BioTime Receives FDA Approval to Market Hextend.BERKELEY, Calif.--(BW HealthWire)--March 31, 1999--BioTime, Inc. (Nasdaq:BTIM) today announced that it has received approval from the U.S. 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. ) to market Hextend(R), the Company's physiologically balanced 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 expander, for the treatment of hypovolemia hypovolemia /hy·po·vo·le·mia/ (-vol-em´e-ah) diminished volume of circulating blood in the body.hypovole´mic hy·po·vo·le·mi·a n. See oligemia. . Hypovolemia is a condition often associated with blood loss during surgery or from injury. Hextend(R) maintains circulatory system circulatory system, group of organs that transport blood and the substances it carries to and from all parts of the body. The circulatory system can be considered as composed of two parts: the systemic circulation, which serves the body as a whole except for the fluid volume and oncotic pressure oncotic pressure Colloid osmotic pressure Physiology The colloid pressure in solutions produced by proteins; in plasma, OP counterbalances the egress of fluid from capillaries due to hydrostatic pressure and keeps vital organs perfused during surgery. Hextend(R), approved for large-volume use in major surgery, is the only blood plasma volume expander that contains hetastarch, buffer, multiple electrolytes, and glucose. Hextend(R) is also completely sterile to avoid risk of infection. "We are gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. that Hextend(R) has received approval," said Dr. Paul Segall, BioTime's chief executive officer. "We have been working closely with our North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. marketing partner, Abbott Laboratories, and preparations for the market launch are moving forward." BioTime, headquartered in Berkeley develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and other applications. 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 BioTime's ability to obtain foreign regulatory approval to market Hextend; competition from products manufactured and sold or being developed by other companies; the price of and demand for Hextend; the Company's ability to negotiate favorable foreign licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in Hextend; and the availability of reimbursement for the cost of Hextend (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 filed with the Securities and Exchange Commission. |
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