2025, at 10:50 a.m. CT during Plenary Session 6 at the Society for Vascular Surgery Vascular Annual Meeting in New Orleans.
What is Humacyte's ATEV technology used for?
ATEV (acellular tissue engineered vessel) is designed for arteriovenous access in high-risk patients with end-stage renal disease who require hemodialysis.
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