Upon completion of primary trial (estimated by Dec 2015). We will immtediately prepare and file for FDA and CEMArk regulatory clearance. The 2017 completion mentioned is only for those patients requiring follow up and does not prevent us from the initial filing! The CEMark clearance for sales o/side the U.S. marketing is expected in prox (estimate) 120 days. FDA clearance take longer, which we estimate in the 2nd half of 2016?
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