MONMOUTH JUNCTION, N.J.,
Oct. 12, 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 full approval of its
Investigational Device Exemption (IDE) application by the FDA to
conduct the pivotal STAR–D (Safe and Timely
Antithrombotic Removal – Direct Oral
Anticoagulants [DOAC]) double-blind, randomized, controlled trial
in the United States to support
FDA marketing approval. This is being performed under the
previously announced FDA Breakthrough Device Designation granted to
the DrugSorb–ATR™ Antithrombotic Removal System for the removal
of apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and
rivaroxaban (Xarelto®, Janssen/Bayer) in a cardiopulmonary bypass
circuit to reduce the likelihood of serious perioperative bleeding
in urgent cardiothoracic surgery.
Full FDA IDE Approval Received to Begin U.S. STAR-D Trial on DOAC
Removal During Urgent Cardiothoracic Surgery
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents
stated, "We are pleased to receive a second IDE approval for the
antithrombotic removal application for the randomized, controlled,
double-blind STAR-D trial designed to support FDA marketing
approval of DrugSorb–ATR™ for intraoperative apixaban and
rivaroxaban removal during cardiothoracic surgery. STAR–D is
the next milestone of our STAR development program. The
STAR-D trial design and operational framework are identical to the
actively screening STAR-T trial for ticagrelor removal, and are
expected to yield extensive scientific, operational, and financial
efficiencies. STAR–D is expected to enroll up to 120 patients
across 25 U.S. clinical sites - of which many are already actively
participating in STAR-T, and will be led once again by Co-Principal
Investigators Drs. Michael Mack and
C. Michael Gibson and an Executive
Committee comprised of world–renowned cardiac surgeons,
interventional cardiologists, and thrombosis/hemostasis
experts. Trial start-up activities are underway and we expect
the study to start in the first quarter of 2022."
Mr. Vincent Capponi, President
and Chief Operating Officer of CytoSorbents, stated, "The full IDE
approval of the STAR-D protocol now positions us to execute the
next step in our DrugSorb-ATR market development strategy.
With this additional approval, we will have two U.S. randomized,
controlled pivotal trials ongoing to support U.S. FDA marketing
approval for the intraoperative removal of the key blockbuster
antithrombotic drugs Brilinta®, Eliquis® and Xarelto® during open
heart surgery to reduce the risk of perioperative bleeding.
If successful, we intend to establish DrugSorb-ATR as the go-to,
easy-to-use, potential standard of care single treatment for this
application in the U.S., targeting an estimated total addressable
market in this country of approximately $1
billion. In doing so, our goal is to address this
major unmet medical need for patients and surgeons, while
establishing a new, potentially significant driver of future
company growth."
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®,
Janssen/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 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 pivotal
trials designed to support U.S. FDA marketing approval of
DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T
(Safe and Timely Antithrombotic Removal of 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 of 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@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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