Acusphere submits CAD imaging agent for FDA approval

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Acusphere has submitted a new drug application (NDA) to the FDA for approval to market its lead product candidate, Imagify.

Imagify(Perflubutane Polymer Microspheres for Injectable Suspension) is an ultrasound imaging agent for the detection of coronary artery disease (CAD), according to the Watertown, Mass.-based company.

The company said its NDA includes data from studies of Imagify in more than 1,000 patients globally, including two international multi-center Phase III clinical trials: RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).

Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of CAD, according to Acusphere.