PLAINSBORO, N.J., Mar 7, 2008 (PrimeNewswire via COMTEX News Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of Integra OS(TM) Osteoconductive Scaffold and the Trel-X(TM) and Trel-XC(TM) Demineralized Bone Matrix products through the Integra Extremity Reconstruction division. Each product has received clearance to be marketed in the United States from the United States Food and Drug Administration (FDA) and will be featured at the 75th annual American Academy of Orthopedic Surgeons (AAOS) Meeting this week.
This new family of osteobiologic products comprises three distinct product lines: Integra OS(TM) Osteoconductive Scaffold, a synthetic bone void filler manufactured from beta tri-calcium phosphate and type I bovine collagen; Trel-X(TM), a demineralized bone matrix; and Trel-XC(TM), a demineralized bone matrix premixed with cancellous bone.
Integra OS(TM) Osteoconductive Scaffold provides a three dimensional osteoconductive scaffold for new bone formation. The collagen portion of the matrix provides a binding site for the cells and proteins that are necessary for new bone deposition. When used in conjunction with patient derived bone marrow, Integra OS(TM) Osteoconductive Scaffold may substitute for harvesting bone graft material from the patient's iliac crest, thus sparing the patient additional surgery and postoperative pain.
Trel-X(TM) Demineralized Bone Matrix is provided in a reverse phase poloxamer carrier to provide exceptional handling characteristics and resistance to irrigation. Each lot of demineralized bone used to make Trel-X(TM) is tested for osteoinductive potential using an in vitro assay. The product is available as both a packable putty and injectable gel to address the varying requirements of reconstructive procedures.
Trel-XC(TM) Demineralized Bone Matrix combines the benefits of Trel-X(TM) with the addition of the osteoinductive properties of cancellous bone chips. Trel-XC(TM) is available as both a packable putty and an injectable paste. The paste form is one of the only available injectable demineralized bone matrix forms with premixed cancellous chips.
"We are very excited about launching our comprehensive line of synthetic bone graft substitutes and demineralized bone matrix products. The addition of these quality products leverages our presence in extremity reconstruction procedures and allows our sales organization to be a one stop shop for our customers," said Bob Paltridge, President of the Integra Extremity Reconstruction Division.
Bone graft substitutes are used in many of the more than 400,000 extremity fusion and osteotomy procedures annually. The extremity reconstruction bone graft market is estimated at more then $50MM annually in the United States. (Source: Hospital and diagnosis data from the Ortho FactBook(TM) 5th Edition, published April 2005 by Knowledge Enterprises).
The Extremity Reconstruction field sales organization, of approximately 80 sales specialists, will sell the Integra OS(TM), Trel-X(TM) and Trel-XC(TM) product lines. The sales force focuses on lower extremity fixation, upper extremity fixation, wound repair, tendon protection, and peripheral nerve repair/protection.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing, and marketing of cost-effective surgical implants and medical instruments. The company's products are used to treat millions of patients every year, primarily in neurosurgery, extremity reconstruction, orthopedics, and general surgery. Integra's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the future use of the Integra OS(TM) Osteoconductive Scaffold, and Trel-X(TM) and Trel-XC(TM) Demineralized Bone Matrix products. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use these products may affect the prospects for their use in clinical procedures. In addition, the economic, competitive, governmental, technological, and other factors identified under the heading "Risk Factors" included in section IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2006 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
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SOURCE: Integra LifeSciences Holdings Corp.
Integra LifeSciences Holdings Corporation John B. Henneman, III, Executive Vice President, Chief Administrative Officer, Acting Chief Financial Officer (609) 936-2481 jhenneman@Integra-LS.com Gianna Sabella, Public Relations Manager (609) 936-2389 gsabella@integra-LS.com
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