Acusphere Inc. announced that it had completed the Marketing Authorisation Application (MAA) dossier for its lead product candidate, Imagify(TM) (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 (EU). The company has also secured an additional $8 million of debt financing this year, following stockholder approval of a reverse stock split in early 2012. Imagify is under development as a cardiovascular drug intended for the detection of coronary artery disease (CAD), the cause of death in Europe and throughout the world, including the U.S. It remains the development candidate for myocardial perfusion assessment with ultrasound. Acusphere believes that Imagify continues to show promise as a radiation-free test for perfusion assessment offering compelling cost and convenience advantages over the current standard of care, nuclear stress testing, as well as safety advantages over nuclear stress testing: each episode of nuclear stress testing delivers a radiation dose equivalent to between 140 and 800 chest x-rays depending upon the radiopharmaceutical used, whereas Imagify is radiation-free. At least 3 million procedures, which translate to a $600 million addressable market for Imagify, occur each year in Europe, based upon existing procedures. Acusphere believes this market could grow significantly since the European population is similar to the U.S. population and the prevalence of heart disease is similar as well (the U.S. addressable market is approximately 10 million procedures/$2 billion).