CytoSorbents Granted Expanded ANVISA Registration to Treat Shock with CytoSorb in Brazil
31 Agosto 2023 - 1:00PM
CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy
leader commercializing its CytoSorb® blood purification technology
to treat cytokine storm and deadly inflammation in critically-ill
and cardiac surgery patients around the world, announced that
CytoSorb® was granted an expanded medical device registration by
the Brazilian Health Regulatory Agency (ANVISA) to treat
shock.
After receiving its first ANVISA registration in
September 2020 to treat cytokine storm in cardiac surgery and
critical illnesses such as COVID-19 in the midst of the COVID
pandemic, CytoSorb has now received an expanded ANVISA registration
to also include the treatment of shock – a common and frequently
fatal complication of critical illness and cardiac surgery. Shock
is a persistent and rapid drop in blood pressure that deprives
vital organs of adequate blood flow and oxygen that can lead to
organ failure and death. To give an example of the burden of shock
in critical care: Septic shock - the most serious form of sepsis,
afflicts approximately one in ten patients in the ICU, where
despite historical standard of care treatment which includes
antibiotics, fluids, and vasopressors, approximately 40-50% will
die. CytoSorb therapy helps to reverse shock, restore natural blood
pressure, and stabilize the patient, representing a potentially
revolutionary therapeutic advance in the treatment of this deadly
condition.
CytoSorb is now commercialized in Brazil through
Fresenius Medical Care (FMC) in the Critical Care segment, and by
Contatti Medical in the field of Cardiac Surgery. Brazil is the 7th
most populous country in the world and Latin America’s largest
medical device market.
Mr. Alexandre Franco, Marketing Director of FMC
Brazil, stated, “Fresenius Brazil is very proud of the registration
approval of CytoSorb by ANVISA, which will help anchor our Critical
Care portfolio. The use of CytoSorb, combined with
other innovations we have implemented in recent years, will provide
us with increasingly complete solutions in the care of severely ill
patients.”
Mr. Mateus Biazus, Head of Marketing and Sales
of Contatti Medical added, “There are around 60,000 cardiac
surgeries per year in Brazil where surgeons may have to deal with
the consequences of an overshooting inflammatory response,
especially in complex and emergency procedures. Thanks to the
ANVISA approval of CytoSorb, Contatti is able to offer a solution
to this problem, contributing to the improvement of patient
outcomes.”
Dr. Phillip Chan, Chief Executive Officer of
CytoSorbents stated, “CytoSorb is used across the world in
different clinical fields and can be integrated into various
extracorporeal platforms to treat life-threatening conditions. We
are pleased to commercialize CytoSorb in Brazil under this expanded
registration through our partners FMC and Contatti Medical, both
well-established and connected experts in their respective clinical
fields. Importantly, we plan to build upon the momentum
of CytoSorb usage during the pandemic in Brazil, and a long track
record of reversing shock in patients worldwide, to make CytoSorb
broadly available to help save patient lives throughout the
country.”
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 flagship
product, CytoSorb®, is approved in the European Union, distributed
in 75 countries worldwide, and has accumulated more than 212,000
human treatments to date, to reduce “cytokine storm” and other
toxins that can cause organ failure. The DrugSorb™-ATR
antithrombotic removal system, based on the same polymer technology
as CytoSorb, has received two U.S. FDA Breakthrough Device
Designations to remove two separate blood thinners during
cardiothoracic surgery, including ticagrelor and the direct oral
anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing
pivotal clinical studies. 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, 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
statements, whether as a result of new information, future events,
or otherwise, other than as required under the Federal securities
laws.
CytoSorbents Contact:
Kathleen Bloch(732) 398-5429 kbloch@cytosorbents.com
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