PLAINSBORO, N.J., Oct. 6, 2003 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that it has reached agreement with ETHICON Inc. for the return to Integra of the exclusive right to sell, market and distribute the INTEGRA Dermal Regeneration Template(R).
The INTEGRA Dermal Regeneration Template is the first and only product to receive FDA approval as a skin replacement system with a claim for regeneration of dermal tissue for the treatment of life-threatening burns and repair of scar contractures. INTEGRA Dermal Regeneration Template was developed by Integra LifeSciences Corporation, and has been sold in the United States since 1996. In that time, the INTEGRA product has helped thousands of patients recover from severe thermal injuries.
ETHICON will continue to sell and market the product through the end of this year under the terms of a 1999 supply and distribution agreement between Integra and ETHICON. In 2004 Integra LifeSciences Corporation will resume exclusive responsibility for the sales, marketing and distribution of the product. Integra and ETHICON are working together to develop a plan to ensure a smooth transition of the product's distribution.
"We are delighted to again take responsibility for the sales, marketing and clinical education for this extraordinary product," said Stuart M. Essig, Integra's President and Chief Executive Officer. "In the four years that ETHICON has managed the INTEGRA product, it has attained widespread use in burn units for the treatment of life threatening burns. Going forward, our objective will be to continue to expand the usage of INTEGRA Dermal Regeneration Template to the plastic and reconstructive markets."
Integra expects the impact of the amendment to be accretive to earnings in 2003 and neutral or accretive to earnings in 2004. Certain amounts, including event payment revenues related to the prior achievement of clinical and regulatory events, and various revenues, transition costs and other income amounts related to the amendment, will be recognized during the third and fourth quarters of 2003. Additional financial information will be made available on Integra LifeSciences' quarterly earnings conference call, which is scheduled for October 31, 2003 at 9:00 a.m.
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 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. Please visit the Company's 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 expectations for Integra's ability to expand the usage of the INTEGRA product to the plastic and reconstructive markets and the impact that the amendment to the supply and distribution agreement will have on Integra's future financial 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, Integra LifeSciences Corporation's ability to successfully recruit and build a direct sales and marketing infrastructure around the INTEGRA product may affect its ability to expand the usage of the product to the plastic and reconstructive markets, and the costs of maintaining such a direct sales and marketing infrastructure may affect Integra LifeSciences Corporation's future financial 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, 2002 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.