Integra LifeSciences Receives FDA Approval and CE Mark for INTEGRA® Dermal Regeneration Template - Terminally Sterilized
PLAINSBORO, N.J., Oct. 11, 2004 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Integra LifeSciences has received approval from the United States Food and Drug Administration (FDA) and CE Mark Certification in the European Union from TUV Product Service to sell the terminally sterilized version of its currently-marketed INTEGRA® Dermal Regeneration Template in the United States and Europe.
INTEGRA® Dermal Regeneration Template - Terminally Sterilized (IDRT-TS) offers customers numerous improvements over the existing INTEGRA® Dermal Regeneration Template. Integra is launching IDRT-TS this week at the American Society of Plastic Surgeon's 2004 Annual Meeting in Philadelphia and plans to launch the product in Europe shortly thereafter. Integra will sell IDRT-TS through its Plastic and Reconstructive Surgery sales force domestically, through its direct sales forces in Germany, England and France, and through distributors in the remainder of Europe.
IDRT-TS is functionally the same as the INTEGRA® Dermal Regeneration Template. However, the packaging configuration and storage requirements of IDRT-TS offer certain benefits over the original product. IDRT-TS does not require refrigeration and can be stored flat, which simplifies considerably the preparation and handling of the INTEGRA product in the operating room. In addition, IDRT-TS requires a significantly shorter rinse time prior to application than does the INTEGRA Dermal Regeneration Template. IDRT-TS is also offered in a new two-inch by two-inch size. Integra estimates that the market opportunity for products used in plastic and reconstructive surgery to treat burns and scar contractures is approximately $220 million.
"The approval of the terminally sterile INTEGRA Dermal Regeneration Template product in the United States and Europe increases our opportunity for market penetration," said Stuart M. Essig, Integra's President and Chief Executive Officer. "This new product offers significant benefits to our customers, particularly in its storage requirements and ease of preparation, and reflects our continuing commitment to advance our core technologies to meet customer needs."
INTEGRA® Dermal Regeneration Template is a two-layer skin regeneration system. The inner layer, which is placed in contact with the excised wound, is constructed of a complex matrix of cross-linked fibers. This porous material acts as a scaffold for regenerating dermal skin cells, which enables the re-growth of a functional dermal layer of skin. The outer layer is a thin silicone film that protects the wound from infection and controls both heat and moisture loss. Once dermal skin has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft, leaving the patient with flexible, growing skin. Since gaining the initial FDA approval in 1996, the INTEGRA Template has been used successfully on over 10,000 patients.
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 market opportunity for IDRT-TS. 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 IDRT-TS may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors Than 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.
CONTACT:
Integra LifeSciences Holdings Corporation
John B. Henneman, III
Executive Vice President
Chief Administrative Officer
(609) 936-2481
jhenneman@Integra-LS.com
Maria Platsis
Director of Corporate Development and Investor Relations
(609) 936-2333
mplatsis@Integra-LS.com