Humacyte, Inc. (HUMA), a biotechnology company, Tuesday announced its plan to file an Investigational New Drug or IND application with the U.S. FDA in 2025 to support a first-in-human clinical study of its small-diameter acellular tissue-engineered vessel or sdATEV for coronary artery bypass grafting or CABG.
The planned IND filing follows positive preclinical results presented at The American Heart Association's Scientific Sessions 2024.
The sdATEV, a 3.5mm vessel, demonstrated sustained patency, recellularization with host cells, and remodeling to reduce size mismatch in preclinical models.
This innovation could provide a much-needed off-the-shelf alternative to traditional grafts, potentially improving patient outcomes in CABG procedures.
Humacyte's approach aims to address limitations of current CABG conduits, such as low patency and complications arising from harvesting autologous veins.
The planned clinical study could transform CABG surgery by offering a universally implantable, off-the-shelf solution.
This IND filing marks a significant step for Humacyte's broader development of acellular tissue-engineered vessels, which are currently in late-stage clinical trials for vascular applications such as arteriovenous access for hemodialysis and peripheral artery disease.
The company is also expanding into pediatric heart surgery and other novel cell and tissue applications.
"We are very pleased to be moving closer to human clinical studies of the sdATEV in CABG," said Laura Niklason, Founder and CEO of Humacyte. "Our preclinical results suggest that sdATEV could be a promising off-the-shelf alternative to native vessel grafts, and we look forward to evaluating this in human studies."
Currently, HUMA is trading at $4.53 up by 2.72 percent.
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