Humacyte has announced that Robert J Kossmann (Fresenius Medical Care, Waltham, USA) and Prabir Roy-Chaudhury (University of North Carolina, Chapel Hill, USA) have joined the company as advisors to prepare for the planned commercialisation of the acellular tissue engineered vessel (ATEV) in haemodialysis access.
The 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, the company says in a press release. Humacyte has recently announced of plans to file a supplemental Biologic License Application with the US Food and Drug Administration (FDA).
Humacyte’s ATEV is a bioengineered human tissue derived from cultured human cells that is designed to be a universally implantable vascular conduit for use in vascular replacement and repair.
“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 haemodialysis patients so that we can get the right access to the right patient at the right time and in the right way,” said 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 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.
