Creative BioMolecules, Inc. Announces Stryker's Submission of OP-1 Implant for Approval in the United States and Europe.
BOSTON--(BW HealthWire)--June 7, 1999--
Creative BioMolecules This page aims to list articles on Wikipedia that describe particular biomolecules or types of biomolecules.
This list is not necessarily complete or up to date - if you see an article that should be here but isn't (or one that shouldn't be here but is), please update the page , Inc. (Nasdaq:CBMI CBMI Christian Blind Mission International (Australia)
CBMI Content Based Multimedia Indexing
CBMI Commercial Building Mold Inspector ) announced today that Stryker Corp. (NYSE NYSE
See: New York Stock Exchange :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 PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy ) to the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) and has also submitted a Marketing Authorization Application (MAA MAA
macroaggregated albumin ) in Europe to the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) 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.