MONMOUTH JUNCTION, N.J.,
Oct. 5, 2015 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy leader commercializing its CytoSorb® blood
purification technology to reduce deadly uncontrolled inflammation
in hospitalized patients around the world, reports on continued
growth and adoption of CytoSorb® at its successful 2nd
International CytoSorb Users Meeting held in Berlin, Germany on October 2, 2015.
This was one of the largest gatherings of worldwide CytoSorb®
users, distributors and partners in the Company's history, with 110
participants from 18 countries globally. The meeting was an
excellent networking event and an opportunity for colleagues to
present and discuss recent case reports, case studies and, for the
first time, preliminary or interim results from several controlled
pilot studies. This planned progression to increased levels
of evidence-based medicine is part of the Company's clinical
development strategy.
Key findings of the symposium were:
- Continued and clear evidence of safety in now more than 8,000
human CytoSorb® treatments in thousands of patients
- These treatments have been in a broad range of serious
conditions such as severe sepsis, septic shock, trauma,
rhabdomyolysis, pancreatitis, lung injury, liver and kidney
transplantation, liver failure, influenza, cardiac surgery,
post-operative inflammation, toxic shock syndrome, necrotizing
fasciitis, and many others
- CytoSorb® therapy has contributed to patients' clinical
stability in many ways including:
- Improved hemodynamic stability
- Less need for vasopressors
- Improvement of metabolic parameters
- New successful uses include the treatment of common tropical
diseases such as Dengue Fever (50 to 100 million infections
worldwide annually) and Scrub Typhus (1 million infections
worldwide annually)
- Recent treatments using CytoSorb® in liver failure patients
have confirmed previous reports of equivalent or superior removal
of hepatic toxins from blood, compared with existing liver dialysis
therapies. This opens up major new potential markets in the
treatment of viral hepatitis, alcoholic liver disease, and
others
- CytoSorb® is easy to implement and use without serious
technical complications in a wide range of blood pump systems,
including dialysis, continuous renal replacement therapy (CRRT),
extracorporeal membrane oxygenation (ECMO), and cardiopulmonary
bypass
- Preliminary results from two completed cardiac surgery
randomized controlled pilot studies from University of
Hamburg-Eppendorf (N=20) and Medical University of Vienna (N=37), where CytoSorb® was used
intra-operatively in a heart-lung machine bypass circuit, in
low-risk cardiac surgery patients, and interim data from 142
cardiac surgery patients in a 3-arm trial at University of
Cologne, comparing inflammatory
mediators in patients undergoing off-pump surgery (n=21), on-pump
surgery without CytoSorb® (n=61), and on-pump surgery with
CytoSorb® (N=60) demonstrate:
- Therapy was well-tolerated and safe without device-related
issues, including no removal of heparin, no bleeding or coagulation
issues, no device set-up concerns
- Preliminary initial cytokine data show that some cytokines are
removed in CytoSorb® treated patients compared to control, but
overall inflammation in these shorter, lower risk surgeries, was
not high. Cytokine and other inflammatory mediator analysis
is continuing. Similarly, the risk of adverse events and
mortality were low in both treatment and control groups
- Now that safety has been determined, all three trial sites are
interested in extending their treatment experience to complex
cardiac surgery, where the risk of inflammation and adverse events
are much higher
- The results support feasibility and safety in REFRESH I, a US
based study that has begun to screen patients where CytoSorb® is
being evaluated to safely reduce plasma free hemoglobin during
complex cardiac surgery
- These clinical data on safety, ease of use, and feasibility are
expected to increase the confidence of the cardiac surgery
community to treat a wide range of open heart surgery patients in
need with CytoSorb®
- CytoSorb® therapy is being used in "real-world" situations much
earlier as an adjunctive therapy to control deadly inflammation and
treat life-threatening illnesses, rather than as a therapy of "last
resort"
Dr. Phillip Chan, CEO of
CytoSorbents stated, "We are pleased with the expanding clinical
experience with CytoSorb® around the world. We are currently
seeking permission from our various investigators to make
presentations and data public from the meeting, given that we did
not sponsor these studies and do not own the data. Many are
in the process of submitting their results for publication, so we
hope in one way or another, data from these studies will be made
available in the future."
Photos, user testimonials, and more information from the event
can be found at www.cytosorb.com and on the Company's Facebook
page.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused
immunotherapy company using blood purification to control severe
inflammation -- 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®, the
Company's flagship product, is approved in the European Union with
distribution in 31 countries around the world, as a safe and
effective extracorporeal cytokine adsorber, 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 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' 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™, ContrastSorb,
DrugSorb, and others. Additional information is available for
download on the Company's
websites: http://www.cytosorbents.com and
http://www.cytosorb.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. 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 31, 2015, 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
Investor Contact:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
Public Relations Contact:
The Ruth Group
Eric Kim
646-536-7023
ekim@theruthgroup.com
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SOURCE CytoSorbents Corporation