CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment
of deadly conditions in the intensive care unit and cardiac surgery
using blood purification via its proprietary polymer adsorption
technology, announces that it has regained compliance with the
Nasdaq Stock Market’s minimum bid price requirement of $1.00 per
share.
On July 26, 2024, CytoSorbents received
notification from the Listing Qualifications Department of the
Nasdaq Stock Market (“Nasdaq”) that it has regained compliance with
the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2)
as a result of the closing bid price of CytoSorbents’ common stock
being $1.00 per share or greater for 10 consecutive trading
sessions ending July 25, 2024. Accordingly, Nasdaq has determined
that this matter is now closed.
Dr. Phillip Chan, Chief Executive Officer of
CytoSorbents stated, “We are pleased to confirm that CytoSorbents
is now back in full compliance with Nasdaq’s listing requirements,
strengthening our market position as we approach our expected
regulatory submissions for DrugSorb®-ATR marketing approval to U.S.
FDA and Health Canada in the next several months. With recent
operational progress on the clinical, regulatory, commercial,
manufacturing, and financing fronts, coupled with continued
aggressive cost cutting, we have been systematically putting into
place the foundation of what we believe will be an exciting new
phase of our business.”
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 lead
product, CytoSorb®, is approved in the European Union and
distributed in 75 countries worldwide. It is an extracorporeal
cytokine adsorber that reduces “cytokine storm” or “cytokine
release syndrome” in common critical illnesses that can lead to
massive inflammation, organ failure and patient death. In these
diseases, the risk of death can be extremely high, and there are
few, if any, effective treatments. CytoSorb is also used during and
after cardiothoracic surgery to remove antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. As of March 31, 2024, more than 237,000 CytoSorb devices
have been used cumulatively. 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 in the United
States.
The DrugSorb™-ATR antithrombotic removal system,
an investigational device based on the same polymer technology as
CytoSorb, 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. The Company has completed the FDA-approved, randomized,
controlled STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) study of 140 patients at approximately 30
centers in U.S. and Canada to evaluate whether intraoperative use
of DrugSorb-ATR can reduce the perioperative risk of bleeding in
patients receiving ticagrelor and undergoing cardiothoracic
surgery. This pivotal study is intended to support U.S. FDA and
Health Canada marketing approval for DrugSorb-ATR in this
application.
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
approximately $50 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™, 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 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
timing of our expected 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, the risks
discussed in our Annual Report on Form 10-K, filed with the SEC on
March 14, 2024, 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:Kathleen Bloch, CFO305
College Road EastPrinceton, NJ 08540+1 (732)
398-5429kbloch@cytosorbents.com
Investor Relations Contact:Eric RibnerLifeSci
Advisors, LLC250 W 55th St, #3401New York, NY 10019+1 (646)
751-4363ir@cytosorbents.com
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