Humacyte to Host In-Person and Virtual Investor Event in New York to Discuss Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma on March 6, 2025

DURHAM, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced it will host an in-person and virtual investor event in New York on Thursday, March 6, 2025 at 12:00 PM ET. To register as an in-person or virtual attendee, please click here.

The event will feature vascular surgery key opinion leaders (KOLs) Michael Curi, MD, MPA (Rutgers New Jersey Medical School) and Sammy Siada, DO, FACS, RPVI (UCSF Fresno), who will join company management to discuss the commercial plans and early market-launch success of Symvess (acellular tissue engineered vessel-tyod) for extremity arterial injury.

Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair. The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess in December 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. Please see full Prescribing Information, including Boxed Warning, for SYMVESS at www.symvess.com.

A live question and answer session will follow the formal presentations. A replay of the webcast will be available for a limited time on the Events & Presentations page within the Investors portion of the Humacyte website.

About Michael Curi, MD, MPA

Michael Curi, MD, MPA is Associate Professor of Surgery and Chief of Division of Vascular Surgery at Rutgers New Jersey Medical School. Dr. Curi is a proud graduate of New Jersey Medical School and received his undergraduate degree from Lafayette College. Prior to medical school he obtained a Master's Degree in Public Administration studying Health Policy & Management from New York University. He completed his surgical residency at University of Chicago where he spent an additional 2 years performing cutting-edge research into the treatment of vascular disease utilizing gene therapy and novel biological agents. He then completed an advanced fellowship in Vascular & Endovascular Surgery at Washington University in St. Louis, where he trained under Dr. Juan Parodi, inventor of the aortic stent graft. He has published many articles in leading vascular journals, authored chapters in surgical textbooks on aortic aneurysms, and has been nationally recognized for his work in vascular research. He is a member of the American College of Surgeons, Society of Vascular Surgery, Peripheral Vascular Surgical Society, and The Eastern Vascular Society and is an investigator on the V005 trial.

About Sammy Siada, DO, FACS, RPVI

Sammy Siada, DO, FACS, RPVI, specializes in vascular and endovascular surgery and is an Assistant Clinical Professor in the Department of Surgery at UCSF Fresno. Dr. Siada attended the University of Texas at Arlington where he earned his Bachelor of Science degree in biology. Upon completing his undergraduate education, Dr. Siada continued his medical education at the University of North Texas Health Science Center to complete his Doctor of Osteopathic Medicine in Fort Worth, TX. After medical school, he joined UCSF Fresno for his residency training in general surgery. Dr. Siada subsequently completed a two-year fellowship in vascular surgery at the University of Colorado School of Medicine. He is board certified in surgery and board eligible in vascular surgery. In addition to providing expert care to vascular surgery patients, Dr. Siada is very involved in the medical community. He is a member of the following organizations: American College of Surgeons, Society for Vascular Surgery, Society for Clinical Vascular Surgery, and the Vascular and Endovascular Surgery Society. Furthermore, Dr. Siada has also authored several research articles in the general and vascular surgery arenas.

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 acellular tissue engineered vessels (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 was approved by the FDA in December 2024. 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.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

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, our plans and ability to commercialize our ATEV in the United States under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV 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, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, each filed by Humacyte with the SEC, and in future 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

[email protected]

[email protected]

Humacyte Media Contact:

Rich Luchette

Precision Strategies

+1-202-845-3924

[email protected]

[email protected]