Stand-alone Blood Pump Business Model is
expected to Enable Expanded Use and Increased Adoption of
CytoSorb®
PRINCETON, N.J., June 1, 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 via its proprietary polymer
adsorption technology, today announced that following a
successful pilot program in three countries, the Company has signed
an expanded non-exclusive agreement with Nikkiso Europe GmbH
(Nikkiso) to distribute their PureADJUST stand-alone hemoperfusion
pump and accessories in a total of 14 countries.
In addition to securing the rights to sell Nikkiso's stand-alone
pump and accessories in Germany,
Austria, and Luxembourg, CytoSorbents has entered into an
expanded multi-country reseller agreement with Nikkiso covering the
following countries: Belgium,
Bosnia and Herzogovina,
Croatia, Finland, France, Iceland, Lichtenstein, Poland, Serbia, Slovenia and Switzerland. CytoSorbents
will also be able to provide field support services in these
countries.
Mr. Yoji Wakabayashi, Chief
Executive Officer of Nikkiso Europe GmbH commented, "We are pleased
to partner with CytoSorbents to make our PureADJUST equipment and
full range of consumables and accessories available to
CytoSorbents' customers in these additional countries.
PureADJUST's compact design, intuitive interface, and easy adsorber
set up is the ideal solution to provide an additional platform to
deliver CytoSorbents' industry-leading blood purification
technology. We look forward to collaborating with
CytoSorbents and growing our business worldwide together."
Dr. Christian Steiner, Executive
Vice President, Sales and Marketing of CytoSorbents added, "This
new business model unlocks a significant opportunity for us to
increase CytoSorb usage. Today, it is very easy to start
CytoSorb on critically ill patients who have developed kidney
failure and are already on dialysis or continuous renal replacement
therapy (CRRT). However, this accounts for only about 10% of
patients in the ICU, where kidney failure often occurs late in the
critical illness, resulting in delayed intervention with
CytoSorb. Our new stand-alone blood pump offering makes it
easy for physicians to start treatment with CytoSorb earlier, even
before patients develop kidney failure. Early start of the
therapy has been shown to be a key predictor of success and was
highlighted in a number of studies. We believe this will
result in more effective treatment, while significantly increasing
the number of patients who could benefit from our therapy."
Mr. Chris Cramer, Vice President
Business Development at CytoSorbents, stated, "We are excited to
partner with a globally recognized leader like Nikkiso to enable
our new stand-alone hemoperfusion pump business model. With
each PureADJUST machine placed at a customer account, we now have
the ability to drive additional usage of CytoSorb across the full
range of approved indications in the ICU. In the future, we
also believe that this business model will enable us to support
"hospital-wide" applications, such as in the emergency room,
surgery suites, and elsewhere."
Financial details of this agreement have not been disclosed.
About Nikkiso Medical
Nikkiso Medical is one of
the world's leading manufacturers of products for both acute and
chronic blood purification therapies. In 1967,
Nikkiso developed Japan's
first dialysis machine. Today, based on this time-proven
technology, Nikkiso is the world's second largest manufacturer
of dialysis machines and disposables and a market leader in
Europe and Asia. Trusted for superior quality and
reliability, over 100,000 Nikkiso devices for blood
purification therapies worldwide are currently used by customers
around the world. To learn more,
visit www.nikkisomedical.com.
About Nikkiso Co., LTD.
Founded in 1953,
Nikkiso has been a pioneer in creating and continuing to drive
the market for medical equipment for dialysis and healthcare
products, industrial special pumps and their system products, and
CFRP aircraft components. Nikkiso's products, which
are born from original concepts and sophisticated technologies,
demonstrate their power under harsh and socially valuable
environments in which "in the unlikely event" is unacceptable, and
are highly regarded by our customers. We at Nikkiso will
continue to develop our technological expertise and enhance our
manufacturing capabilities to meet the expectations of our
customers and the demands of society. To learn more, visit
www.nikkiso.com.
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 170,000 cumulative
CytoSorb devices have been utilized as of March 31, 2022. 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, 30 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, 30
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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