Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced today that it has received conditional approval from the United States Food and Drug Administration (FDA) for its next generation C-Pulse System driver. This new iteration is designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance. The new driver features a single unit which is lighter, quieter and approximately half the size of its predecessor and also features a number of software enhancements.
Conditional approval from the FDA allows the Company to use this next generation driver for investigational purposes in the U.S. at all sites that are currently enrolled in Sunshine Heart's North American feasibility trial. Sunshine Heart plans to provide the C-Pulse driver to all patients currently on its C-Pulse device at all U.S. sites upon Institutional Review Board (IRB) approval. This second generation driver is also expected to be used in the Company's future U.S. pivotal trial once the FDA has approved the Company's investigational device exemption, or IDE, as well as in Europe.
On June 7, 2012, the Company announced that it received Health Canada approval to use its next generation driver in its Canadian study at Royal Victoria Hospital. The Company has also been granted Health Canada approval to expand the number of participants in the trial to 20 patients. All new patients enrolled in the trial and future trials will receive this next generation C-Pulse driver.
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System, an investigational device in the US, 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 expect to submit an IDE application to the FDA in the second half of 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 NASDAQ beginning 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 and commercialization efforts, future use of our second generation driver, future clinical trial activities and results, regulatory acceptance of our filings, research and development activities, ultimate clinical outcomes and benefits of our products to patients, market and physician acceptance of the products, intellectual property protection, and potentially competitive product offerings. 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. 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.
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