Integra LifeSciences Launches TenoGlide Tendon Protector Sheet
PLAINSBORO, N.J., Feb. 14, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the launch of TenoGlide™ Tendon Protector Sheet. Integra has received 510(k) clearance from the United States Food and Drug Administration to market TenoGlide™ Tendon Protector Sheet in the United States.
TenoGlide™ Tendon Protector Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an advanced tendon protection device, composed of a porous matrix of cross-linked collagen and glycosaminoglycan (GAG). The collagen-GAG resorbable matrix provides a protective, biocompatible interface, which creates a favorable environment and gliding surface for tendon healing. Based on available procedural data, Integra estimates that the worldwide market for the protection of tendon injuries is over $100 million.
"In our pre-clinical studies, the data indicate that the use of TenoGlide™ Tendon Protector Sheet during tendon repair in an animal model significantly reduced formation of scar tissue between the tendon and surrounding tissue, as compared to untreated controls," said Mayer Tenenhaus MD, FACS, Associate Clinical Professor of Surgery/Plastic Surgery at University of California, San Diego.
Since tendon and peripheral nerve injuries often occur together, TenoGlide™ Tendon Protector Sheet can be used in conjunction with two previously cleared Integra products: NeuraGen® Nerve Guide for completely transected nerves, and NeuraWrap™ Nerve Protector for nerve injuries, which include compressed or scarred nerves.
TenoGlide™ Tendon Protector Sheet will be sold by Integra's Extremity Reconstruction sales organization, which includes over 60 U.S. sales specialists focused 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. 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 (http://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 TenoGlide™ Tendon Protector Sheet, the NeuraWrap™ Nerve Protector, and NeuraGen® Nerve Guide. 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.
CONTACT: Integra LifeSciences Holdings Corporation
John B. Henneman, III, Executive Vice President,
Chief Administrative Officer
Gianna Sabella, Public Relations Manager