CytoSorbents Announces FDA Approved US Air Force Funded Human Trauma Pilot Study for Rhabdomyolysis

CytoSorbents Announces FDA Approved US Air Force Funded Human Trauma Pilot
Study for Rhabdomyolysis

MONMOUTH JUNCTION, N.J., June 17, 2013 (GLOBE NEWSWIRE) -- CytoSorbents
Corporation (OTCBB:CTSO), a critical care focused company using blood
purification to treat life-threatening illnesses in the intensive care unit,
announced today that the United States Food and Drug Administration (FDA) has
granted approval to begin a U.S.-based human pilot study using CytoSorb® for
the treatment of rhabdomyolysis as a result of trauma under an Investigational
Device Exemption (IDE). Rhabdomyolysis is caused by the massive release of
myoglobin from severely injured skeletal muscle that can lead to kidney
failure.The study was initiated by and will be funded by the U.S. Air
Force.CytoSorbents is the official sponsor of the study, and expects the
study to begin this year.

Dr. Phillip Chan, MD, PhD, Chief Executive Officer stated, "This major
announcement is a significant milestone for CytoSorbents for many reasons:

  *This will be the first human CytoSorb® study to begin in critically ill
    patients in the United States.We are confident that CytoSorb® treatment
    will be easy to implement, after now having safely completed more than
    1,000 human treatments, mostly in Europe, including a number of treatments
    in trauma patients.
  *The U.S. Air Force is funding this study, a major benefit to the Company.
    The trial will be conducted by experienced clinical researchers from both
    the U.S. Air Force and Army.Along with our previously established Trauma
    Advisory Board, we will have a wealth of experience to draw upon for this
  *This collaboration expands our relationship with the U.S. Department of
    Defense to now include the U.S. Air Force, the U.S. Army, and the Defense
    Advanced Research Projects Agency (DARPA).Our collective goal is to
    develop our technologies for the treatment of life-threatening conditions
    such as sepsis, burn injury, trauma and rhabdomyolysis, to protect our
    wounded warfighters and civilians alike.We greatly appreciate the ongoing
    interest and support of these respective agencies.
  *As part of the IDE application process, the FDA has reviewed the CytoSorb®
    treatment safety data from the European Sepsis Trial.We believe this
    early review of the European Sepsis Trial safety data will help streamline
    our future discussions with the FDA about a planned U.S. pivotal trial in
  *Finally, this study will expand the CytoSorb® clinical trial experience to
    now include trials in sepsis and in trauma patients with
    rhabdomyolysis.If successful, the trauma and rhabdomyolysis application
    could represent yet another avenue to seek CytoSorb® approval in the
    U.S.CytoSorb® is currently approved in the European Union and has been
    used successfully in treating a variety of conditions, including sepsis,
    lung injury, influenza, burn injury, trauma, liver failure, and others."

Based on statistics from the National Trauma Institute, trauma accounts for 42
million emergency department visits, 2 million hospital admissions, and more
than 170,000 deaths in the U.S. each year. In severe trauma patients, crush
injury and ischemia can lead to rhabdomyolysis - the destruction and breakdown
of muscle tissue, releasing intracellular myoglobin into the blood.High
levels of myoglobin are toxic to the kidneys and can precipitate acute kidney
injury and kidney failure, which significantly increases the risk of death in
trauma injury.CytoSorb® has demonstrated the ability to efficiently remove
myoglobin in pre-clinical testing and will be evaluated on its ability to
reduce myoglobin levels in human trauma patients with rhabdomyolysis when used
with standard of care therapy, compared to standard of care therapy alone.

About CytoSorbents Corporation

CytoSorbents is a critical care focused therapeutic device company using
blood purification to modulate the immune system and fight multiple organ
failure in life-threatening illnesses.Its purification technology is based on
biocompatible, highly porous polymer beads that can actively remove toxic
substances from blood and other bodily fluids by pore capture and
adsorption.CytoSorb®, the Company's flagship product, is approved in the
European Union as a safe and effective extracorporeal cytokine filter,
designed to reduce the "cytokine storm" that could otherwise cause massive
inflammation, organ failure and death in common critical illnesses such as
sepsis, burn injury, trauma, lung injury, and pancreatitis.These are
conditions where the mortality is extremely high, yet no effective treatments
exist.CytoSorbents has numerous products under development based upon the
same underlying blood purification technology including HemoDefend™,
ContrastSorb, DrugSorb, and others.Additional information is available for
download on the Company's website:

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for
the safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this press
release are not promises or guarantees and are subject to risks and
uncertainties that could cause our actual results to differ materially from
those anticipated. These statements are based on management's current
expectations and assumptions and are naturally subject to uncertainty and
changes in circumstances. We caution you not to place undue reliance upon any
such forward-looking statements. Actual results may differ materially from
those expressed or implied by the statements herein. CytoSorbents Corporation
and CytoSorbents, Inc believe that its primary risk factors include, but are
not limited to: obtaining government regulatory approvals; ability to
successfully develop commercial operations; dependence on key personnel;
acceptance of the Company's medical devices in the marketplace; the outcome of
potential litigation; compliance with governmental regulations; reliance on
research and testing facilities of various universities and institutions; the
ability to obtain adequate and timely financing in the future when needed;
product liability risks; limited manufacturing experience; limited marketing,
sales and distribution experience; market acceptance of the Company's
products; competition; unexpected changes in technologies and technological
advances; and other factors detailed in the Company's Form 10-K filed with the
SEC on April 3, 2013, which is available at

CONTACT: Company Contact:
         CytoSorbents Corporation
         Dr. Phillip Chan
         Chief Executive Officer
         (732) 329-8885 ext. *823
         Investor Contact:
         Alliance Advisors, LLC
         Alan Sheinwald
         (914) 669-0222
         Valter Pinto
         (914) 669-0222 x201
         Media Contact:
         JQA Partners
         Jules Abraham
         (917) 885-7378
Press spacebar to pause and continue. Press esc to stop.