Hopkinton, MA, and Kalamazoo, MI, June 30, 1998Creative BioMolecules (Nasdaq: CBMI) and Stryker Corporation (NYSE: SYK) announced today information regarding the current status of the Pre-Market Approval application (PMA) for the OP-1 bone graft device.
Stryker began a modular PMA submission to the FDA in April of this year based upon positive data from the 122 patient randomized prospective study that demonstrated that the OP-1 device group had comparable clinical success to the autograft group in healing non-union fractures of the tibia without the need for a second invasive procedure to harvest autograft bone from the hip. The modular PMA review is ongoing. In connection with the review of the manufacturing module, Creative is currently revalidating certain manufacturing processes. It is expected that this revalidation will be accomplished within the next several months and that the submission of the modular PMA to the FDA will be completed in the fall.
Creative BioMolecules, Inc. is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Companys morphogenic protein programs include a late stage development effort in orthopaedic reconstruction with Stryker Corporation, ongoing research to develop treatments for renal disease with Biogen, Inc., and the development of proprietary new therapies for stroke and other neurological disorders.
Stryker Corporation develops, manufactures and markets specialty surgical and medical products, including orthopaedic implants, powered surgical instruments, endoscopic systems and patient care and handling equipment for the global market and provides outpatient physical therapy services in the United States.
This news release includes forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Companies expectations include, without limitation, completion of clinical testing, progress with regulatory submissions and reviews, manufacturing process development, validation and inspection, the timely receipt of regulatory clearances required for manufacturing and marketing of products and the other risks and uncertainties detailed from time to time in the Companies periodic reports.
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