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Acusphere Inc.
Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
March 6th, 2009
Acusphere Inc. (OTCBB: ACUS) announced that it has submitted an amendment to its New Drug Application (NDA) for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension. Imagify is designed for the detection of coronary artery disease, the leading cause of death in the United States. The NDA was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million cardiac stress imaging procedures are done each year in the U.S. of which 6.5 million are...
Source: Health Business Week (2009-03-06)
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