Sunshine Heart's Feasibility Study Data to Be Presented at 2012 Transcatheter Cardiovascular Therapeutics Conference
Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced that its flagship C-Pulse Heart Assist System will be featured in two clinical presentations at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The TCT symposium will take place October 22nd through 26th in Miami, Florida.
Sunshine Heart presentations scheduled to take place at the TCT meeting include:
An oral presentation included in Session III. Progress with Ventricular Assist Devices: "Counterpulsation for Chronic Heart Failure," on Tuesday, October 23, 2012, at 2:25 p.m. (EDT) in Room B210-211. National co-lead principal investigator, William T. Abraham, M.D., Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center will present 12-month follow-up data for the 6-month feasibility study of the C-Pulse system.
A poster abstract session on C-Pulse's fully-implantable system to be presented as part of Poster abstract Session II on Tuesday, October 23, 2012 from 8:00 - 10:00 a.m. (EDT) in Room Hall D by Dr. William Cohn, M.D., Director of Minimally Invasive Surgery at Texas Heart Institute.
In addition to formal presentations on behalf of Sunshine Heart at the conference, Sunshine Heart management with be joined by both Dr. William Abraham and Dr. William Cohn to host an analyst and investor breakfast on Wednesday, October 24 at 7:30 a.m. (EDT) held at the Ritz Carlton South Beach. Management will provide a corporate update, followed by presentations by both trial investigators and open Q&A.
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. 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 conditional approval from the FDA in September 2012 to initiate its pivotal trial. In July 2012 Sunshine Heart 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.
Forward-Looking Statements 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 respect to product development, commercialization efforts, future clinical trial activities and results, regulatory acceptance of our filings, ultimate clinical outcomes and benefits of our products to patients, markets and physician acceptance of the products. These forward-looking statements are subject to numerous risks and uncertainties, including without limitation, the possibility that our 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 U.S. Securities and Exchange Commission (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. 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.
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