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Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify™
Monday, December 08, 2008 10:07 AM


Acusphere, Inc. (NASDAQ: ACUS) today announced that the U.S. Food & Drug Administration (FDA) has posted briefing documents on its website for the December 10th Cardio Renal Advisory Committee (CRAC) Meeting. The CRAC will be asked to review and discuss the New Drug Application (NDA) filed by Acusphere for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States.

Briefing documents from FDA and Acusphere can be found on the FDA website at www.fda.gov/ohrms/dockets/ac/acmenu.htm.

In addition, a glossary of terms can be found on the Acusphere website (www.acusphere.com), by following the link from the homepage.

About ImagifyTM

ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease. Myocardial perfusion is blood flow in the heart muscle and is a sensitive marker of coronary artery disease. Currently, perfusion information is not available using cardiac ultrasound but must be obtained using a nuclear stress test, which is the most frequently used imaging procedure for detecting coronary artery disease. Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques.

About CAD

According to the American Heart Association, approximately 16 million people in the United States suffer from coronary artery disease, the single leading cause of death in the United States. CAD is characterized by the accumulation of plaque, which narrows coronary arteries and reduces blood flow in the heart muscle. The reduced blood flow can cause chest pain, and if the plaque ruptures, it may cause a heart attack. The American Heart Association estimates that the direct and indirect cost of CAD in the United States for 2007 is more than $150 billion.

Early detection of CAD can save lives, reduce treatment costs and improve patients’ quality of life. Two of the most common methods of CAD screening are nuclear stress imaging and stress echocardiography, or “stress echo”— ultrasound of the heart.



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