Two weeks ago, Sunshine Heart (SSH) announced the company was taking a temporary pause from enrollment of its COUNTER heart failure trial. Protocols state that if at least three of first 20 patients pass away, for any reason, the trial must be paused / evaluated. Sunshine reported 4 patient deaths on March 6th and as a result traded down 25%.
During the Q4 earnings call, CEO Dave Rosa notified investors that the Clinical Events Committee (CEC) had determined that all 4 patient deaths in the treatment arm of the COUNTER trial were ruled non-device and non-procedure related events. Therefore, the halt was precautionary since trial is comprised of late stage heart failure patients that are on the cusp of death. 4 deaths in such sick patients should not be considered extraordinary.