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Awaiting Biomaterials, Can Drugs Help Heal Fractures?

This article was originally published in Start Up

Executive Summary

The movement in orthopedics toward bone repair and regeneration as a supplement to traditional hardware replacement has been stalled by the Food and Drug Administration's issuing a Non-Approvable Letter to Stryker Corp. for its OP-1 bone graft device. Yet even as surgeons await the first product approvals, early data are emerging on whether drugs might also encourage bones to heal.

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A Last Gasp for Stryker with OP-1? Not Likely.

Few were surprised when an FDA advisory panel recommended against approving Stryker's OP-1 device for spinal fusion. Plus, given the recent focus on off-label use of orthobiologics, OP-1 was not likely to displace its only competitor, InFuse. That said, the off label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.

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When the Body Alone Can't Build Bone

Orthobiologics are now on the horizon, driving suppliers to increase R&D spending. The goal is to develop high-margin products that will actively promote bone formation. Has the slow progress to commercialization of the first two products--bone morphogenic proteins developed by the collaborations of Stryker Corp/Creative Biomolecules and Genetics Institute/Sofamor Danek--helped prime the market to accept a new technology? Or has the perception of delay dampened enthusiasm and scared off some of the big orthopedics players?

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