Humacyte, Inc. announced publication of a preclinical study showing the potential for its investigational small-diameter Human Acellular Vessel?? (HAV??) to treat Tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year. The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled "Evaluation of tissue-engineered human acellular vessels as a Blalock-Taussig-Thomas shunt in a juvenile primate model, describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.

The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients implanted with 6.0mm HAVs. This study also demonstrates the successful extension of Humacyte's manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels. Humacyte's 3.5mm HAV is also currently being tested in large-animal models of adult coronary artery bypass grafting (CABG) to assess the potential of the Humacyte platform to make vessels treating a range of heart conditions, spanning from pediatric to adult.

If the HAV can be shown to grow with the child, this could be transformational for the care of these babies born with heart disease. The 6.0mm HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. The 3.5um HAV is being studied in preclinical models in several different potential indications.

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.