PRINCETON, N.J., May 29, 2025
/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, today
announced that management will present and participate in
one-on-one meetings with investors at the Jefferies Global
Healthcare Conference in New York,
NY on June 4 – 5, 2025.
Presentation Details:
Date: Thursday, June 5, 2025
Time: 9:20 AM ET
Live webcast link: Here
Live webcast of the presentation will be available by selecting
Events and Presentations under the News & Events tab in the
Investors section on cytosorbents.com. A replay of the webcast will
be archived for up to 90 days following the session date.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac
surgery through blood purification. CytoSorbents' proprietary blood
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.
Cartridges filled with these beads can be used with standard blood
pumps already in the hospital (e.g. dialysis, continuous renal
replacement therapy or CRRT, extracorporeal membrane oxygenation or
ECMO, and heart-lung machines), where blood is repeatedly
recirculated outside the body, through our cartridges where toxic
substances are removed, and then back into the body. CytoSorbents'
technologies are used in a number of broad applications.
Specifically, two important applications are 1) the removal of
blood thinners during and after cardiothoracic surgery to reduce
the risk of severe bleeding, and 2) the removal of inflammatory
agents and toxins in common critical illnesses that can lead to
massive inflammation, organ failure and patient death. The breadth
of these critical illnesses includes, for example, sepsis, burn
injury, trauma, lung injury, liver failure, cytokine release
syndrome, and pancreatitis as well as the removal of liver toxins
that accumulate in acute liver dysfunction or failure the removal
of myoglobin in severe rhabdomyolysis that can otherwise lead to
renal failure. In these diseases, the risk of death can be
extremely high, and there are few, if any, effective
treatments.
CytoSorbents' lead product, CytoSorb®, is
approved in the European Union and distributed in over 70
countries worldwide, with more than a quarter million devices used
cumulatively to date. 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.
CytoSorb is not yet approved or cleared in the United
States.
In the U.S. and Canada,
CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal
system, an investigational device based on an equivalent polymer
technology to CytoSorb, to reduce the severity of perioperative
bleeding in high-risk surgery due to blood thinning drugs. It
has 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. In September 2024, the Company submitted a De Novo
Request to the U.S. FDA requesting marketing approval to
reduce the severity of perioperative bleeding in CABG patients on
the antithrombotic drug ticagrelor, which was accepted for
substantive review in October 2024.
On April 25, 2025, the FDA issued a
denial letter regarding the Company's De Novo Request for
DrugSorb-ATR, identifying remaining deficiencies that must be
addressed before the De Novo Request can be granted, and the device
can be authorized for commercialization in the U.S. The
Company believes these items can be most effectively and
expeditiously resolved through the formal appeal process, which
facilitates engagement with FDA senior leadership and our external
surgical experts. Given the expedited timelines associated
with the appeal process, the Company believes that a final
regulatory decision can be achieved in 2025. In
November 2024, the Company received
its MDSAP certification and submitted its Medical Device License
(MDL) application to Health Canada. CytoSorbents'
DrugSorb-ATR application with Health Canada remains under advanced
review. While Health Canada has indicated that application
reviews are currently delayed beyond their target Market
Authorization Times (MAT) due to a backlog, they have reaffirmed
their commitment to issuing a decision at the earliest
opportunity. The Company remains confident in receiving a
final regulatory decision in 2025. DrugSorb-ATR is not yet
granted or approved in the United
States and Canada,
respectively.
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 website
at https://ir.cytosorbents.com/ or follow us
on Facebook and X.
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, representations and contentions, and the outcome
of our regulatory submissions, 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,
our restructuring of our direct sales team and strategy in
Germany, our ability to resolve
deficiencies in the FDA denial letter through a successfully appeal
the FDA's decision, and the risks discussed in our Annual Report on
Form 10-K, filed with the SEC on March 31,
2025, 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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U.S. Company Contact:
Peter J. Mariani, Chief Financial
Officer
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR
Healthcare
ir@cytosorbents.com
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SOURCE Cytosorbents Corp
