HAMPTON, N.J., Jan. 3, 2012 /PRNewswire/ -- Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients in the hospital and ICU settings, today announced that it has commenced its global development program, the PRESERVATION I clinical trial, for its Bioabsorbable Cardiac Matrix (BCM). The CE Mark registration trial has commenced in Australia, and will be followed in Europe. The trial also is expected to commence in other countries, including Israel.
PRESERVATION stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction.BCM, also known as IK-5001, is being investigated to prevent ventricular remodeling and subsequent congestive heart failure (CHF) following acute myocardial infarction (AMI). Ventricular remodeling is the structural alteration of the damaged heart muscle that occurs following an acute heart attack. Once this damage occurs, the weakened heart muscle forces the rest of the heart to compensate. Under this extra workload, the heart muscle dilates, the walls of the heart thin, and the heart further remodels, thereby causing another cycle of dilation and overcompensation. The extra workload to the heart causes further structural damage and can lead to congestive heart failure.
BCM, an aqueous mixture of sodium alginate and calcium gluconate, will be delivered in a bolus injection via the coronary artery during catheterization and flows into the damaged heart muscle, where it forms a flexible scaffold, or "matrix," that provides physical support of the heart muscle during recovery and repair. Once the heart tissue heals, BCM gradually dissipates and is excreted through the kidneys.
"Due to the novel self-assembling and self-disassembling