Integra LifeSciences Announces FDA Approval to Market INTEGRA Dermal Regeneration Template for the Repair of Scar Contractures
INTEGRA Dermal Regeneration Template was designed as a skin replacement system to minimize scar formation and wound contracture in full thickness skin wounds, including during the treatment of severe burns, for which the product was originally indicated. The INTEGRA Template's expanded indication is for the repair of scar contractures in patients who have already recovered from the original injury. Specifically, the product is now indicated not only for acute burns, but also for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.
``We are obviously very happy to receive this approval,'' said Stuart M. Essig, Integra's Chief Executive Officer. ``This new indication will allow Integra and its marketing and sales partner, Johnson & Johnson Wound Management, to train physicians who are not primarily burn surgeons in the use of the product. We hope that as a result many more patients will benefit from INTEGRA Template, even if they were not treated with it at the time of their original injury.''
Human skin consists of an outer layer (epidermis) and a second layer (dermis). The epidermis serves as a protective seal for the body, and the dermis provides structural strength and flexibility and supports the viability of the epidermis through a vascular network. The body normally responds to severe damage to the dermis by producing scar tissue in the wound area. This scar tissue is accompanied by contraction that pulls the edges of the wound closer which, while closing the wound, often permanently reduces flexibility. INTEGRA Template is designed to enable the human body to regenerate functional, flexible dermal tissue that moves, grows and ages as the patient moves, grows and ages.
The INTEGRA Template was first approved in 1996 for the treatment of life-threatening thermal injuries where sufficient autograft is not available at the time. In 1999, Integra LifeSciences entered into a strategic alliance with Johnson & Johnson Wound Management, a division of ETHICON Inc, to distribute INTEGRA Dermal Regeneration Template throughout most of the world. The new approval represents an achievement under the alliance and will allow the first promotion of the device outside of the hospital burn unit.
INTEGRA Template consists of two layers, a thin collagen-glycosaminoglycan matrix and a silicone membrane. The product is applied with the sponge layer in contact with the excised wound. The matrix material serves as a template for the growth of new functional dermal tissue. The outer membrane layer acts as a temporary substitute for the epidermis to control water vapor transmission, prevent re-injury and minimize bacterial contamination. After the patient's dermis is regenerated, the surgeon removes the silicone outer layer and replaces it with a thin epidermal autograft.
INTEGRA Template has been sold commercially in the United States since 1996. Integra LifeSciences estimates that product has been successfully implanted and regenerated dermis in more than 10,000 patients since the approval of the original PMA. INTEGRA Template was the first of a line of collagen-based matrices designed and manufactured by Integra LifeSciences for the repair or regeneration of the body's tissues in vivo. Integra's other tissue repair products include the DuraGen® Dural Graft Matrix (for repair of the dura mater during cranial or spinal surgery), the NeuraGen™ Nerve Guide (for the repair of peripheral nerves), and the BioMend® and BioMend® Extend Absorbable Collagen Membrane (for guided tissue repair in periodontal surgery). The DuraGen and NeuraGen products are sold by Integra's Integra NeuroSciences division, and the BioMend products are sold by the Sulzer Dental division of Sulzer Medica Ltd.
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 600 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 the Company's expectations for the promotion of INTEGRA Dermal Regeneration Template. 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.
Contact:
Integra LifeSciences Holdings Corporation, Plainsboro
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