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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.
Year End
Sunshine Heart ended the year with $14.2 million in cash and cash
equivalents (unaudited), in line with management's expectations. The
Company plans to release its fourth quarter and full year 2012 audited
results on March 11, 2013.
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