Aiming to complete our plans on target

The next critical point is the beginning of the clinical trials with an Investigational Device Exemption (IDE) submission to the FDA planned in 2009. Clinical trial design follows well established FDA guidelines. Following FDA review, the clinical trials are planned to start in Q3 2009 in Europe and in Q1 2010 in the US. Clinical trials results are expected by Q2 2012 in Europe and Q2 2013 in the US. LCV will file a PMA and FDA clearance is planned in Q3 2013.