Humacyte, a Duke University regenerative medicine spinout that got its first loan support in 2006 from the North Carolina Biotechnology Center, has raised $150 million committed Series B preferred stock financing.

The privately held company’s new round of financing, led by a global consortium of new and existing private investors, is among the largest such infusions in the annals of life science company development.

The funding will support the upcoming global phase three clinical trials of Humacyte’s investigational human acellular blood vessel, HUMACYL. Humacyte is engineering the implantable blood vessels from the vessel cells of donors. The technology has received U.S. Food and Drug Administration fast-track designation, to streamline the approval process.

One of the largest biotech rounds to date

“We believe this is one of the largest private funding rounds in biotech to date, comprised of investors from the U.S. and around the world,” said Humacyte Chairman and CEO Carrie Cox. “We are elated by this overwhelming response, and our investors are excited to be part of the effort to bring such ground-breaking technology to patients.

“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.”

Backers include Access Industries, Bangkok Bank Public Company Ltd., Brady Dougan, Pacific Eagle Asset Management, Reignwood Group and Gavril Yushvaev. Humacyte said it expects to issue a second and final tranche of these Series B shares following the achievement of a clinical milestone.

Vessels for severe kidney disease patients

Humacyte is developing HUMACYL for patients suffering from the severe kidney deterioration called end stage renal disease. The patients require hemodialysis, a process of cleansing blood, because their kidneys no longer function adequately.

The funding will also support Humacyte’s development of future tissue-replacement products with the potential to improve treatment outcomes in such procedures as coronary artery bypass, trachea and esophagus replacements, and bypass surgeries to treat peripheral arterial disease.

Potential to replace patients’ own vessels

Humacyte was founded in 2004 by Laura Niklason, M.D., Ph.D., a world leader in tissue engineering and creator of Humacyte’s technology. The company said in a news release that based on studies completed thus far, when HUMACYL vessels are implanted into patients, they have the potential to become very similar to the patients’ own blood vessels. HUMACYL also has the potential to last longer, with fewer complications, than current synthetic products used in hemodialysis access. The company said this could decrease healthcare costs by potentially reducing the number of surgical interventions.

Humacyte received the fast track designation for HUMACYL for vascular access in hemodialysis patients from the U.S. Food and Drug Administration in 2014, and has ongoing phase two trials in the U.S. and Europe for patients with end stage renal disease who need better vessels to enable lifesaving hemodialysis. Humacyte plans to initiate a global phase three study for HUMACYL in the coming months.

In September, Humacyte also announced two significant additions to the company’s board of directors, appointing former U.S. Secretary of Health and Human Services, Kathleen Sebelius and healthcare executive Dale Sander as directors.

Credit Suisse advised and acted as the sole underwriter and placement agent for the transaction.

Subsequent to the initial NCBiotech awarding of the $150,000 Small Business Research Loan to Humacyte in 2006, the company had raised about $50 million in debt financing and another $4.5 million in federal research funding.

On the web: www.ncbiotech.org