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Humacyte to Present Efficacy and Safety Results from V007 Phase 3 AV Access Clinical Trial at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH)

Key Takeaway: Humacyte, Inc. is set to present Phase 3 results from its clinical study on the efficacy and safety of its acellular tissue engineered vessel (ATEV) in comparison to traditional AV fistulas for patients suffering from end stage renal disease. The presentation will take place on November 23, 2024, at the 51st Annual Symposium on Vascular and Endovascular Issues in New York. The ATEV, which is still under investigation and has not received FDA approval, aims to improve treatment options for vascular access in hemodialysis patients.

Market Sentiment Analysis

POSITIVE FACTORS

  • Presentation of Phase 3 results indicating potential advancement in AV access treatment.
  • Innovative platform for bioengineered human tissues aiming to transform medicine.
  • Support from notable medical professionals like Dr. Charles Keith Ozaki enhances credibility.

Full Press Release Details

DURHAM, N.C., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it will present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in patients with end stage renal disease at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024.
Details of the presentation are as follows:
Presentation Title: Results of a Phase 3 Study Comparing Efficacy and Safety of Humacyte Tissue-Engineered Vessel with Autologous AV Fistulas in Patients with End Stage Renal Disease
Presenter: Dr. Charles Keith Ozaki, MD, Vascular Surgeon and Director of Vascular Surgery Research at Brigham and Women’s Hospital; John A. Mannick Professor of Surgery at Harvard Medical School
Session Title: Novel Technologies in Hemodialysis Access
Session Date/Time: Saturday, November 23, 2024, 2:15 – 2:22 PM ET
For more information on the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH), please click here.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive 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 to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. 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 an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. The ATEV is an investigational product and has not been approved for sale by the Food and Drug Administration or any international regulatory agency.
Humacyte Investor Contact:
LifeSci Advisors LLC
Humacyte Media Contact:
Precision Strategies

Frequently Asked Questions

What is the focus of Humacyte's Phase 3 study?

The study compares the efficacy and safety of Humacyte's acellular tissue engineered vessel with autologous AV fistulas in patients with end stage renal disease.

Who is presenting at the VEITH Symposium?

Dr. Charles Keith Ozaki, a vascular surgeon and professor at Harvard Medical School, will present.

When will the VEITH presentation take place?

The presentation is scheduled for November 23, 2024, from 2:15 to 2:22 PM ET.

What does ATEV stand for?

ATEV stands for acellular tissue engineered vessel, which is Humacyte's investigational product.

Has the ATEV received FDA approval?

No, the ATEV is an investigational product and has not yet been approved by the FDA.

Last updated: Nov 22, 2024