News & Events

EDEN PRAIRIE, Minn., Sept. 12, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) announced today the first patient implant in the Company's U.S. pivotal trial, COUNTER HF. The COUNTER HF study is a prospective, randomized, multi-center, controlled trial that will evaluate 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.

"We are excited to be part of this innovative clinical trial," said cardiothoracic surgeon, Sanjeev Aggarwal, M.D., Director of Mechanical Circulatory Support and principal study investigator at Saint Luke's Mid America Heart Institute of Kansas City. "Based on the positive clinical results from our experience during the feasibility study, we are very much looking forward to participating in the COUNTER HF pivotal study. The C-Pulse system, in comparison to other devices used for circulatory support, offers the advantage of implantation through a truly minimally invasive approach without the need for cardiopulmonary bypass or sternal division. Its non-blood contacting interface obviates the need for anticoagulation and allows patients to untether from the device for short periods of time. We are excited to have the opportunity to further investigate the potential benefits of this technology in heart failure patients through this important pivotal study."

"The COUNTER HF study is important for the many heart failure patients who are not being successfully treated with existing therapies," said David Rosa, CEO of Sunshine Heart. "We are pleased to have St. Luke's Mid-America Heart Institute enroll and implant our first patient in the COUNTER HF pivotal trial. They were the top enrolling clinical site in our recently completed U.S. FDA C-Pulse system feasibility study and we look forward to their continued leadership in this trial."

About the COUNTER HF Study

The COUNTER HF 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 enroll 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.

Individuals who are interested in learning more about the trial and if they might qualify for the study can visit www.HFClinicalStudy.com or call 1-888-978-8391.

About Congestive Heart Failure

Heart failure affects over 5 million Americans and is responsible for more than 1 million hospitalizations in the United States each year.^1,2 It is a costly disease, with an estimated $32 billion total costs associated with it in the United States.¹ Patients with heart failure have a poor quality of life and reduced life expectancy, with 50% dying within 5 years.^3,4 There are few effective treatments for patients with advanced heart failure. It is estimated that 1.2 American suffer from moderate heart failure (NYHA Class III).^1.5

About C-Pulse System

The C-Pulse system is an investigational treatment and is a unique approach for treating moderate to severe heart failure. It uses proven balloon counterpulsation technology to assist the heart by reducing the workload of the left ventricle, while increasing blood flow to the heart muscle. The C-Pulse system does not replace the heart function, but rather is designed to assist the heart in doing its job. The System includes the following key components: Cuff, Sensing Lead, Interface Lead and Driver.

The C-Pulse Cuff wraps around the outside of the ascending aorta (the main artery coming out of the heart that delivers blood to the body), much like a blood pressure cuff around your arm. It is connected to the Driver (the pump) by a tube (Interface Lead) that passes through a small hole in the skin. The C-Pulse Cuff pumps in rhythm with the natural heartbeat, which is monitored using a pacemaker-type wire, called a Sensing Lead. The Cuff deflates just before the heart pumps blood, reducing the workload of the heart. The Cuff is timed to re-inflate in between heartbeats, once the heart has finished pumping blood - this allows the Cuff to act like a second heartbeat, producing a surge of blood flow to the heart muscle. The Driver includes a small rechargeable battery, which provides the power for the C-Pulse System.

The C-Pulse is designed to treat heart failure and reduce heart failure symptoms by:

·         Reducing the workload of the heart;

·         Providing more oxygen-rich blood going to the heart muscle; and

·         Improving heart function.

Combined, these potential benefits may 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. There is a potential additional long-term benefit of having patients discontinue use of the device due to sustained improvement in their condition as a result of the therapy. This occurred in some feasibility study patients.

The C-Pulse system is implanted without any incisions into the heart itself or to any major vessels. It does not come in contact with the internal blood system. Patients can disconnect with it for short periods of time if needed. It may be used in combination with other approved devices and medications for treating heart failure.

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.

References

1. Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation. 2013;127: e6-e245.

2. Blecker S, et al. J Am Coll Cardiol. 2013;61(12):1259-1267.

3. Levy D, et al. N Engl J Med. 2002;347:1397–1402.

4. Roger VL, et. al. JAMA. 2004;292:344–350.

5. Farwell D, et al. Eur Heart J. 2000;1246-1250.

CAUTION: C-Pulse is an investigational device. The device is limited by Federal (or United States) Law to investigational use only. It is not available for sale in the United States

C-Pulse is a registered trademark of Sunshine Heart, Inc.

© 2013 Sunshine Heart, Inc. All rights reserved.

CONTACT: For further information, please contact:

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