SYDNEY, July 28 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 randomized U.S. pivotal study to support the submission of a marketing application for C-Pulse in the U.S. during the second half of 2010.
"We continue to be excited with the prospects of the C-Pulse clinical trial in the U.S." 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."
For more information and a video update on C-Pulse clinical trial patients please visit the Company's website at http://www.sunshineheart.com/cpulse-first-us-patient.html.
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.
About Sunshine Heart
Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse(TM) an implantable, non-blood contacting, heart assist therapy for the treatment of people with advanced heart failure. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart's pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20 person U.S. clinical trial with C-Pulse and patient enrollment has commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.
For further information, please visit www.sunshineheart.com or contact:
This press release may contain forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Securities Exchange.
Contact: Investors/Media: Don Rohrbaugh The Ruth Group Chief Executive Officer R.J. Pellegrino/Scott Lerman +1 714 259 0732 646-536-7009/7013 email@example.com firstname.lastname@example.org email@example.com
SOURCE Sunshine Heart