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Our initial clinical development program for Augment Injectable

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fredman   Thursday, 11/06/14 08:00:06 AM
Re: Enterprising Investor post# 44
Post # of 85 
Our initial clinical development program for Augment Injectable has focused on securing regulatory approval for open indications in the United States and in several markets outside the U.S. Recently, we have focused our efforts on securing FDA approval of Augment. The amount of time and cost to complete the Augment Injectable project depends upon the nature of the approval we ultimately receive for Augment, but we currently estimate it could take one to three years.

Our international biologics sales increased 24% as the result of a 49% increase in Asia as the result of the addition of a new distribution partner in China in the second quarter of 2013, and a 19% increase of sales in Australia, primarily related to sales of Augment® Bone Graft acquired from the BioMimetic acquisition in the first quarter of 2013

On October 27, 2014, we received an Approvable Letter from the U.S. Food & Drug Administration (FDA) for our Premarket Approval Application (PMA) for Augment® Bone Graft. The approvable letter indicates the FDA determined Augment® Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections. We currently anticipate that we will be able to sell Augment® Bone Graft in the United States beginning in the first half of 2015.

On October 27, 2014, we announced that we had received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for our Premarket Approval Application (PMA) for Augment® Bone Graft. Following this announcement, the fair value of the CVR's increased significantly and traded at an average value of approximately $125 million in the four days following announcement. Approximately $98 million of the liability associated with the CVR's will be payable shortly after receipt of final approval from the FDA for Augment® bone graft.

Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000051/wmgi930201410q.htm

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