MONMOUTH JUNCTION, N.J.,
Oct. 7, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a leader in
the treatment of life-threatening conditions in intensive care and
cardiac surgery using blood purification, announced the public
availability of preliminary data abstracts from two separate
endocarditis studies, including the REMOVE study, to be presented
at the upcoming European Association for Cardio-Thoracic Surgery
(EACTS) annual meeting taking place in Barcelona, Spain from October 13-16, 2021, where more extensive data
are expected to be made available. A summary of the abstracts
are as follows:
The REMOVE ("Revealing Mechanisms and
Investigating Efficiency Of Hemoadsorption for Prevention of
Vasodilatory Shock in Cardiac Surgery Patients with
Infective Endocarditis") investigator initiated
randomized, controlled trial enrolled 288 patients with documented
infective endocarditis with a EuroSCORE II (European System
for Cardiac Operative Risk Evaluation II) > 3, and who
required open heart valve replacement surgery, and compared the
intraoperative use of CytoSorb and standard of care with standard
of care alone. The investigators concluded that although
intraoperative hemoadsorption reduced plasma cytokines at the end
of cardiopulmonary bypass, it did not reduce the severity of
post-operative organ dysfunction as observed by the change in mean
SOFA (Sequential Organ Failure Assessment) score over nine
days. In addition, the investigators noted no statistical
difference in secondary endpoints, including 30-day mortality and
durations of post-operative hemodialysis, ventilation and
vasopressor therapy.
In a retrospective study entitled "Intraoperative
Hemoadsorption Reduces Sepsis-related Death in All-comers
Undergoing Surgery for Infective Left-sided
Endocarditis," investigators from Nuremberg,
Germany report results from 195
consecutive patients with left-sided endocarditis (i.e. aortic
and/or mitral valve involvement) who underwent valve replacement
surgery at their institution with or without intraoperative
treatment with CytoSorb. A significant proportion of patients
had endocarditis of a prosthetic valve (41% CytoSorb treated, 28%
control). The study analyses focused on the comparison of the
control cohort (n=101) who were treated prior to CytoSorb
introduction at the hospital and the CytoSorb cohort (n=94) who
received intraoperative CytoSorb therapy during the
operation. The two groups had generally comparable baseline
characteristics with a median age of 69 years, however CytoSorb
treated patients had numerically higher baseline EuroSCORE II and
were more frequently treated for prosthetic valve endocarditis.
The use of CytoSorb was associated with significantly lower
post-operative sepsis-related mortality (7.5% vs. 20% control,
p=0.021) and lower levels of C-Reactive Protein (8.8 vs. 9.8 mg/dl;
p=0.019) and white blood cell counts (9.8 vs. 11.7
x10-6/mcL; p=0.033) on post-operative day 1. The
investigators stated that CytoSorb therapy was well-tolerated and
safe and contributed to reduced sepsis-related mortality, CRP and
leucocyte levels after surgery and concluded that "these
data suggest that intraoperative hemoadsorption improves surgical
outcomes in all-comers for left-sided infective
endocarditis."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents
stated, "At the current time, the available data from both studies
are preliminary and limited and do not allow for in-depth
evaluation. We plan to have a detailed statement once the
full formal presentations are completed next week, and more
complete data are made available. From a high level, CytoSorb
therapy tends to work best in carefully selected patients with a
high acuity of illness who are treated with the device early and
for an adequate duration of time. In the case of these two
endocarditis studies, important underlying differences may exist in
the respective patient cohorts that could explain the reported
differences in the observed benefits with the intraoperative use of
CytoSorb during valve replacement surgery. In addition, in
both studies, CytoSorb was only used intra-operatively, where today
in many centers, CytoSorb therapy in infective endocarditis
patients has advanced to be used both intraoperatively and
postoperatively during recovery with reported improved
benefits. Importantly, the investigators from Nuremberg
reported that the intraoperative use of CytoSorb during cardiac
surgery was well-tolerated and safe. We view this as a
positive development that provides added reassurances for our
ongoing clinical programs on intraoperative device use and are
looking forward to reviewing the safety data from the REMOVE trial
that we anticipate will be released during the formal
presentation. We plan to work closely with the investigators
of both studies to better understand the results and determine the
direction for further analyses that could help identify the optimal
endocarditis patient population for CytoSorb use and potentially
inform the design of future endocarditis studies."
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents, stated, "Today, infective endocarditis
makes up a minor part of our overall usage and revenue in cardiac
surgery and we believe that CytoSorb will continue to be used in
selected infective endocarditis populations. For example,
prosthetic heart valve endocarditis is associated with very high
mortality and is increasingly common due to the aging population
with structural valvular disease and increased use of transcatheter
aortic valve replacement (TAVR) and traditional open heart valve
replacements. Overall, infective endocarditis is just one of many
applications of our technology in cardiac surgery and is a much
smaller opportunity than the removal of antithrombotic drugs during
cardiothoracic surgery, for which we have specific approvals in the
E.U., two U.S. FDA Breakthrough Device Designations, and is the
core focus of our U.S. regulatory approval strategy."
Infective endocarditis is a potentially life-threatening
infection of one or more heart valves that is usually caused when
bacteria enter the bloodstream due to a systemic infection, dental
care, or intravenous drug abuse and the use of dirty needles.
Treatment typically involves antibiotics, but for many patients,
cardiac surgery and valve replacement is the only treatment
option. If left untreated, endocarditis can damage a
patient's heart valves and may be fatal.
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in intensive care and cardiac surgery
using blood purification. Its flagship product, CytoSorb®, is
approved in the European Union with distribution in 68 countries
around the world as an extracorporeal cytokine adsorber designed to
reduce the "cytokine storm" or "cytokine release syndrome" seen in
common critical illnesses that may result in massive inflammation,
organ failure and patient death. These are conditions where
the risk of death can be extremely high, yet few to no effective
treatments exist. CytoSorb is also being used during and
after cardiothoracic surgery to remove inflammatory mediators that
can lead to post-operative complications, including multiple organ
failure. More than 143,000 CytoSorb devices have been
delivered to date. CytoSorb was originally introduced into
the European Union under CE-Mark as a first-in-kind cytokine
adsorber. Additional CE-Mark label expansions were received
for the removal of bilirubin and myoglobin in clinical conditions
such as liver disease and trauma, respectively, and both ticagrelor
and rivaroxaban during cardiothoracic surgery. CytoSorb has
also received FDA Emergency Use Authorization in the United States for use in adult critically
ill COVID-19 patients with imminent or confirmed respiratory
failure. The DrugSorb-ATR™ Antithrombotic Removal System,
which is based on the same polymer technology as CytoSorb, has also
been granted FDA Breakthrough Designation for the removal of
ticagrelor, as well as FDA Breakthrough Designation for the removal
of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and
apixaban, in a cardiopulmonary bypass circuit during urgent
cardiothoracic surgery.
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, contract, and other funding of more than
$39.5 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. The Company has numerous marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For
more information, please visit the Company's websites at
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, anticipated future results
and performance, 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, 2021, 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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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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