90-day survival was 74% overall, with early
intervention with ECMO and CytoSorb associated with improved
survival, and shorter duration on ECMO, mechanical ventilation, and
ICU stay compared to late intervention
PRINCETON, N.J., Nov. 2, 2022
/PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a
leader in the treatment of life-threatening conditions in the
intensive care unit and cardiac surgery using its CytoSorb® blood
purification technology, announced the presentation of the final
key results from the U.S. multicenter CytoSorb Therapy in
COVID-19 (CTC) Registry at the 35th Annual Congress of the
European Society of Intensive Care Medicine (ESICM) in Paris last week. CytoSorb was granted
U.S. FDA Emergency Use Authorization (EUA) in April 2020 for use in adult, critically ill
COVID-19 patients with imminent or confirmed respiratory failure to
reduce cytokines and other inflammatory toxins that can cause
hyperinflammation. Severe hyperinflammation is strongly
correlated with more severe COVID-19 illness, need for mechanical
ventilation, and risk of death.
Enhanced lung rest with CytoSorb+ECMO
yields high survival among sickest COVID-19 patients with
refractory lung failure
The CTC registry captured outcomes data on 100 critically ill
hyper-inflamed COVID-19 patients with severe acute respiratory
distress syndrome (ARDS) and refractory respiratory failure who
were treated with an "Enhanced Lung Rest" strategy using CytoSorb
and extracorporeal membrane oxygenation (ECMO) at five major U.S.
ECMO centers. ECMO helps to rest the lungs and avoid
ventilator-induced lung injury (VILI) by pumping blood and
conducting gas exchange outside of the body, and reducing or
eliminating the need for mechanical ventilation. CytoSorb® is
easily installed into the ECMO circuit and actively removes a broad
range of cytokines and other inflammatory toxins from the
bloodstream that can cause blood vessel injury and capillary leak
syndrome – a key pathology in ARDS that results in pulmonary edema,
severely compromised gas exchange, and unrelenting damage to the
lungs. The goal of this "Enhanced Lung Rest" strategy is to
allow the lungs to rest and heal, which we believe is the key to
reversing ARDS, getting patients off of ECMO and mechanical
ventilation, and ultimately to survive.
Primary Outcome: Survival
- In 100 patients treated with CytoSorb and ECMO at 5 U.S.
centers, survival was 86% at 30 days and 74% at 90 days. For
context, the International Extracorporeal Life Support Organization
(ELSO) COVID-19 registry, reported survival of 52% at 90 days in
the North American cohort (11/2/22, n=9,509)
Secondary analyses:
- CytoSorb was initiated significantly earlier following ICU
admission in survivors compared with non-survivors: 64
(34-151) vs. 151(44-260) hours, p=0.007*
- Compared to non-survivors, survivors had significantly lower
levels of inflammatory mediators after 3 days of CytoSorb
treatment, such as CRP: 6.9 (2.1-11.0) vs 9.5 (6.0-17.1) mg/dL,
p=0.04, and ferritin: 743.0 (339.5-1237.0) vs 1,622.0
(986.0-3411.0) ng/mL, p=0.0002, and required less time on ECMO: 302
(161-932) vs. 630 (268-1187) hours, p=0.04*
- Among survivors, those where CytoSorb was initiated early
before the median start time of ≤ 86.7 hours after ICU admission,
had a trend to improved survival (78% early vs 62% late, p=0.08)
and significantly shorter average duration on ECMO (532.76 ± 533.05
vs. 800.74 ± 701.67 hours; p=0.021). Time on mechanical
ventilation [167 (43-597) vs. 321 (67-909) hours, p=0.045] and time
to ICU discharge [17 (10 – 40) vs. 36 (19 – 55) days, p=0.002] were
also significantly reduced in patients treated earlier*
- Combined ECMO and CytoSorb treatment was performed with no
device related adverse events reported by any of the centers
* Values represented as median (interquartile range)
Dr. J.W. Awori Hayanga, MD, MPH, FACS, FRCS, FCCP, Professor in
Cardiovascular & Thoracic Surgery and Director of the ECMO
program at West Virginia University
School of Medicine, led a team of investigators from 5 U.S.
academic institutions to implement the strategy of "enhanced lung
rest" in this population. Dr. Hayanga commented, "We are
pleased with the very favorable survival rates that we observed in
the CTC Registry among the sickest possible COVID-19 patients that
are on life support with ECMO. These results suggest that
hyperinflammation plays a critical role in the severity of
respiratory failure in patients with ARDS and support the strategy
of integrating CytoSorb with ECMO to simultaneously rest and heal
the lungs. This multicenter dataset is very exciting and sets the
stage for further investigation into this novel approach to treat
severe ARDS."
