MONMOUTH JUNCTION, N.J.,
Sept. 14, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a leader in
the treatment of life-threatening conditions in intensive care and
cardiac surgery announces an upcoming live webinar to provide
a global perspective on CytoSorb® blood purification
therapy in COVID-19 patients on Thursday
September 16, 2021, at 11 a.m.
EDT / 5:00 p.m. CET. The
webinar will highlight a growing body of data from seven recently
published journal articles or presentations on the use of CytoSorb
in more than 215 critically ill COVID-19 patients worldwide,
including the recently announced topline results from the U.S.
multicenter CTC Registry using CytoSorb with ECMO under U.S. FDA
Emergency Use Authorization.
Live Webinar details:
Update on CytoSorb
Therapy in COVID-19 Patients
CytoSorbents' International Experts Meeting in Intensive Care
Series
Date: Thursday, September 16, 2021
Time: 11:00 a.m. Eastern / 5:00
p.m. CET
Registration Link: https://cyto.news/IEM-210916
Chairperson:
- Dr. Manu Shakar-Hari,
London/UK
Speakers:
- Dr. Tae Song, Chicago/USA
Topline results from the U.S.
CTC multicenter registry
- Dr. Zsolt
Molnár, Budapest/Hungary
Overview about
current studies and experiences
- Dr. Manu Shankar-Hari, London/UK
Multisystem inflammatory
syndrome
The session will conclude with a live, moderated Question and
Answer session.
Highlighted data to be presented are expected to
include:
- Topline results from the U.S. CytoSorb Therapy in COVID-19
(CTC) Registry, reporting 73% 90-day survival in 52 critically-ill
COVID-19 patients in refractory respiratory failure on ECMO and
CytoSorb under FDA Emergency Use Authorization at 5 U.S. ECMO
centers.1
- Consistently reported key clinical parameters including:
-
- Reductions of inflammatory marker levels, including IL-6, CRP
and ferritin (Ruiz-Rodriguez2, Alharthy3,
Nassiri4, Geraci5, Peng6, and
Wunderlich-Sperl7
- Improvements in hemodynamic stabilization and weaning of
vasopressors (Ruiz-Rodriguez, Nassiri, Peng, Wunderlich-Sperl)
- Improvements in the P/F ratio, considered to be one of the most
clinically relevant measures of lung function in ventilated
patients (Ruiz-Rodriguez, Alharthy, Peng, Wunderlich-Sperl)
- The importance of starting CytoSorb therapy in COVID-19
patients with confirmed respiratory failure, before they develop
irreversible organ injury. Intervening before fulminant
thrombotic ischemic injury has occurred, as evidenced by very high
baseline D-dimer levels appears to be particularly important.
Multiple studies have identified high D-dimers as a
significant risk factor for poor outcome and mortality in
critically ill COVID-19 patients, regardless of whether cytokine
adsorption is used or not.
Dr. Joerg Scheier, Vice President
of Medical and Clinical Affairs of CytoSorbents, stated, "We are
excited to see that the expanding numbers of positive clinical
experiences with CytoSorb in COVID-19 patients are now being
reflected by an increasing number of scientific peer review
publications from many different geographies. We believe the
ability to reduce inflammatory mediators in these patients is a key
reason that common clinical benefits are being reported in COVID-19
patients treated with CytoSorb. Finally, clinicians routinely
comment that CytoSorb is easy to use, irrespective of whether the
device is set up within a renal replacement, an extracorporeal
membrane oxygenation (ECMO), or a standalone circuit in
hemoperfusion mode. This has given physicians greater flexibility
in how and when they treat patients with CytoSorb."
Overall, CytoSorb has been used in more than 6,500 critically
ill COVID-19 patients in more than 30 countries worldwide to reduce
cytokine storm and other circulating inflammatory mediators with
the goals of reducing severe systemic hyper-inflammation and damage
to vital organs like the lungs, heart, and kidneys, while improving
the chances of survival.
References:
- Song, T et al., "CytoSorb Therapy in COVID-19 (CTC) Patients
Requiring Extracorporeal Membrane Oxygenation: A Multicenter,
Retrospective Registry." Intl Symposium on Intensive Care and
Emergency Medicine Presentation - August
2021
- Ruiz-Rodriguez JC, et al., "The Use of CytoSorb Therapy in
Critically Ill COVID-19 Patients: Review of the Rationale and
Current Clinical Experiences." Crit Care Res Pract.
2021
- Alharthy A, et al., "Continuous Renal Replacement Therapy with
the Addition of CytoSorb Cartridge in Critically Ill Patients with
COVID-19 Plus Acute Kidney Injury: A Case Series." Artificial
Organs. 2020
- Nassiri AA, et al., "Blood Purification with CytoSorb in
Critically Ill COVID-19 Patients: A Case Series of 26 Patients."
Artif Organs. 2021
- Geraci T, et al., "Hemoadsorption for Management of Patients on
Veno-Venous ECMO Support for Severe COVID-19 Acute Respiratory
Distress Syndrome." J. Cardiac Surg. 2021
- Peng JY, et al., "Hemoperfusion with CytoSorb in Critically Ill
COVID-19 Patients." Blood Purif. 2021
- Wunderlich-Sperl F, et al., "Adjuvant Hemoadsorption Therapy in
Patients with Severe COVID-19 and Related Organ Failure Requiring
CRRT or ECMO Therapy: A Case Series. Int J Artif Organs.
2021
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 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 cardiothoracic surgery
to remove inflammatory mediators that can lead to post-operative
complications, including multiple organ failure. More than
143,000 CytoSorb devices have been delivered 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 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 rivaroxaban and apixaban in a
cardiopulmonary bypass circuit during urgent cardiothoracic
surgery.
CytoSorb has been granted U.S. FDA Emergency Use Authorization
in the COVID-19 pandemic as an extracorporeal cytokine
adsorber for use in adult, critically ill COVID-19 patients with
imminent or confirmed respiratory failure. The CytoSorb
device 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.
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, anticipated future results
and performance, 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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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