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.