MONMOUTH
JUNCTION, N.J., April 28,
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 10th EuroELSO Congress (EuroELSO
2022) in London, UK being held
May 4-6, 2022, one of the two major
conferences for ECMO (extracorporeal membrane
oxygenation) users worldwide. CytoSorbents is
highlighting the strategy of "enhanced lung rest" using CytoSorb
with ECMO to help treat acute respiratory distress syndrome (ARDS)
and lung failure – both major causes of death in ICU patients.
CytoSorbents Highlights "Enhanced Lung
Rest" Strategy Using CytoSorb + ECMO to Help Treat Lung Failure at
EuroELSO 2022
New clinical data from 56 critically ill COVID-19 patients with
refractory respiratory failure on life support with ECMO and
treated with CytoSorb under FDA Emergency Use Authorization
(EUA) from the U.S. CTC Registry will be presented on
Thursday, May 5, 2022, in an abstract
presentation titled: ECMO Utilization with Adjunctive
Hemoadsorption Therapy in COVID-19 Patients: An Observational
Analysis from the CytoSorb Therapy in COVID-19 (CTC)
Registry. This new analysis supports the importance of
early intervention with CytoSorb and ECMO in treating patients with
COVID-related ARDS, and its potential role in the high observed
survival of 52 patients in an earlier analysis of the registry,
published in the peer-reviewed journal, Frontiers in
Medicine, last year.
CytoSorbents is a platinum sponsor of the Congress and will also
host an onsite educational symposium which will be livestreamed on
the EuroELSO website, entitled "ECMO plus CytoSorb – Are We
Doing It Right?" on Thursday, May 5,
2022, from 12:45-1:45 PM CET
in the St. James room (see detail below).
Chairs
Prof. Roberto
Lorusso (Deputy Director, Department of Cardio-Thoracic
Surgery Heart and Vascular Centre, Maastricht
University Medical Centre, The
Netherlands) and Prof. Federico Pappalardo (Director of Cardiothoracic
and Vascular Anesthesia and Intensive Care, National Hospital
Allesandria, Italy)
Speakers
Dr. J.W. Awori Hayanga (Professor of
Cardiovascular and Thoracic Surgery and ECMO Program Director at
the Heart and Vascular Institute, West
Virginia University School of Medicine, Morgantown, USA)
CytoSorb + ECMO in COVID-19:
Latest Results from the Multicenter CTC Registry
Dr. Endre Németh (Consultant in Anesthesia and Intensive
Therapy and Associate Professor, Semmelweis University,
Budapest, Hungary)
Use
of CytoSorb and VA-ECMO- a Retrospective Study
Dr. med. Ali Akil (Consultant
at Department of Thoracic Surgery and Lung Support, Klinikum
Ibbenbueren, Ibbenbueren, Germany)
One Size does Not Fit All –
A Patient Tailored Therapy is the Key to Success
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "We are pioneering a new way to
treat ARDS and refractory respiratory failure using CytoSorb
with ECMO to achieve what we call "Enhanced Lung Rest". ECMO
enables gas exchange to happen outside the lungs, thereby reducing
damage to the lungs caused by mechanical ventilation, while
CytoSorb removes the circulating inflammatory toxins that cause
ongoing lung injury. Together, the early intervention with
ECMO and CytoSorb may help the lungs to rest, heal, and recover
faster, which is critical to getting patients off of life support
and out of the ICU and hospital alive. The data being
presented on CytoSorb and ECMO at EuroELSO are supportive of
this."
Dr. Chan continued, "More than 6 million people worldwide have
already died from complications of COVID-19 infection, where lung
injury, ARDS, and respiratory failure are among the most
common. Absent COVID-19, ARDS normally afflicts up to 10-15%
of ICU patients due to common everyday illnesses such as influenza
and bacterial pneumonia, sepsis, aspiration, trauma, and other
life-threatening conditions. Despite the best medical
treatment, which includes steroids, ARDS remains a very difficult
disease to treat, where roughly 3 in 10 patients will die. We
have learned much from the COVID-19 pandemic on how to successfully
use CytoSorb to help treat lung injury, with and without
ECMO. We plan to parlay these deep insights into attacking
yet another major unmet medical need in critical care, while
immediately driving a potentially significant growth application
for CytoSorb worldwide."
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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