Biomet Announces FDA Clearance of Palacos G Antibiotic-Loaded Bone Cement.Business Editors/Health/Medical Writers WARSAW, Ind.--(BUSINESS WIRE)--Dec. 18, 2003 Biomet, Inc. (Nasdaq:BMET BMET Biomedical Engineering Technology BMet Bachelor of Metallurgy BMET Bio-Medical Equipment Repair Technician ) announced today the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance of Palacos(R) G antibiotic-loaded bone cement. Utilized in approximately 75% of all total joint replacements, bone cement is a grout Grout A binding or structural agent used in construction and engineering applications. Grout is typically a mixture of hydraulic cement and water, with or without fine aggregate; however, chemical grouts are also produced. used to secure artificial implants to bone. Palacos(R) G bone cement is comprised of standard Palacos(R) bone cement with the addition of Gentamicin gentamicin /gen·ta·mi·cin/ (jen?tah-mi´sin) an aminoglycoside antibiotic complex isolated from bacteria of the genus Micromonospora, . Cleared for use in the second stage of a two-stage revision, Palacos(R) bone cement with Gentamicin has been the standard of care in Europe for nearly 35 years. With Palacos(R) G bone cement, surgeons in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. will now have access to the world's most clinically proven antibiotic-loaded bone cement. Dane A. Miller, Ph.D., Biomet's President and Chief Executive Officer, commented, "We are pleased to receive FDA clearance on Palacos(R) G bone cement which should improve Biomet's current number two position in the domestic market for bone cement and accessories estimated to be in excess of $200 million per year. We expect to begin distributing Palacos(R) G early in 2004." For further information contact Greg W. Sasso, Vice President, Corporate Development and Communications at (574) 372-1528 or Barbara Goslee, Manager, Corporate Communications Corporate communications is the process of facilitating information and knowledge exchanges with internal and key external groups and individuals that have a direct relationship with an enterprise. at (574) 372-1514. This press release contains certain statements that are "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the assumptions, on which the forward-looking statements contained herein are based, are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or non-occurrence of future events. There can be no assurance that the forward-looking statements contained in this press release will prove to be accurate. The inclusion of a forward-looking statement herein should not be regarded as a representation by the Company that the Company's objectives will be achieved. All of Biomet's financial information may be obtained on our website at www.biomet.com or you may contact us by e-mail at investor.relations@biometmail.com. All trademarks are owned by Biomet, Inc., or one of its subsidiaries. |
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