Acusphere Inc (ACUS) SEC Filing 10-Q Quarterly report for the period ending Saturday, June 30, 2007

 

EXHIBIT 99.1

FOR IMMEDIATE RELEASE

Acusphere, Inc. Reports Q2 2007 Financial Results and
Operating Highlights

WATERTOWN, Mass., August 8, 2007 --- Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the quarter ended June 30, 2007 and commented on its operational priorities and progress, including its planned NDA submission in Q4 2007 for its lead product candidate, Imagify

(TM) (perflubutane polymer microspheres) Injectable Suspension, a cardiovascular drug in late-stage development for use in screening for coronary artery disease.

Operating Priorities

Acusphere’s main priorities remain the same:

·                  Preparing for the regulatory submissions for Imagify

·                  Preparing for the commercialization of Imagify

·                  Advancing other product development candidates

The Company continues to focus on the steps necessary to submit an NDA for Imagify and support the MAA filing in Europe by Nycomed, its European partner. In addition to preparing the clinical sections of the NDA in electronic filing format, Acusphere is working to qualify its commercial manufacturing facility for Imagify, including aseptic validation, process performance qualification and continued product stability testing. The Company plans to complete these qualification steps in time to support a Q4 2007 NDA submission. In addition, the Company plans to announce a product development program later in the third quarter this year, addressing other opportunities for the application of its proprietary microsphere technology.

Imagify Clinical Results

On May 1, 2007, the Company announced that it exceeded the criteria for success for two of the primary endpoints, accuracy and sensitivity, in RAMP-2, its second Phase 3 clinical trial of Imagify. All three of the ultrasound-blinded readers had superior sensitivity and non-inferior accuracy to nuclear stress, the most frequently used imaging procedure for the assessment of coronary artery disease. Although RAMP-2 did not achieve the specificity endpoint, the Company had previously reported superior specificity for Imagify in its first Phase 3 trial, RAMP-1. High accuracy and sensitivity were the top priorities in RAMP-2. The Company believes that it now has two Phase 3