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

Given the pointed tone of its advance questions, few were surprised when on March 31, an FDA Orthopaedic and Rehabilitation Devices Advisory Panel recommended 6-1 against approving Stryker Corp.’s OP-1 Putty (recombinant human BMP-7 in a bovine collagen and carboxymethylcellulose matrix) for spinal fusion. The news was unremarkable in several ways. Stryker management and shareholders are more concerned these days with the outlook for its MedSurg business because of reduced hospital capital expenditures nationwide. Plus, given recent regulatory and policing actions around off-label use of orthobiologics, OP-1 was not likely to contribute much to earnings nor displace the only competitor, Medtronic Sofamor Danek’s InFuse (BMP-2). That said, the off-label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.

With hindsight, it’s fair to say that OP-1’s fate was sealed some time ago, when Stryker executed studies of the...