Humacyte, Inc., is a privately held clinical stage biotechnology company developing the technology of human acellular vessels (HAVs). It is a type of bioengineered vein. HAVs are produced in a cell culture bioreactor and then acellularized. Proposed uses include material for coronary artery bypass graft surgery and vascular access for hemodialysis. The company is focused on initial FDA approval for vascular access for hemodialysis. In preclinical studies the bioengineered veins, with a diameter of 3 to 6 mm, were generated in a bioreactor using human smooth muscle cells grown on a tubular polyglycolic acid scaffold, were subsequently decellularized, and were stable at least 12 months at 4ºC. The HAVs were implanted in adult male baboons and mongrel dogs (large animal models). The HAVs demonstrated blood flow, resistance to dilatation, resistance to calcification and resistance to intimal hyperplasia, indicating low risk of occlusion . The HAVs are generated using allogeneic banked cells and have the potential to be manufactured to provide “off-the-shelf” non-immunogenic acellular vascular material for surgeons to use in any patient.
More than half of kidney dialysis patients lack the healthy veins necessary for the procedure and must undergo an arteriovenous graft placement. Humacyte is conducting a pivotal Phase III study assessing the HAV, or HUMACYL®, as a conduit for hemodialysis in patients with end-stage renal disease who are not candidates for fistula placement. 12-month post-implantation patient data from the study is expected during the third quarter of 2018.
Boosting its financing Humacyte has raised $75 million in a Series C preferred stock, led by a global consortium of existing private investors and new investors, including PointState Capital . The funding is expected to support the ongoing phase III trial and help complete the development, testing, and qualification of the proprietary bioprocessing system planned to manufacture HUMACYL®. Recently Humacyte completed construction of its state-of-the-art, R&D and bioprocessing facility in Durham, North Carolina.
“Completing the final stage of clinical testing for our first product candidate later this year will be a significant achievement for our organization and the overall regenerative medicine industry.” – Carrie S. Cox, Chairman and CEO of Humacyte.
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