Humacyte's ATEV met Phase 3 primary endpoint vs AV fistula in dialysis study

Humacyte announced positive interim results from its V012 Phase 3 study showing the acellular tissue engineered vessel (ATEV) achieved superior catheter-free days (91 more days, p=0.00070) compared to standard autologous AV fistula in female dialysis patients. The company plans to file a supplemental BLA with the FDA in H2 2026, potentially addressing a high-unmet-need population and supporting its commercial-stage bioengineered tissue platform.