CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment
of life-threatening conditions in the intensive care unit and
cardiac surgery using blood purification via its proprietary
polymer adsorption technology, today announces an update on the
initial data analysis of primary safety and effectiveness endpoints
and the final independent Data and Safety Monitoring Board (“DSMB”)
analysis for the pivotal U.S. and Canadian STAR-T
(
Safe and
Timely
Antithrombotic
Removal of
Ticagrelor) randomized controlled trial.
STAR-T is a double-blind, randomized,
controlled, multi-center pivotal trial that investigated the
ability of DrugSorb®-ATR to reduce perioperative bleeding in 140
enrolled patients on ticagrelor (Brilinta®, Brilique® -
AstraZeneca) undergoing cardiothoracic surgery before completing
the recommended washout period. Patients were randomized in a 1:1
ratio to receive either DrugSorb-ATR or a sham device during
cardiopulmonary bypass, with a primary composite effectiveness
endpoint measuring perioperative bleeding.
The independent DSMB met recently to perform the
final review of the full unblinded data on all 140 patients in the
STAR-T trial and concluded there were no issues with device safety,
meeting the primary safety endpoint of the study. The Company has
also performed the initial data analysis on the primary
effectiveness endpoint of STAR-T. Based on this analysis, the study
did not meet the primary effectiveness endpoint in the overall
patient population that underwent different types of cardiac
surgeries. However, the study did demonstrate evidence of reduced
bleeding complications in patients in the pre-specified isolated
coronary artery bypass graft (“CABG”) surgery population,
representing more than 90% of the overall study population.
The Company expects to complete the analysis of
the full trial results in the next several weeks. Pending this
final analysis, the Company believes the safety and effectiveness
data from STAR-T may support the regulatory submission of
DrugSorb-ATR to the U.S. FDA and Health Canada. Meanwhile, the
Company had previously submitted a promissory abstract to the
American College of Cardiology 2024 conference, triggering a
“silent” period for publicly discussing detailed study results. If
accepted, the full results of the STAR-T trial are expected to be
presented next April 2024 in Atlanta.
Dr. Efthymios N. Deliargyris, Chief Medical
Officer of CytoSorbents, stated, “We are encouraged that the use of
the DrugSorb-ATR device in this high-risk population was deemed
safe by the independent DSMB. Although the primary effectiveness
endpoint of the study was not met in the overall population, we
identified evidence of benefit of reduced bleeding complications in
patients undergoing isolated CABG surgery, including serious
bleeding events. This suggests a favorable benefit-to-risk profile
in this population that represents the vast majority of
ticagrelor-treated patients requiring cardiac surgery. Additional
analyses are ongoing and we look forward to sharing the detailed
results at a major medical conference in the near future.”
Dr. Irina Kulinets, Senior Vice President of
Global Regulatory of CytoSorbents, stated, “In the next several
weeks, we aim to complete the full data analysis of the
study that is intended to form the basis of anticipated
regulatory submissions. From a regulatory perspective, it is
important that DrugSorb-ATR successfully met the primary safety
endpoint of the study and has demonstrated clinical evidence of
effectiveness in the pre-specified isolated CABG subpopulation.
These data are supported by the successful real-world usage of
CytoSorb® for this same indication, as captured by our
International STAR Registry and as seen in multiple world markets
including Europe, Latin America, Middle East, and others. Although
we cannot predict how FDA will view our results, we are encouraged
that FDA has already granted Breakthrough Device Designation to
DrugSorb-ATR for this application, recognizing the problem as a
major unmet medical need that causes significant patient morbidity
and mortality and has no approved therapy in the U.S.”
Ticagrelor is one of the leading anti-thrombotic
drugs used as part of dual-antiplatelet therapy in patients with
acute coronary syndrome. However, up to 10% of these patients will
need to undergo CABG surgery and risk serious bleeding
complications if the surgery is performed within the first few days
from the last ticagrelor dose. Waiting in the hospital to washout
the drug over the span of 3-5 days is the only acceptable
alternative, but comes with potential clinical risk for
complications while waiting, and high additional hospital costs.
The goal of DrugSorb-ATR is to allow patients to safely get the
critical CABG surgery they need without requiring extensive drug
washout.
DrugSorb-ATR has been previously granted U.S.
FDA Breakthrough Device Designation, acknowledging that
perioperative bleeding in cardiac surgery due to ticagrelor is a
major unmet medical need. There are currently no approved or
cleared therapies for this unmet need in the U.S. or Canada.
Outside of the U.S. and Canada, only CytoSorb® is specifically
approved for this indication. The Breakthrough Devices
Program provides for more effective treatment of
life-threatening or irreversibly debilitating diseases or
conditions - in this case the need to reduce serious or
life-threatening perioperative bleeding due to ticagrelor in
emergent or urgent cardiac surgery. With Breakthrough Designation,
CytoSorbents intends to work with FDA to facilitate the regulatory
review of DrugSorb-ATR, while maintaining statutory standards of
regulatory approval (e.g., 510(k), de novo 510(k), or
premarket approval (PMA)) consistent with the Agency’s mission to
protect and promote public health.
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 Q3 2023, more than 221,000 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 has
completed the FDA-approved, randomized, controlled STAR-T (Safe and
Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at
approximately 30 centers 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 $50 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™, 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 X (fka 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 our preliminary
analysis and expectations with respect to the STAR-T clinical trial
results and our expectations regarding the content and timing of
sharing further detailed results in the future 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.
Please Click to Follow Us on
Facebook
and X (fka Twitter)
U.S. Company Contact:Kathleen Bloch, CFO305
College Road EastPrinceton, NJ 08540+1 (732)
398-5429kbloch@cytosorbents.com
CytoSorbents (NASDAQ:CTSO)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
CytoSorbents (NASDAQ:CTSO)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024