GRAFTJACKET(R) Regenerative Matrix Heals Diabetic Foot Ulcers More Effectively Than Standard Wound Management

Main Category: Diabetes
Also Included In: Dermatology;  Medical Devices / Diagnostics
Article Date: 15 Apr 2009 - 5:00 PDT

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Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced that peer-reviewed data from a prospective, randomized, controlled, multi-center study has been published online and will appear in the June 2009 issue of the International Wound Journal. The data confirms the effectiveness of the Company's GRAFTJACKET® Regenerative Matrix for the treatment of diabetic foot ulcers.

This study, entitled "Clinical Effectiveness of an Acellular Dermal Regenerative Tissue Matrix Compared to Standard Wound Management in Healing Diabetic Foot Ulcers," was led by David G. Armstrong, DPM, PhD, Professor of Surgery and Director, Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College of Medicine. The study included a total of 86 patients who were treated either with GRAFTJACKET® Regenerative Matrix or the standard of care, which was the control group.

Analysis at the study's endpoint of 12 weeks confirmed complete wound healing was achieved in 70% of patients who received a single application of the GRAFTJACKET® Matrix, compared to only 46% of the control group patients. This difference between groups was statistically significant. Additionally, GRAFTJACKET® Matrix treated patients healed more quickly on average than the control group. Given the results of the study, patients treated with GRAFTJACKET® Matrix are two times more likely to experience complete wound healing by 12 weeks versus patients treated with standard wound care.

Diabetic foot ulcers affect more than three million Americans each year, or approximately 15 percent of the 20.8 million Americans with diabetes, and are the primary cause of hospital admissions for all diabetics. Foot ulcers that do not heal properly are at risk for infection which can lead to amputation. According to the American Diabetes Association, one in four patients with a diabetic foot ulcer will eventually require a lower limb amputation.

"The study supports the use of this technology as a clinically and potentially cost-effective modality for the treatment of complex diabetic foot ulcers," notes Dr. Armstrong, principal investigator for the study. "By improving our ability to successfully treat and heal diabetic foot ulcers, we also reduce the risk of a lower limb amputation, a procedure that carries significant social and financial costs and dramatic quality of life implications."

Studies estimate the cost of treating a diabetic foot ulcer using standard wound management is approximately $7,000-$28,000 during the two years following diagnosis. The variation in this cost stems from the extended treatment periods and multiple-application processes associated with current standards of care. Still, every year, about 25 percent of diabetic patients develop ulcer-related complications that ultimately result in amputation. This costs the U.S. more than $1 billion dollars each year according to the National Institutes of Health. In contrast, healing rates associated with a single application of Wright's GRAFTJACKET® Matrix suggest the product may result in a significant cost savings to the healthcare system while improving patient quality of life.

"The results of this study further prove GRAFTJACKET® Matrix to be an effective technology for the treatment of challenging diabetic foot ulcers," said Eric E. Gay, Director of Biologics Marketing at Wright Medical. "We are pleased to reach this milestone publication that will help further strengthen surgeon, patient and payor confidence in our innovative technology. With this new level-1 evidence proving effectiveness, we believe the impact that GRAFTJACKET® Matrix can have on patients' lives, as well as overall healthcare costs, can now be more fully-realized."

Wright Medical's GRAFTJACKET® Matrix is a processed three-dimensional human dermal tissue matrix that allows the body to rebuild areas of deficient tissue. After GRAFTJACKET® Matrix is applied to a wound, the body's natural repair process revascularizes and repopulates the GRAFTJACKET® Matrix with its own cells, gradually converting the graft into the patient's own living tissue. Wright is the exclusive distributor of this acellular human dermis technology, provided through a supply and development relationship with LifeCell Corporation, for all orthopaedic and podiatric applications, including diabetic foot wounds, in the United States, Canada and other select international markets.

Wright Medical Group, Inc. is a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics. The Company has been in business for more than 50 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit our website at http://www.wmt.com.

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, beliefs, estimates, and expectations and express management's current views of future performance, results, and trends and 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. The Company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in the Company's filings with the Securities and Exchange Commission (including the Company's annual report on Form 10-K for the year ended December 31, 2008, under the heading, "Risk Factors"), which could cause the Company's actual results to materially differ from those described in the forward-looking statements. Although the Company believes that the forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A forward-looking statement should not be regarded as a representation by the Company that the results described therein will be achieved. The Company wishes to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statement after this date.

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Wright Medical Group, Inc.