Healthcare Industry News: total shoulder
News Release - June 19, 2006
Exactech Announces FDA Clearance for U.S. Distribution of InterSpace(TM) Shoulder Pre-formed Antibiotic Bone Cement SpacerGAINESVILLE, Fla., June 19 (HSMN NewsFeed) -- Exactech, Inc. (Nasdaq: EXAC ), a developer and producer of bone and joint restoration products including orthopaedic implants and biologic materials, announced today that the U.S. Food and Drug Administration (FDA) has cleared for distribution the only pre-formed cement shoulder spacer containing antibiotic available in the United States.
The InterSpace(TM) Shoulder is a major advancement in treating patients suffering from the complication of infected total shoulder arthroplasty. Like the InterSpace Hip and InterSpace Knee, which Exactech introduced in 2004, the InterSpace Shoulder provides for consistent and uniform antibiotic release into the local infected area, confers mechanical advantages by maintaining the joint space, and offers patients mobility during the interval of spacer management and the opportunity for improved function following the definitive second-stage operation.
Exactech CEO Bill Petty said, "We are proud of our leadership position in the treatment of infected total joint arthroplasty and pleased to expand our InterSpace product family. This fits well with Exactech's commitment to improving patient outcomes for those faced with these difficult problems."
Lynn Crosby, M.D., a leading shoulder surgeon and specialist for infected shoulder arthroplasty, assisted with the FDA submission and conducted cadaveric evaluation of the InterSpace Shoulder. Crosby said, "This is an innovative solution to a challenge I routinely face in the O.R. The InterSpace shoulder complements the Equinoxe(TM) shoulder system, allowing us to meet a wide range of challenges in shoulder reconstruction."
InterSpace is manufactured by Tecres S.p.A., Verona, Italy and distributed in the U.S. exclusively by Exactech.
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments, biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech's orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States and in more than 25 countries in Europe, Asia, Australia and Latin America.
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Additional information about Exactech, Inc. can be found at http://www.exac.com. An online virtual investor kit containing Exactech press releases, SEC filings, current price quotes, stock charts and other useful information for investors can be found at http://www.hawkassociates.com. Investors may contact Chief Financial Officer Jody Phillips at (352) 377-1140 or Julie Marshall or Frank Hawkins, Hawk Associates, at (305) 451-1888, e-mail: email@example.com.
This release contains various 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, which represent the company's expectations or beliefs concerning future events of the company's financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward- looking statements. These factors include the effect of competitive pricing, the company's dependence on the ability of third-party manufacturers to produce components on a basis that is cost-effective to the company, market acceptance of the company's products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.
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