Cortecs files U.S. 510(k) application for Helisal Rapid Blood.LONDON--(BUSINESS WIRE)--August 1, 1995--Cortecs International (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DLVRY/LSE:SEAQ/ASX:CRI CRI constant-rate infusion. ) ("Cortecs"), has filed a 510(k) application in the U.S. with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its Helisal Rapid Blood diagnostic kit for the bacterium Helicobacter pylori. H. pylori is now known to be the most common cause of gastritis and peptic ulcer. It has also been linked with stomach cancer and heart disease and has been declared a Class One carcinogen carcinogen: see cancer. carcinogen Agent that can cause cancer. Exposure to one or more carcinogens, including certain chemicals, radiation, and certain viruses, can initiate cancer under conditions not completely understood. by the World Health Organization. Helisal Rapid Blood uses a finger-stick blood sample to establish the presence of antibodies to H. pylori in patients presenting with ulcer symptoms. The simple, self-contained and cost-effective test can be used in the doctor's office and gives an accurate (equivalent to laboratory analysis) result within the course of a normal consultation without the use of any further apparatus. The test can help the practitioner to make decisions concerning management of the patient, including the option of prescribing therapy to eradicate H. pylori to prevent recurrence of the ulcer. Cortecs is a British-based company quoted on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. , the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. and on NASDAQ. The company specializes in the development of new pharmaceutical delivery systems for the healthcare industry. Cortecs' Helisal Rapid Blood test is already licensed in Japan to Zenyaku Kogyo and to Boehringer Mannheim in eighty-seven other countries. Cortecs also has an agreement with Astra concerning the use of Cortecs' test to assist in Astra's educational activities on H. pylori. Cortecs is still in negotiations for licensing of Helisal Rapid Blood with a partner in the United States. Cortecs' other major areas include: o MACROMOL - a system for the oral delivery of biotechnology drugs, such as Calcitonin calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption. , which is presently in Phase II clinical trials. o Oral Therapeutic Antigens - orally delivered treatments against diseases such as influenza and pseudomonas Pseudomonas A genus of gram-negative, nonsporeforming, rod-shaped bacteria. Motile species possess polar flagella. They are strictly aerobic, but some members do respire anaerobically in the presence of nitrate. infection (in cystic fibrosis) which is currently in Phase I/II trials. o ADEPT - an oral system to prevent and treat diarrhea without antibiotics. o Point-of-Care Diagnostics - a range of innovative diagnostic kits including: - HELISAL - for the detection of Helicobacter pylori. - A rapid test in development to detect bone breakdown indicating the process which leads to the disease Osteoporosis. - A rapid test in development to assist in monitoring the control of diabetes. Cortecs Healthcare markets a range of ethical and OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). medicines and diagnostic products. Notes to Editors The U.S. Food & Drug Administration (FDA) requires that healthcare equipment and diagnostic products be registered and cleared for the use in the USA. The 510(k) application is the procedure by which this is achieved. CONTACT: Cortecs International Dr. Michael Flynn, 011-44-181-568-7071 or Kehoe, White, Savage & Co. Inc. Van Negris, 212/888-1616 |
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