News & Events

Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced today an update on the first four patients implanted with the C-Pulse device at The Ohio State University Medical Center in Columbus, Ohio and Jewish Hospital in Louisville, Kentucky.

Don Rohrbaugh, CEO of Sunshine Heart, commented, "We are very encouraged by the responses we have seen with the first four patients to receive the C-Pulse device in our US trial. All of these patients have shown visible signs of improved circulation and were able to successfully disconnect from the device. Since completing the procedure, they all continue to show improvement and symptomatic relief, with improved quality of life. We look forward to meeting our target enrollment of 20 patients with the goal of supporting US approval of C-Pulse as a minimally invasive solution for heart failure patients. We are
pleased to announce that a video update on these patients is now available on our website, and I urge all of you to take a first-hand look at their progress."

Six university hospitals are involved in the study, including Northwestern University, Pennsylvania State University, University of Louisville, University of Florida and University of Alabama/Birmingham as well as the Ohio State University. Enrollment is expected to be completed during the first quarter of 2010. Cumulative end-point data will be released following review by the DSMB at the completion of the study.

Following the trial's successful completion, the Company will request CE Mark approval to market C-Pulse in the EU and other international countries that honor CE Mark label claims for device safety. In addition, the Company will seek FDA approval for a larger randomized US pivotal study to support the submission of a marketing application for CPulse in the US during the second half of 2010.

For more information and a video update on C-Pulse clinical trial patients including recent media clips please visit the Company's website at http://www.sunshineheart.com.

About Advanced Heart Failure
Heart failure is a common condition in which the heart becomes unable to pump
sufficient blood to meet the body's needs. Over five million people in the United States have heart failure and it results in over 300,000 deaths each year. Heart failure is a progressive condition and typically results from damage to the heart muscle arising from a heart attack or virus.

Cardiologists use a classification system to define the four classes of heart failure; each class is determined by rating a patient's symptoms to everyday activities and quality of life. Over 1.4 million US heart failure patients are in the Class III, an advanced heart failure category, which is defined by the limitation of physical activity. These patients are comfortable at rest, but levels of activity regarded as less than ordinary cause fatigue, palpitation, and/or shortness of breath. The most common treatments for Class III heart failure are drugs, lifestyle adjustments, family education, device therapy (i.e. heart failure
pacemaker with or without a defibrillator), or surgery. A major medical treatment
challenge is that the drug therapy and CRT options often stop alleviating symptoms over time, hence the need for C-Pulse heart assist.