Acusphere, Inc. Issues Letter To Shareholders

Acusphere, Inc. (ACUS.PK) today issued the following letter to shareholders:

Dear Fellow Shareholders:

As I have done in the past, I want to provide you with an update on the Company’s progress since my last letter of October 2009, and our plans moving forward in the coming months. We have made substantive progress on our stated goals, and we are now working diligently on the next phase of our strategy. Moving the development of our lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension, forward remains our critical mission, because it remains the leader in myocardial perfusion assessment with ultrasound, an important investigational area. It continues to show promise in addressing a potential $2 billion market that is growing, and it offers compelling competitive advantages over the standard of care, nuclear stress testing. We continue to believe strongly in Imagify’s potential for the condition proposed, and we are committed to realizing that opportunity.

As you know, in early 2009, we received feedback from the U.S. Food & Drug Administration (FDA) in the complete response letter to our New Drug Application (NDA) stating that another clinical trial would be required for U.S. approval, this one demonstrating that Imagify with ultrasound is superior to ultrasound without Imagify. With that feedback, we quickly took steps to reduce our burn rate dramatically, and we restructured our partnership agreements to regain worldwide rights to our Imagify intellectual property. Since then, we have completed several pivotal tasks that are critical to our ability to close a partnership with a larger pharmaceutical company – achieving greater clarity about the U.S. trial design, cost and timing, as well as the likely requirements for approval of Imagify in Europe. I am pleased with our progress on each of these.

Imagify Is the Leader in Myocardial Perfusion Assessment with Ultrasound

First a word on Imagify’s current market position. Ultrasound is one of the least expensive, most widely available and most convenient ways to image the body, but ultrasound alone is not capable of assessing myocardial perfusion (e.g. blood flow in the heart muscle). The ability to evaluate perfusion in the heart muscle allows for early detection of coronary artery disease (CAD) – the leading cause of death in the U.S. and many other parts of the world. We believe that Imagify, if approved, has the potential to improve the ability of heart stress ultrasound tests (stress ultrasound) to compete with the nuclear stress test, an inconvenient and expensive standard for assessing perfusion today. More than 10 million nuclear stress tests and stress ultrasounds are performed each year in the U.S., providing Imagify with a market potential of more than $2 billion per year in the U.S. alone. In Europe, approximately 3 million CAD imaging procedures are performed each year, representing an additional $600 million market, with substantial opportunity for growth since the prevalence of heart disease is about the same as in the U.S. and the population sizes are similar. We believe our Imagify Phase 3 clinical program demonstrates that the efficacy of Imagify with ultrasound is non-inferior, or equivalent, to nuclear stress. Imagify was evaluated in more than 1,000 patients and as a result, we believe that it is well tolerated, with a safety profile similar to other drugs used in this patient population.