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 it has completed enrollment
of the pivotal
Safe and
Timely
Antithrombotic
Removal –
Ticagrelor (
STAR-T) randomized,
controlled trial, evaluating the ability of DrugSorb®-ATR to reduce
perioperative bleeding in patients undergoing cardiothoracic
surgery on ticagrelor.
The STAR-T trial Principal Investigators, Drs.
Michael Mack, C. Michael Gibson, and Richard Whitlock, commented in
a joint statement, “We want to thank all participating
investigators and their research teams for their commitment and
dedication that helped STAR-T complete enrollment ahead
of projections. Ticagrelor (Brilinta®, AstraZeneca) is used
widely in the U.S. and Canada and we routinely encounter patients
on ticagrelor who require cardiothoracic surgery. Currently,
because of the high risk of bleeding complications in these
patients, we delay surgery for multiple days until the ticagrelor
effect is worn off which carries the risk that these patients
suffer a complication while waiting, but also significantly
increases the length and cost of their hospitalization. The
surgical community is in urgent need of a solution that allows the
safe and timely treatment of these high-risk patients. We look
forward to the results of STAR-T which we plan to present at a
major international cardiovascular conference in early 2024 and
remain committed to lead further trials investigating drug removal
by DrugSorb-ATR of additional antithrombotic agents, such as the
direct oral anticoagulants apixaban (Eliquis®, Bristol-Myers
Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) that are
among the most widely prescribed medications in the world.”
Dr. Efthymios N. Deliargyris, Chief Medical
Officer of CytoSorbents stated, “We are very pleased to deliver
STAR-T across the finish line ahead of schedule. The fast
enrollment pace was the direct result of the high frequency that
eligible patients presented at our participating sites validating
the large size of the unmet need. With this major milestone
achieved, our attention now turns to completion of data collection
and study closeout activities ahead of the final results. With our
clinical operations capabilities now fully in place we look forward
to executing the next round of trials, including STAR-D,
investigating the expansion of antithrombotic drug removal to
additional agents and hospital wide applications beyond cardiac
surgery.”
The STAR-T randomized, controlled trial is a
pivotal study being conducted in both the U.S. and Canada that is
designed to evaluate the ability of DrugSorb-ATR® to reduce
perioperative bleeding by removing the antithrombotic agent,
ticagrelor (Brilinta®, AstraZeneca) in patients undergoing
cardiothoracic surgery. Brilinta is one of the leading “blood
thinners” used as part of dual-antiplatelet therapy in patients
suspected of having a heart attack. But if the patient is one of
the up to 10% that need to undergo coronary artery bypass graft
(CABG) or other open heart surgery, the risk of major fatal or
life-threatening CABG-related bleeding can be as high as 50-65%,
particularly if the surgery is performed within several days of the
last Brilinta dose. Waiting in the hospital to wash out the drug is
the only acceptable alternative, but this comes at high cost and
potential clinical risk. The goal of DrugSorb-ATR is to allow
patients to get the critical surgery they need without delay, while
reducing or preventing this bleeding risk by actively removing the
drug during the surgery. DrugSorb-ATR has received FDA Breakthrough
Device Designation for this indication. The STAR-T pivotal study is
being conducted by many of the leading cardiothoracic surgery
centers in North America and is intended to support U.S. FDA and
Health Canada marketing approval for DrugSorb-ATR in this
application.
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader in the
treatment of life-threatening conditions in the intensive care unit
and in cardiac surgery through blood purification. Its lead
product, CytoSorb®, is approved in the European Union and
distributed in 75 countries worldwide. It is an extracorporeal
cytokine adsorber that reduces "cytokine storm" or "cytokine
release syndrome" in common critical illnesses that can lead to
massive inflammation, organ failure and patient death. In these
diseases, the risk of death can be extremely high, and there are
few, if any, effective treatments. CytoSorb is also used during and
after cardiothoracic surgery to remove antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. At the end of Q1 2023, more than 203,000 CytoSorb devices
had been used cumulatively. CytoSorb was originally launched in the
European Union under CE mark as the first cytokine adsorber.
Additional CE mark extensions were granted for bilirubin and
myoglobin removal in clinical conditions such as liver disease and
trauma, respectively, and for ticagrelor and rivaroxaban removal in
cardiothoracic surgery procedures. CytoSorb has also received FDA
Emergency Use Authorization in the United States for use in adult
critically ill COVID-19 patients with impending or confirmed
respiratory failure. The DrugSorb™-ATR antithrombotic removal
system, based on the same polymer technology as CytoSorb, also
received two FDA Breakthrough Device Designations, one for the
removal of ticagrelor and another for the removal of the direct
oral anticoagulants (DOAC) apixaban and rivaroxaban in a
cardiopulmonary bypass circuit during urgent cardiothoracic
procedures. The Company is currently conducting the FDA and Health
Canada-approved, randomized, controlled STAR-T (Safe and Timely
Antithrombotic Removal-Ticagrelor) study in U.S. and Canada to
evaluate whether intraoperative use of DrugSorb-ATR can reduce the
perioperative risk of bleeding in patients receiving ticagrelor and
undergoing cardiothoracic surgery. This pivotal study is intended
to support U.S. FDA and Health Canada marketing approval for
DrugSorb-ATR in this application.
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
approximately $48 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, statements about potential exposures
resulting from our cash positions, 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, 2023, 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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CytoSorbents Contact: Kathleen Bloch Interim
Chief Financial Officer(732) 398-5429 kbloch@cytosorbents.com
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