PLAINSBORO, N.J., Oct. 20, 2003 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Integra NeuroSciences has received 510(k) clearance from the United States Food and Drug Administration to market the DuraGen Plus(TM) Dural Graft Matrix in the United States. The DuraGen Plus product represents the second generation in Integra's line of absorbable and sutureless onlay collagen matrix grafts for cranial and spinal dural repair. Integra launched DuraGen(R) Dural Graft Matrix, its first onlay graft for dural repair, in 1999.
The dura mater is a tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. Head and spinal injuries often result in laceration of the dura, and neurosurgical procedures require the dura to be opened or removed to gain access to the delicate tissues contained within. In both cases, effective dural closure is imperative to prevent cerebrospinal fluid leaks and allow wound healing to occur. Dural defects may be repaired by several techniques, including commercially available dural graft substitutes. Integra's DuraGen Plus and DuraGen products are the only absorbable dural substitutes that do not require sutures. The onlay graft technique that utilizes the DuraGen Plus and DuraGen products enables neurosurgeons to conclude operations more efficiently than when using materials that require sutures.
"The DuraGen Plus Dural Graft Matrix offers several iterative improvements to our DuraGen product, including enhancements in the uniformity and consistency of the collagen matrix pore structure that result in improved strength and handling characteristics," said Simon Archibald, Ph.D., Integra's Vice President of Research and Development and Clinical Affairs. "DuraGen Plus exemplifies Integra's efforts to actively develop its proprietary extracellular matrix technologies for neurosurgical applications. It is the continuing goal of Integra to meet the needs of the neurosurgical community through the translation of basic science into clinical devices."
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, 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 DuraGen Plus. 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 DuraGen Plus 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.