Humacyte ATEV meets primary endpoints in V007 Phase 3 trial

Humacyte announced positive top-line results from the V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel, ATEV, in arteriovenous access for patients with end-stage renal disease. In the Phase 3 trial, the ATEV demonstrated superior function and patency at six and 12 months compared to autogenous fistula, which is the current standard of care for hemodialysis patients. The V007 Phase 3 trial is a prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Enrolled individuals were randomly assigned to receive either the ATEV or an arteriovenous fistula for hemodialysis access and are being followed for up to 24 months. Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency at six months and secondary patency at 12 months, as co-primary endpoints. At six months, 81.3% of the patients implanted with the ATEV had functional patency compared to 66.4% of the patients receiving an AV fistula. At 12 months, 68.3% of the patients implanted with the ATEV had secondary patency, compared to 62.2% of the patients receiving an AV fistula. The joint test for superiority of the ATEV versus AV fistula at six and 12 months was statistically significant.