Humacyte Announces Presentation of Positive Two-Year Results from Phase 3 Dialysis Access Trial at the American Society of Nephrology’s Kidney Week 2025

Core Insights - Humacyte, Inc. announced positive two-year results from the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) for hemodialysis access, demonstrating superior performance compared to the current gold standard, autogenous fistula, particularly in high-need subgroups [1][2][5] Group 1: Clinical Trial Results - The V007 Phase 3 trial showed that ATEV had a superior duration of use over 24 months compared to autogenous fistula in female, obese, and diabetic patients, who typically have poor outcomes with AV fistula procedures [2][4] - In female patients (n=70), the average duration of ATEV usage was 15.8 months compared to 10.0 months for AV fistula (p<0.0137) [4] - In the target population of females and males with obesity and diabetes (n=110), ATEV had an average duration of access use of 14.8 months versus 9.1 months for AV fistula (p=0.0114) [4] Group 2: Clinical Significance - The ATEV provided a clinically meaningful advantage in early usability and functional patency, enabling faster and more reliable dialysis initiation, especially in high-risk patients [3][5] - The results indicate that ATEV could significantly reduce reliance on catheters for arteriovenous access, which is a major cause of complications and treatment costs in patient care [3][6] Group 3: Safety Profile - After 24 months of follow-up, no unexpected side effects were observed in patients implanted with the ATEV, showing a comparable safety profile to AV fistula with low rates of infection [7] - Although ATEV patients experienced more thrombosis and stenosis events requiring interventions, most cases were successfully treated [7] Group 4: Company Overview - Humacyte is developing a biotechnology platform for universally implantable bioengineered human tissues and has received FDA approval for the ATEV in vascular trauma [9] - The company is also conducting late-stage clinical trials for other vascular applications, including AV access for hemodialysis and peripheral artery disease [9]