Humacyte ATEV meets Phase 3 co-primary endpoints; superior to AV fistula in hemodialysis

Humacyte, Inc.

ATEV showed functional patency 81.3% at 6 months vs 66.4% for AV fistula; secondary patency 68.3% vs 62.2% at 12 months (joint p=0.0071).
Subgroup analyses: ATEV superior in female (p<0.0001), obese (p=0.0001), and diabetic (p=0.0024) patients for patency rates and hemodialysis duration.
Thrombosis reported in 52.1% of ATEV patients vs 9.1% for AV fistula; 94% of thrombotic events successfully treated.
Infection rates low and similar: 9.1% ATEV vs 9.9% AV fistula.
Phase 3 trial enrolled 242 hemodialysis patients in US; ATEV is investigational and not yet FDA-approved.

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