Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse(R) Heart Assist System

EDEN PRAIRIE, Minn. - Sunshine Heart, Inc. today announced it has received unconditional approval from the FDA to conduct an interim analysis of COUNTER HF, the Company's U.S. pivotal study. The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse's unique balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.

"Today's announcement is a significant achievement for the company as it offers the potential to dramatically reduce the development timeline for this important solution for heart failure. The FDA decision to approve this interim analysis is not only unconditional but also arrives earlier than the originally anticipated timeframe of end Q1 2015. We are grateful for the FDA's rapid response to our submission and look forward to working with the Agency through the balance of the COUNTER HF study and on the development of the next generation, fully implantable C-Pulse system," commentedDave Rosa, President and Chief Executive Officer of Sunshine Heart.

A key potential benefit of conducting the analysis is the prospect of reducing the overall duration of the study should COUNTER HF meet the higher statistical threshold of the interim analysis. The study is a prospective, randomized, multi-center clinical trial. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

• NYHA Class III or early Class IV heart failure*;
• Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
• Taking appropriate heart failure medications as prescribed by doctor; and
• Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

Source: Sunshine Heart, Inc.