News & Events

SHC provided an update on the progress of their US pivotal trial for their C-Pulse heart assist system. Currently, seven U.S. sites are engaged in contract negotiations and respective institutional review board (IRB) approval processes for the 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 enrolment set to begin in the first quarter of 2013.

Impact to forecasts and view

We had previously expected the trial to commence late last year so the update represents a slight delay, but will not impact our forecasts materially. The company ended 2012 with US$14.2m in cash (down from US$17.4m as at September 30 2012) which should provide adequate funding through CY13, depending on the R&D spend as the pivotal trial commences. The Company plans to release its fourth quarter and full year 2012 audited results on March 11, 2013.

Call to action

The commencement of the pivotal trial is a key catalyst. The key downside risks to our price target relate to possible delays in recruitment. Buy.

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Disclosure
Analyst own shares in SHC.
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