MMD unknown

FDA Talks Encouraging/Earnings Update

  1. 635 Posts.
    FDA Talks Encouraging/Earnings Update

    MICROMEDICAL INDUSTRIES LIMITED 2002-05-21 ASX-SIGNAL-G
    HOMEX - Brisbane

    MMD is pleased to announce that discussions just concluded with
    United States regulatory authority, the Food & Drug Administration
    (FDA), on the clinical trials process for the VentrAssist(TM)
    "artificial heart", were extremely encouraging, according to the
    Group Managing Director & CEO of MicroMedical Industries, Mr Michael
    Spooner.

    All indications from the FDA lead us to believe that the protocols
    and data, collected as a result of our global clinical trials will be
    acceptable to the FDA as well as other key regulators.

    We expect to achieve sales of the VentrAssist(TM) device initially in
    Europe, which is a key market. This accelerated approach to Europe
    means that MicroMedical will achieve sales more quickly. Importantly,
    this will not affect, and in fact should expedite, our global agenda
    to be a major player in the Left Ventricular Assist Device (LVAD)
    market.

    Formal discussions with hospitals' ethics committees are due to
    commence shortly and initial recruitment of European, United States
    and Australian hospitals has already commenced.

    We are continuing to meet, or exceed, all benchmarks set for the
    commercialisation process for the VentrAssist(TM). In this respect
    the first batch of VentrAssista artificial hearts, which meet fully
    manufactured specifications to support the global clinical trials
    process, have been received and more are expected shortly.

    We remain on track to achieve our goal of commencing the first human
    implant later this year in Australia.

    The company has achieved a number of significant milestones over the
    past 12 months which is reflected in our estimated loss for the
    financial year ended 30 June 2002 of approximately $8.5 million.

    MicroMedical currently has $20 million in cash reserves. These cash
    reserves will enable MicroMedical to continue to achieve key
    milestones in the commercialisation process including a number of
    human implant trials.

    The VentrAssist(TM) "artificial heart" device is a 3rd generation
    Left Ventricular Assist Device (LVAD), which provides a real
    alternative to around 800,000 end-stage congestive heart failure
    patients worldwide facing the prospect of no effective treatment. The
    market for the VentrAssist device is independently valued at between
    US$7b and US$12.5b per annum.

    For further information, please contact:

    Michael Spooner
    GROUP MANAGING DIRECTOR & CEO
    MicroMedical Industries Limited

    T: 02 9422 3100
    E: [email protected]

    Julie Meldrum
    MANAGER CORPORATE COMMUNICATIONS
    MicroMedical Industries Limited

    T: 9244 3100
    M: 0419 228 128
    E: [email protected]

 
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.