Wright Medical Group, Inc. CVR (WMGIZ)

[fredman]

“We submitted our Augment PMA amendment on April 29, 2014. Although it took us a few weeks longer to file
the amendment than we originally anticipated, we believe the extra time allowed us to work collaboratively with the FDA to gain a more
precise understanding of their expectations for the content of the amendment. As previously communicated, we expect the Office of
Device Evaluation to issue a determination on whether the PMA is approvable no later than 180 days after this submission date.”

Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000026/wmgi3312014exhibit991press.htm

On March 10, 2014, we reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The PMA amendment will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. We note that this PMA amendment does not guarantee the approval of Augment® Bone Graft, and that we intend to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvable determination.

Our international sales increased 63% to $22.1 million in the first quarter of 2014, compared to $13.5 million in the first quarter of 2013, primarily due to the Biotech acquisition in the fourth quarter of 2013. Acquired products from Biotech contributed 34 percentage points of the international growth. The remaining growth was driven primarily by a 17% increase in Europe, a 55% increase in Asia as the result of the addition of a new distribution partner in China during the quarter ended June 30, 2013, and a 27% increase in Australia due to increased sales of Augment® Bone Graft acquired in the first quarter of 2013.

Our international biologics sales increased 40% as the result of a 47% increase of sales in Australia, primarily related to sales of Augment® Bone Graft acquired from the BioMimetic acquisition in the first quarter of 2013, and a 55% increase in Asia as the result of the addition of a new distribution partner in China in the second quarter of 2013.

On March 10, 2014, we reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The PMA amendment will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. We note that this PMA amendment does not guarantee the approval of Augment® Bone Graft, and that we intend to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvable determination.

The IPRD projects acquired are as follows:
•
Augment® Bone Graft (Augment) is based on our platform regenerative technology, which combines an engineered version of recombinant human platelet-derived growth factor BB (rhPDGF-BB), one of the principal wound healing and tissue repair stimulators in the body, with tissue specific matrices, when appropriate. This product is intended to offer physicians advanced biological solutions to actively stimulate the body’s natural tissue regenerative process. Augment is targeted to be used in the open (surgical) treatment of fusions. Additionally, Augment may be useful in the future to be used in open fractures. We have evaluated Augment in several open clinical applications, including foot and ankle fusions and distal radius fractures. We believe we have demonstrated that our technology is safe and effective in stimulating bone regeneration with the Canadian regulatory approval of Augment in 2009 and the Australian and New Zealand regulatory clearance of Augment in 2011. A PMA application for the use of Augment in the U.S. as an alternative to autograft in hindfoot and ankle fusion procedures was submitted to the FDA prior to this acquisition. We’ve incurred expenses of approximately $8.2 million for Augment since the date of acquisition and approximately $2.8 million in the three months ended March 31, 2014. Future costs related to Augment depends on the ultimate decision by the FDA on the PMA.

•
Augment® Injectable Bone Graft (Augment Injectable) combines rhPDGF-BB with an injectable bone matrix, and is targeted to be used in either open (surgical) treatment of fusions and fractures or closed (non-surgical) or minimally invasive treatment of fractures. Augment Injectable can be injected into a fusion or fracture site during an open surgical procedure, or it can be injected through the skin into a fracture site, in either case locally delivering rhPDGF-BB to promote fusion or fracture repair. 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. We’ve incurred expenses of approximately $1.9 million for Augment Injectable since the date of acquisition and approximately $0.1 million in the three months ended March 31, 2014. Future costs related to Augment depends on the ultimate decision by the FDA on the PMA.

Source: http://www.sec.gov/Archives/edgar/data/1137861/000113786114000029/wmgi331201410q.htm