Humacyte (HUMA) Study result summary

Study design and background

• V012 was a multicenter, randomized, head-to-head phase III trial comparing ATEV to AVF in women with end-stage kidney disease on hemodialysis, with a primary endpoint of catheter-free days at one year.

• The study enrolled 150 patients, with interim analysis after 80 patients completed one year of follow-up.

• Patient characteristics such as age, obesity, and diabetes were equally distributed between arms.

• AVF maturation failure is common, especially in women, obese, and diabetic patients, leading to prolonged catheter use and higher infection risk.

• ATEV is an engineered, off-the-shelf human vessel, FDA-approved for vascular injury, and designed to integrate with patient tissue.

Study design and presentation

• Phase 3 V012 study results for a bioengineered blood vessel (ATEV) were presented at the Society for Vascular Surgery's Vascular Annual Meeting in Boston.

• The study focused on women on dialysis, comparing ATEV to the standard AV fistula.

• The primary endpoint was catheter-free days, with secondary endpoints including infection rates and patency.

Key efficacy results

• V012 interim analysis met its primary endpoint: ATEV patients had 91 more catheter-free days than AVF (p=0.0007); women receiving ATEV averaged 220 catheter-free days in the first year, versus 129 days for AVF (p=0.00070).

• Six-month catheter-free days were 88 for ATEV and 32 for AVF (p=0.00009).

• ATEV showed superior maturation rates (~90% vs. ~60% for AVF) and faster time to maturation.

• Functional patency over 12 months was 250 days for ATEV and 152 days for AVF (p=0.00057).

• Six-month secondary patency was 87.5% for ATEV and 65.0% for AVF (p=0.0013).