Sunshine Heart announced that the first two patients implanted in April 2009 with the C-Pulse device 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 which include Northwestern University, Pennsylvania State University, University of Florida, University of Louisville and University of Alabama/Birmingham as well as Ohio State University. During the first quarter of 2010 the enrollment is expected to be completed. At the completion of the study cumulative end-point data will be released following review by the DSMB.
The Company following the trial’s successful completion 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. Apart from this the Company will also seek FDA approval for a larger randomized US pivotal study to support the marketing application for C-Pulse 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.