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Oxygen Biotherapeutics and the U.S. Army Institute of Surgical Research Sign a Cooperative Research and Development Agreement to

  Oxygen Biotherapeutics and the U.S. Army Institute of Surgical Research Sign
  a Cooperative Research and Development Agreement to Study the Effects of
  Oxycyte® on Ex Vivo Platelet Function

Business Wire

MORRISVILLE, N.C. -- February 6, 2013

Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT), announced today that it
has signed a Cooperative Research and Development Agreement (CRADA) with the
U.S. Army Institute of Surgical Research (USAISR) at Fort Sam Houston Texas to
explore the potential effects of OBI’s proprietary perfluorocarbon-based
emulsion, Oxycyte, on platelet function and blood hemostasis. This CRADA has
been initiated to complement ongoing research and development work funded
previously by a Department of Defense grant to broaden the safety profile of
the use of perfluorocarbon-based emulsions to treat patients with traumatic
brain injury – an indication for which OBI is conducting Phase II clinical
trials overseas.

Although a known response to perfluorocarbon-based emulsion products is the
transient decline in circulating platelet counts, the mechanism by which this
phenomenon occurs is poorly understood and its impact on overall coagulation
pathways and clinical outcomes remains the subject of debate. Recently
completed in vitro studies using blood from normal healthy human volunteers at
the Children’s Hospital in Boston have demonstrated that Oxycyte has little
effect on the activation and function of platelets. The research being
conducted under the present CRADA will investigate whether Oxycyte alters
platelet activation, aggregation or adhesion in a model of systemic
inflammation. Researchers will conduct ex vivo evaluations of platelet
activity and whole blood clotting functions. Changes in the structural and
functional properties of platelets will be evaluated including receptor
expression and distribution, and aggregation in response to agonists. This
work will be part of a larger study to determine the biodistribution of
platelets following Oxycyte administration in this model. The company has
undertaken this extensive preclinical program to address concerns that the
U.S. FDA has expressed regarding perfluorocarbon-based emulsions.

“This work is important in terms of helping us better understand the mechanism
surrounding platelet count declines in response to Oxycyte administration and
we believe it will go a long way towards allaying the concerns the FDA has
around the use of perfluorocarbon-based drugs and treatments, in general,”
said Michael Jebsen, President and Chief Financial Officer of OBI. “We are
pleased to be working with the highly respected Institute of Surgical Research
at Fort Sam Houston. Their scientists have a strong working relationship with
the Texas Biomedical Research Institute where other critical Oxycyte
preclinical studies are currently underway. Based on the preliminary findings
of a number of our ongoing studies in platelet function and immunocompetence,
we believe we are compiling the data necessary to move Oxycyte back into
clinical trials in the U.S. in the future.”

About Oxycyte

Oxycyte is a sterile, milky white, sub-micron (median diameter of 200-250 nm)
perfluorocarbon (PFC) emulsion intended for intravenous injection. It contains
two key ingredients, perfluoro(t-butylcyclohexane) and egg yolk phospholipids
(an emulsifier), along with several minor ingredients dispersed in water.
Research has shown that PFCs can dissolve and release large amounts of gases,
including oxygen and carbon dioxide. When formulated and delivered as an
intravenous emulsion, PFCs have been shown to enhance the oxygenation of
ischemic tissue.

About Oxygen Biotherapeutics, Inc.

Oxygen Biotherapeutics, Inc. is developing medical products that efficiently
deliver oxygen to tissues in the body. The company has developed a proprietary
perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte^® that is
currently in clinical and preclinical studies for intravenous delivery for
indications such as traumatic brain injury, decompression sickness and stroke.
The company has also developed PFC-based cosmetic creams and gels for topical
delivery to the skin for anti-aging, and potentially for wound care and
dermatologic conditions.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the company
that involve risks and uncertainties and reflect the company’s judgment as of
the date of this release. The forward-looking statements are subject to a
number of risks and uncertainties including matters beyond the company’s
control that could lead to delays in the clinical development and
commercialization of Oxycyte, our clinical study, new product introductions
and customer acceptance of these new products, and other risks and
uncertainties as described in our filings with the Securities and Exchange
Commission, including in the current Form 10-Q filed on December 14, 2012, and
our annual report on Form 10-K filed on July 24, 2012, as well as other
filings with the SEC. The company disclaims any intent or obligation to update
these forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.

Contact:

Oxygen Biotherapeutics, Inc.
Ellen Corliss
SVP, Investor Relations & Corporate Communications
919-855-2112
 
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