Sunshine Heart Provides C-Pulse U.S. Clini... ( ...)

Sunshine Heart Provides C-Pulse U.S. Clinical Update

Date:7/28/2009

SYDNEY, July 28 /PRNewswire/ -- 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 to have shown improvement and were able to disconnect from the device, as intended, for short periods of time. The next milestone for these patients will be evaluation at the 6 month time frame."

Don Rohrbaugh, CEO of Sunshine Heart, commented, "We are very encouraged by these 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 $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 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 E.U. and other international countries that honor CE Mark label claims for device safety. In addition, the Company will seek FDA approval for a larger ra
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