Shares of Sunshine Heart (SSH) are down after the company temporarily suspended enrollment for a study of its signature C-Pulse system.
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.