Creative BioMolecules, Inc. announced that Stryker Corp., its partner in orthopedic and dental reconstruction, has submitted applications in both the United States and Europe seeking marketing approval for the OP-1 bone graft device, also known as the OP-1 Implant.
In a news release, Stryker stated that they have ``submitted the final module of its Pre-Market Approval (PMA) to the U.S. Food and Drug Administration (FDA) and submitted a Marketing Authorization Application (MAA) in Europe to the European Medicines Evaluation Agency (EMEA) for the OP-1 Implant." Both submissions seek approval for the OP-1 Implant to treat long bone nonunions. The FDA and the EMEA have up to 45 days to decide if the submissions are acceptable for filing. Stryker can give no assurance that the submissions will be accepted and, if accepted as filings, that approval for any use of the OP-1 Implant will be obtained.''
Creative BioMolecules, Inc. is a leader in the understanding of tissue formation and repair through the activity of morphogenic proteins.