EDEN PRAIRIE, MN--(Marketwired - May 09, 2013) - Sunshine Heart, Inc. (NASDAQ: SSH) announced today the implant of the first patient in the OPTIONS HF C-Pulse System Multicenter Study. The post market study is intended to treat patients with moderate to severe heart failure.
The patient was implanted on May 7, 2013 at the German Heart Institute - Berlin (DHZB), a leading international hospital dedicated to the treatment of cardiovascular and thoracic diseases. In particular, DHZB is focused on implantation of mechanical circulatory support systems and for heart and lung transplantation. The procedure was completed by Professor Roland Hetzer, Chairman of the Department of Cardiothoracic and Vascular Surgery in cooperation with Dr. Holger Hotz of Cardio Centrum Berlin. The implant utilized Sunshine Heart's enhanced cuff, which is pre-sutured and pre-marked providing ease of use for implanting surgeons.
"We are extremely pleased to announce the implant of the first patient at the German Heart Institute - Berlin in our European multicenter post market study," said Dave Rosa, Sunshine Heart's Chief Executive Officer. "In particular, we are encouraged to see early success of our next generation cuff in its ability to improve the ease of implant and allow for better predictability of proper securement. We anticipate the activation of additional sites in the coming months and look forward to updating the market with our progress as enrollment proceeds."
The World Heart Failure Society estimates that heart failure affects over 16 million Europeans of all ages and is responsible for more hospitalizations than all forms of cancer combined. The OPTIONS HF study is structured to enroll a total of 50 patients with moderate to severe heart failure at ten European centers. This study is designed to provide additional clinical data to assist in publications and reimbursement. The data being collected is similar to that which is being collected in the U.S. 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 trial, 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 conditions 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 trial 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 trial. 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 a wholly owned subsidiary in Australia. The Company has been listed on the NASDAQ Capital Market since February 2012.
Certain statements in this release are forward-looking statements that are based on management's beliefs, assumptions and 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 the net proceeds from the offering, future clinical trial activities and results including patient enrollment in trials. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, that the net proceeds may be lower than we currently expect due to increased offering expenses or otherwise, the possibility that our clinical trials do not meet their enrollment goals, meet their end-points 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.