United States (U.S.) Pivotal Trial
Seven U.S. sites are currently engaged in contract negotiations and respective institutional review board (IRB) approval processes for the pivotal trial of the C-Pulse System. More than forty additional sites are in discussions or have expressed interest in receiving further information about participating in the trial. Early interest in the U.S. program has been encouraging, with over 80 clinical sites contacted to date.
Sunshine Heart continues to project that 30 to 40 active sites will participate in the pivotal trial of C-Pulse System.
The Company expects the first U.S. clinical site to be under contract in February 2013, with patient enrollment set to begin in the first quarter of 2013.
European Post Market Study
Three sites in Germany are currently engaged in contract negotiations and respective Medical Ethics Committee (MEC) approval processes. The Company is also in discussions with additional sites in Germany and three other European countries relating to the post market study of the C-Pulse System, and is on track with management's expectations to have five sites engaged by the end of the first quarter.
The Company expects the first European site to be under contract with patient enrollment commencing in the first quarter of 2013.