Humacyte Innovative Research in Coronary Bypass and Vascular Regeneration to be Highlighted at American Heart Association Scientific Sessions 2026

Humacyte (Nasdaq: HUMA) will feature its regenerative medicine technology in three presentations at the American Heart Association Scientific Sessions 2026.

Rhea-AI Summary

Humacyte (Nasdaq: HUMA) will feature its regenerative medicine technology in three presentations at the American Heart Association Scientific Sessions 2026.

The conference runs November 6–9 at McCormick Place in Chicago. Founder and CEO Laura Niklason will give an invited talk on vascular regeneration on November 7. Two other presentations will cover the first-in-human Phase 2a study design and preclinical results in pig and sheep models for the company’s coronary tissue engineered vessel, intended for coronary artery bypass grafting. Those presentations are scheduled for November 7 and November 8, respectively. The coronary vessel remains investigational and is not approved for sale by the FDA or any other regulatory agency.

Key Terms

phase 2a, coronary artery bypass grafting, biologics license application, regenerative medicine advanced therapy

4 terms

phase 2a medical

"first-in-human Phase 2a study design"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

coronary artery bypass grafting medical

"for coronary artery bypass grafting (CABG)"

Coronary artery bypass grafting is an open-heart surgical procedure that reroutes blood flow around blocked heart arteries by grafting a healthy blood vessel to create a new pathway, like building a detour around a clogged road. It matters to investors because the volume, cost and outcomes of these surgeries influence hospital revenue, medical device and pharmaceutical demand, insurance payouts and long-term healthcare spending, affecting company earnings and sector risk.

biologics license application regulatory

"Humacyte’s Biologics License Application for the acellular tissue engineered vessel"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

regenerative medicine advanced therapy regulatory

"FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation"

Regenerative Medicine Advanced Therapy (RMAT) is a U.S. regulatory designation for cell, gene, and tissue‑based therapies intended to treat serious or life‑threatening conditions; it gives developers a “fast lane” with more frequent agency interaction and eligibility for accelerated review pathways. For investors, an RMAT label signals that a therapy may reach market faster and face less regulatory uncertainty than a standard program, which can raise the potential value and reduce timeline risk—though it is not a guarantee of approval.

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– Founder & CEO Laura Niklason, M.D., Ph.D., to deliver invited talk on engineering the microenvironment to accelerate vascular regeneration.

– Two additional presentations to cover first-in-human Phase 2a study design and preclinical results for Humacyte’s investigational coronary tissue engineered vessel.

DURHAM, N.C., Nov. 03, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at a commercial scale, announced today that the Company’s regenerative medicine technology will be highlighted in three presentations at the American Heart Association (AHA) Scientific Sessions 2026. The conference will be taking place from November 6–9th at McCormick Place Convention Center in Chicago, Illinois.

AHA Scientific Sessions is one of the world’s largest gatherings of cardiovascular clinicians and scientists. Humacyte’s presentations include an invited talk by the company’s Founder, President and Chief Executive Officer, Laura Niklason, M.D., Ph.D., and two presentations highlighting Humacyte’s investigational coronary tissue engineered vessel (CTEV), a small-diameter bioengineered vessel for coronary artery bypass grafting (CABG).

“AHA brings together the cardiac surgeons and cardiologists who will ultimately decide whether an off-the-shelf conduit belongs in bypass surgery, and we are excited for them to see our preclinical data and our study design firsthand,” said Dr. Niklason. “Our approach is built on the idea that the body can repopulate an engineered vessel with a patient’s own cells. With the CTEV, we are taking the next step toward bringing bioengineered vascular technology to coronary bypass surgery through the first U.S. clinical trial of a bioengineered CABG conduit.”

Presentation details:

Invited Talk

• Title: Engineering the Microenvironment to Accelerate Vascular Regeneration
• Presenter: Laura E. Niklason, M.D., Ph.D., Founder and CEO, Humacyte, Inc.
• Date and time: Saturday, November 7, 2026, 10:15 AM CT
• Location: North Hall, Level 3, McCormick Place, Chicago

Clinical Study Design

• Title: First-in-Human Phase 2a Study Design of a Bioengineered Human Coronary Artery for Coronary Artery Bypass Grafting
• Presenters: John Alexander, M.D., M.H.S., Professor of Medicine/Cardiology, Duke Clinical Research Institute at Duke University and Alan Kypson, M.D., Cardiothoracic Surgeon, UNC Rex Hospital
• Date and time: Saturday, November 7, 2026, 3:57 PM CT
• Session/Location: Science and Technology Hall, Level 3, Clinical Science Zone 1, McCormick Place, Chicago

Preclinical CABG Results

• Title: Evaluation of Tissue Engineered Human Vessels in Porcine and Ovine Models of Coronary Artery Bypass Grafting
• Presenter: Robert Kirkton, Ph.D., Executive Director of New Product and Process Development, Humacyte, Inc.
• Date and time: Sunday, November 8, 2026, 9:15 AM CT
• Session/Location: Science and Technology Hall, Level 3, Clinical Science Zone 2, McCormick Place, Chicago

The CTEV 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 Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). 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 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 Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect 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, competitive and/or reputational 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, 2024 and Form 10-Q for the quarter ended March 31, 2025, 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
jallaire@lifesciadvisors.com
investors@humacyte.com

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