Humacyte, Inc. (NASDAQ: HUMAW) is a clinical-stage biotechnology company focused on developing human acellular vessels (HAVs) to address unmet medical needs in vascular surgery, hemodialysis access and traumatic vascular injuries. Leveraging proprietary tissue engineering techniques, the company produces off-the-shelf, bioengineered blood vessels that aim to improve patient outcomes by offering biocompatible alternatives to synthetic grafts or patient-derived vein conduits.
The company’s lead product candidate, the Human Acellular Vessel, is designed to function as a durable and infection-resistant conduit for vascular access in patients undergoing hemodialysis. In addition, Humacyte is advancing clinical programs for the use of HAVs in peripheral arterial disease, vascular bypass procedures and military trauma applications. The program has received U.S. Food and Drug Administration regenerative medicine advanced therapy (RMAT) designation and is in pivotal clinical trials across multiple regions.
Founded in 2004 and based in Durham, North Carolina, Humacyte has built manufacturing capabilities to support large-scale production of its HAV technology. The company’s clinical trials have spanned the United States, Europe and select international sites as it seeks regulatory approvals. Strategic collaborations, including partnerships with academic centers and the U.S. Department of Defense, underpin Humacyte’s efforts to broaden the potential applications of its bioengineered vessels.
Led by a management team with extensive experience in biotechnology, translational research and clinical development, Humacyte aims to establish its acellular vessel platform as a new standard of care in vascular surgery. The company continues to explore additional indications and expand its manufacturing infrastructure to support future commercial launch and global distribution.
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