Baxter Healthcare Corporation has received marketing clearance from the US Food and Drug Administration for TricOs 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 orthopaedic surgeries. Bone harvesting from the patient can increase post-operative pain and the risk of infection," said Gordon Sutherland, general manager of Baxter's BioSurgery business.

TricOs T is a proprietary combination of hydroxyapatite-coated beta tricalcium phosphate (HA/TCP) granules and a fibrin matrix based on Baxter's Tisseel 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, states a Baxter release.

"Early users of this technology have stated that they like the handling characteristics of the product as it is very easy to mould 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 develops and commercialises novel biomaterials for haemostasis and hard and soft tissue repair in surgery.

Baxter has entered a major follow-on research and commercialisation 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 US operating subsidiary of Baxter International Inc. Baxter assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma.