Ed. Note:  The following is a press release issued by Cook Biotech

DECEMBER 3, 2003
FDA Clears Durasis® Dural Substitute from Cook Biotech for U.S. Sales

West Lafayette, Ind. - The U.S. Food and Drug Administration has granted Cook Biotech Incorporated clearance to sell DURASIS® Dural Substitute in the United States. DURASIS, indicated for use as a dura substitute for repairing dura mater, had previously received CE Mark approval for sales in Europe.

Dura mater is the tough, fibrous sheath that surrounds the brain and spinal cord. Portions of the dura mater can be damaged by trauma or removed during neurosurgical procedures. Surgical repair and replacement of the dura mater is important to prevent infection and post-operative cerebrospinal fluid (CSF) leakage.

"We are very pleased to have received FDA clearance for this neurosurgical product," stated Mark Bleyer, president of Cook Biotech. "This clearance is the result of extensive collaboration with key neurosurgeons who helped design this product specifically to repair the unique tissue that covers the brain and spinal cord. Durasis has passed extensive, long-term, pre-clinical tests and has been further proven through a multi-centered clinical trial."

DURASIS utilizes Cook Biotech's innovative Small Intestinal Submucosa (SIS) technology, a collagen biomatrix that supports remodeling of host tissue. SIS is a natural biomaterial harvested from a specific portion of porcine (swine) small intestine and developed into strong, sterile, pliable sheets that provide a rich environment for cell attachment and growth. This tissue has been found to have many of the ideal material properties required for repairing and replacing dura mater. Over time, Durasis takes on the cellular characteristics of surrounding dural tissue while it serves as a scaffold on which human tissue grows. As the biomaterial is replaced with cells, the scaffold is no longer needed and it is absorbed by the body.

"Durasis is an ideal dural substitute," stated Ghassan Bejjani, M.D., clinical assistant professor in the department of neurological surgery at the University of Pittsburgh School of Medicine. "Durasis is easy to handle and suture, does not allow leakage of cerebrospinal fluid, has exceptional strength, is durable, and has the advantage of remodeling into native tissue." Dr. Bejjani was the principal investigator who coordinated the clinical trial for the Durasis product.

Cook Biotech (http://www.cookbiotech.com), a Cook company, is actively developing extracellular matrix (ECM) technology and biological scaffolds for numerous medical purposes. Medical products utilizing Cook's licensed and patented ECM technology are currently marketed worldwide for use in wound management and surgical repair of soft tissues. Together with a network of medical practitioners, Cook Biotech is identifying the medical needs most compatible with ECM technology and developing products to meet these needs.

With international headquarters in Bloomington, Ind., privately held COOK® (http://www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures.
 

Ed. Note:  The following is a press release issued by Integra LifeSciences Holding Corp.

Integra LifeSciences (ticker: IART, exchange: NASDAQ) News Release - 20-Oct-2003

Integra NeuroSciences Launches EnDura™ No-React® Dural Substitute

Plainsboro, New Jersey, October 20, 2003 -- Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced plans to market and sell EnDura™ No-React® Dural Substitute, a new suturable product for repair of the dura mater. Integra is featuring the EnDura product at the Congress of Neurological Surgeons meeting in Denver, Colorado this week and is launching the product in the United States and internationally through its Integra NeuroSciences direct sales force.

EnDura No-React Dural Substitute is a collagen-based material that is treated with the proprietary No-React process. The No-React process reduces the body's inflammatory response to the implant, prolongs its durability and eliminates the need for rinsing prior to implantation. In preclinical studies, the EnDura No-React Dural Substitute demonstrated excellent host tissue response and showed no adhesion to brain tissue.

“The EnDura No-React Dural Substitute is an important addition to our duraplasty product line,” said Robert Paltridge, Integra's Senior Vice President of Sales. “With the suturable EnDura product and our sutureless DuraGen® onlay graft, we can now offer physicians a complete array of solutions for dural repair. Introducing this product is an example of Integra's ability to respond to the needs of physicians, which has made us a market leader in neurosurgery.”

The dura mater is the tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. During neurosurgical procedures, the dura mater may be torn, deficient or removed. Effective dural closure is imperative to prevent cerebrospinal fluid leaks and allow wound healing to occur. While the majority of dural defects can be grafted with Integra's innovative onlay DuraGen product, there remain a significant number of procedures where a suturable graft is the preferred method of closure. These dural defects can now be repaired with EnDura No-React Dural Substitute.

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 the EnDura No-React Dural Substitute product. 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 the EnDura No-React Dural Substitute product 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.

Source: Integra LifeSciences Holdings Corporation
 

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Cook Incorporated

• Specializes in minimally invasive medical devices and technologies for diagnostic and therapeutic procedures

• Founded in 1963

• Headquarters in Bloomington, IN

• Manufactures more than 50,000 products

• Divisions include:  Critical Care, Surgical, Biotech, OB/Gyn, Urology, Vascular, Endoscopy, Gastroenterology, Wound

• Cook Biotech was formed in conjunction with Purdue University to develop commercial medical products from natural tissue sources

• www.cookgroup.com

• www.cookbiotech.com

Integra Life Sciences Holding Corp

• Diversified medical technology company

• Primary markets include neuro-trauma, neurosurgery, plastic and reconstructive surgery, general surgery, and soft-tissue repair

• Mission:  Integra LifeSciences, through internal product development, acquisitions and strategic partnerships, seeks to provide customers with clinically relevant, innovative and cost-effective products that improve the quality of life.

• Nasdaq:  IART

• ~860 employees

• Annual Sales >$100 million

• Market Cap ~ $800 million

• www.integra-ls.com