Biomet, Inc. to Manufacture First Spring-Enhanced, Stress-Sharing Orthopedic Implant Designed to Restore Function to Bone Cancer Patients.Business Editors/Health/Medical Writers WARSAW, Ind.--(BUSINESS WIRE)--Jan. 12, 2004 Biomet, Inc. (Nasdaq:BMET BMET Biomedical Engineering Technology BMet Bachelor of Metallurgy BMET Bio-Medical Equipment Repair Technician ) announced today its plans to manufacture the first spring-enhanced, stress-sharing orthopedic implant designed to salvage bones of patients with certain femoral femoral /fem·o·ral/ (fem´or-al) pertaining to the femur or to the thigh. fem·o·ral adj. Of or relating to the femur or thigh. complications. After a four year clinical study, the U.S. Food and Drug Administration has cleared the ComPreSs(R) Distal Femoral Replacement System to be used in patients with tumors of the distal femur femur (fē`mər): see leg. and revisions of oncologic distal femoral replacements. As the first of its kind to be introduced into the orthopedic market, the ComPreSs(R) System has been primarily used in patients with tumors in the distal femur. The ComPreSs(R) System is used in conjunction with a total knee implant and consists of several springs stacked inside a porous-coated metal shell. The porous coating allows bone to grow onto the ComPreSs(R) System, securing the implant in place. Unlike other implants, the springs in the ComPreSs(R) System generate stress on the host bone. This stress helps prevent bone atrophy, which can potentially lead to loosening and the need for a second surgery. This technology has allowed patients the ability to resume daily functions. "The ComPreSs(R) System provides an alternative to traditional methods of distal femoral replacement and is the only implant out there like that," said Dr. Daniel Martin, staff physician at Kaiser Permanente Santa Clara Medical Center and co-developer of the ComPreSs(R) System. Dr. James Johnston, director of musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. oncology service at Kaiser Permanente Medical Center in South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. and professor emeritus of orthopedic surgery and clinical radiology at the University of California, San Francisco (UCSF UCSF University of California at San Francisco ), was the first clinician to apply the device in a clinical setting. "With this new device, we've changed the whole picture of how forces go through the bone to promote bone growth," Johnston said in a 1999 UCSF press release. Dr. Richard J. O'Donnell, chief of orthopedic oncology service and associate professor of clinical orthopedic surgery at UCSF has been instrumental in researching and performing clinical applications of the ComPreSs(R) System technology. According to a 1999 UCSF press release, O'Donnell said the ComPreSs(R) System might not only help to prevent a knee implant from loosening, but can also allow patients to function over the long term. The ComPreSs(R) System has been studied for more than 10 years. Additional clinical sites utilizing the ComPreSs(R) System include: the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. Department of Orthopaedics and Rehabilitation, Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New in New York, The University of Texas M.D. Anderson Cancer Center, St. Luke's Medical Center in Phoenix and Huntsman Cancer Institute The Huntsman Cancer Institute is a research center in the University of Utah designed to research, learn about, treat, and prevent cancer. It was founded with a pledge, including $100 million of personal wealth, from Jon Huntsman, Sr., a philanthropist and businessman. at The University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. . Biomet's President and Chief Executive Officer, Dane A. Miller, Ph.D., commented, "We are pleased to receive 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 on the ComPreSs(R) System. Although the FDA has cleared the ComPreSs(R) System for strictly distal femoral oncologic use, Biomet is actively pursuing clearance for the ComPreSs(R) System to also be used for revision knees, primary and revision hips, shoulders and elbows. This technology could represent a significant growth opportunity for Biomet as the ComPreSs(R) System potentially may be cleared for numerous applications." Biomet and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy, including reconstructive and fixation devices, electrical bone growth stimulators, orthopaedic support devices, operating room supplies, general surgical instruments, arthroscopy Arthroscopy Definition Arthroscopy is the examination of a joint, specifically, the inside structures. The procedure is performed by inserting a specifically designed illuminated device into the joint through a small incision. products, spinal implants, bone cements, bone substitutes, craniomaxillofacial implants and dental implants, and associated instrumentation. Biomet and its subsidiaries currently distribute products in more than 100 countries. For further information contact Greg W. Sasso, Vice President, Corporate Development and Communications at (574) 372-1528 or Barbara Goslee, Manager, Corporate Communications at (574) 372-1514. 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. 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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