Sunshine Heart’s C-Pulse Device Reaches Treatment Milestone for Heart Failure
25 Patient-Years of Cumulative Utilization across 25 Patients
Eden Prairie, MN: June 18, 2013: Sunshine Heart, Inc. (NASDAQ: SSH) today announced a major milestone for its flagship C-Pulse device. As of today, C-Pulse has been implanted in 25 patients in North America and Germany, representing a cumulative 25 years of active C-Pulse heart failure treatment, or over one billion inflation and deflation cycles. The 25th patient was implanted on June 14, 2013 at German Heart Institute – Berlin (DHZB).
Of particular note, throughout decades of treatment, C-Pulse has never recorded a neurologic event associated with the device, most commonly defined as a stroke or transient ischemic attack (TIA). This neurological safety profile represents a potential unique advantage of C-Pulse as the device does not contact the blood stream nor require blood thinning agents. To date, no other known cardiovascular blood contacting mechanical support devices have shown these results in a published pilot or pivotal clinical trial.
The Company has recently reported an additional two patients have been targeted for weaning from the technology in addition to two previously weaned patients that were permanently disconnected from the device based upon improvement in their heart failure symptoms.
C-Pulse is designed to treat Class III and ambulatory Class IV heart failure. The device utilizes proven balloon counterpulsation technology to assist the heart by reducing the workload of the left ventricle. The device may be implanted via a minimally invasive surgical procedure, which is generally performed in an hour. A pre-sutured cuff is placed around the ascending aorta, outside the patient’s bloodstream. This strategic placement of the device is a likely contributor to the neurologic safety profile relative to competitive devices, reducing the risk of stroke incidence and blood clotting. Additional advantages of the device include a durable cuff, with zero cuff failures being recorded in the North American feasibility and European post-market trials; as well as the ability of patients to seamlessly disconnect (and re-connect) from the device based on symptom improvement, further enhancing patients’ quality of life.
C-Pulse is currently being evaluated in a U.S. pivotal trial, COUNTER HF, which will enroll a total of 388 patients. Two sites have been activated in this trial with ten additional sites in the activation process. A European post-market study of the device is also underway in Europe, which will include 50 patients based on a similar trial design. One site is currently activated with two patients already implanted and three additional sites are now capable of enrolling. C-Pulse achieved CE Mark certification in July, 2012 based upon the results of its U.S. feasibility study, which concluded in 2011.
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 counterpulsation 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. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, 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. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility trial, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their condition as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine® Heart
Sunshine Heart, Inc. (NASDAQ: SSH) is an early-stage 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.
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, our expectations with respect to the net proceeds from the offering, 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, that the net proceeds may be lower than we currently expect due to increased offering expenses or otherwise, 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.
For further information, please contact:
Laura Forman Jeff Mathiesen
Blueprint Life Science Group Chief Financial Officer
T: +1-415-375-3340 Sunshine Heart, Inc.