MARLBOROUGH, Mass. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Humacyte, Inc. and Xcellerex, Inc. have entered into an initial strategic collaboration for Xcellerex to develop a novel manufacturing process that will enable the production of Humacyte’s lead regenerative medicine product using Xcellerex’s XDR single use bioreactor system in its FlexFactory®. Humacyte’s product is a large diameter vascular graft that is based on its innovative and proprietary platform technology for engineering human, extracellular matrix-based tissues that have properties that are similar to native tissues. Humacyte’s vascular grafts represent a breakthrough that will first be used for arterio-venous access in patients on hemodialysis and eventually would be used as a replacement of diseased or damaged blood vessels. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing development fees from Humacyte. Humacyte will utilize the initial grafts produced under this collaboration for preclinical development, and the parties may continue their collaboration for the development of large scale manufacturing of vascular grafts for transplantation for clinical and commercial use. The FlexFactory will enable Humacyte to later scale up its production to meet late stage clinical and worldwide commercial market demands. The technology for cultivation of vascular grafts was developed by Humacyte using small-scale bioreactors that produced one graft at a time. The grafts have successfully completed animal tests, enabling Humacyte to begin scale up for manufacturing of grafts for human clinical trials and eventually commercial production. The collaboration is partially funded by a Small Business Innovation Research grant awarded to the companies by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases.
