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Switching now to last week's positive news regarding

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fredman   Thursday, 11/06/14 08:23:59 AM
Re: fredman post# 45
Post # of 85 
Switching now to last week's positive news regarding the receipt of an approval of letter for Augment Bone Graft. This major milestone paves the way for ultimate commercialization in the U.S. for foot and ankle or hindfoot fusion procedures, and it further underscores our strength in Biologics. Our focus now is on completing the requirements outlined in the approval of letter and bringing Augment Bone Graft to the U.S. market. Final approval was subject to customary preapproval facilities inspections, which we expect to be completed in the December to January time frame. Over the next few months, we will also train our U.S. foot and ankle sales organization in preparation for U.S. commercialization.

Although the exact timing of the Augment launch is not known, a conservative time frame is the first half of 2015, assuming satisfactory approval -- preapproval inspection activity. We expect to be ready to launch Augment in the U.S. immediately upon receipt of the final approval order from the FDA.

We agreed with the FDA on 2 postapproval studies: one, is a fairly typical 24-month conditions of actual use study, which follows the result of surgeons who did not participate in the original pivotal trial; and other -- and the other is a onetime 5-year evaluation of certain number of pivotal study patients. Since virtually, all of the -- those pivotal study trial patients are now 5 years postsurgery, this is not owners. I believe Augment will become a valuable new therapeutic option as an alternative to order graph and ankle and hindfoot fusion procedures, especially as it can eliminate potential complications, morbidity and pain associated with order graph harvest. In addition, Augment provides a platform technology for future new product development, particularly in various upper extremity areas. We look forward to addressing that -- these with additional clinical studies.

I think that we've -- since we announced that we've gotten this approval letter, we've gotten tremendous response from physician community that they just can't wait to get their hands on it, and we just have to kind of like hold them back right now until we can actually get it approved into market.

Brad Mas - Needham & Company, LLC, Research Division
Great. And then just one last quick one. I'm wondering if you guys have any plans to begin additional trials for the injectable form of Augment.

Robert J. Palmisano - Chief Executive Officer, President and Director
Yes. We have an idea on that, and I think that some work has begun on that -- had begun on that, and then we'll continue. As I said in my prepared remarks is that we look -- we see this as a platform technology. And we have other -- we have clinical work ahead of us to expand out of the -- where we're headed in hindfoot and new foot infusions. But we think it's appropriate in different areas. We -- I would say, particularly, in upper extremity. We will -- so we will be doing clinical work starting, I think, sometime in 2015 on other indications. We have -- now with the merger with Tornier, we have a large upper extremities sales force that, hopefully, we can provide them with a terrific biologic for that area as well.

Source: http://seekingalpha.com/article/2646295-wright-medical-groups-wmgi-ceo-robert-palmisano-on-q3-2014-results-earnings-call-transcript

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