Heart failure may occur after the heart muscle has been deprived of oxygen for extended periods of time, damaging the heart muscle and reducing its ability to pump blood to the body. Treatments may include lifestyle changes, diet, medication, catheter-based or stent-based procedures to open up blood vessels, or by-pass surgery. Many patients have symptoms that worsen over time despite maximal medical therapy and the remaining approved medical options for such patients are heart transplantation or surgical implantation of a left ventricular assist device. Chronic heart failure may progress to severe disability, reduced quality of life, and ultimately death.

The use of ADRCs is not approved as a treatment for chronic ischemic heart failure in the U.S. However, preclinical and preliminary clinical data obtained by Cytori and others indicate that it is a promising area of investigation for doctors and scientists seeking therapy for patients with chronic ischemic heart failure that is not amenable to standard-of-care interventional therapies.

In chronic heart failure, the hypothesis (scientific proposal under investigation) is that the multiple actions of ADRCs may rescue salvageable heart muscle cells and may stop or slow progression of heart failure.

Cytori previously completed two preliminary trials in Europe to investigate the application of investigational ADRC Therapy in acute heart attack (APOLLO clinical trial) and chronic heart failure (PRECISE clinical trial). The data obtained in these two trials supports the continued investigation of ADRC Therapy as a potential treatment for chronic heart failure caused by coronary heart disease and therefore Cytori is conducting two clinical trials to explore that possibility. One is a U.S. safety and feasibility trial for chronic ischemic heart failure (ATHENA clinical trial) and the other is a European trial for acute myocardial infarction (ADVANCE clinical trial).