ImagifyTreatment for Diagnostic
Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify
WATERTOWN, Mass.--(BUSINESS WIRE)--Dec 8, 2008 - Acusphere, Inc. today announced that the U.S. Food & Drug Administration (FDA) has posted briefing documents on its website for the December 10 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.
Imagify (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.
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. In 2006, more than 10 million of these screening procedures were performed in the United States, including more than seven million nuclear stress tests and nearly three million stress echo procedures.
About Acusphere, Inc.
Acusphere 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.
Contact: Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
HealthStar Public Relations
Dave Schemelia, 609-468-9325
Posted: December 2008
- Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments - February 18, 2009
- Acusphere Announces Results of FDA Advisory Committee Meeting - December 11, 2008
- Acusphere's Imagify to be Reviewed at FDA Advisory Committee Meeting on December 10, 2008 - October 13, 2008
- Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease - June 30, 2008
- Acusphere Submits New Drug Application for FDA Approval of Imagify - April 29, 2008