Finally, there's the risk that goes with a clinical trial. Investors may perceive the risks with Sunshine Heart higher because C-Pulse is a new and relatively unproven method to treat heart failure. The company must also convince the cardiology community that the C-Pulse system is a new paradigm treatment for later-stage heart failure. Under new Medicare regulations, hospitals are penalized for heart failure and heart attack patients who are re-admitted within 30 days of discharge. By the time C-Pulse potentially gets approved, hospitals will be under pressure to find new procedures to make sure their heart failure patients are getting the best therapy. C-Pulse could become a major part of the solution hospital need. There is massive upside in Sunshine Heart if the C-Pulse pivotal trials are successful in showing clear advantage over current therapy for Class III and ambulatory Class IV heart failure patients. Even factoring in a highly dilutive stock offering in a year or so, the Sunshine Heart's shares are still absurdly cheap. Despite the lack of near-term catalysts, I'm comfortable buying the stock today and wait the time necessary for the stock to turn into a big winner. Rosenblum is long Sunshine Heart.
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.