PLAINSBORO, N.J., Feb. 12, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that it had received 510 K Clearance from the United States Food and Drug Administration for Integra Mozaik(TM) Osteoconductive Scaffold. This new bone void filler combines the benefits of both a highly purified beta-tricalcium phosphate and Integra's proprietary highly purified collagen scaffold, and is designed for use in spinal fusion and in reconstructive surgery of the extremities.
When used with bone marrow aspirate from the patient, Integra Mozaik(TM) Osteoconductive Scaffold may replace the need to harvest bone from the patient's iliac crest, thus sparing the patient additional surgery and postoperative pain. Integra Mozaik(TM) Osteoconductive Scaffold will be available at launch in strip and putty configurations that can be used in posterolateral lumbar fusion and interbody fusion.
Degenerative diseases of the spine may affect nearly all adults during their lives. Patients who experience severe pain, who do not respond to conservative therapies, may require fusion. A spinal fusion is successful when the bones grow together biologically and form a solid mass. To help achieve this biological fusion, bone grafts, or other biological products that promote bone growth, are often used. The use of bone graft substitutes in these procedures represents an estimated $350 million market. In 2006, an estimated 450,000 spinal fusion procedures were performed in the U.S.
Integra Mozaik(TM) Osteoconductive Scaffold is the first significant launch of a spinal product, beyond Integra's DuraGen(R) family of products (for repair of the dura mater), that will be sold directly through Integra's U.S. sales force. Integra is committed to developing a portfolio of biomaterials for spinal surgery that capitalize on Integra's expertise in regenerative technologies. Historically, Integra has been recognized as a leader in the manufacturing of biomaterials used in spine, such as the Absorbable Collagen Sponge used in conjunction with recombinant bone morphogenetic protein (BMP) for spine fusion. Integra Mozaik(TM) Osteoconductive Scaffold and DuraGen Plus(R) Dural Regeneration Matrix will be used to build Integra's presence in the spine market.
"Integra Mozaik(TM) Osteoconductive Scaffold leverages Integra's expertise in regenerative technologies. Examples of other regenerative technologies include Integra(R) Dermal Regeneration Template, the DuraGen(R) family of products and NeuraGen(R) Nerve Guide," said Stuart Essig, CEO of Integra. "The introduction of Integra Mozaik(TM) Osteoconductive Scaffold reinforces our intention to build a business in spine and represents another milestone in Integra's history as a leader in regenerative technologies."
Integra Mozaik(TM) Osteoconductive Scaffold will be sold for spinal applications through Integra's Neurospecialist sales force, which includes a newly formed group of sales specialists dedicated to the orthopedic spine market. For extremity applications, Integra Mozaik(TM) Osteoconductive Scaffold will be sold by Integra's reconstructive extremities sales force. These combined sales forces represent over 200 sales specialists across the United States.
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. Our products, used primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery, are used to treat millions of patients every year. Integra's headquarters are in Plainsboro, New Jersey, and we have research and manufacturing facilities throughout the world. Please visit our website at 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 Mozaik(TM) Osteoconductive Scaffold. 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 Risk Factors section of Integra's Annual Report on Form 10-K for the year ended December 31, 2005, and information contained in subsequent filings with the Securities and Exchange Commission, could affect actual results.