May 4, 2007 - Acusphere Inc. announced that in a test on Imagify, its ultrasound contrast agent, 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.
Imagify is the first ultrasound contrast agent designed to assess perfusion. In the RAMP-2 test, its second Phase 3 clinical trial of Imagify, the company set out to demonstrate that Imagify-enhanced cardiac stress ultrasound is non-inferior to nuclear stress. Results were as follows:
Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p less than or equal to 0.001)
Sensitivity: 3 of 3 ultrasound blinded readers were superior (p less than or equal to 0.020)
Specificity: 1 of 3 ultrasound blinded readers was non-inferior (p = 0.01)
The Company believes that these results will support a strong NDA submission in Q4 2007.
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