Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access

- Dr. Robert J. Kossmann has served as a prominent advocate for kidney disease patients in multiple roles including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America -

- Dr. Prabir Roy-Chaudhury is the Immediate Past President of the American Society of Nephrology, serves as the Drs Ronald and Katherine Falk Eminent Professor at UNC, and is the Co-Director of the UNC Kidney Center -

DURHAM, N.C., July 14, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Robert J. (Rob) Kossmann, MD, FACP, FASN and Prabir Roy-Chaudhury, MD, PhD, FASN, have joined the Company as advisors to prepare for Humacyte’s planned commercialization of the acellular tissue engineered vessel (ATEV) in hemodialysis access. In their roles, these leading nephrologists will contribute to the development of health economic, reimbursement and market access strategies as well as provide peer-to-peer scientific support and medical education. These appointments follow the release last month of positive results from the V012 Phase 3 dialysis access study in women and Humacyte’s announcement of plans to file a supplemental Biologic License Application with the Food and Drug Administration.

Dr. Kossmann is a leading nephrologist and healthcare executive who served in senior medical leadership roles at Fresenius Medical Care from 2014 - 2026, including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America. Prior to joining Fresenius, he practiced clinical nephrology for more than two decades and developed extensive expertise in chronic kidney disease, dialysis, and multi-organ disease management. Dr. Kossmann earned his Doctor of Medicine degree from Case Western Reserve University and completed his nephrology training at the University of Washington. Throughout his career, he has been a prominent advocate for kidney disease patients and the nephrology profession, serving as President of the Renal Physicians Association, participated in founding the organization's Nephrology Coverage Advocacy Program, advising the American Medical Association on nephrology reimbursement issues, and helping establish the New Mexico Renal Disease Collaborative Group.

Dr. Roy-Chaudhury is an internationally recognized nephrologist, researcher, and academic leader who serves as the Drs. Ronald and Katherine Falk Eminent Professor of Nephrology and Co-Director of the UNC Kidney Center at the University of North Carolina at Chapel Hill, as well as a staff nephrologist at the Salisbury VA Medical Center. A graduate of the Armed Forces Medical College in Pune, India, he completed training in internal medicine and nephrology at the University of Aberdeen in Scotland and Beth Israel Hospital at Harvard Medical School. His research focuses on uremic vascular biology, dialysis vascular access, and cardiovascular complications in kidney disease, and he has received extensive NIH, VA, and industry funding. Dr. Roy-Chaudhury has published more than 250 scientific manuscripts and book chapters, delivered hundreds of lectures worldwide, and held numerous leadership positions within the nephrology community, including as President of the American Society of Nephrology (ASN) for 2025. He was also the founding ASN co-chair of the Kidney Health Initiative, a public-private partnership between the ASN and the U.S. Food and Drug Administration aimed at accelerating innovation in kidney disease treatments and technologies.

“I have seen firsthand the negative outcomes, especially catheter infections, experienced by patients who suffer non-working or suboptimal dialysis access. This is particularly problematic for women and other patients having higher risk of AV fistula failure. With the positive V007 and V012 study results in hand, I am excited to work with Humacyte to bring the ATEV to hemodialysis patients so that we can get the right access to the right patient at the right time and in the right way,” said Dr. Roy-Chaudhury.

“Working with patients, both as a treating physician and then as a service provider, has highlighted the clear need for an improved dialysis access methodology. There have been no truly novel dialysis access conduits introduced during my career, and I look forward to assisting Humacyte in meeting the needs of patients while reducing the cost of overall care,” said Dr. Kossmann.

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

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.

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 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

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