Heartware International (HIN)

Shares / Stock Code

HIN

Stock Exchange / Sharemarket

ax

Heartware International (HIN) 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 both the Nasdaq Stock Market and the Australian Securities Exchange (ASX). HeartWare common shares trade on Nasdaq under the symbol "HTWR". HeartWare CDIs (Chess Depository Interests) trade on ASX under the symbol "HIN". Each common share on Nasdaq is equivalent to 35 CDIs on ASX.

Heart failure is a degenerative, terminal disease affecting over 20 million patients worldwide. Approximately 1 million patients suffer from Class IV heart failure, the end stage of the disease. Heart transplantation is considered the best available treatment option, but only approximately 3,000 donor hearts become available worldwide each year. LVADs are used to bridge patients until a donor heart becomes available (so called Bridge-to-Transplant therapy) or, increasingly, as a long- term alternative to transplantation (so called Destination Therapy.) Investors can trade Heartware International shares on the Australian Stock Exchange (ASX).

The HeartWare Ventricular Assist System features a miniaturized implantable centrifugal pump capable of producing up to 10 liters per minute of blood flow. The pump is designed to be implanted above the diaphragm, directly adjacent to the heart, thereby avoiding the abdominal surgery generally required to implant competing devices.

HeartWare has completed enrollment of a 50-patient international clinical trial. The Company received CE Mark approval for the System in January 2009 and the System is now commercially available in Europe. In the United States, the System is the subject of an ongoing Bridge-to-Transplant clinical trial under which HeartWare enrolled 140 patients at 30 participating centers. Patient follow-up for that study is expected to conclude in August 2010, with subsequent PMA submission to the FDA. HeartWare is also seeking to commence a Destination Therapy clinical trial in the United States.

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. The company was listed on Australian Stock Market on 3 November, 2008.