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Humacyte says Phase 3 V012 trial shows ATEV extends catheter-free dialysis time in women

PUBT·08/24/2026 12:00:24
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Humacyte says Phase 3 V012 trial shows ATEV extends catheter-free dialysis time in women
  • Humacyte set a November 2026 supplemental BLA filing to expand its ATEV into dialysis access, following FDA discussions.
  • Clinical results were already presented in June 2026, highlighting improved access durability for women versus standard-of-care fistula.
  • Filing package will also draw on completed Phase 3 studies in broader dialysis-access populations, supporting efficacy and safety for the new use.
  • Move targets a second U.S. indication for ATEV, following its December 2024 FDA clearance in vascular trauma.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Humacyte Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608240800PRIMZONEFULLFEED9814383) on August 24, 2026, and is solely responsible for the information contained therein.