AXP @ $1.34, page-13

Yes, I suspect the update to the CE-Mark was mainly to allow them to sell the enhanced product into Australia. I can't remember seeing figures for EU market potential, but Scott made it clear the low hanging fruit is the USA due to the already established reimbursement. The EU is very fragmented, as you say, and I don't believe they will tackle it until they have decent cash flows from USA.

With FDA risk out of the way, I wonder if current competitors will see the writing on the wall and take them out. The competitors would certainly have all the sales/distribution channels in place to make the synergies justify any premium they pay for the company.