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Positive Results of DuraGen® Dural Graft Matrix Clinical Experience Involving 110 Patients Presented At NASS Annual Meeting in San Diego


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Press Release

Oct 22, 2003

Positive Results of DuraGen® Dural Graft Matrix Clinical Experience Involving 110 Patients Presented At NASS Annual Meeting in San Diego

Positive Results of DuraGen® Dural Graft Matrix Clinical Experience Involving 110 Patients Presented At NASS Annual Meeting in San Diego

Plainsboro, New Jersey, October 22, 2003 -- Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that Dr. Pradeep K. Narotam, MBChB, MMED, FCS (SA), FRCSC of the Creighton University Medical Center's Division of Neurosurgery presented the results of a clinical study "Collagen Matrix (DuraGen&amp;reg;) in Spinal Durotomy - Technique Appraisal and Clinical Results," at the 18th Annual Meeting of the North American Spine Society in San Diego.

Dr. Narotam reported a retrospective analysis of operative results from 110 spinal surgery patients who received repair of spinal dural defects with the DuraGen&amp;reg; Dural Graft Matrix. This study was undertaken to illustrate the safety and efficacy of the DuraGen product for dural repair in spinal procedures.

The dura mater is a tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. Breach of the spinal dura may occur as a result of trauma, intentional surgical procedures to gain access to the spinal cord, or incidental surgical injury. In each case, dural reconstruction is imperative to prevent leakage of cerebrospinal fluid (CSF) and to facilitate proper wound healing.

The DuraGen product is the only material available that may be used effectively as a sutureless onlay graft for the repair of dural defects. In certain cases, such as when addressing lateral or anterior defects, conventional suture-based methods for repair of the spinal dura are not practicable. The DuraGen Dural Graft Matrix onlay graft technique provides a safe, effective and efficient alternative method for dural closure.

"This study demonstrates that DuraGen represents a safe, suitable method for repairing dural defects during spinal surgery," said Dr. Narotam. "After rapidly forming an initial barrier to CSF leakage, the three-dimensional architecture of the DuraGen matrix encourages cell ingrowth and biological repair of the dura mater. Together with closed sub-fascial drainage and early mobilization, the use of DuraGen does not adversely affect patient morbidity and hospital stay. DuraGen can be applied in a variety of spinal and cranial procedures and is time efficient, particularly in anterior spinal surgery or for posterior dural rents and pinhole tears involving nerve root sleeves or the lateral dura."

The DuraGen product is now used in over 1,200 hospitals in the United States and has become a standard protocol for repair of cranial as well as spinal dural defects in neurosurgical procedures. Integra estimates that over 150,000 DuraGen implants have been used in patients worldwide since the commercial launch of the product in 1999.

The DuraGen product is sold through the Integra NeuroSciencesTM sales organization. Integra NeuroSciences is a leading provider of implants, devices, instruments, and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra NeuroSciences' direct selling effort in the United States and Europe currently involves more than 100 professionals. In all other markets, Integra NeuroSciences products are sold through a network of distributors.

Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for Integra's products are neuro-trauma and neurosurgery, plastic and reconstructive surgery, general surgery and soft tissue repair. 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 860 permanent employees.

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 future alternative clinical uses of the DuraGen product. The accuracy of such forward-looking statements is necessarily subject to risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, physicians' willingness to use the DuraGen product may affect the prospects for its use in additional clinical procedures. 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, 2002 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source: Integra LifeSciences Holdings Corporation







CONTACT: Integra LifeSciences Holdings Corporation
Maria Platsis, 609-936-2333
mplatsis@integra-ls.com
John Bostjancic, 609-936-2239
jbostjancic@integra-ls.com