MONMOUTH JUNCTION, N.J.,
Sept. 8, 2016 /PRNewswire/ --
CytoSorbents Corporation (NASDAQ: CTSO), commercializing its
European Union approved CytoSorb® blood purification cartridge to
reduce deadly inflammation and to help save lives in sepsis and
other life-threatening illnesses, announced the advanced
development of its next generation, patent-pending CytoSorb-XL
platform for the treatment of severe sepsis and septic shock, at
the start of the 1st World Sepsis Congress and on the
eve of World Sepsis Day.
CytoSorb-XL is a new, state-of-the-art porous polymer bead
technology that combines lipopolysaccharide (LPS) endotoxin removal
with the robust cytokine, toxin, and inflammatory mediator
reduction achieved by CytoSorb®. CytoSorb-XL and its novel
endotoxin binding chemistry is the subject of a broad composition
of matter patent application, intended to protect the technology
worldwide for the next two decades.
In a head-to-head comparison with the leading endotoxin
adsorber, Toraymyxin™ (Toray, Japan), CytoSorb-XL matched the level of
endotoxin reduction in an in vitro plasma recirculation
system on a comparable volume basis. CytoSorb-XL is expected
to eliminate the need for stand-alone endotoxin specific filters by
offering superior performance in the removal of not just endotoxin,
but a much broader array of inflammatory mediators that drive
uncontrolled deadly inflammation, organ failure, and death in
sepsis.
"The development of CytoSorb-XL is an outstanding achievement
for our company and highlights a clear future evolution of sepsis
treatment using blood purification," stated Dr. Phillip Chan, Chief Executive Officer of
CytoSorbents. "Endotoxin, produced by Gram negative bacteria such
as E. coli, is a potent and deadly trigger of severe sepsis
and septic shock, but wreaks its havoc through the activation of
the immune system and generation of systemic inflammation through
cytokine storm. This is why endotoxin removal alone is not
enough and why the simultaneous removal of endotoxin, cytokines,
exotoxins, and other inflammatory mediators is anticipated to be
much more efficacious. In other words, treatment of sepsis by
CytoSorb-XL is expected to be a classic case where one plus one
equals three."
Dr. Chan continued, "Today, our flagship extracorporeal cytokine
adsorber CytoSorb® has already helped to save the lives of many,
many septic patients around the world. As we continue
international commercialization of CytoSorb® in critical care and
cardiac surgery, we will actively pursue completion of pre-clinical
and clinical development of CytoSorb-XL. CytoSorb-XL is
intended to be a worthy eventual successor to CytoSorb® for all
clinical applications."
Sepsis is the overzealous immune response to a life-threatening
infection often leading to organ dysfunction, organ failure, and
death. According to the Global Sepsis Alliance, sepsis
afflicts an estimated 30 million people each year, is
more common than a heart attack, and claims more lives than any
cancer, killing one person every 3-4 seconds. Sepsis remains
the primary cause of death following an infection and remains a top
10 killer worldwide. The Agency for Healthcare Research and
Quality (AHRQ) lists sepsis as the most expensive condition treated
in U.S. hospitals, costing $23.7
billion in 2013, accounting for 6.2% of the aggregate cost
of all hospitalizations.
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader in critical care
immunotherapy, specializing in blood purification. Its flagship
product, CytoSorb®, is approved in the European Union with
distribution in 37 countries worldwide, as a safe and effective
extracorporeal cytokine adsorber, designed to reduce the "cytokine
storm" or "cytokine release syndrome" that could otherwise cause
massive inflammation, organ failure and death in common critical
illnesses such as sepsis, burn injury, trauma, lung injury and
pancreatitis, as well as in cancer immunotherapy. These are
conditions where the risk of death is extremely high, yet no
effective treatments exist. CytoSorb® is also being used during and
after cardiac surgery to remove inflammatory mediators, such as
cytokines and free hemoglobin, which can lead to post-operative
complications, including multiple organ failure. CytoSorbents is
currently conducting its REFRESH (REduction in FREe Hemoglobin) 1
trial - a multi-center, randomized controlled study evaluating the
safety of intra-operative CytoSorb® use in a heart-lung machine
during complex cardiac surgery. In early 2017, the company
plans to initiate a pivotal REFRESH 2 trial intended to support
U.S. FDA approval. CytoSorb® has been used safely in more than
14,000 human treatments to date.
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. Its technologies have received non-dilutive
grant and contract funding in excess of $18
million from DARPA, the U.S. Army, the U.S. Air Force, the
U.S. Department of Health and Human Services, the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), U.S. Special Operations Command (SOCOM) and
others. The Company has numerous products under development based
upon this unique blood purification technology, protected by 32
issued U.S. patents and multiple applications pending worldwide,
including HemoDefend™, ContrastSorb, DrugSorb and others. For more
information, please visit the Company's
websites: www.cytosorbents.com and www.cytosorb.com or
follow us on Facebook and Twitter.
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. These forward-looking statements include, but
are not limited to, statements about our plans, objectives,
representations and contentions and are not historical facts and
typically are identified by use of terms such as "may," "should,"
"could," "expect," "plan," "anticipate," "believe," "estimate,"
"predict," "potential," "continue" and similar words, although some
forward-looking statements are expressed differently. You should be
aware that the forward-looking statements in this press release
represent management's current judgment and expectations, but our
actual results, events and performance could differ materially from
those in the forward-looking statements. Factors which could cause
or contribute to such differences include, but are not limited to,
the risks discussed in our Annual Report on Form 10-K, filed with
the SEC on March 9, 2016, as updated by the risks reported in
our Quarterly Reports on Form 10-Q, and in the press releases and
other communications to shareholders issued by us from time to time
which attempt to advise interested parties of the risks and factors
which may affect our business. We caution you not to place undue
reliance upon any such forward-looking statements. We undertake no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, other than as required under the Federal securities
laws.
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Cytosorbents
Contact:
Amy Vogel
Investor Relations
(732) 329-8885 ext.
*825
avogel@cytosorbents.com
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Public Relations
Contact:
Amy
Phillips
Pascale
Communications
412-327-9499
amy@pascalecommunications.com
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SOURCE CytoSorbents Corporation