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)
Rhea-AI Summary
Humacyte (Nasdaq: HUMA) announced it will present Phase 3 results comparing the efficacy and safety of its acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in end-stage renal disease patients. The presentation will be delivered by Dr. Charles Keith Ozaki at the 51st Annual VEITH Symposium in New York on November 23, 2024. Dr. Ozaki is the Vascular Surgery Research Director at Brigham and Women's Hospital and John A. Mannick Professor of Surgery at Harvard Medical School. The ATEV remains an investigational product pending FDA approval.
Positive
- Phase 3 clinical trial results ready for presentation
- Study compares company's ATEV with current standard of care (AV fistulas)
- Presentation by prominent medical expert from Harvard Medical School
Negative
- ATEV still pending FDA approval
- No efficacy or safety data disclosed in advance of presentation
News Market Reaction
On the day this news was published, HUMA gained 2.51%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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.
About Humacyte
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:
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
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