Vital Scientific Receives FDA Approval for the Fibron-1 Blood Clotting Analyzer, Diagnostic Assays, and Controls.Business Editors & Technology Writers NEWTON, Mass.--(BUSINESS WIRE)--Nov. 4, 2002 Novitron International, Inc. (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 :NOVI), announced today that its Dutch subsidiary, Vital Scientific NV, has received formal 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. approval, under Section 510(k) of the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. , to market in the United States its new blood coagulation analyzer together with related diagnostic assays and controls. The FDA, under four separate 510K submissions, has approved the Fibron-1(TM) blood clotting analyzer, a Prothrombin Time ("PT") Assay, an Activated Partial Thromboplastin Time Activated partial thromboplastin time Partial thromboplastin time test that uses activators to shorten the clotting time, making it more useful for heparin monitoring. ("APTT APTT, aPTT activated partial thromboplastin time. APTT activated partial thromboplastin time. ") assay, and three reagents used for quality control during testing. The instrument and reagent assays were designed especially for use in small to medium sized medical laboratories and were developed in collaboration with Biomedica Diagnostics, Inc. of Windsor, Nova Scotia Windsor is a small town located in central Nova Scotia at the junction of the Avon and St. Croix Rivers. It is the largest community in western Hants County with a 2001 population of 3,778 and was at one time the shire town of the county. . Under normal circumstances, the complex mechanism of clot formation is a desirable response that enables the body to heal itself. Under certain clinical conditions, however, this same mechanism can cause unwanted clot formation that can be life threatening. These "thrombotic" conditions include patients with angina, heart attack, deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. , mechanical heart valves, strokes and cardiac rhythm disturbances. Thrombotic disorders are generally managed through the use of anticoagulant therapy, employing drugs which decrease the clotting ability of the blood so that unwanted clots are prevented. Such therapy is monitored on a regular basis with a blood coagulation analyzer and related assays. The PT assay is used worldwide for monitoring oral anticoagulant therapy and is the most common way to express the clotting tendency of blood. The effectiveness of oral anticoagulants Anticoagulants Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms. Mentioned in: Embolism, Heart Valve Replacement can vary over time, affected by changes in diet, other medications and ongoing illness. PT is monitored regularly so that drug dosage may be adjusted to allow a patient to stay within the desired therapeutic range. The APTT assay is generally used in hospitalized patients for monitoring therapy with heparin and for the evaluation of disorders of the intrinsic coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or pathway. Israel M. Stein, M.D., Chairman and President of the Company commented, "We are most pleased with obtaining the FDA clearance for marketing this new coagulation system in the United States. As our global network of distributors will also be offering the Fibron-1 system, the respected 510K designation will assist our marketing efforts internationally. The introduction of a coagulation analyzer and assays is a part of our continued strategy of diversification." Abdullah Kirumira, Ph.D., President of BioMedica Diagnostics Inc. commented, "This an important step in the continuing growth of our strategic relationship with Novitron International. We anticipate the successful introduction of our coagulation reagent platform through the Company's worldwide distribution network. We also wish to acknowledge the support of the National Research Council of Canada The National Research Council Canada (NRC) is Canada's leading organization for scientific research and development. History NRC was established in 1916, mainly to advise the government. Then, in the early 1930s, laboratories were built in Ottawa. towards our R & D efforts on this project." Novitron International, Inc. is a multinational company focusing on scientific instrumentation used in clinical and analytical laboratories and in process monitoring. The Company's Dutch subsidiary, Vital Scientific NV, designs and manufactures scientific instrumentation marketed worldwide through distributors and strategic partnerships. The Company's subsidiary Vital Diagnostics Pty. Ltd. distributes diagnostic instruments and assays in the South Pacific. The Company's Dutch subsidiary, NovaChem BV, develops and markets process monitoring technology for petrochemical and environmental applications. BioMedica Diagnostics Inc. is a privately-held Canadian company that specializes in research and development of rapid diagnostic systems for decentralized de·cen·tral·ize v. de·cen·tral·ized, de·cen·tral·iz·ing, de·cen·tral·iz·es v.tr. 1. To distribute the administrative functions or powers of (a central authority) among several local authorities. and resource-poor clinical settings. Except for any historical information contained in this release, the matters discussed herein include forward looking statements, within the meaning of Section 27A of the Securities Act of 1933 (as amended), that involve risk and uncertainties. Actual results could differ materially from those expressed in such statements and readers are referred to the Company's SEC reports and filings. |
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