The HEALING program
The HEALING program,which stands for "Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth", is designed to demonstrate the safety, efficacy, and the healing impact towards a stent designed for endothelial progenitor cell (EPC) capture. HEALING I was the First In Man (FIM) study with 16 patients and was designed to evaluate the safety of the EPC capture concept. The study focused on 1) procedural success, defined as angiographic success and absence of MACE at discharge, and 2) MACE at 30 days. The device used was an early EPC capture prototype that involved "wet chemistry," meaning the stent was provided in a vial with a preservative saline solution; thus requiring hand crimping by the operator. The study achieved 100% procedural success and no 30 days MACE events were reported.
The evolution of the EPC capture technology has culminated in the development of the Genous Bio-engineered R stent, which now has significantly higher antibody activity than the early EPC capture prototype. The Genous Bio-engineered R stent will be studied in HEALING II and subsequent trials.
