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Report on Clinical Study of Synvisc® for Treatment of Osteoarthritis

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By News Release • • February 28, 2000

SUMMARY: 12-month results of a clinical study of Synvisc® yielded uniformly positive and statistically significant results in favor of using it as an arthritis treatment. Study findings showed Synvisc treatment results in long term improvements in pain, function and quality of life.

ABSTRACT: RIDGEFIELD, N.J., Feb. 28 /PRNewswire/ -- Today Biomatrix, Inc. reported that data from a randomized controlled clinical trial analyzing the clinical effectiveness and cost effectiveness of the use of Synvisc® for the management of osteoarthritis of the knee were presented during the annual Canadian Rheumatology Association's Annual Meeting held in Lake Louise, Canada. Synvisc® is the company's novel elastoviscous (a physical device/fluid that acts as a shock absorber and lubricant) therapeutic device for the treatment of osteoarthritis of the knee. This recently completed trial was designed, managed and reported by an independent academic steering committee of international opinion leaders in compliance with published guidelines for pharmacoeconomic studies. Fourteen clinical investigators, specialists in rheumatology or orthopedics, conducted the study over the past two years with patients from all across Canada.

Dr. George Torrance, Ph.D., Professor Emeritus, McMaster University and Innovus Research Inc. of Burlington, Ontario, and the principal economic investigator of the academic Steering Committee for this trial, commented, "We are delighted with all aspects of this study. The design was state of the art, the sites did a terrific job of providing high quality data, the analysis was rigorous to the highest standards, and the results were uniformly positive and statistically significant in favor of the treatment arm which included Synvisc. We look forward to the release of full trial results from this landmark study in a leading peer-reviewed journal."

Dr. Endre Balazs, M.D., Biomatrix' chief executive officer and chief scientific officer, stated, "This study represents an important milestone in the development of treatment for osteoarthritis (OA) using viscosupplementation (the therapeutic procedure that restores the physical properties of diseased synovial fluid with an elastoviscous fluid like Synvisc) with Synvisc. It provides a straightforward comparison of treatment paradigms for knee OA with and without Synvisc, and demonstrates unequivocally that Synvisc treatment results in long term improvements in pain, function and quality of life. Furthermore, the data demonstrate that Synvisc provides health care value, a critical step in the adoption of any new technology."

In conclusion, Dr. Balazs said, "We are pleased with the steering committee's outstanding efforts in carrying out this detailed and comprehensive evaluation of the use of Synvisc for the management of osteoarthritis of the knee. We believe this study will be beneficial in positioning viscosupplementation with Synvisc as a standard therapy within the treatment guidelines for OA of the knee, and in supporting our reimbursement initiatives worldwide."
Source: Biomatrix, Inc.

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