Dr. Joerg Scheier, Vice
President, Medical Affairs - Critical Care at CytoSorbents
commented, "These compelling results support the concept of
improved lung protection and recovery with CytoSorb in combination
with veno-venous ECMO treatment. We see from the data that,
very similar to other CytoSorb application fields, early initiation
of CytoSorb therapy seems to be a key to positive treatment
outcomes. Overall, these very positive results on
ECMO-integrated CytoSorb therapy support the further evaluation of
the promising and safe approach of "enhanced lung rest" by the
combination of ECMO and CytoSorb in the treatment of ARDS."
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "This is the largest multicenter
case series using CytoSorb with ECMO in critically ill COVID-19
patients in the world to date. It highlights that when
CytoSorb is used in the right patients, at the right time, with the
right dose, the outcomes are excellent and reproducible among
different centers. Specifically, we targeted early
intervention with CytoSorb and ECMO in COVID-19 patients with
hyperinflammation who developed refractory respiratory failure and
severe ARDS and rapidly failed mechanical ventilation, and who did
not yet have fulminant thromboembolic disease as measured by
D-dimers. These criteria were based upon knowledge gained
from the CytoSorb-ECMO user community around the world during the
rapidly evolving pandemic, most of whom have had years of
experience integrating the two therapies together to treat
non-COVID ARDS, our own insights, and those from our former Chief
Medical Officer and pioneer of ECMO, Dr. Robert Bartlett. We are grateful to have
had the opportunity to positively impact the lives of critically
ill COVID patients here in the U.S. under FDA EUA and those around
the world and look forward to advancing this concept of "enhanced
lung rest" for the primary treatment of moderate to severe ARDS in
the future."
About CytoSorb FDA Emergency Use Authorization
In April 2020, the United States
Food and Drug Administration (FDA) granted Emergency Use
Authorization (EUA) to CytoSorb® for use in patients with COVID-19
infection. The EUA allows CytoSorb to be commercially sold
to, and used in, all hospitals in the
United States for use in patients, 18 years of age or older,
with confirmed COVID-19 infection who are admitted to the intensive
care unit (ICU) with confirmed or imminent respiratory failure who
have either severe disease, early acute lung injury or acute
respiratory distress syndrome (ARDS), or life-threatening illness
resulting in respiratory failure, septic shock, and/or multiple
organ dysfunction or failure. As with all EUA therapies, the
CytoSorb device has neither been cleared nor approved for the
indication to treat patients with COVID-19 Infection. The EUA
will be effective until the declaration, that circumstances exist
justifying the authorization of the emergency use of the CytoSorb
device during the COVID-19 pandemic, is terminated under section
564(B)(2) of the Act, or the EUA is revoked under section 564(g) of
the Act.
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 lead product,
CytoSorb®, is approved in the European Union and distributed in 75
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to postoperative complications, including multiple organ
failure. As of June 30, 2022,
more than 179,000 CytoSorb devices have been used
cumulatively. CytoSorb was originally launched in the
European Union under CE mark as the first cytokine adsorber.
Additional CE mark extensions were granted for bilirubin and
myoglobin removal in clinical conditions such as liver disease and
trauma, respectively, and for ticagrelor and rivaroxaban removal in
cardiothoracic surgery procedures. CytoSorb has also received
FDA Emergency Use Authorization in the
United States for use in adult critically ill COVID-19
patients with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA Breakthrough
Device Designations, one for the removal of ticagrelor and another
for the removal of the direct oral anticoagulants (DOAC) apixaban
and rivaroxaban in a cardiopulmonary bypass circuit during urgent
cardiothoracic procedures. The company has initiated two
FDA-approved pivotal studies to support FDA marketing approval of
DrugSorb-ATR in the United States. The first is the
randomized, controlled STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate
whether intraoperative use of DrugSorb-ATR can reduce the
perioperative risk of bleeding in patients receiving ticagrelor and
undergoing cardiothoracic surgery. The second study is the
STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral
Anticoagulants) randomized, controlled trial of 120 patients at 30
centers evaluating the intraoperative use of DrugSorb-ATR to reduce
perioperative bleeding risk in patients undergoing cardiothoracic
surgery and taking 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 approximately
$48 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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CytoSorbents Corporation U.S. Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
CytoSorbents Europe GmbH Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
European Public Relations Contact:
Marcus Schult
commponists
+49 69 13823 extension 960
+49 172 4238938
marcus.schult@die-kommponisten.com
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