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

1. HUMAcate's ATEV study accepted at Vascular Annual Meeting. 2. Study shows ATEV outperforms AV fistula in high-risk hemodialysis patients. 3. Presentation scheduled for June 6, 2025, by Dr. Mohamad A. Hussain. 4. FDA approved ATEV for vascular trauma, enhancing market positioning. 5. ATEV targets broader applications including diabetic treatment and heart surgery.

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Why Bullish?

Recent FDA approval and positive trial results may boost investor confidence, similar to past biotechnology successes like Gilead's HIV treatments after regulatory approvals.

How important is it?

The announcement and related study can significantly impact HUMA’s value through increased visibility and upcoming potential revenue from ATEV’s market adoption.

Why Long Term?

The data presented may influence adoption rates in clinical practice, significantly impacting revenue projections long-term, as seen with other FDA-approved devices like Medtronic's heart pumps.

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AV Access Study to be Presented at the Vascular Annual Meeting (VAM25) June 02, 2025 08:00 ET  | Source: Humacyte, Inc 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 AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

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