HeartWare Receives Conditional Appro...( for a mean period of 90 days the Comp...),Health

report to the FDA for review. Enrolment will continue unabated at the

initial 10 centers during this review period. Subject to FDA approval

of the clinical safety report, enrolment can then be expanded to all 28

centers.

-- Patients enrolled in the HeartWare trial will be eligible for discharge

from hospital immediately following their implant.

"Receipt of this conditional approval of an IDE represents one of the most significant milestones since HeartWare's inception," said HeartWare Chief Executive Officer and President, Doug Godshall.

"We believe that the HeartWare(R) LVAS is poised to make a significant impact on the U.S. mechanical circulatory support market. This is reinforced by the high level of interest we are receiving from U.S. physicians, many of whom already anticipate the potential clinical advantages associated with our device's small size, pericardial placement and advanced peripheral systems. We are confident that these advantages, combined with the innovative structure of our trial and the FDA's consent to immediate patient discharge, will help encourage significant clinician support of the study.

"It is also pleasing that we are now within a month or two of generating our first revenue. As previously indicated, we expect to be able to charge for our system during the course of our U.S. clinical trial. We expect to supplement this revenue through commercial sales in Europe once we receive CE Mark later this year."

HeartWare will commence training for our initial U.S. clinical sites later this week and, in parallel, will seek investigational review board (IRB) approval for these sites while working towards satisfying the few conditions to our IDE. The Company expects to shortly release details regarding our initial sites and lead clinical investigators.

About HeartWare

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