Humacyte presented the complete 12-month interim analysis from the CLN-PRO-V012 study, a multicenter, randomized Phase 3 trial evaluating acellular tissue-engineered vessel (ATEV) compared with autogenous arteriovenous fistula (AVF) for hemodialysis vascular access in women with end-stage kidney disease.

Humacyte, Inc. (Nasdaq: HUMA) is proud to announce that in Dec 2024, FDA granted full approval for our Acellular Tissue Engineered Vessel (ATEV), a first-in-class, universally implantable, bioengineered human vessel for extremity arterial trauma. This approval is a significant milestone in regenerative medicine, offering a new treatment option for patients with severe arterial injuries.See the Prescribing Information, including Boxed Warning: https://bit.ly/4dl5tuL This is the first approval in our bioengineered ATEV Platform where we are continuing to investigate use of our lab-grown tissues and organs to improve the lives of patients and transform the practice of medicine. We develop and manufacture acellular tissues that are meant to be universally implantable and remodel with the patient's own cells over time. The goal is to grow spare parts for people. Humacyte’s ATEV is in clinical trials for arteriovenous access for hemodialysis, and peripheral arterial disease. Investigational preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s ATEV for performing hemodialysis in AV Access was the first indication to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation, and the ATEV technology received priority designation for the treatment of extremity arterial repair by the U.S. Secretary of Defense prior to its FDA approval in Dec 2024 for that purpose. For more information, visit https://Humacyte.com.