Sunshine Heart Initiates Animal Study on Applicability of C-Pulse Technology in the Treatment of Pulmonary Arterial Hypertension

EDEN PRAIRIE, Minn., Sept. 9, 2015 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today the commencement of a collaborative effort with Dr. Mark Slaughter and the University of Louisville to study the impact of the C-Pulse technology on the pulmonary circulation and right heart, specifically in the field of pulmonary hypertension and heart failure.

Pulmonary arterial hypertension (PAH) is a debilitating condition characterized by progressive increases in pulmonary vascular resistance and loss of elasticity of the pulmonary artery and large vessels. Patients with PAH suffer from poor quality of life, shortness of breath and greatly reduced functional capacity leading to right ventricular dysfunction and ultimately, right heart failure. PAH afflicts approximately 200,000 patients worldwide and places a significant burden on the healthcare system, with limited treatment options available and 5 year survival rates as low as 34%1. PAH and right heart failure are also commonly associated with left heart failure. Approximately 50% of patients with systolic heart failure or preserved ejection fraction heart failure (HFpEF) have PAH with similar 5 year outcomes2. PAH and right heart failure also continue to remain a significant risk in the left ventricular assist device patient population3.These studies hope to provide scientific rationale for a new application of current C-Pulse therapy by leveraging the existing technology to apply counterpulsation to the pulmonary artery in acute and chronic animal preparations. Biochemical, neurohormonal and pressure-volume data will be used to assess the effects of C-Pulse on pulmonary circulation and right and left heart properties. A fully implantable system may provide therapeutic options in HFpEF population with PAH where there are currently no approved treatments.

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 counter-pulsation 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 may 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.

1. D’Alonzo, GE et al. Ann Int Med 115: 342-349, 1991
2. Miller WL et al. JACC HF 1(4): 290-299, 2013; Guazzi M. Circ. Heart Fail. 7: 367-377, 2014
3. MacGowan, GA and Schueler, S. Curr Opin Cardiol 27(3); 296-300. 2012

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 Securities and Exchange Commission. 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.

CONTACT: For further information, please contact:
         
         Investor:
         Candice Knoll
         Blueprint Life Science Group
         T: +1-415-375-3340 Ext. 4
         
         Claudia Drayton
         Chief Financial Officer
         Sunshine Heart, Inc.
         T: +1-952-345-4200
         
         Media:
         David Schull
         Russo Partners
         T: +1-212-845-4271
         
         Christopher Hippolyte
         Russo Partners
         T: + 1-646-942-5634