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July 20, 2012 —Acusphere Inc. announced that it had completed the marketing authorization application (MAA) dossier for its lead product candidate, Imagify (perflubutane polymer microspheres) for injectable suspension, and is now starting the process of filing the MAA dossier with the European Medicines Agency (EMA) to support the regulatory review of Imagify in the European Union.
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.
Acusphere Inc. announced that in a test on Imagify, its ultrasound contrast agent, all three of the ultrasound-blinded readers had superior sensitivity and noninferior accuracy to nuclear stress, the most frequently used imaging procedure for the assessment of coronary artery disease.