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Wednesday, April 05, 2017 8:55:58 PM
Humacyte is currently undertaking a Phase III clinical trial of HUMACYL compared to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement. The trial involves approximately 35 sites in the U.S., Europe and Israel. The Phase III study’s primary objective is to compare the durable use (secondary patency) of the HAV with that of the ePTFE graft during its use as a conduit for hemodialysis. The company published Phase II results in May 2016, showing HUMACYL may have the potential for long-term use and safety in patients suffering from ESRD who require renal replacement therapy and are not candidates for fistula.
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