San Francisco, CA, February 13, 1997--Creative BioMolecules, Inc. (Nasdaq: CBMI) and Stryker Corporation (Nasdaq: STRY) reported that Stephen D. Cook, Ph.D., Tulane University, today presented at the American Academy of Orthopaedic Surgeons his analysis of preliminary data from two study sites in the clinical trial of Stryker's investigational OP-1 Device. The OP-1 Device is being developed by Stryker for use as a bone graft substitute in collaboration with Creative BioMolecules.
According to Dr. Cook, his analysis of the preliminary data from the two sites indicates that the OP-1 Device is comparable to autograft, the current standard bone graft procedure for the treatment of tibial non-union fractures. The patients involved in the trial all suffered tibial fractures that showed no evidence of healing at least nine months from the initial injury and at least three months after any prior surgical intervention. Patients received either the OP-1 Device implant or autograft bone on a random basis. Autograft uses bone chips removed from a patient's hip in a second operation.
Stryker and Creative BioMolecules emphasized that the data from the two sites presented by Dr. Cook have not yet undergone blinded radiographic analysis by an independent panel and represent only 15% of the patients under study. The overall study is being conducted at 18 sites and involves 122 patients. Full analysis of all the results, including blinded radiographic analysis by an independent panel, the primary endpoint in the study, is currently underway.
The statements in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Company's expectations, include without limitation, varying results from clinical sites within the pivotal trial, different conclusions drawn by evaluators in accordance with pivotal trial protocols, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products, the impact of competitive products and the other risks and uncertainties detailed from time to time in the Company's periodic reports.
Creative BioMolecules is a discovery and development company focused on proprietary therapeutics for human tissue regeneration and restoration. The Company's therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in cell and tissue formation.
Stryker Corporation develops, manufactures and markets specialty surgical and medical products, including orthopaedic implants, powered surgical instruments, endoscopic systems, patient care and handling equipment for the global market and provides outpatient physical therapy services in the United States.
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