BoneSource® Hits the Open Market *
BoneSource®, a calcium phosphate bone cement used to repair and heal cranial defects, began commercial use in November 1997. This Food and Drug Administration (FDA)-approved product was the first material of its kind made available for clinical use. Since its introduction, the material has become widely used in medical centers and may be useful for a vast number of additional clinical applications.
Laurence Chow and W.E. Brown of NIST's Material Science and Engineering Laboratory originally discovered the material that makes up BoneSource® in 1987. As part of their work at the Paffenbarger Research Center (a collaboration between NIST and the American Dental Association Health Foundation), Chow and Brown discovered certain mixtures of calcium phosphate mixed with water hardened in the test tubes when left for a few hours. During hardening, this plaster-like cement turned into hyroxyapatite, the natural mineral component found in bones and teeth.
When tested as bone cement, this discovery successfully facilitated the processes leading to new bone regeneration. The cement adapted to bone surfaces at the microscopic level, reducing the formation of intervening tissues at the bone-implant interface. It also demonstrated the ability to become reabsorbed, allowing new bone formation with no loss in volume.
A small company called Osteogenics Inc. (which, through orthopedic industry acquisitions, is now part of Stryker Howmedica Osteonics, Inc.) won FDA approval to market BoneSource®. The cement is intended for use in the repair of cranial defects with a surface area no larger than 25 cm2 per defect. It is packaged as a powdered material and mixed with sterile water at the time of implantation. The cement remains malleable for about 20 minutes, allowing the doctor time to customize it to the patient's skull.