April 30, 2008 - Acusphere has submitted a New Drug Application (NDA) to the FDA for approval to market Imagify (Perflubutane Polymer Microspheres for Injectable Suspension), an ultrasound imaging agent for the detection of coronary artery disease, which could prove as accurate as nuclear stress testing.
The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).