PLAINSBORO, N.J., March 8, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) will showcase Integra Mozaik(TM) Osteoconductive Scaffold at the AANS Spine Section meeting in Phoenix, Arizona March 7-10, 2007. Integra Mozaik(TM) Osteoconductive Scaffold recently received 510K clearance from the Food and Drug Administration as a bone void filler. Mozaik(TM) Osteoconductive Scaffold is designed to bridge gaps or fill voids in the skeletal structures of the spine, extremities, and pelvis. Mozaik(TM) is available in two configurations, a compression resistant strip and a putty. The strip configuration is intended for procedures such as posterolateral lumbar fusion and interbody fusion. The putty is intended to fill voids and complex cavities.
Sylvain Palmer, M.D., F.A.C.S of Saddleback Memorial Medical Center in Laguna Hills, California, was the first surgeon to use Integra Mozaik(TM) Osteoconductive Scaffold in a lumbar spinal surgery. He chose the bone graft as a scaffold to optimize the surgical environment for bone formation. "Integra Mozaik(TM) Osteoconductive Scaffold offers a compression resistant tricalcium phosphate matrix with a Type I collagen substrate for binding bone growth factors. It was easy to divide into appropriate sizes to fit optimally into the posterior lateral gutter, maximizing the host graft interface," said Dr. Palmer.
Integra Mozaik(TM) Osteoconductive Scaffold provides a framework for fusion by providing a compression resistance scaffold, as well as binding sites for cells and proteins; these elements are critical for the formation of new bone. 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.
The use of bone graft substitutes in spinal procedures, excluding synthetic bone morphogenetic proteins, represents an estimated $350 million market. In 2006, an estimated 450,000 spinal fusion procedures were performed in the U.S. Additional opportunity exists in orthopedic reconstructive applications.
Integra Mozaik(TM) Osteoconductive Scaffold represents Integra's commitment to building a spinal portfolio in biomaterials that capitalizes on an 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 spinal fusion. 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 extremity reconstruction 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 this product may affect the prospects for its 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, 2006, and information contained in subsequent filings with the Securities and Exchange Commission, could affect actual results.