Humacyte Announces Presentation of Preclinical Data on the HAV™ in Coronary Artery Bypass Grafting at the Basic Cardiovascular Sciences Scientific Sessions

Rhea-AI Summary

Humacyte, Inc. (Nasdaq: HUMA) announced the upcoming presentation of six-month outcomes from a preclinical study of its Human Acellular Vessel™ (HAV™) in coronary artery bypass grafting at the Basic Cardiovascular Sciences (BCVS) Scientific Sessions, scheduled for July 25-28, 2022, in Chicago, IL. The poster entitled 'Tissue-engineered Human Acellular Blood Vessels for Coronary Artery Bypass Grafting' will be presented by Dr. Adam Williams. Humacyte's HAVs are designed for vascular repair and have been used in nearly 500 patient implantations, highlighting their growing clinical significance.

Positive

• Presentation of six-month outcomes from HAV preclinical study at BCVS Scientific Sessions.
• HAVs intended for vascular repair are in two Phase 3 trials and one Phase 2/3 trial.
• HAV was the first product to receive RMAT designation from FDA.

Negative

• None.

DURHAM, N.C., July 19, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced that six-month outcomes from a preclinical study of a small diameter Human Acellular Vessel™ (HAV^TM) in coronary artery bypass grafting will be presented at the Basic Cardiovascular Sciences (BCVS) Scientific Sessions taking place in Chicago, IL July 25-28, 2022.

Details of the poster presentation are as follows:

Title: Tissue-engineered Human Acellular Blood Vessels for Coronary Artery Bypass Grafting
Date and Time: July 25, 4:30-7 p.m. CDT
Presenter: Adam Williams, M.D., cardiothoracic surgeon, Duke University

Sponsored by the American Heart Association’s Basic Cardiovascular Sciences Council, the annual BCVS Scientific Sessions is one of largest meetings in the world dedicated to fundamental and translational research to improve heart health. For more information, visit https://professional.heart.org/en/meetings/basic-cardiovascular-sciences.

About HAV
Human Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement – it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. The HAV is currently being evaluated in two Phase 3 trials in arteriovenous access and a Phase 2/3 trial for vascular trauma, and has been used in nearly 500 patient implantations. Humacyte’s 6mm HAV for AV access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), and has also received FDA Fast Track designation. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue 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 opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. 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 HAV for arteriovenous (AV) access for performing 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. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
media@humacyte.com

 

FAQ

What is the purpose of the HAV study presented by Humacyte?

The HAV study aims to evaluate the effectiveness of Human Acellular Vessels in coronary artery bypass grafting.

When will the HAV study results be presented?

The results will be presented on July 25, 2022, at the BCVS Scientific Sessions in Chicago.

What are the ongoing trials for Human Acellular Vessels?

Humacyte's HAVs are involved in two Phase 3 trials for arteriovenous access and one Phase 2/3 trial for vascular trauma.

What is the significance of RMAT designation for Humacyte's HAV?

The RMAT designation from the FDA signifies that HAVs have potential for expedited development due to their promising clinical evidence.

How many patient implantations have utilized HAV?

Nearly 500 patient implantations of HAV have been conducted, indicating its clinical applicability.