Humacyte, Inc.

Humacyte, Inc. is a commercial-stage biotechnology platform company that develops universally implantable, bioengineered human tissues at a commercial scale. In the first quarter of 2025, the company began the United States commercial launch of its first FDA-approved product. Humacyte focuses on developing and manufacturing off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs, and organ systems. The company uses its scalable technology platform to develop proprietary, bioengineered, acellular human tissues for treating diseases and conditions across various anatomic locations and therapeutic areas. Initially, Humacyte engineers and manufactures acellular tissue engineered vessels, or ATEVs. On December 19, 2024, the FDA granted full approval for the ATEV, branded as Symvess®, for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible. ATEVs are designed for easy implantation into any patient without causing a foreign body response or immune rejection. Humacyte is developing a portfolio, or "cabinet," of ATEVs with different diameters and lengths. This ATEV cabinet initially targets the vascular repair, reconstruction, and replacement market, including vascular trauma, arteriovenous ("AV") access for hemodialysis, and peripheral artery disease ("PAD"). The company is also developing the ATEV for coronary artery bypass grafting ("CABG") and pediatric heart surgery. In the longer term, Humacyte is developing its ATEV for delivering cellular therapies, such as pancreatic islet cell transplantation to treat Type 1 diabetes (known as BioVascular Pancreas or "BVP™").