Stryker Corp. and Creative BioMolecules Inc. on Monday saidthey have received Food and Drug Administration approval tobegin clinical trials of Stryker's Osteogenic Protein Device torepair non-union fractures.
The device consists of a human recombinant osteogenic protein(OP-1) developed by Hopkinton, Mass.-based CreativeBioMolecules and a bioresorbable carrier to provide a scaffoldfor bone growth. OP-1 probably stimulates the commitment ofundifferentiated cells to induce the formation of new bone, saidCharles Cohen, president and chief executive of Creative.
The studies, to begin in January, will compare the device withautografts in the repair of non-union fractures. Non-unionfractures are ones that haven't made progress toward repairfor nine months.
Other potential indications include delayed unions, acutefractures and spinal fusions, Cohen said.
Stryker (NASDAQ:STRY) of Kalamazoo, Mich., and privately heldCreative have had a research, development and supplyagreement for OP-1 since 1985.
Genetics Institute Inc. of Cambridge, Mass., plans to beginclinical trials of a competing product, bone morphogenicprotein-2 (BMP-2), for bone repair before mid-1992. OP-1corresponds to another of Genetics Institute's bonemorphogenic proteins, BMP-7, according to Creative. GI(NASDAQ:GENI) declined to specify BMP-7's stage ofdevelopment. -- KB
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