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Humacyte Makes Fierce 15 List for Regenerative Medicine Platform

By Barry Teater, NCBiotech Writer

Humacyte's Humacyl vessel made from regenerative medicine technology. -- Humacyte photo

Morrisville-based Humacyte’s novel technology for growing bioengineered blood vessels and potentially other human tissues has caught the eye of a national medical device publication.

FierceBiotech Medical Devices named Humacyte to its annual Fierce 15 list of innovative medical device companies for 2016.

Humacyte’s lead product, Humacyl, is a bioengineered blood vessel that’s undergoing two clinical trials in patients with peripheral arterial disease and end-stage renal disease.  But it’s the broader implications of the technology underlying Humacyl that intrigued the publication.

“The prospects for that product, while important to Humacyte and potentially hemodialysis patients, are dwarfed by the possible impact of the process behind its creation,” FierceBiotech Medical Device’s contributing writer Nick Paul Taylor writes in the publication’s profile of Humacyte. “Humacyte envisages a future of off-the-shelf implants.”

The article quotes Humacyte CEO Carrie Cox, who says, “The platform technology, once you learn how to grow a new human tissue that can be implanted into almost any patient or virtually any patient, that’s pretty astounding. I think the potential that it creates to go farther is certainly there and one that we’ll have fun exploring in the future.”

Writes Taylor: “Creating new vessels for coronary artery bypass graft (CABG) surgery is high on Humacyte’s to-do list. Beyond that, Cox and her team have an eye on addressing all vascular injuries and needs. The potential of the technology has attracted the Department of Defense, which is working with Humacyte to see if bioengineered blood vessels could be used to save the limbs of soldiers who suffer injuries as a result of improvised explosive devices (IEDs).”

Humacyte was spun out of Duke University in 2004 by scientists Laura Niklason, Shannon Dahl and Juliana Blum.

The privately held company received a $150,000 Small Business Research Loan from the North Carolina Biotechnology Center in 2006. In October 2015 it raised $150 million in a Series B preferred stock financing  ̶  among the largest ever by a life science company in North Carolina.

In August 2016 Humacyte received a $9.9 million investment from the California Institute for Regenerative Medicine (CIRM) to support a phase 3 clinical trial of Humacyl for kidney disease.

Unlike most regenerative medicine companies, Humacyte does not use a patient’s own cells as therapies or products.

Humacyl is derived from the company’s proprietary cell-culture technology in which vascular cells are seeded onto a degradable scaffold and then cultured so they secrete a matrix that forms a tissue in the shape of the scaffold. The vascular cells are then removed to avoid triggering an immune response in patients receiving the tissue.

These investigational tissues have many potential uses in regenerative medicine and vascular surgery as off-the-shelf products that can be easily stored until doctors and patients need them, the company says.

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