PLAINSBORO, N.J., June 26, 2008 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of the Tibiaxys(TM) Plating System. The Tibiaxys(TM) Plating System has received clearance from the United States Food and Drug Administration (FDA), and a CE Mark Certification in the European Union, The Tibiaxys(TM) Plating System was designed with the help of Professor Beat Hintermann, MD, Kantonsspital, Liestal, Switzerland.
The Tibiaxys(TM) System is designed specifically to address ankle arthritis and deformity, and is manufactured from titanium alloy for strength and biocompatibility. The system includes four distinct plating types - anterior ankle fusion plates, medial and lateral distal tibial osteotomy plates and fibula fracture plates. All plates incorporate the patented Surfix(R) locking technology, which allows the surgeon to place the plate at the optimal distance from the bone and then lock the screws. The Tibiaxys(TM) plates are also the first system to incorporate Surfix Alpha(TM) variable angle locking technology. Surfix Alpha(TM) provides all the proven benefits of standard Surfix(R) locking technology, with the advantages of variable angle fixation.
"We are very excited about the addition of the Tibiaxys(TM) Plating System to Integra's extensive line of mid and hind foot plating systems, which include the Advansys(TM) and Uni-CP(TM) systems," said Robert Paltridge, President of Integra Extremity Reconstuction. "We feel that Integra provides excellent surgical options for the complex reconstructive procedures used to address mid and hind foot arthritic disease. The Tibiaxys(TM) System will be a significant addition to the surgeon's armamentarium."
The use of plating systems is becoming an increasingly popular technique for the treatment of ankle fractures. Plating is also being used extensively in arthrodesis procedures for the treatment of degenerative diseases of the ankle joint, a technique by which the joint is fused to reduce pain and aid walking. Based on available procedural data, Integra estimates that there are over 20,000 ankle fusion procedures performed annually in the United States, with an estimated market value of $10-20 million.
The Tibiaxys(TM) Plating System will be sold by Integra's eighty person Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
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. Integra's products, used primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery, are used to treat millions of patients every year. The company's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. For more information visit 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 Tibiaxys(TM) Plating System, and the Advansys(TM) and Uni-CP(TM) systems. 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 heading "Risk Factors" included in section IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2007 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
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