Wright Medical Group N.V. Announces FDA Premarket Approval for AUGMENT® Injectable Bone Graft
AMSTERDAM, The Netherlands, June 13, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for AUGMENT® Injectable Bone Graft for the same clinical indications as AUGMENT® Bone Graft. AUGMENT Injectable is a combination product consisting of recombinant human platelet derived growth factor (rhPDGF-BB) and a blend of Type I collagen and Beta tri-calcium phosphate, which provides a clinically proven and safe and effective alternative to autograft for use in hindfoot and ankle fusion in an easy to use flowable formulation.
Robert Palmisano, president and chief executive officer, stated, “Building on the commercial and clinical success of AUGMENT Injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven AUGMENT franchise and meet the needs of foot and ankle surgeons in the U.S. with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site. In addition to the significantly improved handling characteristics with AUGMENT Injectable, one of the key differentiators continues to be the strength of the clinical evidence. Our approved PMA supplement for AUGMENT Injectable builds upon the existing body of evidence supporting the safety and effectiveness of AUGMENT Bone Graft and leverages clinical data from the U.S. and Canada for the injectable formulation.”
The U.S. launch of AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years with a gradual ramp as the injectable form is reviewed by hospital value analysis committees and physician education programs are executed. The company will immediately start the process of finalizing its packaging carrying the FDA approved labeling and expects to begin selling product in the U.S. shortly and complete the rollout in the next four to six weeks.
Dr. Timothy Daniels, Chief of the Division of Orthopaedic Surgery of St. Michael’s Hospital and Professor at the University of Toronto in the Department of Surgery, commented, “In Canada, my colleagues and I have been using AUGMENT Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results. FDA approval of AUGMENT Injectable provides a valuable enhancement to the existing AUGMENT product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting.”
Dr. Jeremy McCormick, Associate Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis, Missouri, added, “I adopted AUGMENT Bone Graft shortly after it launched as a clinically proven tool that has improved patient outcomes. As my confidence in the product has grown, so too has my use of AUGMENT. Now, with the introduction of the new injectable version, delivery of the product to the fusion site will be simplified and more consistent, helping foot and ankle specialists use it more dependably in patients.”
AUGMENT Injectable is the first clinically proven injectable protein therapeutic to come to the U.S. orthopaedic market offering an alternative to autograft in ankle and/or hindfoot fusion procedures, which translates into an estimated market opportunity of approximately $300 million in the U.S. As FDA-approved alternatives to autograft in ankle and/or hindfoot fusion procedures, AUGMENT Bone Graft and AUGMENT Injectable offer a clear patient benefit by avoiding secondary surgical sites for the harvest of autograft tissue, which can result in prolonged harvest site pain and other comorbidities in some patients.
As a result of this approval, the company plans to update its 2018 annual guidance on its second quarter earnings call scheduled for August 8, 2018.
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About Wright Medical Group N.V.
Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide. Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics. For more information about Wright, visit www.wright.com.
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This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance, market availability and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Investors & Media:
Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com
