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Humacyte released interim Phase 3 results from its V012 trial in women undergoing hemodialysis, showing that those treated with the investigational ATEV product experienced 91 more catheter-free days through 12 months compared with those given an AV fistula.
The company emphasized that ATEV is not approved by the FDA for this indication, and its safety and efficacy have not yet been established for hemodialysis access.
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Humacyte previously announced plans to present interim Phase 3 V012 results of ATEV for hemodialysis access in women at Kidney Week, according to a company statement. Initial reports also indicated that trial data would be shared at ASN Kidney Week 2026, as noted in earlier disclosures. The ongoing trial focuses on evaluating ATEV’s potential use in women needing hemodialysis access.