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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START-UP counts some 40 commercial development efforts in cartilage repair and regeneration. Some are implanting synthetic scaffolds, and some are offering cell-based therapies used with or without scaffolds. It's a crowded and confusing category. So many companies are chasing a market that is still somewhat undefined and doesn't seem large enough to support them all. What's clear, however, is that almost 15 years after the introduction of Carticel, the first cell-based implant for cartilage repari, there is still an unsatisified market of patients aged 20-60 with knee pain due to cartilage damage or degeneration.
FDA's Orthopedic and Rehabilitation Devices advisory panel voted 6-1 to recommend against approval of Stryker Biotech's OP-1 Putty spinal fusion product March 31
While most Wall Street analysts predict that the current economic crisis will have little effect on the spine industry over the long haul, there are storm clouds on the horizon that should put spine product manufacturers on guard. With crackdowns by the Department of Justice tipping over into the spine arena and whistleblower lawsuits regarding surgeon/industry relationships in the news, along with several important bills before Congress designed to change how the business of spine surgery is done, current financial constraints may be only the tip of the iceberg in terms of things to come.