great news! good things come to those who wait!
best of luck friend!
biz.yahoo.com
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Wednesday March 31, 6:35 pm Eastern Time
BioTime Receives FDA Approval to Market Hextend
BERKELEY, Calif.--(BW HealthWire)--March 31, 1999--BioTime, Inc. (Nasdaq:BTIM -
news) today announced that it has received approval from the U.S. Food and Drug
Administration (FDA) to market Hextend®, the Company's physiologically balanced
blood plasma volume expander, for the treatment of hypovolemia.
Hypovolemia is a condition often associated with blood loss during surgery or
from injury. Hextend® maintains circulatory system fluid volume and oncotic
pressure and keeps vital organs perfused during surgery. Hextend®, approved for
large-volume use in major surgery, is the only blood plasma volume expander
that contains hetastarch, buffer, multiple electrolytes, and glucose. Hextend®
is also completely sterile to avoid risk of infection.
''We are gratified that Hextend® has received approval,'' said Dr. Paul Segall,
BioTime's chief executive officer. ''We have been working closely with our
North American 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.
Contact:
BioTime, Inc.
Victoria Bellport, 510/845-9535
www.biotimeinc.com |
