40 million Americans now have new treatment for chronic dental pain

Ortek Therapeutics Inc. announced today the launch of ProClude(TM) to dental professionals.

ProClude is the first, FDA approved, prophylaxis paste that significantly reduces tooth sensitivity. Prophylaxis pastes are normally applied to teeth by a hygienist or dentist for polishing and stain removal following a dental cleaning. It is estimated that 40 million Americans suffer from tooth sensitivity, making it a major dental health problem.

Tooth sensitivity is a painful condition that consists of short, sharp and frequent jabs of pain when teeth come in contact with cold or hot foods or liquids, cold air and sweet or acidic foods. If left untreated this painful condition can significantly reduce quality of life and lead to pulp death and tooth loss. Additionally, sensitive teeth can lead to patient compliance issues for ongoing dental procedures.

Tooth sensitivity begins with gum recession. Gums recede with aging, aggressive brushing, periodontal disease and certain dental procedures. As a result, the tooth's root dentine can be uncovered when a very thin protective layer, the cementum, is removed mechanically or by acidic foods. Microscopic fluid-filled dentinal tubules, now exposed, lead to the tooth's pulp. Oral stimuli can disturb the fluid in the tubules to a point where its movement reaches pulpal nerve fibers causing the sharp pain associated with tooth sensitivity.

ProClude's innovative desensitizing components, which include the amino acid arginine, in a unique combination with carbonate-bicarbonate and calcium, forms a paste that plugs and seals the exposed tubules. This process is like spackling a wall that has holes or defects in it. In University-based tests, completely exposed tubules in dentinal discs treated with ProClude remained sealed even after being bathed in hydrochloric acid for 24 hours. United States and International patents for ProClude have been filed.

"As a periodontist, one of the unfortunate results of periodontal treatments, both surgical and non-surgical, is tooth sensitivity. I have used many products in attempts to reduce or resolve my patients' post-treatment sensitivity. ProClude is by far the most effective desensitizing agent that I have ever used" said Maria Emanuel Ryan, DDS, PhD, Associate Professor, Department of Oral Biology and Pathology, School of Dental Medicine, State University of New York at Stony Brook. "My patients have experienced immediate and long-lasting relief of their dental sensitivity with this product."

Two clinical trials evaluating 61 patients with 640 chronic sensitive teeth have been completed. These studies, conducted at a major dental school, have clearly demonstrated ProClude's ability to provide relief of dentinal sensitivity. A four week study testing ProClude's duration after a single application has shown immediate and long-lasting protection. Sensitivity reductions between 84 to 90 percent remained constant throughout the study period.

"Individuals with sensitive teeth can now enjoy ice cream and their favorite hot or cold beverages without experiencing those agonizing jabs of pain" said Mitchell Goldberg, President of Ortek. "ProClude is a much needed and convenient new therapy. Patients can now be treated simultaneously for dentinal sensitivity while having their teeth cleaned and polished by their dentist or hygienist."

Ortek Therapeutics, Inc. is a fully integrated specialty pharmaceutical company primarily engaged in developing and commercializing proprietary products for the treatment of dental disorders. In addition to ProClude the Company is currently developing additional products for dentinal sensitivity and new therapies for tooth decay, drug resistant infections and cancer. All technology is exclusively licensed by the Company from The Research Foundation of State University of New York, and developed in The Department of Oral Biology and Pathology, State University of N.Y. at Stony Brook.