HUMA HUMACYTE INC

Humacyte Appoints Jim Mercadante as Chief Commercial Officer

Humacyte Appoints Jim Mercadante as Chief Commercial Officer

– Industry veteran with more than 25 years of experience will lead next phase of biotech company’s commercial expansion –

– Seasoned medtech commercial leader brings extensive field-specific success in vascular and cardiothoracic surgery markets –

– Appointment strengthens commercial leadership as Symvess® (acellular tissue engineered vessel-tyod) market launch accelerates and pipeline advances toward planned BLA filing in dialysis –

DURHAM, N.C., April 22, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the appointment of Jim Mercadante as Chief Commercial Officer. Mercadante, a veteran commercial executive with more than 25 years of experience in the healthcare and medical technology industries, will oversee all aspects of the Company's commercial strategy, including sales, marketing, and market access, as Humacyte continues to expand the U.S. launch of Symvess and prepares for potential future commercial indications. Mr. Mercadante is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. Over his career, he and his teams have launched over 50 new products and delivered millions of dollars in growth for multiple companies.

“Humacyte stands at the forefront of regenerative medicine, and I am honored to join the Company at such an exciting time,” said Mercadante. “Symvess represents a true breakthrough – the first FDA-approved, universally implantable bioengineered tissue – and the potential of the broader ATEV platform across dialysis access, coronary artery bypass grafting, and beyond is remarkable. I look forward to working with the innovative men and women at Humacyte to accelerate commercial growth and ensure that as many patients as possible can benefit from their products.”

Mercadante has held senior leadership positions at prominent healthcare companies, including Abbott, Johnson & Johnson, GE, Terumo, and Rapid AI, overseeing and building deep expertise in sales marketing, commercial operations, strategic partnerships and national accounts which delivered rapid and significant sales growth across both U.S. and international markets. He most recently served as Chief Commercial Officer of Qure.ai, a global provider of AI-powered healthcare solutions, where he led global sales and business development strategy.

“We are thrilled to welcome Jim Mercadante to Humacyte,” added Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Jim brings an exceptional combination of deep commercial acumen and a record of proven results across complex healthcare markets. His track record building high-performance teams, executing successful product launches and forging strategic partnerships will accelerate Humacyte’s mission to expand patient access to regenerative vascular solutions. As we continue to expand the market adoption of Symvess in the vascular trauma indication, pursue international expansion, and advance our pipeline toward potential additional approved indications, Jim's leadership will be instrumental in maximizing the impact of our bioengineered tissue platform and bringing these transformative products to patients and surgeons who need them.”

Symvess is the Company's first FDA-approved product, indicated for the treatment of extremity vascular trauma. Since its commercial launch, Humacyte has continued to expand access to Symvess through hospital Value Analysis Committee (VAC) approvals, inclusion in the U.S. Defense Logistics Agency's Electronic Catalog (ECAT), and international regulatory expansion, including a Marketing Authorization Application filing in Israel.

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 .

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, 2025, 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



Humacyte Media Contact:

Rich Luchette

Precision Strategies







EN
22/04/2026

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