MONMOUTH
JUNCTION, N.J., April 29,
2022 /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, announced today that the first patient has been
enrolled in the Safe and Timely Antithrombotic
Removal-Direct Oral Anticoagulants
(STAR-D) double-blind, randomized, controlled clinical
trial designed to support FDA marketing approval of the
DrugSorb™-ATR Antithrombotic Removal System for intraoperative
removal of apixaban and rivaroxaban during cardiothoracic
surgery. The STAR-D trial is being performed under the
auspices of an FDA Breakthrough Device Designation and is
expected to enroll up to 120 patients across 30 sites in the United
States. The first patient was enrolled at Virginia Commonwealth University's Pauley Heart
Center by Principal Investigator Dr. Patricia A. Nicolato, D.O, Cardiothoracic
Surgeon and Associate Professor in the Department of Surgery,
Division of Cardiothoracic Surgery, Director of the Extracorporeal
Life Support Program.
CytoSorbents Enrolls First Patient in U.S.
STAR-D Pivotal Trial
Dr. Nicolato stated, "We frequently encounter patients on direct
oral anticoagulants, such as apixaban and rivaroxaban, who need
urgent cardiac surgery and are at very high risk for serious
bleeding complications. Currently, there are no available
solutions to help our team manage this complex clinical scenario
and reduce the significant associated morbidity and excess
costs. We are pleased to enroll the first patient in
the pivotal STAR-D trial investigating the ability of
DrugSorb™-ATR to remove apixaban or rivaroxaban during urgent
cardiac surgery. If the results of STAR-D are positive, then
DrugSorb™-ATR can be a safe and easy to implement solution to help
cardiac surgeons around the world effectively address this
important unmet medical need."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "The successful enrollment of the first
patient in STAR-D represents another major executional milestone in
our strategy to obtain FDA approval for antithrombotic drug removal
during cardiac surgery. We continue to observe very high levels of
interest from U.S. sites to participate in our STAR-T and STAR-D
trials, and as such we obtained FDA approval to expand each study
to 30 sites. We anticipate most of the study sites to participate
in both trials, as they routinely operate on patients on
ticagrelor, apixaban, or rivaroxaban, who all face an equally
high risk of serious perioperative bleeding. DrugSorb-ATR is
potentially a "one-stop-shop" solution to allow cardiac surgeons to
operate on patients taking any of these drugs in a safe and timely
manner. Importantly, we expect the total addressable market for
this application to continue to grow globally, supported by the
increasing usage of these latest generation antithrombotic agents
worldwide and their upcoming generic availability in the
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 perioperative bleeding from 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
patients[1] 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 more than 70 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 162,000
cumulative CytoSorb devices have been utilized as of December 31, 2021. 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 has
initiated two FDA approved pivotal trials designed to support U.S.
marketing approval of DrugSorb-ATR. The first is the 120-patient,
30 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, 30 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, future
targets and outlooks for our business, expectations regarding the
future impacts of COVID-19 or the ongoing conflict between
Russia and the Ukraine, 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 10, 2022, 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
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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