Sunshine Heart Inc. Shares Sink Despite Rebooted Study

Sunshine Heart Inc.

fell sharply on Tuesday despite restarting patient enrollment in a trial of its lead product for treating heart failure. Shares of the Eden Prairie, Minnesota company are off more than 26 percent in the past three months, and changed hands recently down 3.5 percent at $4.13. Sunshine said Tuesday that the Food and Drug Administration approved a modified protocol as well as the resumption of patient enrollment in its pivotal study for the C-Pulse Heart Assist System. Patient enrollment in the study, aimed at assessing safety of the device, was halted by regulators in March after several subjects died. All four of the reported patient deaths were determined to be non-device related, the company said in April. Protocol modifications will exclude patients with certain severe disease and establish a committee to ensure the patients meet the study entry criteria. The modifications will improve the study "and should increase the likelihood of study success," Chief Executive David Rosa said in a statement. The study had enrolled eight patients when it was halted in March and was on phase to enroll its total of 20 patients as an additional 50 patients were being evaluated. The device aims to to increase blood flow to the coronary arteries by using balloon counter-pulsation applied outside the aorta. Its goal is to help sustain the patient's current condition or, in some cases, reverse the heart failure process. Analysts on average maintain a Buy rating at $10.14 target on Sunshine, according to FactSet.