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Synthes Chooses Alternative-To-BMP Route In Bone Growth Factor Search

This article was originally published in The Gray Sheet

Executive Summary

Synthes-Stratec plans to forego immediate development of an orthobiologic bone growth factor, citing doubts about the product's feasibility in musculoskeletal repair applications

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Stryker OP-1 clarification

U.S. approval by 2006 for use of the orthobiologic bone growth factor in posterior lateral spine procedures is expected by the company; enrollment in a 300-patient U.S. pivotal trial is ongoing. OP-1 has been available in the U.S. for recalcitrant long bone, non-union fractures via humanitarian device exemption since 2001; the firm also is pursuing a full long-bone indication. In March, "The Gray Sheet" incorrectly reported that OP-1 was not approved for any indication (1"The Gray Sheet" March 31, 2003, p. 33)...

Stryker OP-1 clarification

U.S. approval by 2006 for use of the orthobiologic bone growth factor in posterior lateral spine procedures is expected by the company; enrollment in a 300-patient U.S. pivotal trial is ongoing. OP-1 has been available in the U.S. for recalcitrant long bone, non-union fractures via humanitarian device exemption since 2001; the firm also is pursuing a full long-bone indication. In March, "The Gray Sheet" incorrectly reported that OP-1 was not approved for any indication (1"The Gray Sheet" March 31, 2003, p. 33)...

OrthoLogic Chrysalin Phase III Fracture Repair NDA Study To Begin This Fall

OrthoLogic believes that pursuing approval of its orthobiologic product Chrysalin through a new drug application (NDA) will enable fuller discussion of the product's method of action in marketing materials

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