EDEN PRAIRIE, Minn., April 3, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq: SSH ) today announced that its flagship C-Pulse® Heart Assist System will be the subject of presentations at The International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting and Scientific Sessions, April 10-13 at the Manchester Grand Hyatt in San Diego, CA.
Dr. Holger Hotz of Cardio Centrum Berlin will present a poster (Abstract 553) titled "Preliminary Results From the C-Pulse® System European Multicenter Study" The poster will be available on Thursday April 10, 2014 10:00 AM - 7:15 PM in the Harbor and Seaport Foyer (poster hall). The oral presentation is scheduled for Thursday, April 10, 2014 between 6:15PM and 7:15PM at the same location.
Dr. Allen Cheng of the University of Louisville will present a poster titled "Extended Extra-aortic Counterpulsation Support with C-Pulse Device Does not Alter Aortic Wall Structure" (Abstract 885). The poster will be available on Friday April 11, 2014 10:00 AM - 6:30 PM in the Harbor and Seaport Foyer (poster hall). The oral presentation is scheduled for Friday, April 11 2014 between 5:30PM and 6:30PM at the same location.
The abstracts for the presentations that will be made at the ISHLT Annual Meeting 2014 will be available at www.sunshineheart.com .
About the OPTIONS HF Study
Initiated in February, 2013, the OPTIONS HF study is a post market, multi-center, prospective, open label study that will include 50 patients across eight to ten European centers. The study also includes a Canadian based center. OPTIONS HF is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system concurrent with the Company enrolling in its COUNTER HF™ US investigational pivotal trial.
About the C-Pulse ® Heart Assist System
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their condition as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to investigational use.
About Sunshine ® Heart
Sunshine Heart, Inc. (Nasdaq: SSH ) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.
Forward-Looking Statements
Certain statements in this release are forward-looking statements that are based on management's beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption "Risk Factors" and elsewhere in our filings with the SEC. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.
For further information, please contact: Investor: Candice Knoll Blueprint Life Science Group T: +1-415-375-3340 Ext. 105 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. T: +1-952-345-4200 Media: David Schull Russo Partners T: +1-212-845-4271 Andreas Marathis Russo Partners T: +1-212-845-4235
