DURHAM, N.C., Oct. 23, 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 host a virtual KOL event on Thursday, October 31, 2024 at 8:00 AM ET. To register, click here.

The event will feature Charles Keith Ozaki, MD (Brigham and Women’s Hospital), Mohamad Anas Hussain, MD, PhD (Brigham and Women’s Hospital), and Timmy Lee, MD, MSPH (University of Alabama at Birmingham), who will discuss the current treatment landscape and unmet need for improved arteriovenous (AV) access in hemodialysis patients.

During the event, the surgeons will share case studies and highlight the V007 Phase 3 clinical results for Humacyte’s acellular tissue engineered vessel (ATEV) product candidate versus arteriovenous fistula (AVF), for hemodialysis access in patients with end-stage kidney disease. The ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair and dialysis access.

The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

About Charles Keith Ozaki, MD

Charles Keith Ozaki, MD is a Vascular Surgeon and the Director of Vascular Surgery Research at Brigham and Women’s Hospital (BWH). In addition, he is the John A. Mannick Distinguished Chair in Surgery at BWH. Dr. Ozaki earned his medical degree from Duke University School of Medicine. He completed a general surgery residency through the Deaconess/Harvard Surgical Service (now Beth Israel Deaconess Medical Center) and later completed a fellowship in vascular surgery at the University of Michigan Health System. He is board certified in general surgery and vascular surgery. He currently leads the Ozaki Basic Vascular Biology Lab within the Division of Vascular and Endovascular Surgery at BWH, which aims to delineate how physical forces alter the morphology of the blood vessel wall. Recent investigations have focused on inflammatory and adipose-driven mechanisms. His clinical interests include arterial aneurysm, cerebrovascular disease and wound healing. He has authored over 90 peer-reviewed publications. In addition to his clinical and laboratory responsibilities, Dr. Ozaki is the director of resident research. In this role, he prepares surgical trainees for their two to three years of academic enrichment time embedded in their surgical residency.

About Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS

Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS is a 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 in Boston. He is board certified in vascular surgery by both the American Board of Surgery and the Royal College of Physicians and Surgeons of Canada. He obtained his medical degree from the Michael G. DeGroote School of Medicine at McMaster University. He completed a vascular surgery residency and a PhD in clinical epidemiology and health services research through the Surgeon Scientist Training Program at the University of Toronto. He also completed a cardiovascular research fellowship at the Brigham. Dr. Hussain’s clinical practice is focused on general vascular and endovascular surgery, with special interests in complex hemodialysis access surgery, aortic dissection and aneurysm surgery, and thoracic outlet syndrome surgery. His research lab VESEL (Vascular & Endovascular Surgery Epidemiology Lab) conducts observational and clinical research to improve the care of patients with vascular diseases with special interests in population-based health services research, prediction with machine learning, enhancing causal inference research using target trial emulation, and clinical trials. Dr. Hussain also serves at the Director of Resident Education and Research in Vascular Surgery and Associate Clerkship Director in the Department of Surgery at the Brigham.

About Timmy Lee, MD, MSPH

Timmy Lee, MD, MSPH is a Professor of Medicine in the Department of Medicine and Division of Nephrology with a secondary appointment in the Department of Biomedical Engineering at the University of Alabama at Birmingham. Dr. Lee received his medical degree at the Louisiana State University Health Sciences Center in Shreveport and completed his Internal Medicine residency and Nephrology fellowship at the University of Alabama at Birmingham, Nephrology research fellowship at the University of Alabama at Birmingham, and Master of Science in Public Health at the University of Alabama at Birmingham. Dr. Lee is the Vice Chair for Research in the Department of Medicine at the University of Alabama at Birmingham and Section Chief of Nephrology at the Birmingham Veterans Affairs Medical Center. He also serves as the Associate Director of Interventional Nephrology, Associate Nephrology Fellowship Director, Associate Director of the Nephrology Research Training Center in the Division of Nephrology at the University of Alabama at Birmingham, and Director of the Hemodialysis Program at the Birmingham Veterans Affairs Medical Center. Dr. Lee has been involved in hemodialysis vascular access research since 2002 and has over 80 publications in vascular access research. He has active research programs in clinical trials and large epidemiologic studies in dialysis vascular access and a laboratory-based translational research program in dialysis vascular access studying human vascular access blood vessel tissue biorepositories and mechanisms of arteriovenous fistula dysfunction using animal models (mouse, rat, and pig). The goal of his research program is to develop novel therapeutics to prevent and treat complications of hemodialysis vascular access dysfunction and improve the delivery and processes of care for patients requiring a hemodialysis vascular access. Dr. Lee’s research program is currently funded by the National Institutes of Health, Veterans Affairs Medical Center, and foundation grants.

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. Humacyte 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. For more information, visit www.Humacyte.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in subsequent SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
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Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
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