re: Ann: Major Milestone - First Module of PM... Sydney...

re: Ann: Major Milestone - First Module of PM... Sydney AUSTRALIA 3 December 2008: Ventracor Limited (ASX:VCR) reported today that the first module in the Pre-Market Approval (PMA) Application for the VentrAssist®
Left Ventricular Assist Device (LVAD) has been filed with the US Food and Drug
Administration (FDA).
The first submission is the Design Module which describes the design elements and testing of the VentrAssist LVAD, and will be followed by additional technical modules
detailing manufacturing, software validation, biocompatibility, and the Company’s quality system. The last module to be submitted will be the Clinical Module, with detailed results of the US Bridge To Transplant (BTT) Clinical Trial.
Ventracor’s Chairman, Mr. John Ward, said “On behalf of the Board, I congratulate all Ventracor employees who have worked tirelessly to prepare and submit the first part of
our PMA application. It represents an outstanding achievement by an Australian based company to be the first company in the world to start the FDA PMA application process for a third generation implantable LVAD.”
Ventracor’s Chief Executive Officer, Mr. Peter Crosby, stated: “This is a very important milestone for the Company, as it sets us on the path to full commercialisation in the US.
As we approach completion of enrolment in the BTT clinical trial, we can see that goal in sight.”
Ventracor is asking shareholders to continue to support the Company by participation in a Share Purchase Plan (SPP), details of which have been mailed to all shareholders in
Australia and New Zealand, and are available on the Company’s web site, www.ventracor.com. The closing date for the SPP is Tuesday 9 December 2008.
The VentrAssist LVAD is a third generation centrifugal pump implanted in the body to provide therapy for patients with end stage heart failure. There have now been 384
patients implanted with the VentrAssist LVAD worldwide, the longest surviving patient is over four years, and there is now over 208 cumulative patient years of experience, which is more clinical experience than all other third generation centrifugal pumps, combined.