MONMOUTH JUNCTION, N.J.,
Aug. 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, announced that the Company has
been granted a second Breakthrough Device designation for its
DrugSorb-ATR Antithrombotic Removal System by the U.S. Food and
Drug Administration (FDA). This Breakthrough Device designation
covers the removal of the Direct Oral Anticoagulants (DOACs)
apixaban and rivaroxaban in a cardiopulmonary bypass circuit to
reduce the likelihood of serious perioperative bleeding in urgent
cardiothoracic surgery. It follows the Breakthrough Designation
received in April 2020 to remove
ticagrelor for the same application.
DrugSorb-ATR Granted FDA Breakthrough Designation For Removal of
Apixaban & Rivaroxaban In Urgent Cardiothoracic Surgery
Dr. David Cox, Vice President of
Global Regulatory Affairs of CytoSorbents remarked, "The U.S.
Prescribing Information for apixaban and rivaroxaban, two leading
DOACs taken to reduce the risk of blood clots and associated
complications, clearly warns that dosing should be stopped prior to
a surgical procedure to reduce the risk of bleeding. Unfortunately,
in unexpected urgent cardiothoracic surgery, this is often not
possible, posing the risk of life-threatening bleeding in these
patients. We are pleased that the FDA has recognized the
potential of our DrugSorb-ATR Antithrombotic Removal System to
reduce levels of these drugs in a patient's blood, potentially
decreasing the risk of life-threatening perioperative bleeding. The
achievement of two Breakthrough Designations in these situations
where no approved or cleared alternatives exist is a major Company
milestone that is expected to expedite our regulatory and clinical
goals."
Mr. Vincent Capponi, President
and Chief Operating Officer of CytoSorbents stated, "We are pleased
that the DrugSorb-ATR Antithrombotic Removal System has been
granted a second Breakthrough Device designation by the FDA. With
this achievement, we continue to execute upon our multi-phase U.S.
strategy to potentially establish DrugSorb-ATR as an
easy-to-implement, new standard of care to remove antithrombotic
drugs during cardiothoracic surgery. The U.S. STAR-T (Safe and
Timely Antithrombotic Removal - Ticagrelor) pivotal randomized,
controlled clinical trial is now underway and we look forward
to working with the FDA in pursuit of the next IDE approval for the
U.S. study on DOAC removal during cardiothoracic surgery. We
estimate the total addressable market for DrugSorb-ATR to remove
ticagrelor, apixaban, and rivaroxaban during cardiothoracic surgery
is more than $500 million in the U.S.
alone today, which is expected to significantly increase based on
prescribing trends and generic availability of these drugs."
Apixaban (Eliquis®, Bristol Myers Squibb/Pfizer) and
rivaroxaban (Xarelto®, Jansen/Johnson & Johnson) 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.
DrugSorb-ATR has the potential to address this major unmet medical
need.
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 critically ill COVID-19 patients with
imminent or confirmed respiratory failure. CytoSorbents'
technology has also been granted FDA Breakthrough Designation
for the removal of ticagrelor, rivaroxaban, and apixaban in a
cardiopulmonary bypass circuit during urgent cardiothoracic
surgery, and if FDA marketing approval is obtained, would be
marketed as DrugSorb-ATR™ in the United
States.
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
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