On October 28, 2024, Humacyte, Inc. announced the presentation of positive results from its V007 Phase 3 clinical trial at the American Society of Nephrology’s (ASN) Kidney Week 2024. The trial evaluated the acellular tissue engineered vessel (ATEV) for arteriovenous (AV) access in patients with end-stage renal disease.
The ATEV demonstrated superior functional patency at six and 12 months, which were the co-primary endpoints, compared to autogenous fistula, the current standard of care. Notably, the ATEV also showed superior function and patency in female, obese, and diabetic patients, subgroups that historically experience poor outcomes with AV fistula procedures.
At six months, 81.3% of ATEV patients had functional patency compared to 66.4% for AV fistula patients, with a statistically significant joint test for superiority (p=0.0071). These results highlight the potential for the ATEV to significantly improve hemodialysis access outcomes for a high-need patient population.
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