MONMOUTH JUNCTION, N.J.,
Sept. 1, 2021 /PRNewswire/ --
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the
treatment of life-threatening conditions in intensive care and
cardiac surgery using blood purification, announced that
topline results from its CytoSorb Therapy
in COVID-19 (CTC) multicenter registry were
presented at the 40th International Symposium on
Intensive Care and Emergency Medicine (ISICEM 2021) in
Brussels, Belgium yesterday.
The CTC Registry included 52 consecutive critically ill
COVID-19 patients with refractory acute respiratory distress
syndrome (ARDS) on life support with ECMO and
CytoSorb enrolled at 5 U.S. medical centers under FDA
Emergency Use Authorization (EUA). The primary outcome of
90-day ICU mortality was 27% in the CTC Registry. For
context, the 90-day mortality in the North American cohort of the
international Extracorporeal Life Support Organization (ELSO)
COVID-19 ECMO Registry that includes more than 4,600 adult
patients was 50%1. Importantly, all 5 centers
participating in the CTC registry reported that
CytoSorb was easily integrated in the ECMO circuit and
well-tolerated, with no unanticipated device-related adverse
events.
Topline Results from U.S. CTC Registry Show High Survival using
CytoSorb® in Critically Ill COVID-19 Patients on ECMO
CytoSorb received FDA Emergency Use Authorization in
April 2020 for use in critically ill
COVID-19 patients, 18 years of age or older with confirmed or
imminent respiratory failure to reduce pro-inflammatory cytokine
levels, and can be used with a wide range of blood pumps, including
ECMO. ECMO is a machine that pumps and oxygenates blood
outside of the body, reducing the dependence on the lungs for gas
exchange, and allowing mechanical ventilator settings to be lowered
to prevent ventilator-induced lung injury. The CTC Registry
inclusion criteria required that CytoSorb use adhere strictly to
the patient selection criteria and device use guidelines outlined
by the EUA, including standardized training and treatment schedules
with CytoSorb, thereby providing high fidelity evidence in a
relatively uniform study population. Highlights from the
presentation included:
- Overall demographics and comorbidities of the CTC cohort were
comparable to the ELSO Registry cohort with the exception of higher
rates of obesity in the U.S. CTC cohort, a recognized risk factor
for death in COVID-19
- Primary outcome of 90-day ICU mortality was 26.9% from the
initiation of CytoSorb treatment, well below the 50% reported in
the North American cohort of the ELSO registry
- Rates of ICU discharge and recovery exceeded ICU mortality
rates throughout the follow-up period. All patients discharged
alive from the ICU also survived to hospital discharge
- CytoSorb treatment led to a decrease in elevated baseline
inflammatory biomarkers
- Survival was associated with earlier initiation of CytoSorb
therapy, lower baseline D-dimer levels, and a lower baseline
Sequential Organ Failure Assessment (SOFA) score
- Very high baseline D-dimer levels (breakdown products of blood
clots) were associated with a potential increased risk of death by
logistic regression analysis. This is consistent with published
literature on D-dimers and the associated increased risk of severe
disease and death in COVID-19 patients, presumably due to the
consequences of high blood clot burden, including respiratory
failure caused by pulmonary emboli, and diffuse tissue and vital
organ ischemic injury caused by thrombotic microangiopathy
- CytoSorb demonstrated no unanticipated device-related adverse
events
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "We are encouraged by the topline CTC Registry
results presented at ISICEM, particularly the favorable safety
profile of CytoSorb when used as an adjunct therapy in the highest
risk COVID-19 patients requiring life support with ECMO and by the
high survival rates observed that compare favorably to the global
experience with ECMO alone captured in real time by the ELSO
COVID-19 Registry. The CTC Registry has important strengths
including: uniform profile of included patients, standardized
training and instructions for device use, and most importantly a
multicenter design that underscores the external validity and
generalizability of the results. Intensive care teams around
the world continue to use CytoSorb in their critically ill COVID-19
patients based on the observed benefits in their own patients.
The CTC results bolsters their observations and reinforces
that CytoSorb may be a safe, potentially life-saving adjunct
therapy in selected COVID-19 patients on ECMO with confirmed
respiratory failure."
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "ECMO was pioneered by our former
Chief Medical Officer, Dr. Robert
Bartlett, and has been used broadly around the world during
the COVID-19 pandemic to rescue patients whose lung injury is so
severe that standard mechanical ventilation fails. These are
the sickest of COVID-19 patients and without ECMO, these patients
would normally die. Using ECMO alone to achieve gas exchange
and lung rest, the ELSO registry demonstrates that approximately
half of these patients survive. We believe the early use of
CytoSorb with ECMO can augment this lung-rest strategy by reducing
circulating inflammatory cytokines and other factors that cause
ongoing lung injury, with the goal of promoting lung rest and
healing. This is a prerequisite to weaning patients off of
mechanical ventilation and ECMO, and ultimately surviving.
The CTC registry data support this concept and demonstrate
enhanced survival compared to ECMO alone, as reported by ELSO.
We believe these results give us a blueprint on how to expand
the use of CytoSorb with ECMO for the treatment of severe lung
injury and ARDS around the world during the COVID-19 pandemic
and beyond."
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.
After one year, the registry enrolled 52 consecutive ECMO
patients from 5 U.S. medical centers comprising the current cohort.
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 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.
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
1 ELSO COVID-19 ECMO Registry,
www.elso.org/Registry/FullCOVID19RegistryDashboard.aspx, accessed
8/31/21.
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