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Exactech Cleared by FDA for U.S. Distribution of InterSpace(TM) Pre-formed Antibiotic Cement Bone Spacer
THURSDAY, JANUARY 29, 2004 8:59 AM
- PR Newswire
GAINESVILLE, Fla., Jan 29, 2004 /PRNewswire-FirstCall via COMTEX/ -- Exactech, Inc., (EXAC) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for distribution of the only pre-formed cement hip spacer containing antibiotic available in the United States.
The pre-formed InterSpace(TM) hip spacer is a major advancement in treating patients suffering from the complication of infected total hip arthroplasty. Used in two-stage revision hip surgery, it provides an orthopaedic surgeon with a new method for a more effective and efficient surgical procedure in these difficult situations. The spacer allows for consistent and uniform release of antibiotic into the local infected area. It also offers patients the opportunity for improved function after the first stage treatment and better rehabilitation after the definitive second stage operation.
Exactech CEO Bill Petty said, "This new device eliminates costly additional operating time and replaces the inconsistent quality of the intra- operatively hand-fashioned devices currently being used, thus allowing the surgeon to deliver much more effective treatment."
"InterSpace further enhances Exactech's leadership position in providing surgeons with products for treating the entire spectrum of patients with joint disease from the simple to the more complex," said Gary Miller, executive vice president of research and development.
Jody Phillips, chief financial officer, said, "We are pleased to have received FDA clearance for InterSpace this early in the year and expect full product release during the second quarter. The impact of this product was reflected in our prior full year 2004 guidance."
InterSpace is manufactured by Tecres S.p.a., Verona, Italy and distributed in the U.S. exclusively by Exactech.
About Exactech
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and 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. Copies of EXAC press releases, SEC filings, current price quotes and other valuable information for investors may be found on the websites http://www.exac.com and http://www.hawkassociates.com
An investment profile on Exactech may be found on the website www.hawkassociates.com/exactech/profile.htm
Additional information about Exactech, Inc. can be found on the website 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 on the Hawk Associates website www.hawkassociates.com Investors may also contact Frank Hawkins or Julie Marshall, Hawk Associates, Inc. at (305) 852-2383. Email: info@hawkassociates.com

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