CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment
of life-threatening conditions in the intensive care unit and
cardiac surgery using blood purification via its proprietary
polymer adsorption technology, reports on excellent outcomes from a
groundbreaking randomized controlled trial (RCT) using CytoSorb®
blood purification during heart transplant, recently published in
the European Society of Cardiology journal, ESC Heart Failure.
As co-lead authors Drs. Endre Németh and Adam
Soltesz from the Heart and Vascular Center at Semmelweis
University, Budapest, Hungary explain, as more complex and higher
risk patients become eligible for heart transplant, so does the
risk of serious complications such as multiple organ failure, that
not only is the second leading cause of death following heart
transplant, but results in high costs due to protracted ICU and
hospital stays. In particular, vasoplegic syndrome (VS), a form of
circulatory failure or shock, is routinely seen in these patients
and can cause worsened organ failure. In a prior observational
study, CytoSorb was associated with the reduced severity of
vasoplegia in heart transplant patients, in addition to other
clinical benefits.
In this prospective, single-center, open-label
RCT, 60 heart transplant recipients were randomly assigned to
either receive intraoperative CytoSorb hemoadsorption or standard
of care. Key statistically significant findings of the study were
that the CytoSorb group, compared to the control group, had:
- Better hemodynamic stability and lower rates of
post-operative shock
- Patients in the CytoSorb group had lower median
Vasoactive-Inotropic Scores (27.2 [14.6–47.7] vs. 41.9 [22.4–63.2],
p=0.046) and Vasoplegic Syndrome rates (20.0% vs 48.0% control,
p=0.028)
- The odds of early Vasoplegic Syndrome were 6.4 times lower in
the CytoSorb group (p=0.029).
- Shorter median time on mechanical ventilation
- 25 [19–68.8] hours vs. 65 [23–287] hours in control,
p=0.025
- Lower rates of acute kidney injury (AKI) and need for
renal replacement therapy (RRT)
- AKI: 36.7% vs. 76.0% control, p=0.004
- Renal replacement therapy: 0% vs. 16.0% control, p=0.037
- Shorter median time in the ICU
- 8.5 [8.0–10.3] days vs. 12 [8.5–18.0] days in control,
p=0.022
- No relevant removal of the anti-rejection drug
mycophenolic acid (MPA)
- Similar rates of cardiac allograft rejection, 30-day
mortality, and 1-year survival between groups
- There were no reported device-related adverse events
during the study period
Dr. Daniel Wendt, Vice President Medical –
Cardiovascular at CytoSorbents stated, "Over the years,
cardiothoracic surgeons have repeatedly observed the benefits of
intraoperative CytoSorb blood purification in improved hemodynamic
stability, reduced incidence and severity of vasoplegic shock,
decreased incidence of organ dysfunction, reduced inflammatory
responses, and favorable post-operative outcomes. Now, Nemeth,
Soltesz, and colleagues have confirmed many of these observations
in this rigorous and well-designed groundbreaking randomized
controlled trial in orthotopic heart transplant patients. These
vital and statistically significant clinical
outcomes highlight the critical importance of CytoSorb in
cardiothoracic surgery and are expected to be a catalyst for
continued adoption, usage, and reimbursement in this arena. Also,
on the heels of recent positive data in lung transplant using
CytoSorb, these results continue to advance our pioneering role in
the field of solid organ transplant in general."
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 antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. At the end of Q3 2023, more than 221,000 CytoSorb devices
had 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
completed the FDA-approved, randomized, controlled STAR-T (Safe and
Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at
approximately 30 centers in U.S. and Canada to evaluate whether
intraoperative use of DrugSorb-ATR can reduce the perioperative
risk of bleeding in patients receiving ticagrelor and undergoing
cardiothoracic surgery. This pivotal study is intended to support
U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in
this application.
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 $50 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™, 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 X (fka 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, statements about potential exposures
resulting from our cash positions, 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, 2023, 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
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or otherwise, other than as required under the Federal securities
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U.S. Company Contact:Kathleen Bloch, CFO305
College Road EastPrinceton, NJ 08540+1 (732) 398-5429
kbloch@cytosorbents.com
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