MONMOUTH JUNCTION, N.J.,
Sept. 10, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a leader in
the treatment of life-threatening conditions in intensive care and
cardiac surgery using blood purification via its proprietary
polymer adsorption technology, announces the filing of an
Investigational Device Exemption (IDE) application to gain FDA
approval to conduct the clinical study, "Safe and
Timely Antithrombotic Removal – Direct
Oral Anticoagulants (STAR-D)," in the United States to support FDA marketing
approval. This is being performed under the previously
announced FDA Breakthrough Device Designation granted to
DrugSorb-ATR® for the removal of apixaban and rivaroxaban in
a cardiopulmonary bypass circuit to reduce the likelihood of
serious perioperative bleeding in urgent cardiothoracic
surgery.
CytoSorbents Files IDE for U.S. Clinical Trial on Apixaban and
Rivaroxaban Removal During Urgent Cardiothoracic Surgery
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated "The investigational plan set forth in this IDE
filing comes approximately one month after the FDA granted
Breakthrough Designation for this application, demonstrating the
operational efficiencies of our clinical and regulatory teams and
the leveraged synergies with the previously approved and currently
active U.S. STAR-T pivotal trial to remove ticagrelor during urgent
cardiothoracic surgery. We expect discussions with FDA on the
current IDE application to conclude in the fourth quarter of 2021
and if approved, plan to commence study initiation activities for
this second DrugSorb-ATR trial immediately thereafter. We
plan to provide more details on the STAR-D trial, designed to
support U.S. FDA marketing approval for this additional
application, in the near future."
In August 2021, the FDA granted
CytoSorbents Breakthrough Device Designation to remove the Direct
Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the
risk of serious bleeding during urgent cardiothoracic surgery,
recognizing this major unmet medical need. Apixaban
(Eliquis®, Bristol Myers Squibb/Pfizer) and rivaroxaban
(Xarelto®, Jansen/Bayer) are two of the most commonly
prescribed anticoagulants worldwide, including more than 5 million
patients1 annually in the
United States who are chronically on these medications to
reduce the risk of deadly blood clots due to atrial fibrillation,
prior history of heart attack or stroke, deep vein thrombosis,
pulmonary embolism, and peripheral artery disease. We expect
the number of patients prescribed these drugs to continue to climb
based on the superior performance of these agents compared to older
alternatives, underlying demographic trends in the aging baby
boomer population, improved disease detection rates, and other
factors. When patients on various "blood thinners", like
apixaban or rivaroxaban, require urgent cardiothoracic surgery, the
risk of serious or life-threatening bleeding and complications is
very high. Based on our estimates, at least 1% of patients in
the U.S. on apixaban or rivaroxaban may require urgent
cardiothoracic surgery on an annual basis. Today there are no
approved or cleared alternatives in the U.S. to reduce bleeding
risks during cardiothoracic surgery caused by direct oral
anticoagulants. With the appropriate U.S. marketing approvals
for removal of ticagrelor and the two leading DOACs during
cardiothoracic surgery, DrugSorb-ATR has the potential to address
these major unmet medical needs, while targeting an estimated U.S.
total addressable market of one billion
dollars.
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@runbensteinpr.com
1 Agency for Healthcare Research and Quality. Number
of people with purchase in thousands by prescribed drug,
United States, 1996-2018.
Medical Expenditure Panel Survey. Generated interactively
May 27, 2021. CytoSorbents
estimates.
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SOURCE CytoSorbents Corporation