BioTime Files for Canadian Regulatory Approval of Hextend.BERKELEY, Calif.--(BW HealthWire)--Nov. 5, 1999-- BioTime, Inc. (AMEX AMEX See: American Stock Exchange :BTX (Balanced Technology EXtended) A motherboard design from Intel introduced in 2004 that supersedes the ATX. Unlike the ATX, the placement of all chip sockets in the BTX is defined in order to provide sufficient air flow over the processor and display adapter. ) announced today that its application to market Hextend(R) in Canada has been found acceptable for review as a New Drug Submission by the Canadian Health Protection Branch (HPB HPB Health Promotion Board (Singapore) HPB Hrvatska Poštanska Banka (Croatian Post Bank) HPB Half Price Books (retail store) HPB High Ping Bastard ). If the application is approved, Hextend can be marketed in Canada to treat 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. . Hextend, the Company's physiologically compatible 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. expander is currently sold in the US for the treatment of hypovolemia. Hypovolemia is a condition often associated with blood loss during surgery or from injuries. Hextend is the only plasma volume expander containing lactate Lactate A salt or ester of lactic acid (CH3CHOHCOOH). In lactates, the acidic hydrogen of the carboxyl group has been replaced by a metal or an organic radical. Lactates are optically active, with a chiral center at carbon 2. , balanced electrolytes and glucose approved for large volume use in major surgery. Hextend is a synthetic sterile formulation and thus does not carry the risks associated with blood-derived products. "We are happy to announce our first international filing for marketing approval of Hextend," said Dr. Paul Segall, BioTime's chief executive officer. Dr. Segall noted that, in clinical trials, large volumes of Hextend have been used to replace blood volume lost in major surgery without any serious related adverse events. BioTime has licensed to Abbott Laboratories the right to manufacture and sell Hextend in the United States and Canada. BioTime, headquartered in Berkeley, California develops blood plasma volume expanders, blood replacement solutions for 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, 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 its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for its products; the Company's ability to negotiate favorable foreign licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in its products; and the availability of reimbursement for the cost of new 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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