MONMOUTH JUNCTION, N.J.,
Oct. 20, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a leader in
the treatment of life-threatening conditions in intensive care and
cardiac surgery using CytoSorb®1 blood
purification, makes additional comments on the
investigator-initiated REMOVE study following the formal
presentation of trial results on Saturday,
October 16th at the European Association for
Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain.
CytoSorbents Comments on REMOVE Study Presentation
This presentation adds to the information made publicly
available by the preliminary data abstract at EACTS for 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, and commented
upon in a press release dated October 7,
2021. The presentation by REMOVE Study Director, Dr.
med. Mahmoud Diab, from University
Hospital Jena, Germany included
additional patient demographic and adverse event data from the
study. No study population subgroup analyses were reported.
Dr. Diab commented on safety and concluded that there
was "no signal for harm due to the use of CytoSorb® in patients
undergoing surgery for infective endocarditis."
Professor Dr. med. Torsten Doenst, Head of the Cardiothoracic
Surgery Department, University Hospital Jena, Germany, and coordinating center of the REMOVE
study stated, "The REMOVE topline results presented at the EACTS
meeting contribute significant and valuable information on the
intraoperative use of CytoSorb in patients undergoing valve
replacement surgery for infective endocarditis. Although
the pre-specified primary outcome of the study was
neutral, we demonstrated CytoSorb's ability to reduce
cytokines. In addition, REMOVE also suggests that the use of
CytoSorb in this setting is safe, with a similar adverse event
profile to standard of care therapy. Even though our data
suggest that the intraoperative use of CytoSorb in a general
endocarditis patient population may not be helpful, it is also not
harmful, and it is conceivable that specific patient types may
benefit from the therapy's ability to lower cytokine
levels. We plan to work collaboratively with
CytoSorbents to perform additional exploratory analyses of the
REMOVE data to better characterize and identify the best
populations to be included in future studies. We are pleased
with CytoSorbents' continued commitment to high quality evidence
generation in cardiac surgery."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "We want to congratulate the REMOVE
investigators who executed this important trial. We are
encouraged that the intraoperative use of CytoSorb during
cardiothoracic surgery had a favorable adverse event profile in
this large randomized, controlled trial and that it reduced
cytokines, validating CytoSorb's mechanism of action. Taking
all evidence into account, we continue to believe that CytoSorb
treatment of select endocarditis patients with high acuity of
illness may provide clinical benefits, such as improved hemodynamic
stabilization, especially when use of the therapy is extended
postoperatively. We look forward to our continued
collaboration with Professor Doenst and his investigative team
to better understand and analyze the results from the REMOVE trial
to inform the design of future potential studies using CytoSorb in
more specific infective endocarditis populations.
Importantly, the accumulating evidence of promising safety
with intraoperative CytoSorb use during cardiothoracic surgery,
including both studies presented at the recent EACTS conference,
bodes very well for our U.S. FDA-approved clinical programs in
cardiac surgery investigating intraoperative use of CytoSorbents'
technology in additional indications, specifically the REFRESH
2-AKI, STAR-T, and STAR-D pivotal studies."
1 CytoSorb is approved in the European Union.
CAUTION: In the United States,
CytoSorb is classified as an investigational device limited by
United States law to
investigational use.
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 152,000 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, apixaban and
rivaroxaban, in a cardiopulmonary bypass circuit during urgent
cardiothoracic surgery. The Company is initiating two FDA
approved pivotal trials designed to support U.S. marketing approval
of DrugSorb-ATR. The first is the 120-patient, 20 center
STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) randomized, controlled trial
evaluating the ability of intraoperative DrugSorb-ATR use to reduce
perioperative bleeding risk in patients on ticagrelor undergoing
cardiothoracic surgery. The second is the 120-patient, 25
center STAR-D (Safe and Timely
Antithrombotic Removal-Direct Oral
Anticoagulants) randomized, controlled trial, evaluating the
intraoperative use of DrugSorb–ATR to reduce perioperative bleeding
risk in patients undergoing cardiothoracic surgery on direct oral
anticoagulants, including apixaban and rivaroxaban.
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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SOURCE CytoSorbents Corporation