Agreement brings innovative anti-inflammatory treatment to
cardiac surgery teams in six European countries
ANN ARBOR, Michigan and
MONMOUTH JUNCTION, New Jersey,
Sept. 12, 2016 /PRNewswire/
-- Terumo Cardiovascular Group, a global leader in medical
devices for cardiac and vascular surgery and subsidiary of
Japan-based Terumo Corporation
(TSE: 4543), and CytoSorbents Corporation (NASDAQ: CTSO),
manufacturer of the CytoSorb® extracorporeal blood
purification adsorber that reduces excessive levels of inflammatory
mediators in critically-ill and cardiac surgery patients, announced
today that they have entered into a multi-country strategic
partnership to commercialize CytoSorb for cardiac surgery
applications.
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Under the terms of the agreement, Terumo has the exclusive
rights to distribute the CytoSorb cardiopulmonary bypass (CPB)
procedure pack for intra-operative use during cardiac surgery in
France, Sweden, Denmark, Norway, Finland, and Iceland.
"Our collaboration with CytoSorbents enables us to offer this
innovative, easy-to-use blood purification therapy to address our
customers' most challenging cardiac cases," stated Arik Anderson, President of Perfusion and
Surgical Devices Division at Terumo. "CytoSorb integrates with the
heart-lung machine platform, giving surgical teams, for the first
time, the ability to safely reduce dangerous inflammatory mediators
in real-time as they are being generated during cardiac
surgery."
"We believe Terumo's extensive relationships in cardiac surgery
centers, combined with the benefits and simple implementation of
CytoSorb, will accelerate adoption of CytoSorb as a cost-effective,
standard-of-care therapy to control severe inflammation in patients
undergoing cardiac surgery," said Anderson.
"We are proud to begin working with Terumo," commented Dr.
Phillip Chan, Chief Executive
Officer of CytoSorbents. "Terumo has an outstanding reputation for
its commitment to the highest level of patient care, making it the
ideal cardiac surgery partner to advance CytoSorb in these European
countries."
Chris Cramer, CytoSorbents Vice
President of Business Development added, "The success of CytoSorb
under this agreement provides the foundation for future expansion
into strategically important markets, such as Japan, where Terumo is a leading medical
device manufacturer."
There are nearly 92 million people in France and the Nordic countries of
Denmark, Finland, Iceland,
Norway, and Sweden. Citizens of these countries are
covered by universal healthcare funded by the government, but many
supplement their healthcare with private insurance. France is the second-largest medical device
market in Europe, spending nearly
$300 billion annually on healthcare.
Sweden, Denmark, Norway, Finland, and Iceland are among the highest GDP-per-capita
countries in the world and collectively spend approximately
$142 billion on healthcare each year.
Across the territory, it is estimated that about 70,000 heart
surgeries are performed each year.
CytoSorb is CE Mark certified as an extracorporeal cytokine
adsorber to reduce the excessive production of inflammatory
mediators in a broad range of conditions including cardiac surgery.
Worldwide, over 1.5 million open heart surgeries are performed
annually. Many procedures require extended surgical times on the
heart-lung machine for cardiopulmonary bypass which could result in
increased destruction of blood cells, production of toxic free
hemoglobin, cytokines, and other inflammatory substances that can
trigger severe inflammation. Left untreated, this inflammation may
lead to hemodynamic instability, an increased need for vasopressor
and extracorporeal life support, and an elevated risk of organ
dysfunction and failure. CytoSorb therapy has already been used
safely in thousands of cardiac surgeries as a new strategy to
regain control of severe inflammation, with the potential to
improve surgical outcomes, reduce post-operative complications, and
lower the overall cost of care.
Financial terms of this agreement have not been disclosed.
About CytoSorbents Corporation
CytoSorbents Corporation is a leader in critical care
immunotherapy, specializing in blood purification. Its flagship
product, CytoSorb is CE Mark certified and is currently distributed
in 37 countries around the world as a safe and effective
extracorporeal cytokine adsorber, designed to reduce the "cytokine
storm" or "cytokine release syndrome" that could otherwise cause
massive inflammation, organ failure and death in common critical
illnesses such as sepsis, burn injury, trauma, lung injury, and
pancreatitis, as well as in cancer immunotherapy. These are
conditions where the risk of death is extremely high, yet no
effective treatments exist. CytoSorb is also being used during and
after cardiac surgery to remove inflammatory mediators, such as
cytokines and free hemoglobin, which can lead to post-operative
complications, including multiple organ failure. CytoSorbents is
currently conducting its REFRESH (REduction in FREe Hemoglobin) 1
trial - a multi-center, randomized controlled study evaluating the
safety of intra-operative CytoSorb use with a heart-lung machine
during complex cardiac surgery. In early 2017, the company
plans to initiate a pivotal REFRESH 2 trial intended to support
U.S. FDA approval. CytoSorb has been used safely in more than
14,000 human treatments to date.
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. The Company has numerous products under
development based upon this unique blood purification technology,
protected by 32 issued U.S. patents and multiple applications
pending, including HemoDefend™, ContrastSorb, DrugSorb and others.
Additional information is available for download on the Company's
websites: http://www.cytosorbents.com and
http://www.cytosorb.com.
About Terumo Cardiovascular Group
Terumo Cardiovascular Group manufactures and markets medical
devices for cardiac and vascular surgery with an emphasis on
cardiopulmonary bypass, intra-operative monitoring and vascular
grafting. The company is headquartered in Ann Arbor, Michigan, with manufacturing
operations in the U.S., Europe and
Asia. It is one of several
subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac
and vascular specialties. For more information,
visit www.terumo-cvgroup.com.
About Terumo Corporation
Tokyo-based Terumo Corporation
is one of the world's leading medical device manufacturers with
$5 billion in sales and operations in
more than 160 countries. Founded in 1921, the company develops,
manufactures, and distributes world-class medical devices including
products for use in cardiothoracic surgery, interventional
procedures and transfusion medicine; the company also manufactures
a broad array of syringe and hypodermic needle products for
hospital and physician office use. Terumo contributes to society by
providing valued products and services to the healthcare market and
by responding to the needs of healthcare providers and the people
they serve.
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, 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, 2016, 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.
CytoSorbents
Contact:
|
Terumo
Cardiovascular Group
|
Amy Vogel
|
Carol
Widmayer-Flint
|
Investor
Relations
|
Director of Strategic
Marketing
|
(732) 329-8885 ext.
*825
|
734-663-4145 ext
6535
|
avogel@cytosorbents.com
|
|
|
|
Public Relations
Contact:
|
Public Relations Contact:
|
Amy
Phillips
|
Carol
Widmayer-Flint
|
Pascale
Communications
|
Director of Strategic
Marketing
|
412-327-9499
|
734-663-4145 ext
6535
|
amy@pascalecommunications.com
|
|