Daxor Receives FDA Clearance to Market the Blood Volume Analyzer - BVA-100 - and its Injection Kit.NEW YORK--(BUSINESS WIRE)--Jan. 6, 1998--The Daxor Corporation has received clearance from the 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. to market the injection kit system to be used with its Blood Volume Analyzer. On Sept. 30, 1997 Daxor had received FDA clearance to market the Blood Volume Analyzer. The BVA BVA British Veterinary Association (London, UK) BVA Blinded Veterans Association BVA Board of Veterans' Appeals BVA Bond Van Adverteerders (Dutch Association of Advertisers) BVA British Video Association is the first instrument for blood volume measurement to receive a United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. patent. The instrument is designed to work in conjunction with a single-use injection system which delivers a precise amount of albumin I-131, a tracer used for the measurement of human blood volume. The company has a separate patent on the quantitative injection kit. The company filed in February, 1997 for approval of the injection kit system. The kit can also be used in other situations where a precise injection is needed. For the measurement of human blood volume, a highly precise injection amount of albumin I-131 is required. The injection kit delivers the injection with 99.8 percent accuracy. Blood volume measurements are important in any medical or surgical situation were there has been blood loss or the need for transfusion. There are an estimated four million people in the US who receive blood transfusions blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. every year. Precise knowledge of the amount of blood in a specific patient is essential in determining the need and the amount of blood needed for transfusions. A blood transfusion is a form of a transplant. Over-transfusion or under-transfusion can have serious medical consequences. Standard tests such as the hemoglobin hemoglobin (hē`məglō'bĭn), respiratory protein found in the red blood cells (erythrocytes) of all vertebrates and some invertebrates. measurement or hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. which are used to evaluate blood loss may be grossly inaccurate in conditions where there has been sudden blood loss, such as during surgery or after trauma. The company intends to market its instruments primarily to hospitals, but also to outpatient facilities where blood volume measurements would provide precise data. There are a number of medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. such as liver, kidney and heart disease which are accompanied by serious fluid imbalances. Precise knowledge of blood volume in such patients could provide key information in evaluating medical therapy. The company will initially provide a limited number of instruments on a loaner basis to academic medical centers to familiarize physicians with the use of the instrument. It would also provide technical and teaching support to such facilities. The instrument is designed to provide a blood volume measurement in 18-25 minutes. Blood volume analysis had previously been primarily available in research settings. The test involved a complex technical preparation requiring five to ten hours of technician time for each test. As a result the test has been infrequently used in hospital situations. The BVA-100, a semi-automated instrument, would for the first time make accurate blood volume measurements readily available to physicians involved in critical decision making. For further information please contact Andrea Webber, Investor Relations Investor relations The process by which the corporation communicates with its investors. , or Dr. Joseph Feldschuh, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . CONTACT: Daxor Corporation Dr. Joseph Feldschuh or Andrea Webber, 212/244-0555 |
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