EDEN PRAIRIE, Minn., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) announced today a collaboration with St. Paul-based Minnetronix® for a transcutaneous energy transfer ("TET") system to power the Company's fully-implantable C-Pulse device under development. Minnetronix is a leader in med-device engineering, providing design and manufacturing support for many of the world's largest medtech companies.
A TET system enables power transfer across the skin without direct electrical connectivity utilizing time varying magnetic fields. TET is used to power implanted devices, such as heart assist devices, artificial hearts and electrical stimulators. The agreement leverages Minnetronix's existing TET technology and includes milestone payments due to Minnetronix prior to U.S. regulatory approval for the fully-implantable C-Pulse system.
"We are pleased to have entered into our second partnership with Minnetronix," said Dave Rosa, CEO of Sunshine Heart. "Currently, they are the supplier of our second generation C-Pulse driver and we have been pleased with the quality, responsiveness and service they have provided. We look forward to closely partnering with them for our TET system for our fully implantable C-Pulse system."
"Minnetronix is very excited to collaborate with Sunshine Heart on their fully implantable heart assist system," said Rich Nazarian, President and CEO of Minnetronix. "Sunshine Heart's novel technology represents the next generation in chronic circulatory support devices and holds great promise for less invasive and more effective treatment of congestive heart failure."
Sunshine Heart initiated its COUNTER HF™ U.S. pivotal trial for its C-Pulse system earlier this year. As announced on August 7, 2013 in conjunction with its second quarter earnings release, the Company intends to initiate animal studies for its fully-implantable pump in the fourth quarter of this year. The C-Pulse device is also in an ongoing OPTIONS HF European post-market study.
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 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 a 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.
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, 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, the possibility that our clinical trials 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.