EDEN PRAIRIE, Minn., July 30, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart SSH announced today an update on its next generation, fully implantable version of the Company's flagship C-Pulse® technology. Sunshine Heart is pleased to report that it will commence a first-in-human study using the novel transcutaneous energy transmission (TET) system and a new smaller implantable pump in Q3 2016.
The study will initially enroll patients at hospitals outside the U.S., and will target patients suffering from advanced Class III/IV heart failure, similar to the patient population of Sunshine Heart's current ongoing COUNTER HF™ Study. Feasibility of implant, safety and short term durability will be the primary objectives. Performance and efficacy data will be collected to evaluate patient quality of life, freedom from heart failure symptoms and other standard heart failure measures including the ability to bridge to other therapies.
Dr. William Cohn, Director of Center for Technology and Innovation, Texas Heart Institute, who has been involved since the inception of the program, will lead the study. Dr. Cohn commented that "the development of a completely implantable circulatory assist device that obviates the need for a driveline will be an important milestone in the evolution of heart failure therapies. The system will also be non-blood contacting and non-obligatory and may prove to be a real game changer for patients with intermediate stage heart failure."
The development of a fully implantable system will eliminate the need to manage a driveline and will address the risk of exit site infections. Together with smaller and lighter wearable components, the system is designed to provide an improved quality of life for patients. The company believes this system will lead to increased market access to target all Class III HF patients, similar to CRM and neuromodulation devices. In addition, the unique ability to deliver chronic counterpulsation therapy and augment coronary blood flow, may afford a new market opportunity for the treatment of angina and ischemic heart disease where morbidity and mortality remain high in heart failure populations with reduced and preserved ejection fraction.*
The benefits of C-pulse and counterpulsation on the pulmonary circulation and the high prevalence of pulmonary hypertension in the latter population may also provide for a therapeutic opportunity with a fully implantable system in this large population with an unmet need.
*Moran, AE. The Global Burden of Ischemic Heart Disease in 1990 and 2013: The Global Burden of Disease 2013 Study. Circ. Cardiovasc. Qual. Outcomes, 2015.
*Clinical Characteristics and Outcomes of Patients with Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients with Heart Failure and Preserved Systolic Function Trial. - Badar AA, et al. Circ Heart Fail. 2015.
About the C-Pulse II (CPII) Fully Implantable System
The CPII system is designed to provide circulatory support for heart failure patients without making blood contact and without the need for a driveline. The system is based on the same extra-aortic counterpulsation principle as the C-Pulse® System to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. The system includes a small implanted pump that inflates and deflates the ascending aortic balloon with power provided across the patient's skin by a TET system. Sunshine Heart has partnered with Cirtec Medical Systems (Los Gatos, Ca) and Minnetronix (St. Paul, MN) for the engineering development of the specialized pump and TET system.
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.
About Sunshine® Heart
Sunshine Heart, Inc. 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 U.S. 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.
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