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Update on Augment® Bone Graft (7/29/15)

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Enterprising Investor Member Level  Wednesday, 07/29/15 08:29:48 PM
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Update on Augment® Bone Graft (7/29/15)

The Company previously announced that an Augment® Bone Graft vendor received a Form 483 at completion of an FDA pre-approval facility inspection in January of 2015. Late in March 2015, the vendor was notified by the FDA that its facility would be reinspected and must be in substantial compliance with the current Good Manufacturing Practice (cGMP) regulation as a condition for approval of the Augment® Bone Graft Premarket Approval Application (PMA). The vendor’s facility was subsequently reinspected by the FDA in June of 2015, and the vendor received a Form 483 at the completion of the inspection, which included seven observations. None of the observations was specifically related to Augment® Bone Graft. The vendor has submitted its response to the FDA. The Company worked closely with the vendor to address the observations and prepare its response. The FDA has not informed the Company if a reinspection of the vendor’s facility will be required. Assuming no additional reinspection is required, the Company anticipates final approval of Augment® Bone Graft in the second half of 2015.

http://www.sec.gov/Archives/edgar/data/1137861/000113786115000025/wmgi6302015exhibit991press.htm

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