News & Events

EDEN PRAIRIE, Minn., April 28, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced the appointment of Kimberly Oleson to the post of Senior Vice President, Clinical Affairs. In this capacity, Ms. Oleson will manage all aspects of the Company's US pivotal study (COUNTER HF™) and EU post-market study (OPTIONS HF) for its flagship C-Pulse® Heart Assist System, a medical device addressing Class III and ambulatory Class IV heart failure.

"Kim brings to the Company deep expertise across all aspects of medical device trial enrollment and management. Having been involved with over 400 clinical trials in her career, it is a pleasure to welcome someone of Kim's caliber to the Company and is a testament to the potential role the C-Pulse System will play in the treatment landscape for heart failure patients," said Dave Rosa, Chief Executive Officer of Sunshine Heart.

Prior to joining Sunshine Heart, Ms. Oleson was Vice President of Global Clinical Operations at Medtronic, Inc. (NYSE:MDT), one of the world's largest medical technology companies where she was the strategist responsible for building the company's first centralized clinical operations organization serving Medtronic's broad portfolio of clinical trials and developing contemporary methods related to total product lifecycle risk management and clinical trial risk management. Trained as a biostatistician, Ms. Oleson's distinguished career includes positions of increasing responsibility across large and venture-based businesses within Medtronic, resulting in the global commercial release of multiple medical therapies in the fields of cardiology, interventional cardiology, cardiac electrophysiology, neurology and drug delivery. In addition to her clinical trial expertise, Ms. Oleson has co-authored 10 peer-reviewed publications and is credited with 4 issued/filed patents. She is an industry representative for regulatory standard technical committees including the International Standards Organization which published the ISO 14155:2011 Good Clinical Practice standard for medical device clinical trials. Ms. Oleson holds a B.A. in Biometry from the University of Minnesota.

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.