Healthcare Industry News:  surgical sealant 

Devices Orthopaedic FDA

 News Release - January 9, 2006

Baxter Expands BioSurgery Product Portfolio With FDA 510(k) Marketing Clearance for TricOs T Bone Void Filler

TricOs T Represents Baxter's First Commercially Available Orthobiologic Product in the United States

DEERFIELD, Ill., Jan. 9 (HSMN NewsFeed) -- Baxter Healthcare Corporation announced today it has received marketing clearance from the U.S. Food & Drug Administration (FDA) for TricOs(TM) T Bone Void Filler, which is indicated for voids or gaps in bone that are not intrinsic to the stability of the bony structure, including bone defects from surgery or traumatic injury. The clearance of TricOs T further expands Baxter's BioSurgery product portfolio and represents the company's first commercially available orthobiologic product in the United States.

"TricOs T is an alternative technology to harvesting bone from the patient in certain spinal and orthopedic surgeries," said Gordon Sutherland, general manager of Baxter's BioSurgery business. "Bone harvesting from the patient can increase post-operative pain and the risk of infection."

TricOs T is a proprietary combination of hydroxyapatite-coated beta tricalcium phosphate (HA/TCP) granules and a fibrin matrix based on Baxter's TISSEELŪ VH [Fibrin Sealant] contained in one convenient kit. TricOs T provides a three-dimensional osteoconductive environment for the formation of new bone. The product is also biocompatible, allowing it to be resorbed by the body over time.

"Early users of this technology have stated that they like the handling characteristics of the product as it is very easy to mold into the correct shape to fit the bone defect," Sutherland added.

The company expects full market availability for the product in the United States to occur in the second half of 2006.

Baxter's BioSurgery business is focused on developing and commercializing novel biomaterials for hemostasis and hard and soft tissue repair in surgery. In addition to TISSEEL, other products in the BioSurgery portfolio include FLOSEALŪ [Hemostatic Matrix] for rapid hemostasis, and COSEALŪ [surgical sealant], a vascular sealant. With annual sales of approximately $250 million, BioSurgery has become one of Baxter's fastest growing businesses.

The company's accelerated investments in this business have resulted in recent research and development collaborations, including an agreement signed this month with Innovata PLC to acquire a global license for Adept, an adhesion reduction solution for use in obstetric and gynecologic surgery.

Baxter also announced a major follow-on research and commercialization agreement with Kuros AG in November, which includes the development of a variety of biomaterials addressing hard and soft tissue repair. This research agreement includes future enhancements to the TricOs T product.

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX ). Baxter assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patientsī lives. For more information about Baxter, please visit http://www.baxter.com.

This release includes forward-looking statements concerning the timing of full market availability of the product, the company's collaboration with Kuros and future product development involving biomaterials. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: successful scale-up of operations; clinical developments relating to the existing product and future products; receipt of all necessary regulatory approvals; and other risks identified in the company's most recent filing on Form 10-Q. The company does not undertake to update its forward-looking statements.


Source: Baxter

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