Humacyte makes “spare parts for people” and will hear from the Food and Drug Administration soon about whether those parts will be approved to treat patients.
Humacyte is a biotech company in Durham, NC, that makes artificial blood vessels. The Artificial Tissue Engineered Vessels or ATEVs have been in development for almost two decades, but so far have been available only to patients in clinical trials. But with an FDA decision coming up, that could change. And an approval would be a win not only for the company, but also for the growing research and development presence in the Triangle region.
Bringing an innovative product to the market
Humacyte’s ATEVs have been tested extensively in clinical trials for more than a decade, and have been in development since 2005. Humacyte’s CEO and co-founder Laura Niklason is hopeful that after many years of work, the FDA will approve the ATEVs for use on August 10.
“That will allow us to launch our product into hospitals where trauma surgeons and vascular surgeons will be able to use it to treat patients who are wounded,” she said.
Those could be patients who have been in car accidents or suffered gunshot wounds, and receiving an artificial blood vessel could salvage limbs or even save lives.
“Our engineered tissues, when we implant them, they don’t have any cells in them,” Niklason said. “But after they do get implanted, cells from the patient sort of crawl in and take up residence in the tissue and turn it into a living tissue. It becomes self.”
Scientists have dreamed about this kind of engineered tissue for decades, but so far Humacyte is the only company that has been able to make a product like that a reality.
“It’s very exciting for the company, because this represents an incredibly long journey,” Niklason said. “To get to this point where we’re getting to approval for something that’s really fundamentally new is pretty cool.”
Read the full article here.