Humacyte prepares to launch clinical trial after raising $150M

When Humacyte announced last month that it had raised $150 million, it marked the Research Triangle Park-based company as one of the most promising biotechnology startups in the U.S.

It also put the 11-year-old company on the path to potentially getting its technology approved by regulators in the U.S. and Europe.

The money will enable Humacyte to complete Phase 3 clinical trials for HumaGraft, its promising treatment for dialysis patients, said Laura Niklason, Humacyte’s founder. The company hopes to seek approval from the Food and Drug Administration in 2018.

The trials will compare patient outcomes for those using Humacyte’s technology with those undergoing standard dialysis treatment using plastic grafts. Humacyte’s technology involves implanting engineered blood vessels in the arms of dialysis patients, an approach that the company believes has several advantages.

“In the long run we hope we’ll lower patient care costs and maybe even improve life spans – certainly quality of life for these folks,” Niklason said.

Humacyte hopes to begin enrolling patients at 30 clinical trial sites in the U.S., Europe and Israel early next year. About 350 patients are expected to participate. Up until now, Humacyte’s engineered blood vessels have been implanted in about 60 dialysis patients.

“We’ve already seen hints from our early clinical trials that these grafts seem to work better than plastic grafts,” Niklason said. “They seem to last longer and suffer fewer complications, like infections.”

The failure rates for plastic grafts are high, she said, with roughly 40 out of 100 needing to be replaced within a year. The devices fail for a number of reasons – infection, clotting, scarring and other complications that result from patients having blood drawn three times a week.

The potential market for HumaGraft is large, and getting bigger.

In the U.S., there are now about 380,000 dialysis patients, Niklason said. That figure is growing by about 3 percent annually as the population ages and rising levels of obesity and diabetes cause more people to suffer kidney failure.

“These markets are enormous, in dialysis alone there’s about 80,000 to 100,000 grafts we could place in the United States,” Niklason said. “The numbers could become very big very fast.”

Niklason started Humacyte along with two of her former Duke University students, Juliana Blum and Shannon Dahl. The company named veteran pharmaceutical executive Carrie Cox as CEO in 2010 but Niklason, who is now a professor of biomedical engineering and anesthesia at Yale University, remains on Humacyte’s board of directors and is closely involved in the technical aspects of the business.

The company, which has 51 employees, plans to expand its manufacturing capabilities in the coming months as it prepares to commercialize the technology. It now partners with a Denver-based company to manufacture the blood vessels, but expects to expand its own capabilities in the future.

Humacyte’s appeal to investors goes beyond just tapping the dialysis market. The company’s technology could potentially be used to replace any blood vessel in the body.

Thus far the company has applied its approach to one other patient scenario – people suffering from atherosclerosis, a narrowing of the arteries in the legs. Humacyte’s blood vessels were used to bypass the leg arteries in such patients. The company has completed a small clinical trial involving 20 such patients in Europe, but the results have not yet been reported.

Humacyte raised its Series B funding from a group of global investors that includes Access Industries, Bangkok Bank Public Company, Pacific Eagle Asset Management, Reignwood Group and two individuals, Brady Dougan and Gavril Yushvaev.

Niklason said the company’s ability to raise such a large amount of money speaks to just how widely its technology could ultimately be applied.

“I think investors really saw how this could go in a lot of different directions, so we’re talking about multiple big markets here, something that’s really transformational,” she said.

David Bracken: 919-829-4548, @brackendavid