Creative BioMolecules, Inc. Announces Stryker's Submission of OP-1 Implant for Approval in the United States and Europe.
Creative BioMolecules, Inc. (Nasdaq:CBMI) announced today that Stryker Corp. (NYSE:SYK), its partner in orthopaedic 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(TM).
In a news release issued this afternoon, 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 has also submitted a Marketing Authorization Application (MAA) in Europe to the European Medicines Evaluation Agency (EMEA) for its OP-1 Implant(TM). Both submissions seek approval for the OP-1 Implant(TM) to treat long bone nonunions. The FDA and the EMEA have up to 45 days to decide if the submissions are acceptable for filing. The Company (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(TM) will be obtained."
Creative BioMolecules, Inc. is a leader in the understanding of tissue formation and repair through the activity of morphogenic proteins.
This news release includes forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Company's expectations include, without limitation, the course of the research and development programs, including the achievement of development milestones by the Company and/or its partners, the inability to partner programs, the initiation, progress and completion of clinical testing, the impact of competitive products, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products, including acceptance of submissions by regulatory agencies, and the other risks and uncertainties detailed from time to time in the Company's periodic reports.
NOTE: Creative BioMolecules' news releases are available on the Internet at http://www.creativebio.com.