BioTime Applies to Sell Hextend in Europe.Business Editors/Health & Medical Writers BERKELEY, Calif.--(BW HealthWire)--Aug. 29, 2000 BioTime, Inc. (BTX-AMEX) announced today that it has submitted its first application for approval to sell Hextend(R) in a European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community nation. The Marketing Authorization Application, submitted to the Swedish Medical Products Agency, is the first step in the process of obtaining regulatory approval to sell Hextend throughout the European Union. Under the European Union mutual recognition process, BioTime would be permitted to market Hextend in all 16 European Union countries once approvals are obtained in the requisite number of member nations. Hextend is BioTime's proprietary physiologically-balanced plasma volume expander. The application cites findings from both successful Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the in the 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. on which its approval in the US was based, as well as the results of more recent clinical trials in the United Kingdom. The submission details a variety of significant benefits of using Hextend, as well as the safety and efficacy of the product when used in high volumes. These benefits include a reduced risk of acidosis acidosis /ac·i·do·sis/ (as?i-do´sis) 1. the accumulation of acid and hydrogen ions or depletion of the alkaline reserve (bicarbonate content) in the blood and body tissues, decreasing the pH. 2. and maintenance of blood biochemistry, without impairment of 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 . "The Marketing Authorization Application for Hextend contains a number of very compelling findings, which make a convincing case for the use of Hextend when replacing large blood volumes lost during major surgery," said Dr. Paul Segall, BioTime's Chairman and Chief Executive Officer. "We have been working to make BioTime products the new standard of care in plasma volume expansion in the United States, and we look forward to doing the same overseas. After European regulatory approval, Hextend will provide Europe with a safe and effective volume replacement for blood, reducing the need for blood, plasma, and other flawed older products such as albumin, saline-based starch solutions, gelatins and dextrans." BioTime, headquartered in Berkeley, California Berkeley is a city on the east shore of San Francisco Bay in Northern California, in the United States. Its neighbors to the south are the cities of Oakland and Emeryville. To the north is the city of Albany and the unincorporated community of Kensington. , is engaged in the research and development of blood plasma blood plasma n. The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended. volume expanders, blood replacement solutions during hypothermic hy·po·ther·mi·a n. Abnormally low body temperature. [hypo- + Greek therm (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and other applications. Information about BioTime can be found on the web at www.biotimeinc.com. The matters discussed in this press release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated. Such risks and uncertainties include but are not limited to the results of clinical trials of BioTime products; BioTime's ability to obtain 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. and foreign regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for BioTime's products; BioTime's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in BioTime products; and the availability of reimbursement for the cost of BioTime products (and related treatment) from government health administration authorities, private health coverage insurers and other organizations. These and other risk factors are discussed in BioTime's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission. |
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