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Sunshine Heart to Commence First-in-human Study Using Implantable Version of C-Pulse Technology in Q3 2016


Sunshine Heart (NASDAQ: 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

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