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Humacyte to Host Virtual KOL Event on the Use of Acellular Tissue Engineered Vessel (ATEV™) for AV Access in Hemodialysis on October 31, 2024

HUMA 10.23.2024

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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 onThursday, October 31, 2024at8:00 AM ET. To register,click here.

The event will featureCharles Keith Ozaki, MD (Brighamand Women’s Hospital),Mohamad Anas Hussain, MD, PhD (Brighamand Women’s Hospital), andTimmy 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.

AboutCharles Keith Ozaki, MD

Charles Keith Ozaki, MD is a Vascular Surgeon and the Director ofVascular Surgery ResearchatBrighamand Women’s Hospital (BWH). In addition, he is the John A. Mannick Distinguished Chair in Surgery at BWH.Dr. Ozakiearned his medical degree fromDuke University School of Medicine. He completed a general surgery residency through the Deaconess/Harvard Surgical Service (nowBeth Israel Deaconess Medical Center) and later completed a fellowship in vascular surgery at theUniversity of Michigan Health System. He is board certified in general surgery and vascular surgery. He currently leads theOzaki Basic Vascular Biology Labwithin theDivision of Vascular and Endovascular Surgeryat 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. Ozakiis 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.

AboutMohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS

Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS is a Vascular and Endovascular Surgeon-Scientist atBrighamand Women’s Hospital, Core Faculty at theCenter for Surgery and Public Health, and Assistant Professor of Surgery atHarvard Medical SchoolinBoston. He is board certified in vascular surgery by both the AmericanBoard of Surgeryand theRoyal College of Physicians and Surgeons of Canada. He obtained his medical degree from theMichael G. DeGroote School of MedicineatMcMaster University. He completed a vascular surgery residency and a PhD in clinical epidemiology and health services research through the Surgeon Scientist Training Program at theUniversity of Toronto. He also completed a cardiovascular research fellowship at theBrigham. 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. Hussainalso serves at the Director of Resident Education and Research in Vascular Surgery and Associate Clerkship Director in theDepartment of Surgeryat theBrigham.

AboutTimmy Lee, MD, MSPH

Timmy Lee, MD, MSPH is a Professor of Medicine in theDepartment of MedicineandDivision of Nephrologywith a secondary appointment in theDepartment of Biomedical Engineeringat theUniversity of Alabama at Birmingham.Dr. Leereceived his medical degree at theLouisiana State University Health Sciences Centerin Shreveport and completed his Internal Medicine residency and Nephrology fellowship at theUniversity of Alabama at Birmingham, Nephrology research fellowship at theUniversity of Alabama at Birmingham, and Master of Science in Public Health at theUniversity of Alabama at Birmingham.Dr. Leeis the Vice Chair for Research in theDepartment of Medicineat theUniversity of Alabama at BirminghamandSectionChief of Nephrology at theBirmingham Veterans Affairs Medical Center. He also serves as the Associate Director of Interventional Nephrology, Associate Nephrology Fellowship Director, Associate Director of theNephrology Research Training Centerin theDivision of Nephrologyat theUniversity of Alabama at Birmingham, and Director of the Hemodialysis Program at theBirmingham Veterans Affairs Medical Center.Dr. Leehas 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 theNational Institutes of Health,Veterans Affairs Medical Center, and foundation grants.

AboutHumacyte

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.Humacytedevelops 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 theU.S.Secretary of Defense. For more information, visitwww.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 thatHumacytemay 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 endedDecember 31, 2023, filed byHumacytewith theSEC, and in subsequentSECfilings. 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 AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.com investors@humacyte.com

Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.com media@humacyte.com

Source: Humacyte, Inc

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Humacyte to Host Virtual KOL Event on the Use of Acellular Tissue Engineered Vessel (ATEV™) for AV Access in Hemodialysis on October 31, 2024

HUMA 10.23.2024

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