Humacyte wins expedited review designation for acellular vessel

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 Humacy...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Regulatory/Clearance Vascular Wall Street Beat Humacyte Inc. Source Type: news