Humacyte said today that the FDA granted its investigational human acellular vessel, Humacyl, the regenerative medicine advanced therapy designation. The regulatory win means that the FDA will expedite its review of the HAV for patients in need of life sustaining hemodialysis. The designation is new and follows the model of other FDA programs such as the […]
Humacyte said yesterday that it started a phase II trial of its human acellular vessel, Humacyl, as an artificial bypass graft in patients with peripheral arterial disease. The non-randomized trial is slated to enroll 20 patients over the next year. Humacyl will be surgically implanted above the knee in the legs of PAD patients in […]
Humacyte is launching a Phase III study of its lab-grown blood vessel Humacyl in 350 patients with end-stage renal disease who are on hemodialysis and don’t qualify for a standard surgical treatment, and Boston’s Brigham & Women’s Hospital plans to take part. Plans to move ahead to Phase III follow a promising Phase II clinical study […]
Humacyte said today that it raised a $150 million Series B round it plans to use to back a Phase III trial of its Humacyl lab-grown blood vessel technology. Research Triangle Park, N.C.-based Humacyte, which raised a $12 million Series A round back in 2010, uses a proprietary technology to engineer human tissues that can be shaped […]
Duke University spin-off Humacyte Inc. landed a $12 million investment and pharmaceutical industry veteran Carrie Cox for CEO.
The Durham, N.C.-based regenerative medicine company recently raised $12 million from a single investor through a debt offering, according to an amended filing with the Securities & Exchange Commission. Another amended filing shows the company raised $7 million in debt about a year ago.