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HeartWare International, Inc.
(formerly known as HeartWare Limited)

Corporate Profile

HeartWare International, Inc. (HeartWare) is a medical device company developing a family of implantable Left Ventricular Assist Devices ("LVADs") for the treatment of advanced heart failure. The Company is listed on the Australian Stock Exchange and trades under the symbol "HIN".

Heart failure is a degenerative, terminal disease affecting over 10 million patients worldwide. Despite advances in medical therapy, the one year survival rate for patients with severe heart failure is approximately 25%. Heart transplantation is considered the best available treatment option, but fewer than 4,000 donor hearts become available worldwide each year. The use of LVADs is gaining increasing clinical acceptance, both as a bridge to transplantation and as an alternative long term therapy.

HeartWare's lead device, the HVADTM Left Ventricular Assist Device, is a miniaturized, full-output, "3rd generation" heart pump designed to be implanted above the diaphragm. The device's small size and novel configuration are expected to lead to significant clinical benefits.

HeartWare has completed an international clinical trial for the HVADTM device involving five investigational centres in Europe and Australia. HeartWare applied for CE Mark for the device in September 2008. The Company expects the device to be commercially available in Europe in early 2009.

In August 2008 HeartWare commenced a Bridge to Transplant clinical trial for the HVADTM device in the United States. Under the clinical trial HeartWare will enroll up to 150 patients at a maximm of 28 participating centres.

HeartWare is also developing a portfolio of further miniaturized devices, implantable by progressively less invasive surgery.

HeartWare's corporate headquarters are in Framingham, Massachusetts. The Company's operating and manufacturing activities are based in Miami Lakes, Florida

updated 17th December, 2008


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