Look up the Texas Heart Institute .Framingham, MA and Sydney, Australia: HeartWare Limited (ASX: HTW) today announced that
Texas Heart Institute (Texas Heart) became the first US centre to be trained in the use of the
HeartWare® Left Ventricular Assist System (LVAS). The training session was attended by 3 cardiac
surgeons and 15 clinical support staff. The team at Texas Heart is now ready to begin implants in the
United States under HeartWare’s pivotal Bridge-to-Transplant clinical trial, subject to approval by
Texas Hearts’ Institutional Review Board.
The Texas Heart Institute is one of the largest cardiovascular hospitals and one of the highest-volume
heart transplantation centres in the United States. Texas Heart also runs one of the world’s most
active mechanical circulatory support programs, implanting approximately 70 ventricular assist
devices each year. The program is led by Dr O. Howard ‘Bud’ Frazier, Chief of Cardiopulmonary
Transplantation and Director of Cardiovascular Surgical Research. Dr Frazier, who also chairs
HeartWare’s Medical Advisory Board, is credited with having performed more VAD implants than
any other surgeon worldwide.
“It seems fitting that Texas Heart is our first center trained since Dr. Frazier has been intimately
involved in both the development of our technology and in the strategic direction of the company for
several years,” said Jeff LaRose, the Company’s Chief Scientific Officer.
As detailed in the Company’s announcement of 5th May 2008, HeartWare is permitted initially to
open up to ten centres under the conditional approval of its Investigational Device Exemption[JHF1]. It
is expected that all ten centres will undergo training in the use of the HeartWare® LVAS over coming
weeks.
Redomiciliation
As noted in recent filings and at the Company’s Annual General Meeting last week, it is the
Company’s intention to redomicile to the United States in the second half of 2008, subject to due
diligence and the satisfaction of relevant legal requirements, including approval by the holders of our
shares, share options and performance rights and approval by the Australian Federal Court.
Redomiciliation is expected to allow greater access to the US capital markets and also reduce
significant compliance and other administration costs that HeartWare currently faces as a company
required to comply with US and Australian reporting and other legal requirements.
After the redomiciliation, the Company intends to maintain its listing on the ASX. The Company’s
current business, operations, directors and management will not change as a result of the
redomiciliation.
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