EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA--(Marketwire - August 30, 2012) - Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced today that it has filed its submission for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA).
The Company's IDE submission relates to the proposed use of the C-Pulse Heart Assist System for patients suffering with moderate to severe heart failure. If successful, the Company believes this trial should provide the data required by the FDA to permit approval, which would allow the Company to commercialize the C-Pulse System in the U.S. This pivotal trial follows the FDA's review of the six month safety and efficacy data reported from the 20-patient North America feasibility study. In March, 2012, the FDA completed its review of the C-Pulse System feasibility trial data and concluded that applicable requirements had been met for the Company to move forward with an IDE application for its pivotal trial. Dr. Bill Abraham of Ohio State University Medical Center will be the national principal investigator for this proposed 388 patient pivotal trial. The proposed primary endpoint is reduction of events such as re-hospitalization due to worsening heart failure and heart failure-related mortality. The study will evaluate results for patients that receive the C-Pulse System in comparison to a control group that is managed on optimal medical therapy.
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. Operating outside the patient's bloodstream, the extra-aortic approach of the C-Pulse technology offers greater flexibility, allowing patients to safely disconnect to have intervals of freedom to perform certain activities such as showering. The C-Pulse System may help maintain the patient's current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine® Heart
Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) is an early-stage global medical device company committed to the commercialization of the C-Pulse Heart Assist System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure. The C-Pulse System can be implanted using a minimally invasive procedure and is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology, which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart's pumping load. We have 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 us that we can move forward with an investigational device exemption (IDE) application. We submitted an IDE application to the FDA in August 2012 for approval to initiate our pivotal trial. In July 2012 we received CE Mark for our C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004 and on the NASDAQ since February 2012. For more information, please visit www.sunshineheart.com.
Certain statements in this report are forward-looking statements that are based on management's beliefs, assumptions and 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 IDE submission approval, the FDA's acceptance of our data, our product development and commercialization efforts, regulatory acceptance of our filings and ultimate clinical outcomes and benefits of our products to patients. These forward-looking statements are subject to numerous risks and uncertainties, including without limitation, the possibility that our IDE submission is not accepted by the FDA, clinical trials do not meet their end-points or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse Heart System, the possibility 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 and ASX. 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. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart 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.