Ann: Montefiore enrolls Patients in US Early Feasibility Study, page-11

All this trial is doing is setting the stage for the larger pivotal trial, which is what will eventually get us an FDA approval. Only the 30 day outcomes will be needed to move to the next step so once we get the 30 day data for all 15 patients it will be assembled and presented to the FDA and the design of the pivotal trial will be finalized. The pivotal trial will require 900-1100 patients and will involve up to 60 hospitals so it'll be a massive undertaking and should start next summer.