Readout of topline results expected before
year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage
for potential regulatory submission to FDA and Health Canada as the
first reversal agent for the blood thinner,
Brilinta®
PRINCETON, N.J., Aug. 14,
2023 /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 it has completed the pivotal STAR-T (Safe and
Timely Antithrombotic Removal –
Ticagrelor) randomized, controlled trial, following the last
scheduled patient follow-up. The STAR-T trial is evaluating
the ability of DrugSorb®-ATR to reduce perioperative bleeding due
to the widely-used blood thinner, ticagrelor (Brilinta®,
AstraZeneca) in patients undergoing cardiothoracic surgery.
Readout of topline results expected before
year-end on FDA Breakthrough Device, DrugSorb-ATR.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "We are very pleased to complete all patient
related procedures in the STAR-T trial without a single study
subject lost to follow-up. This is another critical step of
the process delivered on time and with 100% success. We are
focused on ensuring complete and high-quality study data
collection, ultimately leading to database lock and triggering the
statistical analyses that will provide the readouts of the
trial. We continue to expect topline results by the end of
the year."
Brilinta® is one of the leading "blood thinners" used as part of
dual-antiplatelet therapy in patients suspected of having a heart
attack. However, in the up to 10% of patients that are not
eligible for a cardiac stent and now require coronary artery bypass
graft (CABG) surgery, Brilinta confers a risk of major fatal or
life-threatening CABG-related bleeding as high as 50-65%,
particularly if the surgery is performed within the first five days
of receiving the drug. Waiting in the hospital to wash out
the drug is the only acceptable alternative, but comes at high cost
and potential clinical risk. The goal of using 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 from blood during the surgery when installed in
the heart-lung machine. DrugSorb-ATR has received FDA
Breakthrough Device Designation for this indication. The STAR-T
pivotal study was conducted by many 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 flagship
product, CytoSorb®, is approved in the European Union, distributed
in 75 countries worldwide, and has accumulated more than 212,000
human treatments to date, to reduce "cytokine storm" and other
toxins that can cause organ failure. The DrugSorb™-ATR
antithrombotic removal system, based on the same polymer technology
as CytoSorb, has received two U.S. FDA Breakthrough Device
Designations to remove two separate blood thinners during
cardiothoracic surgery, including ticagrelor and the direct
oral anticoagulants (DOAC) apixaban and rivaroxaban, and
is undergoing pivotal clinical studies. 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.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
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SOURCE CytoSorbents Corporation