CytoSorbents Corporation Achieves European Union Regulatory Approval for CytoSorb(TM)
March 31 2011 - 7:29AM
Marketwired
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused
company using blood purification to treat life-threatening
illnesses, is pleased to announce that it has achieved European CE
Mark approval for its flagship product, CytoSorb™, as an
extracorporeal cytokine filter in situations where excessive
cytokine levels exist. This milestone certifies that CytoSorb™ has
met the safety and label efficacy claim requirements of the
European Medical Devices Directive and can now be sold in the
European Union (E.U.) for human clinical use.
The European Sepsis Trial has successfully demonstrated
CytoSorb™'s robust ability to reduce circulating plasma cytokine
levels during the extracorporeal treatment of critically-ill
patients with sepsis and respiratory failure. CytoSorb™ has
achieved its primary endpoint of IL-6 (interleukin-6) reduction
with statistical significance based on an interim analysis of the
trial. The data demonstrates that CytoSorb™ plus standard of care
therapy reduced IL-6 levels by an average of 49.1% (p = 0.01)
during the CytoSorb™ treatment period compared to standard of care
therapy alone. The treatment was well-tolerated, with no serious
device related adverse events reported to date in more than 300
treatments in septic patients.
Dr. Phillip Chan, Chief Executive Officer, stated, "Obtaining
European regulatory approval for CytoSorb™ is the most significant
accomplishment in our company's history and we thank our employees
and our shareholders for their dedication and support. To our
knowledge, we are the only device approved in the E.U. specifically
as a cytokine filter, opening up many opportunities to not just
treat patients with sepsis, but also patients with a host of
life-threatening and non-life threatening inflammatory conditions
where cytokine levels are elevated. As we analyze the clinical data
from our current trial in sepsis, we look to continue to lead and
foster additional clinical studies with a strong focus on sepsis
and other critical care illnesses such as acute respiratory
distress syndrome, severe burn injury, trauma, and pancreatitis,
where the need is great and the human and financial costs are
staggering. The goal is to drive broad usage of our technology and
generate valuable clinical data across many fields."
Dr. Chan continued, "Now that we are permitted to manufacture
CytoSorb™ devices for clinical use in the E.U. under CE Mark
approval and ISO 13485 certification, we will ramp manufacturing
for a controlled-market release in select territories in the second
half of this year. The goal for 2011 is to build a solid foundation
for future growth and responsibly make the transition from a
development stage to a commercial stage medical device company. Our
longer term goal is to pursue trials in the U.S. and attain FDA
regulatory approval as well." Dr. Chan concluded, "With this major
milestone, we continue to advance our mission to change the face of
critical care medicine and to help save patients' lives."
About CytoSorbents and CytoSorb™
CytoSorbents Corporation is a critical care focused therapeutic
device company in clinical trials to treat severe sepsis, the end
result of "overwhelming infection," with a novel blood purification
device called CytoSorb™. Severe sepsis afflicts more than 1 million
people in the United States (U.S.), 1.5 million people in the
European Union (E.U.), and an estimated 18 million people worldwide
each year, killing one in every three patients despite the best
medical treatment. In the U.S., more die from severe sepsis than
from either heart attacks, strokes or any single form of cancer.
Severe sepsis is typically triggered by bacterial infections like
pneumonia, or viral infections like influenza. However, it is the
body's abnormal immune response to the trigger that leads to severe
inflammation and the unregulated, massive production of cytokines,
often called "cytokine storm," that then causes multi-organ failure
and often death. CytoSorb™ is a cartridge containing highly porous
polymer beads that are designed to filter cytokines and treat
potentially fatal cytokine storm. As blood is pumped repeatedly
through the CytoSorb™ cartridge using standard dialysis equipment,
the beads bind and remove cytokines and other toxins from blood.
The treated blood is then returned to the patient. The Company is
finalizing its European Sepsis Trial -- a multi-center, randomized,
controlled clinical trial using CytoSorb™ to treat up to 100
patients with severe sepsis in the setting of respiratory failure.
Importantly, cytokine reduction via CytoSorb™ has broad
applicability to a number of other critical care diseases where
cytokine storm plays a detrimental role, including burn and smoke
inhalation injury, trauma, acute respiratory distress syndrome,
advanced influenza, acute pancreatitis and others. In March 2011,
the Company successfully achieved CE Mark approval to market its
CytoSorb™ device as an extracorporeal cytokine filter. CytoSorbents
has also achieved ISO 13485:2003 Full Quality Systems
certification, an internationally recognized quality standard
designed to ensure that medical device manufacturers have the
necessary comprehensive management systems in place to safely
design, develop, manufacture and distribute medical devices in the
E.U. Assuming availability of adequate and timely funding, and
continued positive results from our clinical studies, the Company
intends to begin commercializing its product in Europe and then
seek to commence clinical trials in the U.S. for approval.
CytoSorb™ is one of a number of different resins the Company has
designed for various medical applications, including improved
dialysis, the potential treatment of inflammatory and autoimmune
disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs
during treatment of cancer with high dose regional chemotherapy,
drug detoxification, and others. Additional information is
available for download on the Company's website:
www.cytosorbents.com
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. Forward-looking
statements in this press release are not promises or guarantees and
are subject to risks and uncertainties that could cause our actual
results to differ materially from those anticipated. These
statements are based on management's current expectations and
assumptions and are naturally subject to uncertainty and changes in
circumstances. We caution you not to place undue reliance upon any
such forward-looking statements. Actual results may differ
materially from those expressed or implied by the statements
herein. CytoSorbents Corporation and CytoSorbents, Inc believe that
its primary risk factors include, but are not limited to: obtaining
government approvals including required FDA and additional CE Mark
approvals; ability to successfully develop commercial operations;
dependence on key personnel; acceptance of the Company's medical
devices in the marketplace; the outcome of pending and potential
litigation; compliance with governmental regulations; reliance on
research and testing facilities of various universities and
institutions; the ability to obtain adequate and timely financing
in the future when needed; product liability risks; limited
manufacturing experience; limited marketing, sales and distribution
experience; market acceptance of the Company's products;
competition; unexpected changes in technologies and technological
advances; and other factors detailed in the Company's Form 10-K
filed with the SEC on March 31, 2011, which is available at
http://www.sec.gov.
Contact: CytoSorbents Corporation David Lamadrid (732)
329-8885 ext. 816 DavidL@cytosorbents.com
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