Business Services Industry
Wright Medical Group, Inc.'s ALLOMATRIX® Custom Biocomposite Cleared for Use in Spine
Business Wire, March 20, 2006
ARLINGTON, Tenn. -- Wright Medical Group, Inc. (NASDAQ:WMGI), a global orthopaedic medical device company, has received marketing clearance from the United States Food and Drug Administration (FDA) for use of its ALLOMATRIX(R) Custom Biocomposite as a bone graft extender in the spine. Over 300,000 spinal fusion procedures are performed annually in the United States as a measure to alleviate severe back pain.
In a prospective clinical study comparing lumbar fusions using an autograft from the patient's iliac crest with ALLOMATRIX(R) Custom Biocomposite combined with bone marrow aspirate (BMA) and local bone, outcomes were found to be substantially equivalent. Yet patients treated with the ALLOMATRIX(R) Custom Biocomposite are spared the additional operative time, blood loss, cost and discomfort that is common with the iliac crest harvesting procedure.
According to Bruce Frankel, M.D., Associate Professor of Neurosurgery at the Medical University of South Carolina, "This surgeon-blended composite graft very closely mimics the physical and biochemical properties of harvested iliac crest bone by combining a protein-laced cancellous scaffold with high volumes of autologous marrow when combined with BMA."
ALLOMATRIX(R) Custom Biocomposite is unique in that it is delivered to the customer in a freeze dried, powdered form, thus ensuring the DBM (demineralized bone matrix) proteins are preserved until mixed and prepared at the time of surgery. The powdered DBM is combined with a high volume of large cancellous bone chips, enabling the surgeon to deliver high volumes of the patient's own osteogenic bone marrow to the fusion site to aid in the complex bone repair cascade.
About Wright
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 www.wmt.com.
This press release may contain "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. 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, 2005 under the heading, "Factors Affecting Future Operating Results," and in its quarterly reports), 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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