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]
MMD
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