Humacyte presented Phase 3 V012 results at the Society for Vascular Surgery Vascular Annual Meeting in Boston, showing its acellular tissue-engineered vessel, or ATEV, outperformed autologous arteriovenous fistula for women on dialysis.
Women who received the ATEV averaged 220 catheter-free days in the first year versus 129 days for av fistula, a statistically significant difference (p=0.00070).
Infection rates were about 6 infections per 100 patient years with ATEV compared with 23 per 100 patient years for av fistula; none of the infections in the ATEV group were tied to the vessel itself and no ruptures occurred in either group.
Secondary endpoints also favored ATEV, including six-month catheter-free days (88 versus 32; p=0.00009), 12-month functional patency (250 versus 152 days; p=0.00057) and six-month secondary patency (87.5% versus 65.0%; p=0.0013).
Safety profiles were reported as comparable when adjusted for patient-years, with serious adverse events at rates of 1.73 for ATEV versus 4.77 for AV fistula.
In line with the study protocol, enrollment will end after meeting the primary superiority endpoint and Humacyte plans to file a supplemental biologics license application with the FDA in the second half of 2026, targeting adults at increased risk of av fistula maturation failure.
