Company Announces U.S. Launch of PROstep™ Minimally Invasive Surgery System
Company Initiates U.S. Commercial Distribution and Sale of AUGMENT® Injectable Bone Graft
AMSTERDAM, The Netherlands, July 11, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it will highlight new innovations at the American Orthopaedic Foot & Ankle Society (AOFAS) 2018 Annual Meeting taking place at the Hynes Convention Center in Boston, Massachusetts, from July 11-14, 2018. Wright will feature its full range of lower extremities and biologic solutions at exhibit booth #907, including the PROstep™ Minimally Invasive Surgery System and AUGMENT® Injectable Bone Graft.
Specifically designed for foot and ankle surgery, the PROstep system provides a minimally invasive, procedurally integrated solution that features specifically designed implants and instrumentation for percutaneous surgery of the foot. The PROstep System can be used to treat a variety of forefoot and hindfoot pathologies, including one of the most common, Hallux Valgus, commonly known as bunions, a painful foot deformity that is prevalent in approximately 23% in adults aged 18-65 years and 35.7% in elderly people aged over 65 yearsi. Compared to a traditional open surgery, the PROstep System has been shown to get patients back on their feet faster, with less pain and an improved cosmetic result. More information on PROstep can be found at www.ProstepMIS.com.
“With the PROstep Minimally Invasive Surgery approach to bunion and other foot and ankle deformities, my patients experience far less post-operative pain and experience a faster return to function much more quickly than traditional open surgery,” said Dr. Peter Mangone, EmergeOrtho: Blue Ridge Division, Asheville and Hendersonville, N.C. “This could mean returning to sports, wearing their shoe of choice or just walking pain free in a very short period of time.”
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. The launch of AUGMENT Injectable provides 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, while eliminating the need for autograft and the associated morbidities of autograft harvest. More information on AUGMENT can be found at www.augmentbonegraft.com.
Robert Palmisano, president and chief executive officer, commented, “We have continued to expand our best-in-class foot and ankle product portfolio to meet the needs of orthopaedic surgeons and patients and further enhance our leadership position in the fast-growing lower extremities and biologics markets. The launch of our PROstep Surgery System is a key new product launch for our core foot and ankle business and highlights our ability to help physicians provide a minimally invasive procedure option to patients to reduce pain and provide a more rapid recovery time, ultimately resulting in higher patient satisfaction. The U.S. launch of PMA-approved AUGMENT Injectable expands our proven AUGMENT franchise to 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. AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years.”
Wright also announced the achievement of a clinical milestone, surpassing 30,000 total ankle replacement (TAR) procedures globally since 2008. Wright offers a complete continuum of care from primary through revision TAR procedures including the INBONE™ Total Ankle System, the INFINITY™ Total Ankle System, the INVISION™ Total Ankle Revision System and the PROPHECY™ Preoperative Navigation System.
Other products to be featured at the AOFAS include:
SALVATION™ 2 Limb Reconstruction System – The SALVATION 2 Limb Reconstruction System is the first truly comprehensive product solution design to address limb salvage procedures in neuropathic patients. The system is designed to help simplify this often-complex procedure, while giving surgeons the options needed to best address these challenging cases. The external fixation system provides preassembled components, patient positioning tools and reproducible wire placement guides to streamline application and eliminate surgical steps.
INVISION™ Total Ankle Revision System with PROPHECY Preoperative Navigation – The first and only system developed specifically for total ankle revision arthroplasty with preoperative planning, the INVISION Total Ankle Revision System helps surgeons re-build bone lost through previous surgeries and provides modularity to help restore natural joint height. The introduction of INVISION with PROPHECY is an important addition to Wright’s total ankle portfolio, extending the use of the only preoperative planning system for total ankles to the entire continuum of care from primary through revision procedures.
ORTHOLOC™ Universal Anterior Ankle Fusion Plate – The Universal Anterior Ankle Fusion Plate is the latest addition to the ORTHOLOC™ Ankle Fusion Plating System, which features Wright’s innovative 3Di polyaxial locking technology. By offering multiple points of talus fixation, the option for tibio-talar-calcaneal fusion and an external lag screw targeting guide, the Universal Anterior Ankle Fusion Plate provides surgeons with a versatile, intraoperative solution for patients requiring ankle fusion.
For more information about Wright Medical’s portfolio of foot and ankle products, visit: www.totalankleinstitute.com
Internet Posting of Information
Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com. The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.
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 quality of life for patients worldwide and is a recognized leader of surgical solutions for the upper extremity (shoulder, elbow, wrist and hand), lower extremity (foot and ankle) and biologics markets, three of the fastest growing segments in orthopedics. For more information about Wright, visit www.wright.com.
Cautionary Note Regarding Forward-Looking Statements
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 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.