C-Pulse Study FAQ What are the objectives of the Study? The purpose of the study is to expand the C-Pulse™ clinical experience beyond the Australian/ New Zealand clinical experience with a focus on the unmet clinical need for patients with moderate to severe heart failure. The study will determine assurance of safety and performance, such that C-Pulse™ will merit FDA approval for continuation into a pivotal study to examine the safety and efficacy of the device for US market approval. Secondary objectives are intended to provide additional information on patient response and device performance to allow planning for the pivotal study. Can you talk about what exactly C-Pulse is? C-Pulse is an innovative heart assist system for the long-term therapy of patients with moderate heart failure: a condition where the heart progressively loses its ability to efficiently pump blood throughout the body. The C-Pulse system is an implantable, non-blood contacting, less-invasive heart assist system. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output and coronary blood flow while reducing the heart’s pumping workload. What are the unique features about C-Pulse? C-Pulse is a simple, safe, straight-forward implant procedure with long-term measurable benefits to the growing number of patients with moderate to severe heart failure that are refractory to drugs. The less invasive non-blood contacting feature of the device make it unique as C-Pulse augments the heart’s function while reducing risks such as bleeding and stroke. C-Pulse can be turned off safely and detached. Similarly, in failure modes, C-Pulse is considered to have an associated low risk of death or disability, other than the possible reoccurrence of heart failure symptoms. What is the protocol of the study? The study will enroll both men and women with ACC/AHA Stage C, NYHA Class III moderate heart failure and ambulatory, early stage Class IV heart failure who meet the study’s criteria. These patients will be fitted with the C-Pulse device and monitored by the patient’s physician. How many patients will be enrolled? The study will include 20 patients How many sites will be involved in the study? Where are they located and why were these clinical sites selected? The study will be conducted at six university based North American Centers. Ohio State University Northwestern University Pennsylvania State University University of Louisville University of Alabama at Birmingham University of Florida These clinical sites were selected for not only their world class reputation in the treatment of heart failure but also for the potential to treat a large number of patients due to their location near regions with the highest incidence of heart failure deaths. Who will be the Principal Investigators for the U.S. trial? International renowned Drs. William Abraham of Ohio State University, Columbus, Ohio, and Patrick McCarthy of Northwestern, Chicago Illinois, have agreed to be the co-national principal investigators for the C-Pulse feasibility trial. Dr. Abraham has participated in more than 100 drug and device clinical trials and Dr. McCarthy has a similarly distinguished history as a clinical investigator in several heart assist device trials. These eminent clinicians lend great credibility to the C-Pulse trial within the international medical community. Additionally, each clinical site has a team of trained cardiologists and cardiovascular surgeons. The cardiologists will treat and refer eligible patients while the cardiac surgeons implant the C-Pulse device in this collaborative relationship. How long will the study last? The total duration of the Feasibility Study is expected to be approximately 18-24 months. The period of patient follow-up will be 6 months to assess the safety and performance before initiating the pivotal clinical trial. Patients will be followed for up to 5 years. When do you expect to release study results? Patient data will be collected at baseline, 1, 3 and 6 months. Results will be presented and published by the national co-investigators. What is the next clinical step after completion of this study? Following successful completion of this Feasibility Study, a pivotal study will be conducted to examine the safety and efficacy of the C–Pulse™ system in patients in moderate to severe heart failure. The pivotal trial is expected to measure the similar variables as the Feasibility Study. What kind of market potential exists for a product like C-Pulse? We believe C-Pulse provides Sunshine Heart with a very attractive business model that sits alongside the heart failure pacemaker market, which in 2008 exceeded $3 billion globally. With over 1.4 million U.S. people classified as moderate heart failure patients, we modestly assume a 5% penetration for C-Pulse creating a $1.4 billion a year global market potential. How does this approach compare to other devices like LVAD’s and pacemakers? The C-Pulse heart assist system has been designed and validated for a class of heart patients similar to the pacemaker-treated heart failure patients and is an earlier therapy than other heart assist devices (LVADs) that treat end-stage patients. The targeted C-Pulse patient population is large. C-Pulse’s system is based on the proven method of counterpulsation - a technique that synchronizes the external pumping of blood with the heart's cycle to assist the circulation and decreasing the work of the heart. Counterpulsation causes to increase blood flow and oxygen to the heart and body when the heart is refilling. When the heart begins to pump