MONMOUTH JUNCTION, N.J.,
July 6, 2021 /PRNewswire/ --
CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval
of its Investigational Device Exemption (IDE) application to
conduct the pivotal STAR-T (Safe and Timely
Antithrombotic Removal – Ticagrelor)
double-blind, randomized, controlled trial (RCT) in the United States to support FDA regulatory
clearance. This study is being performed under the previously
announced FDA Breakthrough Designation granted for the removal of
ticagrelor in a cardiopulmonary bypass circuit during urgent and
emergent cardiothoracic surgery with CytoSorbents' proprietary
polymer adsorption technology.
CytoSorbents Receives Full FDA Approval to Commence STAR-T Trial in
the U.S., Expects Enrollment to Start this Summer
Efthymios Deliargyris, MD, Chief Medical Officer of
CytoSorbents stated, "We are pleased to announce the FDA has
granted full IDE approval for the randomized, controlled,
double-blind STAR-T trial designed to support regulatory clearance
of the newly designated DrugSorb-ATR™ Antithrombotic Removal system
for intraoperative ticagrelor removal during cardiothoracic
surgery. STAR-T will enroll up to 120 patients across
20 U.S. clinical sites and is expected to begin enrollment this
summer. The primary endpoint of the study will evaluate
whether the use of DrugSorb-ATR with standard of care in patients
on ticagrelor undergoing cardiothoracic surgery reduces the risk of
peri-operative bleeding complications compared to standard of care
alone. The trial will also evaluate reductions in ticagrelor
blood levels and a number of additional outcomes to capture the
full potential clinical and cost-economic benefits of DrugSorb-ATR.
We believe the study can be completed in 2022 based on the
high level of excitement and engagement we are seeing from
participating sites. Finally, we will continue to collaborate
closely with the FDA to leverage the priority review associated
with our ticagrelor removal application in the spirit of the
granted Breakthrough Designation."
Michael Mack, MD, Chair of
Cardiovascular Service Line at Baylor Scott & White Health,
President of Baylor Scott & White Research Institute, and
Principal Co-Investigator of the STAR-T study stated, "Performing
cardiac surgery in patients while on antithrombotic agents such as
ticagrelor is a major issue at every U.S. cardiac surgery center
due to the very high risk of perioperative bleeding. Such
bleeding is a major cause of morbidity, mortality and added costs,
and is a vexing patient management problem for cardiac surgeons
worldwide. Currently we have to either delay surgery until the
effects of the antithrombotic agent wear off, or if the patient
cannot wait due to the urgency of their condition, proceed with the
elevated bleeding risk. The STAR-T study will evaluate whether
intraoperative removal of ticagrelor with DrugSorb-ATR can safely
reduce bleeding complications. We designed the STAR-T trial with
the rigor of a randomized controlled trial to generate the highest
level of evidence to determine outcomes that will hopefully benefit
every heart center worldwide."
C. Michael Gibson, MD, Professor
of Medicine, Harvard Medical School and
President and Chief Executive Officer of the non-profit Baim
Institute (formerly Harvard Clinical Research Institute) and also
Principal Co-Investigator of STAR-T, stated, "The continuing
worldwide growth in the use of antithrombotic medications and the
numbers of patients who require surgery and are at risk of bleeding
while on them, continues to rise. DrugSorb-ATR is a novel,
easy-to-implement potential solution to this major clinical
problem. Evidence from real-world use of this technology in
Europe to remove antithrombotic
drugs during cardiac surgery suggests significant benefits to
patients due to reductions in perioperative bleeding with
substantial cost savings to hospitals. Should these same
results be confirmed in the STAR-T randomized controlled trial,
then DrugSorb-ATR could become the new global standard of care for
these challenging patients."
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, they 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 cleared by the FDA,
DrugSorb-ATR™ would be marketed in the
United States for ticagrelor removal in a cardiopulmonary
bypass circuit during cardiothoracic surgery. The product
name reflects the intended premium indication of ticagrelor removal
in the U.S. and is consistent with our future goal of expanding the
U.S. label to remove other antithrombotic agents.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit 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 cardiac surgery to remove inflammatory mediators
that can lead to post-operative complications, including multiple
organ failure. CytoSorb has been used in more than 131,000
human treatments 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 in a
cardiopulmonary bypass circuit during emergent and urgent
cardiothoracic surgery, and if FDA clearance 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, 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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CytoSorbents
Investor Relations Contact: Terri Anne Powers
Vice President of
Investor Relations and Corporate Communications
732-482-9984
tpowers@cytosorbents.com
|
Public Relations
Contact:
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Rubenstein Public
Relations
212-805-3052
ekim@rubensteinpr.com
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