NEW YORK ( TheStreet) -- Heart failure is a major medical problem in this country affecting well over five million Americans. However, the development of new and effective heart-failure therapies has lagged for the past several decades. Sunshine Heart ( SSH) is developing a new heart-assist device to treat patients with later stage (class 3 and early class 4) heart failure who fall between the cracks of current therapy. These are typically patients who no longer respond to drug therapy but are too healthy to be considered for transplant or an implanted ventricular assist device i.e. "mechanical heart." Currently, when drug therapy ceases to be effective, heart-failure patients are fitted with a pacemaker or implantable defibrillator. These devices are considered stopgap treatments because all they do is prevent arrhythmias but don't improve a patient's condition. In fact, the shocks delivered by the devices can actually cause further heart damage over the long term. Sunshine Heart's C-Pulse Heart system assists the heart in pumping blood through the left ventricle using a proven balloon counter-pulsation technique. A cuff is placed around the outside of the aorta and is attached to a sensing lead that detects when the heart's electrical signal. When the heart is pumping blood, the cuff inflates to increase blood flow. When the cuff deflates, the pumping required by the left side of the heart is decreased. C-Pulse reduces the workload of a patient's heart and increases blood flow through the arteries. And since the cuff is placed around the outside of the aorta, the risk of infection and stroke is significantly reduced. Patients are not required to take blood-thinning drugs due to C-Pulse. In a feasibility study of 20 patients using the C-Pulse system, 50% of heart failure patients improved after 12 months, achieving an average reduction in heart-disease classification of over 1 class. The mean improvement in the six-minute walk test was over 50 meters. One patient completely disconnected from the device because he no longer had any symptoms of heart disease. Another patient died due to aortic disruption. Sunshine Heart is targeted a large commercial market with the C-Pulse system. More than 5 million patients are diagnosed with heart failure in the U.S., with 10% of these patients class III or ambulatory Class IV making them eligible for the C-Pulse.
Sunshine Heart (SSH) plunges after the company, known for its C-Pulse Heart Assist System to treat moderate to severe heart failure, reported a fourth-quarter loss per share that was wider than analysts' expectations and also provided a discouraging update on a pivotal trial. The company noted a loss of 42 cents a share, wider than the consensus estimate of 40 cents a share. Sunshine Heart reported no revenue, as expected. Sunshine Heart also provided an update on its pivotal C-Pulse® COUNTER HF U.S. investigational study and noted the activation of eight sites with a total of 24 additional sites committed to participate, which increases the total number to 32. The company reported in January 2014 that one additional patient had enrolled in the trial for a total of three patients through year-end. Unfortunately, the pace of enrollment in the trials has been extremely slow. The trial, which would have an estimated enrollment of 388, began in Nov. 2012 and has an estimated data collection date of April 2016 and an estimated study completion date of April 2017.