Humacyte(US:HUMA) Globenewswire·2025-06-09 12:00Core Insights - Humacyte, Inc. presented data from its V007 Pivotal Phase 3 clinical trial, demonstrating the superiority of its acellular tissue engineered vessel (ATEV™) over autologous arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease [1][2][3] Group 1: Clinical Trial Overview - The CLN-PRO-V007 trial was a multicenter, randomized controlled trial involving 242 end-stage kidney disease patients, focusing on the efficacy and safety of ATEV compared to AVF [3] - The trial specifically targeted high-risk patients, including women and individuals with obesity and diabetes, who are more likely to experience AVF maturation failure [3][4] - ATEV showed better functional patency and usability, with a comparable access-related complication profile to AVF in the high-risk subgroup [3][4] Group 2: Results and Implications - ATEV demonstrated a lower need for maturation and surgical revision procedures compared to AVF, indicating its potential as a more effective option for high-risk patients [3][4] - The safety profile of ATEV was comparable to AVF, with low rates of infections, although there were more thrombosis and stenosis events in the ATEV group, most of which were successfully treated [3][4] - The results highlight a significant unmet medical need in the dialysis access market, particularly for the high-risk demographic, which represents over half of the market [4] Group 3: Company Background and Future Outlook - Humacyte is focused on developing universally implantable bioengineered human tissues and has received FDA approval for ATEV in vascular trauma indications [6][7] - The company is advancing ATEV through late-stage clinical trials for various vascular applications, including hemodialysis access and peripheral artery disease [6][7] - Humacyte anticipates publishing the V007 trial results in a major peer-reviewed medical journal soon, which could further validate the findings and support market adoption [4]