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Wright Medical Updates Augment's FDA Approval Status

Background:
 
In 1Q15, Wright Medical announced that an Augment® Bone Graft vendor received a Form 483 with 13 observations following an FDA pre-approval facility inspection. Later that quarter, the vendor was notified by 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. 
 
Update:
 
Following reinspection in late 2Q15, the vendor received a Form 483 including seven observations—none specifically related to Augment Bone Graft. 
 
The vendor has submitted its response to the FDA, and FDA has not informed Wright Medical if a vendor reinspection will be required. Assuming no additional reinspection, Wright anticipates final approval of Augment Bone Graft in 2H15. 
 
In the 2Q15 earnings call, Wright Medical President & CEO Bob Palmisano stated, “Let me be clear, that based upon the approval letter that we received from the FDA, we continue to believe that Augment will be approved and the product, as well as the PDGF [Platelet-Derived Growth Factor] technology platform, will be important drivers of long-term growth for our business for years to come.” Also, “we’re not changing our previously provided [2015] revenue guidance, given the strength of our first half sales results, our current sales trajectory and currency rate as of today.” He later noted that the timing of the approval will impact where Wright falls within that guidance range.
 
The PDGF pipeline includes an Augment Injectable format and potential applications for rotator cuff and tennis elbow repair. Augment Injectable presently sells in Australia, with a reportedly strong positive response to its ease of use. 
 

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