Contrast developer Acusphere has filed a Marketing Authorization Application (MAA) in the EU for its Imagify (Perflubutane Polymer Microspheres) cardiovascular disease detection agent.
Imagify is an injectable cardiovascular drug for the detection of coronary artery disease in stable chest pain patients with suspected or known coronary artery disease, and is based on technology that permits control of the porosity and size of nanoparticles and microparticles, Acusphere said.
Combined with stress ultrasound, Imagify delivers accurate and radiation-free myocardial perfusion assessment at a cost far lower than gold-standard nuclear stress testing, the company said. The MAA application is backed by 11 scientific studies in humans, including two Phase 3 pivotal studies that were conducted in the targeted patient population of stable chest pain patients with suspected cardiovascular disease, Acusphere said.
Acusphere submitted the MAA under a special procedure that would allow for simultaneous approval in all EU countries, the company said. The validation process has been completed and the Committee for Medicinal Products for Human Use (CHMP) is engaged in a substantive review that is expected to be completed in 2013, Acusphere said.
The company foresees an EU market of $600 million based on three million potential procedures currently being performed in the EU. Due to the high prevalence of cardiovascular disease in the U.S. and Europe, the potential market is as high as $2 billion representing 10 million nuclear stress procedures, the company said.
