WARSAW, Ind.--(BUSINESS WIRE)-- Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, today announced clearance of its Active Articulation™ E1® Dual Mobility Hip System, by the United States Food and Drug Administration.
The Active Articulation™ Hip System is Biomet’s first hip system in the United States to merge the concept of dual mobility with the benefits of Biomet’s exclusive E1® Antioxidant Infused technology and a proven cup design1.
The dual mobility hip concept was developed over 30 years ago2 and has since experienced clinical success.2,3 The concept utilizes a small femoral head that articulates within polyethylene. The large polyethylene bearing, when triggered, acts as a large head bearing that articulates within a metal cup.
“The Active Articulation™ Hip System provides an excellent combination of wear resistance and implant stability,” said Jon Serbousek, President of Biomet’s U.S. Orthopedics division. “We believe this new product will provide an important implant solution to orthopedic surgeons performing hip replacement surgery.”
About Biomet Biomet, Inc. and its subsidiaries design manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy. Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and softgoods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements are often indicated by the use of words such as “will,” “intend,” “anticipate,” “estimate,” “expect,” “plan” and similar expressions. Forward-looking statements involve certain risks and uncertainties. Actual results may differ materially from those contemplated by the forward looking statements due to, among others, the following factors: the success of the Company’s principal product lines; the results of ongoing investigations by the United States Department of Justice and the United States Securities and Exchange Commission; the ability to successfully implement new technologies; the Company’s ability to sustain sales and earnings growth; the Company’s success in achieving timely approval or clearance of its products with domestic and foreign regulatory entities; the impact to the business as a result of compliance with federal, state and foreign governmental regulations and with the Corporate Integrity Agreement; the impact to the business as a result of the economic downturn in both foreign and domestic markets; the impact of federal health care reform; the impact of anticipated changes in the musculoskeletal industry and the ability of the Company to react to and capitalize on those changes; the ability of the Company to successfully implement its desired organizational changes and cost-saving initiatives; the impact to the business as a result of the Company’s significant international operations, including, among others, with respect to foreign currency fluctuations and the success of the Company’s transition of certain manufacturing operations to China; the impact of the Company’s managerial changes; the ability of the Company’s customers to receive adequate levels of reimbursement from third-party payors; the Company’s ability to maintain its existing intellectual property rights and obtain future intellectual property rights; the impact to the business as a result of cost containment efforts of group purchasing organizations; the Company’s ability to retain existing independent sales agents for its products; and other factors set forth in the Company’s filings with the SEC, including the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. 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 as to the accuracy of forward-looking statements contained in this press release. 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. The Company undertakes no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
1 Multi-Center Study. Data on File at Biomet. 2 Leclerq S, et al. Charnley-Kerboull-Bousquet hybrid THR after 10 years. Total Hip Arthroplasty; 3rd International Symposium, 2000. 3 Aubriot P, Lesimple S. Study on Cementless Bousquet Type Cup in 100 Hybrid Total Hip Replacements (Femoral Stem Cemented Charnley Type) Average Follow-up 5 Years. Acta Orthopeaidica Belgica. 59: 1993.
Contact:
Biomet, Inc. Bill Kolter, 574-372-1535 Corporate Vice President, Government Affairs, Public Affairs and Corporate Communication bill.kolter@biomet.com
