Its off-the-shelf human acellular vessels (HAVs) initially being developed for vascular repair, reconstruction and replacement.

HAV is intended to overcome long-standing limitations in vascular repair and replacement – it can be manufactured at commercial scale, it has the potential to eliminate the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue.

Currently, HAV is being evaluated in two Phase III trials in AV access and a Phase II/III study for vascular trauma, and has been implanted in more than 430 patients. It is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration, and has also received FDA Fast Track designation.

Laura Niklason, the founder, president and chief executive, is one of only a handful of women in history to found a biotechnology company that she also took public as the CEO, at a valuation exceeding $1 billion.

She has said that Humacyte will make commercial-scale bioengineered tissues a reality for patients.