Humacyte ATEV meets Phase 3 endpoints in hemodialysis access; superiority over standard of care

Humacyte, Inc.

ATEV showed superior functional patency at 6 months (81.3% vs 66.4%) and secondary patency at 12 months (68.3% vs 62.2%); p=0.0071.
ATEV also demonstrated significantly longer hemodialysis duration over 12 months (p=0.0162).
Company plans to discuss potential market authorization pathway with FDA soon.
More adverse events were reported in the ATEV arm compared to the fistula arm.
Over 800,000 Americans have end-stage renal disease; ATEV is an off-the-shelf bioengineered vessel.

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