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