News: Wright Medical Group, Inc. Announces FDA Approval for AUGMENT(R) Bone Graft
First Clinically Proven, Cost-Effective Alternative to Autograft for Ankle and/or Hindfoot Fusion Indications
Company Can Now Initiate Commercial Sale and Distribution of AUGMENT® Bone Graft in the U.S.
MEMPHIS, Tenn., Sept. 01, 2015 (GLOBE NEWSWIRE) -- Wright Medical Group, Inc. (NASDAQ:WMGI) today announced that its BioMimetic subsidiary has received an approval order from the U.S. Food and Drug Administration (FDA) for its Premarket Approval Application (PMA) for AUGMENT® Bone Graft. The approval order indicates that FDA determined that AUGMENT® Bone Graft is safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications. Wright can now initiate commercial sale and distribution of AUGMENT® Bone Graft in the U.S.
A document accompanying this release is available at:
Robert Palmisano, president and chief executive officer, stated, “The FDA approval of AUGMENT marks a capstone achievement that demonstrates the strength of our science and provides a breakthrough therapeutic option as an alternative to autograft in ankle and hindfoot fusion procedures. We will begin commercial sale and distribution of AUGMENT in the U.S. and believe this product, as well as the PDGF technology platform, will be important drivers of the long-term growth of our business for years to come.”
The Company continues to anticipate AUGMENT® revenue in the U.S. to be in the range of $10 million to $12 million in the first seven to eight months post-approval. The revenue ramp is expected to build gradually during the first six months following the launch of the product as launch activities, such as review by hospital value analysis committees and physician education, are initiated. The company expects to begin selling product in the U.S. in the next several weeks once inventory is moved into its U.S. distribution network.
Palmisano continued, “This approval also underscores the significant effort and perseverance from our clinical trial investigators and Wright’s clinical, regulatory and legal teams to bring the product to market. This success can be attributed to everyone involved in the clinical trial, especially the study investigators and coordinators; our R&D, regulatory and clinical teams; our partners and suppliers; and most importantly, the patients who participated in the landmark prospective, randomized study comparing AUGMENT Bone Graft to autograft.”
Dr. Christopher DiGiovanni, lead U.S. investigator for the AUGMENT® Bone Graft North American pivotal trial and Chief of the Foot and Ankle Service in the Department of Orthopaedic Surgery at Massachusetts General Hospital, Harvard Medical School, said, “The FDA approval of AUGMENT provides a valuable new therapeutic healing option as an alternative to autograft in ankle and/or hindfoot fusion procedures, which is especially important since the outcomes of these interventions can at times be complicated by delayed union or non-union. This approval is based on strong clinical data showing that AUGMENT offers clear patient benefit by enabling a healing rate and safety profile equivalent to autogenous bone graft--while simultaneously avoiding the additional surgery required to harvest autograft bone graft tissue that can result in site-specific complications and/or prolonged harvest site pain in some patients.”
AUGMENT® Bone Graft is the first clinically proven protein therapeutic to come to the U.S. orthopaedics market in over a decade, 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 combination of two components, recombinant human Platelet-Derived Growth Factor (rhPDGF) and Beta-tricalcium phosphate (Beta-TCP), is key to the product’s activities. rhPDGF provides a biological stimulus for the recruitment and proliferation of cells, including osteoblasts, which are responsible for the formation of bone, while Beta-TCP provides a framework or scaffold for new bone growth to occur. As an FDA-approved alternative to autograft in ankle and/or hindfoot fusion procedures, AUGMENT® offers a clear patient benefit by avoiding secondary surgical sites for the harvest of autograft tissue, which can result in prolonged harvest site pain in some patients.
An investor presentation is available on Wright’s website at www.wmt.com in the investor relations section.
Internet Posting of Information
Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wmt.com. Wright encourages investors and potential investors to consult its website regularly for important information.
About Wright Medical
Wright Medical Group, Inc. is a specialty orthopaedic company that provides extremity and biologic solutions that enable clinicians to alleviate pain and restore their patients’ lifestyles. The company is the recognized leader of surgical solutions for the foot and ankle market, one of the fastest growing segments in medical technology, and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit www.wmt.com.
This press release contains “forward-looking statements,” as defined under U.S. federal securities laws, concerning, among other things, the positive effects final PMA approval of AUGMENT® Bone Graft is anticipated to have for patients, surgeons and our business, our 2015 guidance, and the potential for future growth in our business. These statements reflect management's current knowledge, assumptions, beliefs, estimates, and expectations and express management's current view of future performance, results, and trends.Forward-looking statements may be identified by their use of terms such as anticipate, believe, could, estimate, expect, intend, may, plan, predict, project, will, and other similar terms.Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The reader should not place undue reliance on forward-looking statements.Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date. Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements in this press release include the risk that market acceptance of AUGMENT® Bone Graft is less than anticipated, the risk that product quality or patient safety issues have an adverse impact on our sales of AUGMENT®Bone Graft and/or product development plans for the AUGMENT® platform, or result in product liability claims, the risk that we are unable to achieve our operations targets for the balance of fiscal 2015; and the additional risks and uncertainties that are discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year endedDecember 31, 2014, and as may be supplemented in our Quarterly Reports on Form 10-Q and other SECfilings).