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29/07/05
11:34
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ASX ANNOUNCEMENT 29 July 2005 HeartWare HVADs Implanted Successfully in Experimental Biventricular Support Procedure HeartWare is pleased to announce that, in an experimental procedure at the Texas Heart Institute (Houston, Texas), Dr O.H. (Bud) Frazier implanted two HeartWare HVADs configured to provide fully implanted biventricular support in a calf. Dr Frazier said of the BiVAD procedure using the HVAD: "This initial experimental procedure was performed to assess both the feasibility of fitting and the function of two HVADs configured as a BiVAD. The result of the short term implantation was favourable in every aspect. The size and geometry of fit of the HVAD is more conducive to use as a BiVAD than other available continuous flow pumps. I believe that this technology offers the greatest hope for accelerating the viability of implantable biventricular support." Dr. Frazier is Chief of Cardiopulmonary Transplantation Services at the Texas Heart Institute and is Chairman of the HeartWare Advisory Board. He is widely credited as being a pioneer in the area of cardiac assist device surgery. Together with HeartWare, Dr Frazier plans further procedures with the HVAD to refine the techniques used to implant the BiVAD. As detailed in the Company's Prospectus, HeartWare's primary target for the HVAD remains left ventricular support. However, the use of two HVADs specifically configured to provide biventricular support gives rise to an entirely new application for the device, providing access to a potentially large additional patient population. The HVAD's small size, which allows it to be implanted within the thoracic cavity, along with its full cardiac output capacity, position the device uniquely for use in this new clinical application. About Biventricular Support Biventricular support is required when patients suffer failure of both their right and left ventricular chambers, putting them at imminent risk of death. Many of these patients are too ill to receive a heart transplant, even when a donor organ is available. Biventricular support is currently only available using large volume displacement pumps, temporary external systems or the total artificial heart. The HeartWare HVAD is currently the smallest continuous flow pump capable of generating sufficient flow to completely replace the heart's full output. HeartWare ASX Announcement – 29 July 2005 2 About HeartWare HeartWare is developing a family of proprietary circulatory heart assist devices to treat patients with congestive heart failure. Heart failure affects 10 million people globally, with over one million new patients diagnosed every year. HeartWare's first left ventricular assist device, the HVAD, is expected to commence human clinical trials in early 2006, with first sales planned for 2007. With a volume of 45cc, the HVAD is substantially smaller than other "third generation" full output pumps in development, giving rise to significant potential clinical advantages. Further information on HeartWare is available at