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 breakthrough therapy designation.
“Being 1 of the first companies to receive the regenerative medicine advanced therapy designation from the FDA is an honor and a testament to the significant potential for Humacyl to address a great unmet medical need for patients who are undergoing dialysis,” chairman & CEO Carrie Cox said in prepared remarks. “We look forward to continuing to work closely with the FDA to facilitate the development and expedited review of Humacyl with the goal of bringing this novel vascular access product to patients requiring hemodialysis. We applaud the efforts of the FDA in expanding support to advanced therapeutic products through this great new program.”
Humacyte is evaluating Humacyl in a phase III trial, comparing the product to an expanded polytetrafluoroethylene grant in 350 patients with kidney failure who are not candidates for fistula placement. The study aims to compare the durable use of Humacyl with that of the ePTFE graft during its use as a conduit for hemodialysis, according to the company.
In December last year, Humacyte launched a phase II trial for 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 the hopes of improving blood circulation. The goal of the study is to evaluate the vessel’s performance in the arterial bypass position and its efficacy at repairing human arterial blood vessels.
The Research Triangle Park, N.C.-based company’s phase II trial follows previous arterial trial surgeries at sites in Poland in 2013 that finished last year.