Imagify™ Highlights
- Cardiovascular drug for evaluating myocardial perfusion, an important marker of coronary artery disease (CAD). Potential first-to-market drug in $600 million and $2 billion addressable market in E.U. and U.S. respectively.
- Radiation-free with significant cost and convenience advantages over the standard-of-care for evaluating myocardial perfusion, nuclear stress testing.
- Two Phase 3 trials demonstrated myocardial perfusion assessment with Imagify™ (perflubutane polymer microspheres) injectible suspension is equivalent to nuclear stress testing.
- Pre-submission meetings for Marketing Authorisation Application (MAA) completed with European Medicines Agency (EMA) and rapporteurs. Discussions underway with FDA regarding special protocol assessment (SPA) for trial required for U.S. approval.
- Strong patent position with global rights owned by Acusphere and complete freedom to operate.