Humacyte Lands $150M Series B for Phase 3 Study of Lab-Grown Veins

Xconomy Raleigh-Durham — 

Regenerative medicine company Humacyte has nabbed $150 million in financing to take its lab-grown blood vessels into late-stage testing.

The funding for the Research Triangle Park, NC-based company comes from a group of new and existing investors including Access Industries, Bangkok Bank Public Company Ltd., Pacific Eagle Asset Management, Reignwood Group, and individual investors Brady Dougan and Gavril Yushvaev. The Series B funding has two tranches; Humacyte got the first today, and will get the other if it hits an unspecified milestone in the upcoming Phase 3 trial. Humacyte didn’t disclose the size of either tranche.

Humacyte has developed a way to make blood vessels in a lab intended to be an alternative to the synthetic implants now used to treat patients with a blood flow problem, such as a blocked blood vessel in a limb. First, it takes smooth muscle cells from humans and grows them on a scaffold in the shape of a tube. After this structure forms, the human cells are washed away, leaving a collagen structure that forms the engineered vein. Because those human cells are gone, it’s less likely a patient’s body would reject the engineered vein after it’s transplanted. The company says a patient’s own tissue can then grow into the new vein, enabling it to perform more like a human’s own blood vessel. The technology, originally developed at Duke University, is intended to produce “off-the-shelf blood vessels” that can be produced and implanted in any patient.

The new funding supports a late-stage trial of Humacyte’s technology, called Humacyl, in patients with kidney failure who require hemodialysis. Humacyte is trying to show that its technology is longer lasting, and safer than synthetic replacements for blood vessels, which are made from Teflon or Dacron. Humacyte says that these synthetic vascular grafts are prone to thickening in their walls that leads to clotting. Humacyte hopes that its lab-engineered vessels, which are flexible unlike their synthetic counterparts, will function more like a human’s own blood vessels, reducing the need for additional surgeries.

Humacyte was founded in 2004 by Yale University professor Laura Niklason, back when she was a faculty member and physician at Duke University. The company raised $12 million in 2010 and began clinical trials two years later. In 2014, the FDA gave Humacyte’s technology “fast track” status, which speeds the regulatory review of treatments that address unmet medical needs. Humacyte expects to start its Phase 3 study in coming months.

Humacyte can also use its technology to develop structures in the body besides veins. It’ll use the cash to develop a pipeline of products that could be used in a variety of medical procedures, such as coronary artery bypass, trachea and esophagus replacements, and surgical bypass for peripheral arterial disease.

“This funding will further support our team’s work to develop a much needed alternative to current dialysis access products, and will allow us to continue the progressive research and development of future products where Humacyte’s technology may be applied for patients with significant unmet medical needs,” Carrie Cox, CEO and chairwoman of Humacyte said in a written statement.