Acusphere Announces Publication of Imagify Phase 3 Trials in the European Journal of Echocardiography
Paper concludes that Imagify is well-tolerated and its diagnostic performance is comparable with nuclear imaging
WATERTOWN, Mass.--(BUSINESS WIRE)--Jan 21, 2009 - Acusphere, Inc. (OTCBB: ACUS) today announced that an original paper summarizing the Phase 3 clinical trial results 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, has been published in the current issue of the European Journal of Echocardiography. The paper concludes that Imagify Perfusion Stress Echo is well-tolerated, and that its diagnostic performance in chest pain patients is comparable with single photo emission computed tomography, or SPECT, perfusion imaging. The paper, entitled “Detection of Coronary Artery Disease with Perfusion Stress Echocardiography Using a Novel Ultrasound Imaging Agent: Two Phase 3 International Trials in Comparison with Radionuclide Perfusion Imaging,” is authored by Dr. Roxy Senior, Consultant Cardiologist and Director of Cardiac Research, Department of Cardiovascular Medicine and Institute of Postgraduate Medical Education and Research at Northwick Park Hospital in the U.K., among others. Dr. Senior was the lead clinical investigator for Acusphere's clinical trials for Imagify.
The paper appears in the January 2009 issue, Volume 10, Pages 26-35.
About Acusphere, Inc.
Acusphere (OTCBB: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (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 procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
Posted: January 2009