Wright Medical Group, Inc. CVR (WMGIZ)

[fredman]

Update on Augment:

Robert J. Palmisano - Chief Executive Officer, President and Director

I would like to provide a brief update on the status of our appeal for Augment Bone Graft. As previously disclosed, we submitted an amendment to our premarket application on April 29 of this year. We continue to work interactively with the FDA to answer their questions and still expect the Office of Device Evaluation to issue an approvability determination no later than October 26, 2014. Although we view the amendment process and the interactions with the FDA as constructive, it is important to reiterate there is no guarantee this PMA Amendment will result in approval for Augment Bone Graft. We will continue to keep you informed through our normal communication channels.

We are looking forward to the resolution of the Augment PMA Amendment by the end of October. While we have no way of knowing the final determination with the FDA, we believe that the PMA Amendment that we submitted has excellent science behind it and meets the FDA's needs for approvability for this breakthrough biologic.

Additionally, we continue to make good progress on our Vital Few initiatives and the Augment PMA Amendment process.

Matthew O'Brien - William Blair & Company L.L.C., Research Division
Okay. And then just -- that's very helpful. One more for me. I know you don't want to speculate on -- on Augment approval, but given that your sales force has been coming through getting trained on other products and INFINITY and so on, have you been engaging in any kind the activities right now, in preparation for a potential Augment approval? [indiscernible] start selling kind of next day if you were to get that approval at the end of October?

Robert J. Palmisano - Chief Executive Officer, President and Director
No. We haven't. I'll tell you why. Is that my expense with these PMAs, and this may be a big exception, but my experience with these PMAs is that even if we're fortunate enough to get an approvable letter, there's still things to work out with the agency that's going to take several months. They're always looking for a post-market study, a post-approval study. There may be some labeling discussions. So if we're -- if we do get this approvable status as of the end of October, it's going to be several months actually, I think, before we're in the market and that will give us time to really gear up.

Now we hope that Augment will work out, but that has been kind of a struggle for us and for me to get my mind around. I still think that given the information we had, it was a good decision and hopefully, it'll turn out well.

Joanne K. Wuensch - BMO Capital Markets U.S.
Briefly, you started off by talking about the FDA process for Augment. Have you been having any back-and-forth conversation with the FDA?

Robert J. Palmisano - Chief Executive Officer, President and Director
Yes. We have a dialogue that is quite robust, is the way I would put it. There's a lot of back-and-forth with them. If I were to look at it, there's two things. There's form and substance. Substantively, there's no change. We don't know how this is all going to turn out. But the form of it, the process is, it seems good to me in terms of we're able to get our questions answered, we have very clear lines of communication, there's a lot of communication. And I think so from a process point of view, it's good. But given that, I don't know, again, what the final result will say. But there is a lot of communication between us and them.

Joanne K. Wuensch - BMO Capital Markets U.S.
At 1 stage you were talking about a $300 million market opportunity. Do you still think it's that large? And how long do you think it takes for you to tap that?

Robert J. Palmisano - Chief Executive Officer, President and Director
Yes, we do. We do think it's that large. And I suspect that that's the total market. I don't know if you're ever going to tap all of it. But I think that -- I don't know what time period but maybe within 5 years or so, it might be a good time now to get that full amount. If things always do start out and take time to build. But I do think that the market, based upon the number of cases and the ASPs that we're thinking of, get you to that number pretty comfortably.

Source: http://seekingalpha.com/article/2385855-wright-medical-groups-wmgi-ceo-robert-palmisano-on-q2-2014-results-earnings-call-transcript