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Recently Approved Spinal Fusion Device and Bone Graft Using Genetically Engineered Protein Utilizes Integra LifeSciences' Absorbable Collagen Sponge


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Press Release

Jul 15, 2002

Recently Approved Spinal Fusion Device and Bone Graft Using Genetically Engineered Protein Utilizes Integra LifeSciences' Absorbable Collagen Sponge

Recently Approved Spinal Fusion Device and Bone Graft Using Genetically Engineered Protein Utilizes Integra LifeSciences' Absorbable Collagen Sponge Plainsboro, New Jersey, July 15, 2002-- Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that its Absorbable Collagen Sponge is part of a new product that was recently approved by the U.S. Food and Drug Administration (FDA). Medtronic Sofamor Danek's (NYSE: MDT) INFUSET Bone Graft was recently approved by the FDA for use with its LT-CAGET Lumbar Tapered Fusion Device to treat certain types of spinal degenerative disc disease, a common cause of low back pain. The INFUSE Bone Graft includes the Absorbable Collagen Sponge developed and manufactured by Integra LifeSciences.

INFUSE Bone Graft contains recombinant human bone morphogenetic protein (rhBMP-2), which was discovered and developed by Wyeth BioPharma (NYSE: WYE) and is manufactured at their Andover, Massachusetts biopharmaceutical facility. rhBMP-2 is the genetically engineered version of a naturally occurring protein that is capable of initiating bone growth, or bone regeneration, in specific, targeted areas in the spine. Using INFUSE Bone Graft with the LT-CAGE device in spine surgery induces the body to grow its own bone where it is needed. This reduces the pain and complications associated with the second surgery required to harvest bone from a patient's hip, as is done in traditional spinal fusion procedures.

To use INFUSE Bone Graft, surgeons reconstitute the rhBMP-2 powder with supplied sterile water and then apply it to Integra's Absorbable Collagen Sponge. The Absorbable Collagen Sponges are inserted inside each of two LT-CAGE Lumbar Tapered Fusion Devices, which are then implanted between the vertebrae to stabilize the spine while it is fusing and also to maintain the proper height between the vertebrae.

"We are very pleased with the FDA's decision to approve this innovative new medical technology," said Stuart Essig, Integra's President and Chief Executive Officer. "Since 1994, we have supplied the Absorbable Collagen Sponge to Wyeth in support of its rhBMP-2 development program and have worked closely with Wyeth and Medtronic in their efforts to obtain FDA approval for the INFUSE product. This further enhances Integra's reputation as a strategic partner and a leader in the field of tissue repair."

Integra's Absorbable Collagen Sponge for the INFUSE product joins Integra's other leading tissue repair products. They include the INTEGRA&amp;reg; Dermal Regeneration Template for regeneration of the dermis, the DuraGen&amp;reg; Dural Graft Matrix for repair of the dura mater, the NeuraGenT Nerve Guide for repair of peripheral nerves, and the Biomend&amp;reg; products for guided tissue repair of the periodontal ligament in dental surgery. The INTEGRA Dermal Regeneration Template is sold through Johnson & Johnson Wound Management, a division of Ethicon, Inc., the Biomend line of products is sold through Centerpulse Ltd., and the DuraGen and NeuraGen products are sold through Integra NeuroSciences, the neurosurgical products division of Integra LifeSciences Holdings Corporation.

Integra LifeSciences Holdings Corporation develops, manufactures and markets medical devices, implants and biomaterials primarily used in the treatment of cranial and spinal disorders, soft tissue repair and orthopedics. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. The Company has its corporate headquarters in Plainsboro, New Jersey, with manufacturing and research facilities located throughout the world. The Company has approximately 620 permanent employees. Please visit the Company's 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 relating to the ultimate prospects for commercial success of the INFUSE product. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2001 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

INFUSET Bone Graft and LT-CAGET Lumbar Tapered Fusion Device are trademarks of Medtronic, Inc.

SOURCE: Integra LifeSciences Holdings Corporation

CONTACT:

Integra LifeSciences Holdings Corporation
John B. Henneman, III, Senior Vice President,
Chief Administrative Officer
(609) 936-2481
jhenneman@Integra-LS.com

John Bostjancic, Senior Director of Finance
(609) 936-2239
jbostjancic@Integra-LS.com