Congestive heart failure related to dilated cardiomyopathy is a lethal condition in which a patient's heart begins to lose functionality and blood-pumping capability. This condition is responsible for over 300,000 deaths each year. It is estimated that 5 million Americans have CHF with another 4 million having mitral valve regurgitation. This number will double by 2020. CHF failure is most common in those who are age 65 years and older and is the number one reason older people are hospitalized. Annual expenditures for heart failure are estimated in the tens of billions. The Company's initial product for the reversal of heart failure, Algisyl-LVR, targets over 2 million patients in the U.S. alone.
Post-operative atrial fibrillation (POAF) targets approximately 1 million annual cardiac surgical procedures representing an annual market potential of over $800 million worldwide. Currently no effective treatment option exists for the POAF patient population. Plexisyl-AF is intended to be used prophylactically at the time of surgery to mitigate the onset of post-operative atrial fibrillation.