Company to Showcase CARTIVA® Synthetic Cartilage Implant, PROstep™ Minimally Invasive Surgery System, Total Ankle Continuum of Care and AUGMENT® Injectable Bone Graft
Company Completes Enrollment in UK-based Post-Market INFINITY™ Total Ankle System
AMSTERDAM, The Netherlands, Sept. 12, 2019 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ: WMGI) announced it will highlight new innovations at the American Orthopaedic Foot & Ankle Society (AOFAS) 2019 Annual Meeting taking place at the Hyatt Regency Chicago in Chicago, Illinois, from September 12-15, 2019. Wright will feature its full range of lower extremities and biologic solutions at exhibit booth #133, including the Cartiva® synthetic cartilage implant, PROstep™ minimally invasive surgery system, Total Ankle continuum of care and AUGMENT® Injectable bone graft.
Wright Medical also recently completed enrollment in its UK-based post-market INFINITY™ Total Ankle Replacement follow-up study. With 500 patients enrolled across 12 sites in the UK, this marks one of the largest total ankle replacement studies ever conducted. The multicenter, prospective study will evaluate 10-year implant survivorship and outcomes associated with the INFINITY Total Ankle System. Study investigators include 20 non-inventor surgeons led by Mr. David Townshend, MBBS FRCS (Orth), Consultant Orthopedic Surgeon, Northumbria NHS Healthcare Trust, UK.
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. At this year’s AOFAS meeting, a number of presentations and posters will highlight the growing body of compelling clinical evidence for our market leading lower extremities product portfolio, including the Cartiva synthetic cartilage implant, our total ankle replacement product portfolio and AUGMENT bone graft.”
Palmisano continued, “Completing enrollment in our UK post-market INFINITY study is an important milestone for total ankle replacement and represents our ongoing commitment to surgeons and their patients. The data collected by this study will drive the continued evolution of treatment options that improve quality of life for patients suffering from end-stage ankle arthritis. We are especially proud that one poster presentation demonstrated a significant reduction and cessation in post-operative opioid consumption using Wright’s PROstep minimally-invasive surgery products and was recognized as a finalist for the prestigious Roger A. Mann Award, which is given in recognition of the outstanding clinical paper presented at the AOFAS Annual Meeting.”
Wright will feature its full range of lower extremities and biologic solutions at exhibit booth #133, including the following products:
- CARTIVA® Synthetic Cartilage Implant (SCI) – As the first new articulating surface material to receive U.S. Premarket Approval (PMA) by the FDA in 18 years, the CARTIVA SCI is indicated for treating arthritis at the base of the great toe and the only product of its kind backed by Level 1 clinical evidence. Unlike fusion, Cartiva reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion. More information on the CARTIVA SCI can be found at www.cartiva.net.
- PROstep™ Minimally Invasive Surgery (MIS) System – 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.
- AUGMENT® Injectable Bone Graft – 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.
- Total Ankle Continuum of Care – Comprised of Wright’s INBONE™ and INFINITY™ Total Ankle Systems, the INVISION™ Total Ankle Revision System and PROPHECY™ Preoperative Navigation System, this comprehensive product portfolio is the surgeons #1 choice for primary and revision ankle arthroplasty. The INFINITY total ankle system combines a low-profile tibial implant design with a resurfacing talar component designed for full fluoroscopic visualization to ensure proper implant seating. The INVISION™ Total Ankle Revision System is the first and only system developed specifically for total ankle revision arthroplasty and is now available with preoperative planning. The PROPHECY Preoperative Navigation System is the first and only preoperative navigation for total arthroplasty, combining computer imaging and the patient’s own CT scan data to create patient-specific alignment guides for use during the surgical operation. More information on Wright’s total ankle products can be found at www.myankle.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 30, 2018 filed by Wright with the SEC on February 27, 2019 and subsequent SEC filings by Wright, including without limitation its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019. 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.