MONMOUTH
JUNCTION, N.J., March 17,
2022 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac
surgery using blood purification, announced that the Company
will participate in the 41st International Symposium on Intensive
Care and Emergency Medicine (ISICEM 2022) Congress in Brussels, Belgium being held March 22-25, 2022. CytoSorbents is a
platinum sponsor of the Congress and will have a strong contingent
of sales, marketing, and medical affairs personnel in
attendance.
CytoSorbents Highlights Activities at the
41st International Symposium on Intensive Care and Emergency
Medicine (ISICEM)
Importantly, new data from the CytoSorb Therapy in
COVID-19 (CTC) Multicenter Registry will be presented
on Tuesday, March 22, 2022, in an
abstract titled: Relationship of Lung Oxygenation to Timing of
Hemoadsorption Therapy Initiation in COVID-19 Patients Requiring
Extracorporeal Mechanical Oxygenation (ECMO): An Observational
Analysis from the CytoSorb Therapy in COVID-19 (CTC) Registry.
This new analysis on 56 critically ill COVID-19 patients on life
support with ECMO and treated with CytoSorb under FDA Emergency Use
Authorization (EUA) provides additional insights into the
mechanisms underlying the high survival rates published in the
journal, Frontiers in Medicine, last year.
The CTC Registry has now completed enrollment after reaching the
milestone of 100 critically ill COVID-19 patients enrolled with
refractory respiratory failure on both CytoSorb and
ECMO. Top-line results from these 100 patients confirm the
high survival rates reported previously on the first 52 patients,
and are expected to be presented and published in detail later this
year.
CytoSorbents will also hold an onsite educational symposium and
virtual webinar entitled Hemoadsorption with CytoSorb as
Part of an Individualized Therapy in Critically Ill
Patients on Thursday, March 24,
2022, from 12:30-1:30 PM CET
in the Copper Hall.
Chair
Prof. Manu
Malbrain (Leuven, Belgium) and Dr.
Yatin Mehta (Chairman, Institute
of Critical Care and Anesthesiology, India)
Speakers
Dr. Axel
Nierhaus (University Medical Center
Hamburg-Eppendorf, Germany)
How to Balance Sepsis
Campaign Guidelines and the Need for Patient Tailored Care?
Dr. Gabriella Bottari
(Bambino Gesù Children's Hospital, Rome, Italy)
Use of CytoSorb
in Different Pediatric Indications – an Overview
Prof. Dietmar Fries
(Medical University Innsbruck, Austria)
Hemoadsorption in
Severe Rhabdomyolysis and for Prevention of DOAC Associated
Bleeding Complications
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "We are pleased to be able to
sponsor and actively participate in next week's ISICEM scientific
meeting, one of the first major in-person medical conferences for
us this year. It is a sign that business activities are
starting to slowly return to normal. We are excited to be
meeting with key opinion leaders, customers, and partners from the
global medical community to communicate our progress, and to share
our latest experiences and clinical data with them, using CytoSorb
in a diverse set of critical care applications. We encourage
attendees to visit our exhibit booth and attend our educational
symposium on March 24, 2022."
About U.S. FDA Emergency Use Authorization
CytoSorb
received U.S. FDA EUA in April 2020
for use in adult, critically ill COVID-19 patients with confirmed
or imminent respiratory failure and is indicated to reduce
cytokines in these patients. It has neither been cleared nor
approved for the indication to treat patients with COVID-19
infection. The CytoSorb device is authorized only for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of the CytoSorb device under
Section 564(b)(l) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
About the CTC Registry
CytoSorbents launched the
multicenter CTC Registry following the issuance of U.S. FDA
Emergency Use Authorization for CytoSorb therapy in adult,
critically ill COVID-19 patients with confirmed or imminent
respiratory failure in April 2020. The registry was designed
to capture high fidelity data on device utilization patterns and
associated clinical outcomes from participating U.S. centers with a
pre-specified primary endpoint of ICU mortality. The CTC
Registry has now completed enrollment after reaching the milestone
of 100 patients enrolled. For more information on the CTC
Registry, please view study number NCT04391920 on
www.clinicaltrials.gov.
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 more than 70 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 162,000 cumulative CytoSorb devices have
been utilized as of December 31,
2021. 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 has
initiated 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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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
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SOURCE CytoSorbents Corporation