Healthcare Industry News: joint replacement
News Release - May 3, 2006
Biomet Receives FDA Clearance for Regenerex(TM) Acetabular SystemWARSAW, Ind.--(HSMN NewsFeed)--May 3, 2006--Biomet (NASDAQ:BMET ) announced today that the U.S. Food & Drug Administration has issued regulatory clearance for the Company's Regenerex(TM) Porous Titanium Construct acetabular system for primary and revision hip surgery. Regenerex(TM) Porous Titanium Construct is a highly porous structural material engineered for optimal biological fixation. The system includes acetabular shells and augments designed to address complex revision procedures. The product launch is scheduled to begin during the first half of fiscal year 2007.
Interim President and CEO Daniel P. Hann commented, "We are pleased to announce the recent regulatory clearance of Biomet's Regenerex(TM) acetabular system, providing surgeons the first opportunity to utilize a highly porous titanium construct for their acetabular reconstruction cases. The acetabular system is the first of many offerings planned for this uniquely designed titanium material. The Regenerex(TM) shells and augments are a great addition to the Company's broad revision platform and will meet surgeon demand for a titanium solution in the growing porous metal market."
Titanium, a well-established and clinically proven material, which was pioneered by Biomet for use in orthopedics, is a preferred metal for its biocompatibility and strength. Biomet's Regenerex(TM) material represents an engineering breakthrough in porous metal technology. Compared to tantalum, used in currently marketed highly porous metal products, titanium is a more readily available material and more efficient to manufacture, thus offering greater design flexibility for future product introductions.
Biomet, Inc. and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy. The Company's product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, 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 more than 100 countries.
This press release contains certain statements that are "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. 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.
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