Humacyte says Phase 3 study shows bioengineered ATEV blood vessel beats AV fistula in women on dialysis

Humacyte, Inc.

Humacyte, Inc.

HUMA

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  • Humacyte presented Phase 3 V012 results at the Society for Vascular Surgery’s Vascular Annual Meeting in Boston.
  • The study showed its bioengineered blood vessel kept women on dialysis off catheters longer than standard AV fistula access.
  • Results also indicated fewer infections versus fistula, with no device-related infections reported in the treatment arm.
  • The company plans to file a supplemental BLA with the FDA in the second half of 2026, targeting adults at higher risk of fistula failure.


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