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| |  New Product Launched to Repair Diseased Gums CHICAGO, April 16, 1997 -- A new periodontal product, emdogain(R), was launched today at the 1997 American Academy of Periodontology/Regenerative Surgery Conference in Orlando, Fla. Emdogain is a biology-based product, comprised of enamel matrix proteins, that predictably initiates the regrowth of tooth-supporting tissues lost to periodontal disease. In September 1996, Emdogain was approved by the United States Food and Drug Administration (FDA) as an adjunct to periodontal surgery in the treatment of advanced periodontitis. "Applying Emdogain onto the diseased root surface tricks the body into believing it is forming a new tooth and initiates the natural formation of tooth supporting tissue," said Dr. Lars Heijl, BIORA's Chief Medical Officer. "The product is easy to apply with little or no increase in chair time for the patient during surgery, while predictably demonstrating rapid initial healing with minimal or no postoperative pain and swelling." In 15 clinical studies conducted in the United States and Sweden, periodontists reported that Emdogain-treated periodontal defects regained two-thirds bone lost due to periodontitis, compared with no gain or further loss experienced in untreated defect sites in the same patient. Results of these clinical studies have been accepted for publication by the Journal of Clinical Periodontology. A recent U.S. survey showed that one in eight Americans are affected by advanced periodontal disease. Periodontitis causes a progressive loss of the supporting hard and soft tissues surrounding the tooth, which, if left untreated, will eventually cause tooth loosening and potential tooth loss. Every year, more than five million periodontal flap surgeries are performed worldwide to halt the deterioration of tooth supporting tissue. According to the American Dental Association, approximately two million of these procedures were performed in the United States in 1990. However, flap surgery alone is shown to produce only minimal regain of tissue lost due to the disease, leaving a cosmetic problem of large spaces between the teeth. Emdogain is applied in a gel form directly onto the tooth-root surface during periodontal flap surgery. Its key component, amelogenin, is a structural protein naturally produced by the body during normal tooth development. This protein is involved in the formation of all tooth- supporting tissues. Once applied, Emdogain is naturally absorbed by the body, leaving only a residue of enamel matrix proteins on the debrided root surface. This natural and insoluble surface layer encourages the migration of cementum-forming cells from the surrounding tissues. Following cementum formation, the periodontal ligament is established and ultimately alveolar bone is formed. The product was developed by Biora Inc., which has recently initiated a U.S. clinical trial of the product at five research institutions including Eastman Dental Center in Rochester, New York; University of Pittsburgh; University of Minnesota; University of Texas at San Antonio; and Louisiana State University.
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