first sales

ASX ANNOUNCEMENT
31 March 2009
First International Sales of HeartWare® Ventricular Assist System and
US Clinical Trial Enrolment Update
Framingham, MA and Sydney, Australia, 31 March 2009 – HeartWare International, Inc.
(NASDAQ: HTWR - ASX: HIN) today announced that it had commenced international sales of the
HeartWare® Ventricular Assist System, with the Company having sold systems in both Europe and
Australia over recent weeks.
In Europe, receipt of CE Mark allows the system to be sold as an approved medical device. In
Australia, prior to the system being approved by the Therapeutic Goods Administration (TGA), the
system is being made available to hospitals at normal commercial pricing under the TGA’s Special
Access Scheme. The first international sale was made to St Vincent’s Hospital in Sydney, Australia
in mid February. The first sale in Europe was to Hannover Medical Center, Germany.
The company’s U.S. clinical trial has now enrolled 17 patients. Implants have been conducted at 7
centers, including Washington Hospital Center, Jewish Hospital Louisville, Northwestern Memorial
Hospital, The University of Michigan Medical Center, The Cleveland Clinic, Ohio State Medical
Center and Penn State Hershey Medical Center.
“It is pleasing to witness momentum building in our U.S. clinical trial in concert with our first
international commercial revenues,” said HeartWare CEO, Doug Godshall. “We expect to see
revenues continue to build month to month as we accelerate international commercial activity and as
the number of active U.S. clinical sites continues to increase.”
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or Left
Ventricular Assist Devices (LVADs), to treat patients suffering from advanced heart failure. The
HeartWare® Ventricular Assist System features the HVAD™ pump, the only full-output pump
designed to be implanted next to the heart, avoiding the abdominal surgery generally required to
implant competing devices. HeartWare has completed an international clinical trial for the device
involving five investigational centres in Europe and Australia. The device is currently the subject of a
150-patient clinical trial in the United States for a Bridge-to-Transplant indication.