EVANSTON, Ill., June 5 /PRNewswire-FirstCall/ -- Northfield Laboratories
Inc. (Nasdaq: NFLD), a leading developer of an oxygen-carrying blood
substitute for trauma and elective surgery situations, today announced the
manuscript describing the use of PolyHeme in trauma and urgent blood loss
situations has been accepted for publication in the October 2002 issue of the
Journal of the American College of Surgeons.
"This is another significant accomplishment as we continue to describe the
life-sustaining capacity of PolyHeme in the setting of massive blood loss when
red blood cells may be unavailable," said Dr. Steven A. Gould, president.
"The preliminary report of this experience was presented at the Papers Session
of the Annual Meeting of the American College of Surgeons in New Orleans last
fall. This acceptance of the manuscript for publication following peer review
by independent, external reviewers represents validation of our results within
the medical and scientific communities, and is further evidence of the
significance of our work."
Dr. Gould also discussed his recent appearance at the Oxygen Therapeutics
and Transfusion Alternatives Conference of the American Association of
Bloodbanks in Arlington, VA. Gould commented, "The meeting gave us an
opportunity to provide an update on our progress to leading members of the
scientific and transfusion communities as well as authorities from the
Department of Defense, the National Institutes of Health, the Food and Drug
Administration, and other federal agencies. We continued to emphasize our
promising data that illustrate PolyHeme's utility in massive trauma
situations, and we are gratified with the enthusiastic response of the
participants at the conference."
Northfield Laboratories, founded in 1985, is a leading developer of an
oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood
substitute undergoing clinical trials that has been tested at large enough
dosages to be considered a substitute for acute blood loss in trauma and
surgical settings. As a result of the process used to manufacture the blood
substitute, essentially a solution of polymerized hemoglobin, PolyHeme has a
longer shelf life than blood, requires no cross matching and does not transmit
disease.
Statements in this release that are not strictly historical are "forward-
looking" statements that are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks, which may cause the company's
actual results in the future to differ materially from expected results.
Northfield cautions that the FDA approval process for PolyHeme continues to be
subject to significant risks and uncertainties. The FDA could refuse to
accept Northfield's BLA in its current form. If Northfield's BLA is accepted,
the FDA could deny its approval for the commercial sale of PolyHeme or could
require additional clinical tests as a condition to its approval. If FDA
approval for the commercial sale of PolyHeme is granted, the indication uses
for which PolyHeme may be marketed could be significantly limited by the FDA.
Other risks may include: competition from other blood substitute products;
the company's ability to obtain regulatory approval to market PolyHeme
commercially; the company's and/or its representative's ability to
successfully market and sell PolyHeme; the company's ability to manufacture
PolyHeme in sufficient quantities; the company's ability to obtain an adequate
supply of raw materials; the company's ability to maintain intellectual
property protection for its proprietary product and to defend its existing
intellectual property rights from challenges by third parties; the
availability of capital to finance planned growth; and the extent to which the
hospitals and physicians using PolyHeme are able to obtain third-party
reimbursement, as described in the company's filing with the Securities and
Exchange Commission.
Visit the Northfield website at: http://www.northfieldlabs.com
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, +1-847-864-3500, or Investors, Bill
Schmidle, +1-312-640-6753, or Media, Cindy Martin,
+1-312-640-6741, both of FRB Weber Shandwick
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