News & Events

Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced today that the first two patients implanted with the C-Pulse device in April 2009 at The Ohio State University Medical Center in Columbus, Ohio have successfully completed their 3 month follow-up evaluation.

Sunshine Heart's Medical Director, William Peters MD reported, "Both patients were reviewed in the outpatient clinic by hospital staff and all tests scheduled at three months were completed. Both patients appeared well perfused and were able to disconnect from the device as intended for short periods for personal convenience. The two patients will return to hospital for study end-point testing at six months."

Don Rohrbaugh, CEO of Sunshine Heart, commented, "We are very encouraged by the patients' response with the C-Pulse device. We look forward to generating additional data from this study to support our global regulatory strategy. We are particularly pleased to report the Company received reimbursement of US$108,000 from The Ohio State University for these two patients; the first such revenue for Sunshine Heart."

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 Ohio State University. Enrollment is expected to be completed during the first quarter of 2010. Cumulative end-point data will only 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.

"We continue to be excited with the prospects of the C-Pulse clinical trial in the US", said Dr Peters, co-founder of Sunshine Heart and inventor of C-Pulse. "As demonstrated in prior clinical studies, the C-Pulse system increases blood flow to the body and to the heart muscle itself without coming into direct contact with the blood. Importantly, the non-blood contacting feature of the device allows patients to intermittently disconnect from C-Pulse for convenience. It is anticipated that C-Pulse will offer patients a significant improvement in quality of life and with an acceptable risk profile."