Ischemic heart failure is caused by an obstruction of the arteries feeding blood to the heart tissue. The resulting insufficient flow of oxygen and nutrients reduces the heart’s ability to pump blood efficiently to the rest of the body. Ischemic is often manifested in angina pectoris, or chest pain, which in its early stages can be managed by drugs. Generally, heart disease is progressive, requiring more significant interventions over time. Current treatment options for ischemic heart failure include surgical procedures, bi-ventricular pacers, drug therapies, implantable cardiac defibrillators, and ventricular assist devices. For a variety of reasons, including the location or number of the obstructions, these treatments are not effective or appropriate for some patients. Once ischemic heart failure patients have exhausted all potential revascularization options, their only other option is a heart transplant, if they are eligible for one.

According to the American Heart Association, 5.7 million patients in the United States suffer from heart failure, with an additional 670,000 new cases of heart failure diagnosed each year. In a study we commissioned, Trinity Partners estimates that approximately 70% of U.S. heart failure patients, or approximately 3.7 million patients, have ischemic heart failure. There is no definitive data on the number of ischemic heart failure patients who no longer have revascularization options and whose only treatment option is a heart transplant. However, Trinity Partners estimates that there are between 200,000 and 300,000 patients who fall into this category. According to the Healthcare Cost and Utilization Project, the median hospital cost associated with heart transplantation is approximately $307,000 per transplant. Based on an assumed patient population of 200,000, we estimate the annual market potential for ALD-201 in the United States is $5.0 billion.