Humacyte Appoints Two Leading Nephrologists To Support Commercial Launch Of ATEV For Hemodialysis Access

Humacyte, Inc., a commercial-stage biotechnology company developing bioengineered human tissues for clinical use, has announced the appointment of two internationally recognized nephrology experts, Dr. Robert J. (Rob) Kossmann and Dr. Prabir Roy-Chaudhury, as advisors. Their appointments are part of the company's preparations for the planned commercialization of its acellular tissue engineered vessel (ATEV) for use in hemodialysis access.

In their advisory roles, Dr. Kossmann and Dr. Roy-Chaudhury will help Humacyte develop strategies related to health economics, reimbursement, and market access. They will also support scientific discussions with healthcare professionals and contribute to medical education initiatives as the company advances its commercialization plans. Their appointments come shortly after Humacyte reported positive results from the Phase 3 V012 clinical trial evaluating ATEV in women requiring dialysis access and announced its intention to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).

Dr. Robert J. Kossmann brings decades of clinical and leadership experience in nephrology. Between 2014 and 2026, he held several senior leadership positions at Fresenius Medical Care, including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America. Before joining Fresenius, he spent more than 20 years practicing clinical nephrology, building extensive expertise in chronic kidney disease, dialysis treatment, and the management of complex multi-organ disorders. He earned his medical degree from Case Western Reserve University and completed his nephrology fellowship at the University of Washington.

Throughout his career, Dr. Kossmann has played an active role in advancing kidney care and supporting the nephrology community. He previously served as President of the Renal Physicians Association, helped establish the organization's Nephrology Coverage Advocacy Program, advised the American Medical Association on nephrology reimbursement policies, and contributed to the formation of the New Mexico Renal Disease Collaborative Group.

Dr. Prabir Roy-Chaudhury is widely recognized as one of the leading experts in nephrology research and academic medicine. He currently 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. In addition, he is a staff nephrologist at the Salisbury VA Medical Center.

Dr. Roy-Chaudhury graduated from the Armed Forces Medical College in Pune, India, and completed his 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 vascular biology in kidney disease, dialysis vascular access, and cardiovascular complications associated with chronic kidney disease. His work has received significant funding from the National Institutes of Health (NIH), the U.S. Department of Veterans Affairs (VA), and industry partners.

Over the course of his career, Dr. Roy-Chaudhury has authored more than 250 scientific publications and book chapters, delivered hundreds of lectures around the world, and held several leadership positions within the nephrology community. He served as President of the American Society of Nephrology (ASN) in 2025 and 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 the development of innovative treatments and technologies for kidney disease.

Commenting on his appointment, Dr. Roy-Chaudhury said he has witnessed the serious complications experienced by patients whose dialysis access fails or functions poorly, particularly catheter-related infections. He noted that these challenges are especially significant for women and other patients who face a higher risk of arteriovenous (AV) fistula failure. Based on the positive results from the V007 and V012 clinical studies, he said he is looking forward to working with Humacyte to make ATEV available for hemodialysis patients, helping ensure that patients receive the most appropriate dialysis access at the right time.

Dr. Kossmann also emphasized the need for innovation in dialysis access. Drawing on his experience as both a practicing physician and a healthcare executive, he said there has been a long-standing need for improved dialysis access options, as no truly novel dialysis access conduit has been introduced during his career. He added that he looks forward to supporting Humacyte's efforts to improve patient care while also helping reduce the overall cost of treatment.

Humacyte noted that, apart from its FDA-approved indication for treating extremity vascular trauma, the acellular tissue engineered vessel (ATEV) remains an investigational product for other uses, including hemodialysis access. It has not yet been approved by the FDA or any other regulatory authority for these additional indications.