Clinically Proven, Cost-Effective,
Injectable Formulation of AUGMENT® Approved in U.S. for Ankle
and/or Hindfoot Fusion
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.
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
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.
™ and ® denote trademarks and registered trademarks of Wright
Medical Group N.V. or its affiliates, registered as indicated in
the United States, and in other countries. All other
trademarks and trade names referred to in this release are the
property of their respective owners.
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, 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
OfficerWright Medical Group N.V.(901)
290-5817julie.dewey@wright.com
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