Question-and-Answer Session
Operator
(Operator instructions) We'll have our first question from Vivian Cervantes, Rodman & Renshaw.
Vivian Cervantes – Rodman & Renshaw
Hi, good afternoon, thank you for taking the question. I'll start off with OsseoScrew. Looks like you guys are poised to submit at the end of December. Wanted to just check in to see if you're submitting with bone cement or without bone cement?
Dirk Kuyper
We haven't totally decided. We're still discussing that with our FDA consultant in terms of what the best way to submit OsseoScrew is. Our intention is to get it cleared as a pedicle screw, obviously, as quickly as possible. And then look for clinical studies beyond that, that would allow us to make additional claims in the future. So – but we're not totally decided, we'll probably in the next month or so we'll come to that decision.
Vivian Cervantes – Rodman & Renshaw
Okay. That sounds good. And then moving along to OsseoFix, (inaudible) you guys are starting to train European docs and that you're poised to do another lab again in December. Can you give us a sense for when we'll begin to see active selling efforts for this product? I know you've signed a second exclusive distributor in Europe, but at what point, do you think we'll begin to see some contributions there?
Dirk Kuyper
Okay. So, that's a good question. We did train – we had a lab at the end of the NASS meeting, Friday evening, actually and several European surgeons participated in that. They primarily are linked to the ongoing clinical study that we have ongoing in Germany. We do have a number of surgeons that are very interested in beginning to use OsseoFix that are in the countries where we've already established distribution. And those are the surgeons that will be coming to the lab in early December; it's actually scheduled for the 12th. So we anticipate shipping product prior to the lab, providing the formalized training on December 12, and then starting to see revenue and patients being treated with OsseoFix, very quickly thereafter. So, we probably will see a little bit of contribution in the fourth quarter. But really, I think first quarter of '9 is when we should see a steep pickup. What we're very encouraged about is, both at the NASS meeting, at the lab after NASS, and then we recently conducted a lab, actually, this last weekend in Las Vegas. The response to OsseoFix is universally positive. So we're very encouraged by that and believe that this will really help us to drive at a much faster rate into the European market going forward.
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