MONMOUTH JUNCTION, N.J.,
Oct. 14, 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 today that the first
patient has been enrolled in the Safe and Timely
Antithrombotic Removal-Ticagrelor
(STAR–T) double-blind, randomized, controlled clinical trial
designed to support FDA marketing approval of the DrugSorb-ATR™
Antithrombotic Removal System for intraoperative removal of
ticagrelor during cardiothoracic surgery. The STAR-T trial
received full FDA IDE Approval in July
2021, and is being performed under the auspices of FDA
Breakthrough Designation granted in April 2020. The STAR-T
trial is expected to enroll up to 120 patients across 20 sites and
be completed by 2022. The first patient was enrolled by Dr.
Bradley S. Taylor, Chief of the
Division of Cardiac Surgery and Director of Coronary
Revascularization and site Principal Investigator at the
University of Maryland Medical
Center.
First Patient Enrolled in U.S. STAR-T Trial Evaluating
DrugSorb-ATR™ to Remove Ticagrelor During Cardiothoracic
Surgery
Dr. Bradley S. Taylor stated,
"Ticagrelor is an antiplatelet agent routinely used in the
management of patients with acute coronary syndrome to reduce the
risk of death, myocardial infarction, and stroke. However,
when urgent surgery is required, patients on ticagrelor are at very
high risk of serious and potentially fatal bleeding. We are
very pleased to enroll the first patient in the landmark STAR-T
study that is investigating the ability of DrugSorb-ATR™ to
remove ticagrelor during surgery and reduce the risk of bleeding in
these patients. If positive, STAR-T could
establish DrugSorb-ATR as an easily implemented solution that
addresses a long-standing, frequent, and critical unmet medical
need faced by cardiac surgery centers around the world."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "Removing antithrombotic agents
intraoperatively with the DrugSorb-ATR system in patients requiring
urgent cardiac surgery has the potential to save lives, reduce
morbidity and provide substantial cost savings to heart centers
around the world. The FDA approved STAR-T trial has now left
the station and we will work diligently to deliver on our stated
goal to finish the trial in 2022. Following the granting of a
second Breakthrough Designation for the removal of apixaban and
rivaroxaban, we recently received full FDA approval of our IDE
application to conduct the Safe and Timely
Antithrombotic Removal-Direct Oral
Anticoagulants (STAR-D) trial, a second, very similar study
that will leverage the existing infrastructure of STAR-T. We
anticipate fast study start-up and estimate that the first patient
will be enrolled early in 2022. The goal of both studies is
to gain FDA marketing approval for the most widely prescribed next
generation antiplatelet and anticoagulant agents and unlock an
estimated $1 billion U.S. market
opportunity."
In April 2020, the FDA granted
CytoSorbents Breakthrough Device Designation to remove ticagrelor
during cardiothoracic surgery, recognizing this major unmet medical
need. Each year, ticagrelor is prescribed to millions of
cardiovascular patients worldwide to reduce the risk of recurrent
heart attack, stroke, or cardiovascular death. Ticagrelor is
frequently preferred as first-line therapy in patients presenting
to hospitals with an acute coronary syndrome in preparation of
percutaneous coronary intervention (PCI) and stent placement.
However, up to 10% of these patients will require coronary artery
bypass graft (CABG) open heart surgery. As several clinical
studies, such as the PLATO trial, have shown, these patients face a
very high risk of severe or life-threatening perioperative
bleeding. CytoSorbents' CytoSorb® therapy is the only
treatment approved to remove ticagrelor during cardiopulmonary
bypass in the E.U. The DrugSorb-ATR™ Antithrombotic Removal
system is based on the same polymer technology as CytoSorb®.
If FDA marketing approval is obtained by the FDA, DrugSorb-ATR™
would be marketed in the United
States for ticagrelor removal during urgent cardiothoracic
surgery, with the intention of reducing the risk of bleeding.
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.
Please Click to Follow Us on Facebook and Twitter
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/first-patient-enrolled-in-us-star-t-pivotal-trial-evaluating-the-drugsorb-atr-antithrombotic-removal-system-to-remove-ticagrelor-during-cardiothoracic-surgery-301400119.html
SOURCE CytoSorbents Corporation