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Michael Catalin Vlaicu
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  • FDA Watchlist - ACUS 1 comment
    May 9, 2009 10:28 AM | about stocks: ACUSD

    Acusphere, Inc.

    (Public, OTC:ACUS)

    It is important to note that as with all FDA pending approvals, there is a tremendous amount of uncertainty. However, just remember that amongst uncertainty lies opportunity!

    That being said, continuing with the FDA journey to riches I have chosen ACUS as my next prime target. I see alot of benefit and potential in this company, not only from its currently cheap PPS, but also from the vast potential market. The time is now to load up on this company (if you haven’t already done so) while the price is still at a discount. I expect big things to come within the next two weeks, so fasten your seat belts and let your portfolio fly.


    About: Acusphere, Inc. is a specialty pharmaceutical company that develops drugs and formulations of existing drugs using its porous microparticle technology. This technology enables the Company to control the size and porosity of particles, including nanoparticles and microparticles, so that the particles can be customized to address the delivery needs of a variety of drugs.

    FDA News: Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.

    Approximately 16.0 million people in the United States suffer from coronary artery disease (NYSEARCA:CAD), and it is the leading cause of death in the United States. [American Heart Association, Heart Disease and Stroke Statistics, 2007]. CAD is characterized by the accumulation of plaque and can reduce blood flow in the heart muscle often leading to recurrent chest pain, heart attack, or death. Early identification and intervention are crucial.


    A key indicator of the presence of CAD is blood flow (perfusion) deficits in the heart muscle (myocardium). The current standard for detecting perfusion deficits is through conducting a Nuclear SPECT Stress Test (Nuclear Stress Test) which is expensive, time consuming and exposes patients and providers to radiation.

    We are developing Imagify™ to address a clinical need for an effective and rapid non-invasive means to identify the presence of CAD before a patient has an event without the use of radiation.

    Imagify is an ultrasound imaging agent comprised of perflubutane gas in a synthetic biodegradable microsphere whose primary components are already used in other approved pharmacologic products such as surgical sutures. Imagify is administered intravenously and is intended to allow visualization of perfusion deficits in the myocardium in addition to movement of the muscular walls of the heart.

    Potential benefits of cardiac ultrasound enhanced with a perfusion imaging agent include the following:

    Clinical Information

    • Cardiac stress ultrasound with a perfusion imaging agent has the potential to provide information on both myocardial perfusion and real-time wall motion simultaneously.
    • Cardiac stress ultrasound has the potential to provide real-time information without requiring post-processing and analysis.

    No Radioactivity

    • Ultrasound contrast agents usually do not require special licensing for storage and handling, have a long shelf life, and are convenient to use and store.
    • Nuclear stress tests use radioactive materials that create additional costs due to preparation, storage and disposal requirements.

    Less Time

    • Nuclear stress tests typically take five hours, while ultrasound procedures typically take less than one hour.

    Lower Expense

    • The cost of performing an ultrasound imaging procedure using ultrasound with a perfusion contrast agent is expected to be significantly less than for a nuclear stress test.

    Stay tuned as next week I will release news on a company with treatment of chronic heart failure which has amassed a very high probability of FDA approval based on preliminary tests and studies.

    Stocks: ACUSD
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Comments (1)
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  • Harry M
    , contributor
    Comment (1) | Send Message
     
    Hey Mike
    I was doing some research about ACUS, everything was looking in favor of ACUS until one comment on 'GOOGLE Finance' forced me to think about that
    and i believe that guy has valid point about ACUS.
    He said that everyone is talking about an expected PDUFA decision date of 5/31/09, but he hasn't seen anything like this on company's website or anyother official resource, he claims that some smart people are spreading this rumor just to get more profit. Now i'm concerned too.
    Would you please clear our doubt.
    21 May 2009, 03:09 AM Reply Like
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