EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA--(Marketwire - July 23, 2012) - Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) Sunshine Heart announced today that two-year follow-up was completed for a patient that was implanted with the C-Pulse Heart Assist System in the North America feasibility trial which completed enrollment in June 2011. This was the first patient to reach two-year follow-up in the trial.
"I witnessed this patient experience an amazing recovery of function," commented Dr. Andrew Kao, Heart Failure Cardiologist at St. Luke's Hospital in Kansas City, MO. "The first time I met him, he could not walk or even say a few words without extreme perspiration and shortness of breath. After C-Pulse implantation, he can do many more activities -- he can walk around comfortably and also has improved self-confidence. He and his family are extremely grateful for this amazing chance at a renewed life."
In addition, the Company released the 12-month extended follow-up efficacy and safety data for the Feasibility Study of its C-Pulse Heart Assist System. The study's 6-month preliminary results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in November 2011. The 6-month preliminary data of 20 patients suggested positive efficacy trends for C-Pulse with statistically significant results in NYHA Class Reduction and Minnesota Living with Heart Failure (MLWHF) Quality of Life, respectively. Two patients were disconnected permanently, given their level of improvement on the device. At both 6 and 12 months, no neurological events or strokes occurred in subjects supported with the C-Pulse, which we believe is most likely due to its non-blood contacting feature. We believe this is one of the potential benefits over currently approved mechanical assist heart failure therapies.
Extended 12-month follow-up data included further positive trends in efficacy with continued improvements in NYHA Class reduction, MLWHF Quality of Life score and 6 Minute Hall Walk. Furthermore, at 12 months there were no additional patients with device related serious adverse events (SAEs) including exit site infections.
"We are extremely encouraged to see the continued trends in positive efficacy and safety for our C-Pulse device," said Dave Rosa, Sunshine Heart's CEO. "We are especially pleased to see improvements in several efficacy endpoints without additional patients experiencing exit site infections over the 12-month follow-up period. We are also proud of reaching a two-year milestone for the technology and are equally pleased to hear how the technology is positively impacting patient's lives. We believe our preliminary results continue to illustrate that C-Pulse has the potential to improve the longevity and quality of life for moderate to severe heart failure patients."
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System, an investigational device, 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 it completed its review of the C-Pulse System feasibility trial data, concluded we met the applicable agency requirements, and indicated 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. We are also seeking CE Mark for our C-Pulse System in Europe and anticipate that we will obtain approval in the second half of 2012. 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.
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, results of clinical trials, timing of regulatory filings and approvals, 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, and the possibility we may be unable to raise the funds necessary for the development and commercialization of our products 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.