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Acusphere Announces Results of FDA Advisory Committee Meeting
Wednesday, December 10, 2008 8:01 PM


Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere’s ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension is not sufficient to justify the risks associated with the product. The vote was sixteen against, one in favor and one abstention. The Committee also discussed concerns that they would like addressed to support approval of the product for the detection of coronary artery disease.

“We appreciate the support Imagify has received from a wide variety of cardiologists, who are eager for FDA to enable them to use the drug in their practices to improve accessibility, reduce costs and avoid exposure to radiation,” said Sherri C. Oberg, President and CEO, Acusphere. “We continue to believe in Imagify for its intended purpose and will work with FDA through the completion of the review process to determine what additional information might be required for approval.”

The Advisory Committee’s recommendations, while not binding, will be considered by the FDA in its review of the New Drug Application (NDA) of Imagify. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.

Conference Call

Acusphere plans to hold a conference call with investors tomorrow, Thursday, December 11, 2008, commencing at 8:30 am (Eastern Time). The conference call will cover the Advisory Committee meeting, and will be led by Sherri C. Oberg, President and Chief Executive Officer and Lawrence A. Gyenes, Senior Vice President and Chief Financial Officer. These Acusphere representatives will also be available for investor questions. The conference may be heard live via the investor relations section of the Company's website at www.acusphere.com or by dialing 1-800-299-7635, or internationally 1-617-786-2901 using the confirmation code: 52594832. After the conference call, a replay of the call webcast will be made available via the Company's web site and a telephone replay will be available through January 11, 2009, by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 50372331.

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.



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