Healthcare Industry News: Allograft
News Release - September 26, 2006
Exactech Gains FDA Clearance for DBM with Bone Chips, Optecure(TM)+CCCGAINESVILLE, Fla., Sept. 26 (HSMN NewsFeed) -- Exactech, Inc. (Nasdaq: EXAC ), a producer and distributor of bone and joint restoration products including orthopaedic implants and biologic materials, announced today that the Food and Drug Administration (FDA) has issued 510(k) clearance for a new formulation of the company's Optecure(TM) Allograft which includes cortical cancellous bone chips.
According to Bruce Thompson, senior vice president and general manager of Exactech's Biologics Division, "Optecure+CCC is the latest addition to Exactech's platform of demineralized bone matrix (DBM) products. Optecure+CCC offers the same unique handling characteristics that have made Optecure DBM the choice of leading spine surgeons throughout the country. The Optecure+CCC formulation contains osteoconductive bone chips, providing surgeons with a wider range of products for application-specific solutions." Thompson said that additional Optecure products are currently in development.
Optecure+CCC is indicated for use as a bone graft extender in the extremities, spine and pelvis and as a bone void filler in the extremities and pelvis. Initial surgeries are expected to take place by the end of 2006, and a national market launch is scheduled for the first quarter of 2007.
Exactech launched the Optecure line in early 2005 as its entry into the biologics segment of the spine reconstruction market. Designed and manufactured according to processes developed and validated by Exactech, Optecure is comprised of DBM in a synthetic bioabsorbable polymer carrier. This innovative carrier was licensed from Genzyme Corporation and represents the foundation of the product platform. Optecure was the first FDA-cleared medical device that includes human DBM as a component.
A distinguished group of spine surgeons are participating in a prospective randomized clinical evaluation of Optecure DBM. They are meeting prior to the annual meeting of the North American Spine Society in Seattle, Wa., to discuss their early results and experiences to date.
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 Exactech's press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com and http://www.hawkassociates.com.
An investment profile on Exactech may be found at http://www.hawkassociates.com/exacprofile.aspx.
Questions should be directed to Frank Hawkins or Julie Marshall of Hawk Associates, Inc. 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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