Data Presented in Oral Session at American Heart Association Meeting
Further Demonstrates Imagify’s Clinical Value
Acusphere, Inc. (NASDAQ: ACUS) announced that additional analyses from
its Phase 3 clinical trials of Imagify™
(Perflubutane Polymer Microspheres) for Injectable Suspension were
presented today at the annual American Heart Association Scientific
Sessions in New Orleans, Louisiana. These results build upon the thesis
presented at AHA last year that Imagify Perfusion Stress Echo is an
effective and well-tolerated, minimally invasive approach to evaluating
chest pain patients at risk for heart attack. The new analysis ascribes
incremental predictive value to the use of Imagify for detecting
coronary artery disease over other current clinical risk factors.
Imagify is the first echocardiography imaging agent designed and shown
in clinical trials to assess myocardial perfusion (blood flow in the
heart) accurately. Myocardial perfusion is a sensitive marker of
coronary artery disease (CAD). Currently, perfusion information is not
available using stress echocardiography (cardiac ultrasound), but must
be obtained using a nuclear stress test. Imagify Perfusion Stress Echo
would have many potential benefits over nuclear stress testing including
quicker results, lower cost and no exposure to radioactivity. More than
10 million stress imaging procedures are done each year in the U.S. to
detect CAD, the leading cause of death in the United States.
“We are pleased that the American Heart
Association has once again selected additional analyses of Acusphere’s
clinical trials on Imagify for oral presentation to the physician
community here at the Scientific Sessions. We are confident that the
continuing interest from clinicians for a valuable non-invasive
predictive tool that helps detect coronary artery disease early on will
assist us as we await approval from the U.S. Food & Drug Administration
for Imagify,” said Sherri C. Oberg, President
and CEO of Acusphere. “Imagify is a novel
cardiac perfusion imaging agent, which for the first time will enable
myocardial blood flow assessment in stress echo procedures, addressing a
significant medical need.”
Michael Picard, M.D., Director, Clinical Echocardiography at
Massachusetts General Hospital Heart Center gave the presentation and
stated, “As described in the presentation, we
continue to see that Perflubutane Polymer Microspheres for Injectable
Suspension represent a technique that can easily be integrated into the
current application of echocardiography. While we currently detect wall
motion abnormalities with cardiac ultrasound the simultaneous addition
of myocardial blood flow information that this technique makes
possible should provide strong benefits in helping us better evaluate
patients at risk for heart disease.