ROSLYN HEIGHTS, N.Y. – Study Results to Be Presented June, 28, 2003 at the 81St General Session of the International Association of Dental Research Goteborg, SwedenOrtek Therapeutics Inc. announced today that CaviStat(TM), a new cavity fighting agent, was significantly more effective than fluoride in reducing cavities in a two-year 726 patient toothpaste study.

The findings of this clinical trial will be presented at the 81st General Session of the International Association of Dental Research, Goteborg, Sweden on June 28, 2003. According to the study, children who brushed with a CaviStat toothpaste had 96% fewer cavities than children who brushed with fluoride toothpastes.

This study, which was sponsored by Ortek, was conducted by researchers at the State University of New York at Stony Brook and the University of Central Venezuela in Caracas.

CaviStat is the first in a new class of cavity fighting compounds that can counter the production of harmful plaque acids while simultaneously promoting remineralization of the teeth. CaviStat contains the amino acid, arginine, in conjunction with bicarbonate and calcium carbonate. These components are food grade, and unlike fluoride, are safe for young children to swallow in a toothpaste and can be added to candies and gum.

This is a very important additional benefit of CaviStat since excessive ingestion of fluoride during early childhood can cause dental fluorosis, a discoloring of the permanent teeth. In fact, to reduce the risk of fluorosis for children aged 6 or under, the Center for Disease Control, in an August 2001 report on fluoride use, recommended that toothpaste manufacturers develop a “child-strength” toothpaste with lower concentrations of fluoride.

Cavities are still one of the most prevalent diseases worldwide. It affects people of all age groups. This infectious disease occurs when bacteria on tooth surfaces convert sugars to harmful acids that dissolve the teeth over time.

CaviStat(TM) is designed to interrupt this process. Alongside the acid-producing bacteria are other bacteria that metabolize arginine and produce base, which neutralizes the cavity forming acids. This elevated pH environment also promotes absorption of calcium back into the teeth, a process called remineralization.

CaviStat, which is based on over 30 years of research on saliva’s substantial role in preventing tooth decay, was developed by Dr Israel Kleinberg, Distinguished Professor and Chairman of the Department of Oral Biology and Pathology at Stony Brook University.

Dr Israel Kleinberg said, “CaviStat represents a new direction in the battle against tooth decay. This unique compound can be very beneficial for children and for the millions of adults who are prone to root cavities due to poor saliva production. Reduced saliva flow, which often results in a rapid rise in the development of cavities, is caused by hundreds of prescription and non prescription drugs, cancer therapies and Sjogren’s syndrome, an autoimmune disease.”

Ortek Therapeutics, Inc. was granted exclusive worldwide licensing rights to CaviStat by the Research Foundation of the State University of New York. Ortek’s President, Mitchell Goldberg said,

“There has been little innovation in the fight against tooth decay since the introduction of fluoride more than five decades ago. Based on the findings of this study and the large amount of laboratory data, we expect that CaviStat will eventually replace fluoride in the $5 billion worldwide toothpaste market. We are currently evaluating regulatory strategies to commercialize CaviStat as quickly as possible.”

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