3 data and comment 3, page-5

From Ventracor's web site -ABN Report:

Extract:
" Pilot Trial underway.
The pilot trial involves implanting the VentrAssistTM device in up to 10 patients who suffer from end-stage congestive heart failure and have not responded to traditional drug therapy or are not eligible for a heart transplant.

The Pilot Trial will be conducted by a medical team led by Prof Don Esmore and Prof David Kaye. The aim of the pilot trial is to assess the safety of the VentrAssist device as a permanent support system for the heart.

Assuming the pilot trial is successful, a larger Pivotal Trial involving a larger number of patients will commence at up to 20 trial centres. Data from the pivotal trial will be used to gain the appropriate regulatory approvals to enable the device to be sold.

Pivotal Trials are key to product registration We expect in early calendar 2004 a more extensive ’pivotal trial’ will commence involving approximately 55 to 60 implants. At this stage, the pivotal trials are likely to first commence in Europe and then in the US.

The focus is on the European markets, where the regulatory hurdles are slightly easier with an emphasis on proving the safety of the device. Assuming the data from the pivotal trial is positive, this should enable Ventracor to first enter Europe.

We are now assuming that the first sales are to be made into the European market in FY05. European markets represent just under 50% of the target market. We expect sales will commence in the US in FY07".

Gerry
Please do your own research and you decide if and when to buy, hold or sell.