Ventracor (ASX: VCR) today reported growing momentum in its European BRACE Study (Better Results And Cost Effectiveness) of the VentrAssist, building on the achievement of major milestones in December_2006.
Ventracor’s Chief Executive Officer, Peter Crosby, said: “The BRACE Study is a crucial element of our European marketing effort of the VentrAssist. There are now six European centers implanting under the BRACE protocol, with growing interest.”
Mr Crosby added, “On 16 January the BRACE investigators’ meeting in Switzerland was attended by over 20 investigators from over 10 participating centers from UK, France, Germany, Scandinavia, and other European countries.”
Ventracor’s recent achievements include:
CE Mark Approval to market the VentrAssist in Europe; Target recruitment reached of ten patients in the US Bridge to Transplant (BTT) Feasibility Trial; FDA agreement to the Company’s request to expand the number of patients and number of centers under the feasibility protocol; Agreement with the FDA on the BTT Pivotal Protocol; Conditional approval from the FDA for a novel and innovative trial design for Destination Therapy, which it is anticipated will lead to more rapid recruitment than previous DT trials.
Mr Crosby added, “Ventracor has the greatest world wide experience of a third generation centrifugal LVAD with over 42 cumulative patients years of support in more than 80 implants and 13 implanting centers in Europe, Australia, New Zealand, and the US. We believe there are more VentrAssist implants than all other 3G centrifugal pumps combined. The VentrAssist is the only third generation LVAD in clinical trials in the US, and the only centrifugal pump in clinical trials in the US.”
Mr Crosby and the Company’s Chief Financial Officer, Graeme Fallet, have recently been meeting with investment analysts and institutional investors in both the US and Australia to communicate the strong recent progress. A copy of the presentation is attached.