Heart Failure

BGM Galectin-3™

According to the American Heart Association, an estimated 5.8 million Americans suffer from heart failure, with an approximate 670,000 new cases occurring each year, and a similar prevalence in Europe. It is estimated that heart failure is responsible for over 282,000 deaths per year in the United States. The estimated direct and indirect cost of heart failure in the United States for 2010 is estimated at $39.2 billion.

Heart failure is a condition caused by a combination of diseases or factors that damage or overwork the heart muscle, resulting in its inability to pump blood efficiently to meet the needs of other body organs. Heart failure may lead to serious complications and is a leading cause of death. The most common cause of heart failure is coronary artery disease, including heart attack and unstable angina. The cardiac injury caused by coronary artery disease often results in the development of adverse remodeling. Patients with heart failure typically exhibit non-specific signs and symptoms such as swollen legs or ankles, shortness of breath or weight gain. Although the condition is usually progressive, the rate of progression varies markedly from no noticeable deterioration over multiple years to rapidly progressive, resulting in death in just weeks or months.

BG Medicine has developed and optimized a novel assay for measuring galectin-3 levels in blood plasma or serum, BGM Galectin-3™ . Galectin-3, part of the galectin family of proteins, has been shown to play an important role in heart failure in animal and human studies. In animal experiments, administration of galectin-3 to the heart resulted in the formation of cardiac fibrosis, or stiffening, in the heart muscle, a process often referred to as adverse remodeling. In these animal studies, adverse remodeling reduced the heart’s ability to pump normally, causing the animals to develop heart failure. This link between galectin-3 and adverse remodeling is significant, as cardiac remodeling is an important determinant of the clinical outcome of heart failure and is linked to disease progression and poor prognosis.

Only a segment of heart failure patients have elevated levels of galectin-3, suggesting the presence of galectin-3-dependent heart failure. Patients with elevated galectin-3 levels have a worse prognosis in terms of mortality or risk of hospitalization than comparable patients with low or normal levels of galectin-3. Measurement of galectin-3 in patients with heart failure offers clinically useful information that physicians may use as an aid in the stratification of patients diagnosed with heart failure. For more information about galectin-3 and its role in cardiac disease visit www.galectin-3.com.

The BGM Galectin-3 test is currently available for clinical use only in the European Union and certain other European countries. The BGM Galectin-3 test is not available for sale or distribution in the United States or Canada. The Company has submitted a 510(k) application to obtain clearance from the U.S. Food and Drug Administration to sell the test in the United States.

* The BGM Galectin-3 Test (pending 510(k)) is not available for sale within the United States and is not authorized for sale in Canada.