Cardiac Ischemia

Coronary heart disease (CHD) is the single greatest cause of death for American males and females. Once every 26 seconds, an American suffers a coronary event and about once every minute, someone will die from one. In 2007, an estimated 1,200,000 Americans had a new or recurrent coronary attack, or succumbed to fatal CHD. Myocardial infarction (MI), commonly known as a heart attack, occurs when the blood supply to a part of the heart is interrupted. According to the study of American Heart Association (AHA) in 2007, the estimated annual incidence of MI in the US is 565,000 new attacks and 300,000 recurrent attacks. CHD results in enormous economic burden to the U.S. healthcare system, with an estimated direct and indirect cost of $151.6 billion in 2007.

Although patients with chronic ischemia are offered a number of treatment choices, a significant portion of the affected patient population continue to fail current surgical treatments. This “No-Option” chronic ischemic patient is the initial target for Arteriocyte’s lead cell therapy product (ACY001).

The Company initiated a Phase I clinical trial in January 2006 to evaluate the safety of ACY001 in chronic cardiac ischemia. The Company has completed enrollment of this trial, and the cohort has completed one year follow up. Plans for a multi-center Phase II clinical trial are currently in development.