Full Press Release Details
CytoSorbents Reports First Quarter 2025 Financial
Results and Provides Business Update
N.J., May 14, 2025 - 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 reported financial results for the first quarter ended March 31, 2025, and recent business highlights.
First Quarter 2025 Financial Results
growth in our distributor and other direct sales territories across the E.U. helped to substantially offset a temporary disruption in
direct sales in Germany during the quarter. This was primarily due to our proactive reorganization and strategic realignment of our German
commercial team and sales approach that is intended to renew sales growth in the country through deeper customer engagement, more effective
market development, and improved sales representative productivity," stated Dr. Phillip Chan, Chief Executive Officer
of CytoSorbents. "We are making steady progress with this important initiative and are confident it will lead to stronger execution
and improved performance in Germany and our financial results overall this year, as we continue to advance our core business toward near
"Meanwhile, our message - Treating the right patient, at the right time, with the right dose of CytoSorb
- continues to resonate strongly with clinicians. The approach is much like using antibiotics: start early, treat aggressively, and
complete the full course. When used this way, CytoSorb has been shown to disrupt the deadly cycle of inflammation, stabilize patients
in shock, protect organ function, and ultimately improve clinical outcomes. Recent data confirm that early and aggressive use of CytoSorb
leads to statistically significant improvements in survival and other key clinical indicators. We are now using this evidence to train
our users and are confident our guidance will continue to drive broader adoption and more effective usage of this critical therapy."
Additional Business Highlights
Company remains deeply committed to bringing DrugSorb -ATR, an Investigational FDA Breakthrough Designated Device, to the large
and important North American market, as a critical solution to address the serious, unmet need of reducing life-threatening bleeding in
patients on Brilinta undergoing coronary artery bypass grafting (CABG)
surgery. Awareness of DrugSorb-ATR's potential to lessen bleeding severity in this high-risk population continues to grow. Compelling
new real-world data from Europe on our technology, being presented and published throughout 2025, further reinforces the device's
potential clinical impact to meaningfully reduce perioperative bleeding severity and provide surgeons with an important therapy to address
this ongoing challenge in cardiac surgery.
On April 25, 2025, the U.S. Food and Drug
Administration (FDA) issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, citing outstanding items that
must be addressed before the device can be authorized for U.S. commercialization. The Company believes these items can be most effectively
and expeditiously resolved through the formal appeal process that enables direct interaction and engagement with FDA senior leadership
and our external experts. Given the expedited timelines associated with the appeal process, we believe that a final regulatory decision
can be achieved in 2025.
Dr. Efthymios N. Deliargyris, Chief Medical
Officer of CytoSorbents stated, "We remain confident in the strength of our DrugSorb-ATR De Novo Request and believe the remaining
issues can be successfully addressed. We are committed to working collaboratively with the FDA to secure marketing authorization for this
FDA Breakthrough Designated Device, which has the potential to address a significant and routine challenge faced by cardiac surgery centers.
We believe the formal appeals process offers the most efficient path forward to resolve the remaining issues and bring this important
technology to patients in the U.S. Meanwhile real-world adoption continues to grow with an increasing number of heart centers around the
world incorporating our technology as part of their standard care to reduce bleeding complications in patients on blood thinners undergoing
cardiac surgery based on the growing evidence from our international STAR Registry showing that our device is a safe and effective strategy
to address this major clinical need."
Finally, 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, Health Canada has confirmed its commitment to issuing a decision at the
earliest opportunity. We remain confident in receiving a final regulatory decision in 2025.
First Quarter 2025 Earnings Conference Call
CytoSorbents' management will host a live conference call, presentation
webcast, and a question-and-answer session with the following information:
Date: Wednesday, May 14,
North American toll-free:
International toll: 1-646-357-8785
Live webcast link: https://app.webinar.net/Vbq3lbYwAy5
It is recommended that participants dial in approximately
10 minutes prior to the start of the call.
An archived recording of the conference call will
be available under the Investor Relations section of the Company's website at https://ir.cytosorbents.com/
About Non-GAAP Financial Measures
To supplement our condensed consolidated financial
statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and
amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation.
We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes
non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively.
These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute
for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies.
In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The
reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with
GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means
to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information
regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing
our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful
to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and
operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of
our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and
working capital requirements.
About CytoSorbents Corporation (NASDAQ: CTSO)
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.
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.
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