News Release

European approval trial enrolment gathers momentum

Business Announcement

Research Australia

Ventracor Limited (ASX:VCR) today said recruitment at CE Mark Trial sites outside Australia was gathering momentum worldwide with the recent implantation of a patient in New Zealand, bringing the total number of patients implanted to 27 – including nine as part of the pilot trial.

Ventracor Limited Chief Executive Officer, Colin Sutton PhD said: "We are now recruiting and implanting in three countries. With our growing clinical experience outside Australia, we are on track to complete the CE Mark Trial and submit an application for approval to quickly begin selling our implantable heart device in the major market of Europe."

"Building a track record of implants enables us to gather information to demonstrate the VentrAssist is safe and efficacious, and then use that data to achieve our regulatory milestones within the predicted timeframe," he said.

"We are developing robust and repeatable treatment protocols, greatly reducing the clinical risks to patients and building confidence with the cardiologists and surgeons that recommend and use the device," Dr Sutton added.

He also noted the first patient outside Australia to be implanted at Papworth Hospital near Cambridge in England was discharged home last week.

Dr Steven Tsui, the consultant cardiac surgeon who leads the Papworth team which performed the operation told BBC Television: "His (the patient's) quality of life has been transformed with the VentrAssist and he can safely go home to wait for a suitable donor heart and have a heart transplant.

"We are very excited to be involved with this clinical trial and so far, we have been most impressed by the device," Dr Tsui said.

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About Ventracor Ventracor (ASX:VCR) is an international medical technology company that has developed a life-saving heart pump, the VentrAssistTM left ventricular assist system (LVAS) for patients in cardiac failure. The company is expects to bring the VentrAssistTM to global markets in record time, and obtaining a significant share of the potential LVAS market, which independent analysts expect to be valued at over $US5 billion per year.

The CE Mark

In Europe, the letters 'CE' on a manufactured product are a guarantee it meets the essential requirements of the relevant European Directives. For medical device manufacturers like Ventracor, this is the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. Approval to apply the CE mark to a product indicates it can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA).

For further information, please contact:

Andrew Geddes
Manager, Investor Relations
Ventracor Limited
61-294-063-086


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