About one half of all fatalities due to cardiovascular disease can be attributed to myocardial ischemia, a result of coronary artery disease. A significant number of patients worldwide who suffer from myocardial ischemia have developed Angina Pectoris, chest pain, resulting from an inadequate supply of oxygen to the heart muscle. The U.S. prevalence for Angina Pectoris is 9.5 million patients with a 500,000 annual incidence rate. Refractory Angina due to ischemia not amenable to current available therapies (e.g., CABG, PCI, optimal medical therapy) remains a major unmet medical need. In the U.S. alone, the disease prevalence is reported to be 1.2 million while annual incidence is 50,000. Theregen believes that the treatable number of patients for its Anginera product could approach 200,000/year.
Minimally-invasive delivery of Anginera
Anginera was delivered successfully by mini-thoracotomy to patients. hearts in the Company.s Phase I studies. In addition, it has been delivered successfully through a port onto a beating pig heart. The Company believes that the patch is deliverable by minimally invasive means using currently available technology. This approach may allow the Company to treat patients with Anginera as a sole therapy, and therefore demonstrate an unequivocal therapeutic effect. The port delivery is of particular interest to surgeons who perform robotic cardiac surgery.