Integra LifeSciences Announces CE Mark for DuraGen Plus(TM) Adhesion Barrier Matrix


PLAINSBORO, N.J., Oct. 18, 2004 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received CE Mark Certification for the DuraGen Plus(TM) Adhesion Barrier Matrix. The product is approved as a barrier against adhesions following spinal and cranial surgery and for restoration of the dura mater. Integra is introducing the DuraGen Plus(TM) Adhesion Barrier Matrix to international physicians at the 54th Annual Meeting of the Congress of Neurological Surgeons in San Francisco this week. Integra will launch the product outside the United States during the fourth quarter through its direct sales force and international distributor network.

Spinal adhesions are a frequent consequence of spine surgery and are associated with post-operative pain and disability. A significant portion of laminectomy and discectomy patients require re-operation for severe pain. DuraGen Plus Adhesion Barrier Matrix provides a treatment option for prophylactic adhesion prevention. Integra estimates that the total available worldwide market for treatment of spinal adhesions is in excess of $300 million, and the worldwide market for duraplasty is approximately $110 million. Both markets are addressed by DuraGen Plus Adhesion Barrier Matrix.

"Our application for CE Mark certification for these expanded indications was supported by clinical studies demonstrating that application of DuraGen Plus matrix provides an effective method for preventing dural adhesions following spinal and cranial surgical procedures," said Simon Archibald, Ph.D., Vice President of Clinical Affairs. "Since it was launched in the U.S., DuraGen Plus has proven to be a highly effective dural grafting system. This recent CE Mark approval, as an adhesion barrier matrix, is another significant milestone for this family of products."

The outcomes of a clinical study of the application of the DuraGen matrix to prevent spinal adhesions will be summarized at the CNS meeting in a poster entitled, "Dural graft matrix as an adhesion barrier," presented by Doctors Inaki Arrotegui and J. Luis Llombart of Valencia, Spain. The investigators concluded that application of the DuraGen matrix resulted in reduced post-operative patient pain, lower incidence of adhesions as assessed by MRI, and an overall decrease in the incidence of pain-related re-operation.

Integra previously launched the DuraGen Plus Dural Graft Matrix, its next-generation onlay dural graft, to the U.S. market in October, at the 2003 CNS meeting. The DuraGen Plus Adhesion Barrier Matrix, with expanded adhesion barrier indications, is not available or cleared for sale within the United States.

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 our products are neuro-trauma and neurosurgery, plastic and reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. We have approximately 1,200 employees. 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 use of the DuraGen Plus(TM) Adhesion Barrier Matrix. 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 relative effectiveness of competitive products and the willingness of physicians to use the DuraGen Plus(TM) Adhesion Barrier Matrix may affect the extent of its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors That May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2003 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.



            

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