Humacyte Clinical Results in High-Risk Dialysis Patients from V007 Pivotal Phase 3

Rhea-AI Summary

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.

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™) 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 “Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial” will be presented at the VAM25 meeting in New Orleans this Friday, June 6, 2025.

Details of the presentation are as follows:

Presentation Title: “Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial”

Presenter: Dr. Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s 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 here.

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.

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 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 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.