counterpulsation works to decrease the heart's workload and lessen oxygen demand. Heart failure pacemakers synchronize the chambers of the heart to improve the native heart’s contractility to increase blood flow and are appropriate for about 30% of moderate heart failure patients. LVADS are designed to perform the total blood pumping function of the heart and are targeted for end-stage severe heart failure patients. C-Pulse is a heart augmentation device (a true assist device) which increases blood flow, reduces the heart’s workload and provides addition blood to the heart to aid in recovery of the heart’s native function. C-Pulse does not preclude the use of other heart failure therapies such as valve surgery, heart transplantation, or LVADs. Where is C-Pulse manufactured? The C-Pulse manufacturing specifications and procedures are controlled by the Company’s Australia team. However, the C-Pulse is manufactured by a variety of internationally certified quality medical device firms, many located within the United States. Heart Failure FAQ What is heart failure? Despite the way it sounds, heart failure does not mean that the heart suddenly stopped working or that you are at immediate risk of death. Rather, heart failure is a condition that usually develops slowly as the heart muscle weakens and needs to work harder to keep blood flowing through the body. Heart failure develops following injury to the heart such as the damage caused by a heart attack, long-term high blood pressure, or an abnormality of one of the heart valves. The weakened heart must work harder to keep up with the demands of the body, which is why people with heart failure often complain of feeling tired. As a patient’s HF gets worse, the heart grows larger and larger since it must work harder to pump the blood needed for the body to function properly. These patients usually have shortness of breath, low blood pressure, extra fluid, and cannot exercise. There are four (4) types of heart failure, each one worse than the last. The formal way the types are divided is based on standards from the New York Heart Association, abbreviated as NYHA. A patient with early HF and has fewer symptoms may be considered NYHA Class 1-2. Those with moderate HF would likely be categorized as Class 3 and have HF symptoms during mild exercise. End-stage HF patients are Class 4 and have symptoms at rest. Heart failure is often not recognized until a more advanced stage of heart failure, commonly referred to as congestive heart failure, in which fluid may leak into the lungs, feet, legs, and in some cases the liver or abdominal cavity. How many people have heart failure? According to the American Heart Association, nearly five million Americans are living with heart failure, and there are almost 550,000 new cases diagnosed each year. What are the symptoms of heart failure? Heart failure can be difficult to diagnose because symptoms may be subtle and are often mistaken for normal signs of aging. Please note that these symptoms are common and may represent other diseases Symptoms that may signify heart failure are: Breathing Difficulties o Shortness of breath from walking stairs or simple activities (dyspnea) o Trouble breathing when resting or lying down o Waking up breathless at night (paroxysmal nocturnal dyspnea) o Needing more than two pillows to sleep (orthopnea) Fatigue/Exercise Intolerance o Tiring Easily o Swelling of feet, ankles or legs (edema) o General feeling of fatigue Coughing o Frequent coughing o Coughing that produces a mucus or pink, blood-tinged sputum o Dry, hacking cough when lying flat in bed What kind of physician specializes in heart failure? Cardiologists, heart failure cardiologists, cardiothoracic surgeons and electrophysiologists treat heart failure patients. As specialists in the structure, function and disorders of the heart, cardiologists are the first line of treatment for many heart failure patients. Heart failure cardiologists focus exclusively on patients with this condition. If surgery is necessary, a cardiothoracic surgeon or electrophysiologist will be involved. How is heart failure diagnosed? Only your doctor can tell you if you have heart failure. When you visit your doctor, he/she should review your medical history and conduct a full physical examination. Physicians often order a number of tests when exploring a possible diagnosis of heart failure. Many of them are painless and simple. The most important of these tests is an echocardiogram, or "echo" for short. This test tells your doctor what your ejection fraction, or "EF," is. The ejection fraction is a measurement of how well your heart is pumping. People with a healthy heart usually have an ejection fraction of 50 percent or greater. Most people with heart failure, but not all, have an ejection fraction of 40 percent or less. Is there a cure for heart failure? While there is no specific cure for heart failure, the good news is that with proper medical care symptoms can be improved. Living a healthier lifestyle by limiting your risk factors and taking your medications as directed can make a big difference in improving your condition and quality of life. What are the treatment options? In the very early stages, lifestyle changes and medical management can be enough to control the symptoms of heart failure. However, as the disease progresses, advanced-stage heart failure patients may find that, though important, lifestyle changes and drug therapy may not be enough to relieve symptoms. The C-Pulse has been designed to treat patients with Class III heart failure.