BXM news of favorable clinical results:
Twelve Month Data Reported from Clinical Study of Synvisc(R) in Management of Osteoarthritis of the Knee
Data Presented at Canadian Rheumatology Association Meeting
RIDGEFIELD, N.J., Feb. 28 /PRNewswire/ -- BIOMATRIX, INC. (NYSE: BXM) today reported that data from a randomized controlled clinical trial analyzing the clinical effectiveness and cost effectiveness of the use of Synvisc(R) 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(R) is the company's novel elastoviscous 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 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."
Biomatrix has developed and is manufacturing viscoelastic therapeutics for a variety of medical applications. Synvisc is marketed in the US, most countries of the European Economic Area, and certain countries in Latin America and Asia. Biomatrix has contracts to market Synvisc in over 90 countries through marketing and distribution agreements with a number of large, multi-national healthcare companies, and through its wholly-owned subsidiaries. Wyeth-Ayerst Laboratories has distribution rights and markets Synvisc in the US and certain European and Middle Eastern countries; Boehringer-Ingelheim in France; F. Hoffmann-La Roche Ltd. in Sweden and South Africa; Novartis Pharma AG throughout Latin America; and Bayer AG in Australia, New Zealand and certain countries in Asia.
Hylaform(R) is an injectable viscoelastic hylan gel treatment for the correction of facial wrinkles and depressed scars. It is marketed in 23 countries by Inamed Corp., (OTC Bulletin Board: IMDC), formerly Collagen Aesthetics, Inc. Gelvisc(R) Vet is an elastoviscous hylan product for the treatment of arthritis in veterinary medicine that is distributed by Boehringer-Ingelheim in France. Biomatrix' Hylashield(R) products are elastoviscous therapeutics for the protection of the surface of the eye from noxious environmental conditions and are distributed in Canada by I-MED Pharma Inc., and in Europe, Asia and Australia by Medical Devices Laboratories Europe GmbH (MDLE) under the name i.com(TM) Comfort Shield. Biomatrix also manufactures patented elastoviscous intermediates for the skin care industry. Clinical studies are underway in Biomatrix' Clinical Development Program to commercialize products from our core hylan biopolymer technology that address the unmet therapeutic challenges in a variety of medical disciplines, including orthopedics, rheumatology, ophthalmology, dermatology, general and plastic surgery, otology, rhinology, neurology and urology. Human clinical trials are completed on two of these products and the results have been submitted to regulatory agencies for market approval. Other products are in human clinical trials or before the U.S. Food and Drug Administration (FDA) to begin human clinical trials.
Biomatrix, Inc., headquartered in Ridgefield, New Jersey is an international biomedical company that develops, manufactures and commercializes elastoviscous products made from proprietary biological polymers called hylans, which are used in therapeutic medical applications and in skin care products.
Certain statements in this press release are forward-looking statements that involve risks and uncertainties including, but not limited to, the regulatory approval process, obtaining and enforcing patents, reimbursement by private health care providers, manufacturing capabilities, projected earnings and financial results, growing product demand, product liability, inventory levels of our marketing partners, future product development, and other risks detailed in Biomatrix' reports filed under the Securities Exchange Act, including Forms 10-Q and Biomatrix' annual report on Form 10-K for the year ended December 31, 1998. For more information on Biomatrix, please visit the Company's web site at biomatrix.com.
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SOURCE: Biomatrix, Inc.
CONTACT: Endre A. Balazs, M.D., Chief Executive Officer, Rory Riggs, President, or Anne Marie Fields, Investor Relations all of Biomatrix, Inc., 201-945-9550 |
