Unmet Need in CAD
There is a large unmet need for an accurate, inexpensive, radiation-free test for myocardial perfusion assessment (blood flow in the heart muscle), a sensitive marker for coronary artery disease (“CAD”). Each year, 15 million non-invasive cardiac stress studies are performed on intermediate risk CAD patients in the U.S. and Europe. These cardiac stress studies help cardiologists determine which of these patients should progress to the more invasive and expensive coronary angiogram for further testing and treatment. There are two types of cardiac stress studies done in intermediate risk CAD patients: nuclear stress testing, which evaluates myocardial perfusion, and cardiac stress ultrasound, which evaluates cardiac wall motion. Nuclear stress testing is the more sensitive test, and therefore the most prevalent test, because of its ability to evaluate myocardial perfusion. However, nuclear stress testing is expensive, time-consuming, not readily available in all settings, and exposes the patient and medical staff to a high level of ionizing radiation. Cardiac stress ultrasound is incapable of detecting myocardial perfusion and relies on the evaluation of cardiac wall motion, a less sensitive marker of CAD. As a result, cardiac stress ultrasound has a relatively small share of the cardiac stress market even though it has many other cost and convenience advantages over nuclear stress and is better at evaluating cardiac structure.
Imagify™ (perflubutane polymer microspheres) injectible suspension is a cardiovascular drug designed to enable ultrasound to accurately assess myocardial perfusion. With Imagify, Acusphere is poised to offer the first ultrasound contrast agent capable of reliable myocardial perfusion detection and therefore rivaling nuclear stress testing. Ultrasound with Imagify offers the additional benefits of being more convenient, less expensive, more universally available, and radiation-free.