EDEN PRAIRIE, Minn., May 24, 2016 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (NASDAQ:SSH) announced today that its C-Pulse® Heart Assist System was featured in a clinical presentation at the Heart Failure Association of the European Society of Cardiology Meeting, taking place from May 21st to May 24th in Florence, Italy.
On Saturday, May 21st, Dr. Dimitrios Georgakopoulos, Sunshine Heart’s Chief Scientific Officer, presented data collected from a European multi-center, post-market study designed to observe the clinical outcomes of heart failure patients treated with C-Pulse. The data demonstrated improvements in quality of life, functional capacity and cardiac remodeling with a favorable safety profile. No patients experienced stroke or sepsis, and the driveline infection rate was 13.3% (two patients out of the fifteen participating in the study). The data showed significant increase in Left Ventricular Ejection Fraction and significant reduction in Left Ventricular End Systolic Volume. The data also showed a trend downward in Left Ventricular End Diastolic Volume. These three commensurate data points have been shown to correlate with an 80% likelihood of improvement in outcomes based on the meta-analysis of several large trials studying systolic heart failure patients.¹
Sunshine Heart is excited about its recently announced clinical results especially the latest data showing the neuromodulation effect of C-Pulse. Sunshine Heart will continue to pursue additional data in a short term study that will help clarify the path forward to the fully implantable system and a larger market potential.
¹Kramer DG et al. J Am Coll Cardiol. 2010;56:392.
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 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.
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 moderate to severe heart failure patients. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. After terminating enrollment in its US pivotal study, COUNTER HF, Sunshine Heart will be finalizing a short term clinical strategy to begin a study of the C-Pulse Heart Assist System in the United States. A long-term path is being developed in parallel that will focus on accelerating the development of a fully implantable system, which will be critical to driving the adoption of C-Pulse therapy. 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.
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, clinical and pre-clinical study designs and activities, research and development activities, expectations regarding ultimate clinical outcomes and benefits of our products to patients, design and development of future studies, site activations, patient enrollment in studies, timing of regulatory filings and approvals, regulatory acceptance of our filings, our expectations with respect to product development and commercialization efforts, market and physician acceptance of our products, intellectual property protection, and potentially competitive product offerings. The risk factors described in our filings with the SEC could cause actual events to adversely differ from the expectations indicated in these forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart 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. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility we may be unable to raise the funds necessary for the development and commercialization of the C-Pulse System and other risks and uncertainties described in our filings with the SEC. 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.
CONTACT: For further information, please contact: Claudia Drayton Chief Financial Officer Sunshine Heart, Inc. T: +1-952-345-4205 Investor Relations Sunshine Heart Inc. firstname.lastname@example.org