On November 8, 2024, Humacyte, Inc. announced its financial results for the third quarter ended September 30, 2024. The company reported that the Biologics License Application (BLA) for its acellular tissue engineered vessel (ATEV) in vascular trauma remained under review by the U.S. Food and Drug Administration (FDA), with no specific timeline provided for completion.
During the quarter, Humacyte highlighted the presentation of expanded results from its V007 Phase 3 clinical trial for hemodialysis access at Kidney Week 2024, showing superior functional patency over autologous fistula. The company also submitted its New Technology Add-on Payment (NTAP) application to CMS and received a third Regenerative Medicine Advanced Therapy (RMAT) designation for advanced peripheral artery disease.
The company continues to advance its broader pipeline, including the BioVascular Pancreas (BVP) product candidate, which received expanded patent protection. These updates reflect ongoing clinical and regulatory progress despite the extended FDA review for the trauma indication.
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