ASX ANNOUNCEMENT2 November 2005Successful Completion of Animal...

ASX ANNOUNCEMENT
2 November 2005
Successful Completion of Animal Studies
HeartWare is pleased to announce the completion of animal studies for
the HVAD, the Company's lead
mechanical assist device for the treatment of patients in cardiac failure.
In the second quarter of 2005 HeartWare commenced its final series of
animal studies for the HVAD,
conducted at the Texas Heart Institute under Good Laboratory Practice
(GLP) conditions. As previously
detailed to the market, this study required the implantation of the
device in six sheep, each for a period of 90
days.
We are pleased to advise that surgeons at the Texas Heart Institute
last week explanted the sixth device,
marking the end of the GLP study. As with the previous implants,
pathology analysis has confirmed that the
device performed exceptionally well during the implant period.
Specifically, the level of haemolysis (blood
damage) was minimal and there was no evidence of pump-related
thrombogenesis (blood clotting).
HeartWare CEO, Mr Stuart McConchie, commented:
"Early this year we made the decision to conduct our entire GLP study
in sheep, without the use of anticoagulants,
thereby subjecting the pumps to a particularly rigorous test protocol.
Despite this, all six pumps
have achieved the 90 day implant period and performed according to
design. The results of this final explant
confirm the HVAD's exceptional performance characteristics.
The completion of our GLP study marks a significant transition for
HeartWare. Data from the study form a
critical component of HeartWare's submissions to various regulatory
authorities to commence our human
clinical trial. We expect to lodge these submissions within weeks and
remain confident of achieving our first
human implant within the first quarter of 2006."
About HeartWare
HeartWare is developing a family of proprietary circulatory assist
devices to treat patients with congestive
heart failure. HeartWare's lead 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 the smallest "third generation"
full output pump in development.
For further information:
www.heartware.com.au