CytoSorbents Expands CytoSorb(R) Dosing Study to Eight Clinical Trial Sites

CytoSorbents Expands CytoSorb(R) Dosing Study to Eight Clinical Trial Sites 
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 08/21/13 --  CytoSorbents
Corporation (OTCBB: CTSO), a critical care focused company
commercializing its European Union approved CytoSorb(R) blood filter
to treat life-threatening illnesses in the intensive care unit,
announced today the formal expansion of its CytoSorb(R) dosing study
to eight leading clinical trial sites in Germany.  
The following institutions join University of Goettingen, Helios
Erfurt, and University of Aachen in the trial: 


 
--  University of Jena
    
    
--  University of Hamburg - Eppendorf
    
    
--  University of Greifswald
    
    
--  University of Leipzig
    
    
--  University of Oldenburg

  
With the last site expected to be initiated shortly, all of these new
clinical sites have been initiated to begin new patient enrollment,
which is expected to significantly accelerate the completion of the
trial, with the intent of having at least interim data by the end of
the year. 
The matched-pairs dosing study was designed to evaluate the safety
and preliminary efficacy of extended CytoSorb(R) treatment, in order
to give physicians more flexibility on how to treat critically ill
patients with CytoSorb(R). The two treatment arms of the study
include 24 hours of treatment, each day for 7 days (ongoing), and 6
hours of treatment, each day for up to 14 days or until clinical
improvement (planned). In addition, the study is intended to support
the design of a pivotal trial protocol in the United States. This
pivotal study in sepsis is expected to start in 2014, pending
successful discussions with the FDA, with the goal of definitively
demonstrating the effectiveness of CytoSorb(R) for the treatment of
sepsis, and to seek U.S. regulatory approval. The FDA has already
approved an investigational device exemption (IDE) application to run
a small CytoSorb(R) sepsis trial in the U.S. and has recently
reviewed the human safety data on CytoSorb(R) from the European
Sepsis Trial in approving the U.S. Air Force funded trauma and
rhabdomyolysis trial using CytoSorb(R). 
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents
Corporation, stated, "These trial sites and investigators are amongst
some of the most productive and influential in sepsis and critical
care research. Their desire to join our trial complements a growing
number of investigators at outstanding tertiary care hospitals in
Germany, Austria, and the United Kingdom that are collaborating with
CytoSorbents on numerous studies. We are pleased to welcome them to
our trial." 
About CytoSorbents Corporation  
CytoSorbents is a critical care focused therapeutic device company
using blood purification to modulate the immune system -- with the
goal of preventing or treating multiple organ failure in
life-threatening illnesses. Organ failure is the cause of nearly half
of all deaths in the intensive care unit, with little to improve
clinical outcome. CytoSorb(R), 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'
purification technologies are based on biocompatible, highly porous
polymer beads that can actively remove toxic substances from blood
and other bodily fluids by pore capture and surface adsorption.
CytoSorbents has numerous products under development based upon this
unique blood purification technology, protected by 32 issued US
patents and multiple applications pending, including HemoDefend(TM),
ContrastSorb, DrugSorb, and others. Additional information is
available for download on the Company's website:
http://www.cytosorbents.com 
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. Risk factors are detailed in the Company's
Form 10-K filed with the SEC on April 3, 2013, which is available at
http://www.sec.gov. 
Company Contact:
CytoSorbents Corporation
Dr. Phillip Chan
Chief Executive Officer
(732) 329-8885 ext. *823
pchan@cytosorbents.com 
Investor Contact:
Alliance Advisors, LLC
Alan Sheinwald
(914) 669-0222
asheinwald@allianceadvisors.net 
Valter Pinto
(914) 669-0222 x201
valter@allianceadvisors.net 
Media Contact:
JQA Partners
Jules Abraham
(917) 885-7378
jabraham@jqapartners.com 
 
 
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