asx release: htw patent case., page-8

Thank you for your interest Hildweler. Here's the trial update but go to the htw website for more help:

ASX ANNOUNCEMENT
1 August 2005
HeartWare Completes Final HVAD Implant in GLP Study
HeartWare is pleased to announce that surgeons at the Texas Heart Institute last week performed a
sixth successful pre-clinical implantation of the HeartWare HVAD under Good Laboratory Practice
(“GLP”) conditions. HeartWare expects this to be the final implant required under the GLP study.
Also last week, a further two HVAD GLP studies reached the 90 days required by the pre-clinical
protocol. This brings to four the number of HVAD devices which have successfully concluded the
90 days GLP implant period. In all four cases, analysis of the device along with pathology tests
conducted at the Texas Heart Institute indicates that the pumps performed very well. The fifth GLP
study will be concluded in August.
HeartWare CEO, Mr Stuart McConchie, commented:
“These excellent pre-clinical results indicate that the HVAD continues to perform according to
design. HeartWare remains on track to commence clinical trials in the first quarter of 2006 as
forecast in our Prospectus. The HeartWare team in both Miami and Sydney, along with the staff at
the Texas Heart Institute, should be commended for their dedication and skill in achieving these
outstanding results.
The HVAD continues to demonstrate that HeartWare’s patented technology represents the state-ofthe-
art in implantable mechanical cardiac assistance. Together with the BiVAD procedure
performed by Dr Frazier at the Texas Heart Institute last week, HeartWare has reinforced the
opportunity for its products to address the full range of clinical applications for mechanical cardiac
assistance”.
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
www.heartware.com.au
For more information:
Howard Leibman Paula Hannaford / Stuart Barton
HeartWare Limited Gavin Anderson & Company
(02) 8215 7604 / 0402 440644 0413 940 180 / 0404 054 857