Yahoo Finance

Dr. Chan continued, "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

• Completed Shareholder Rights Offering and raised total proceeds of $6.8 million, net of fees, from the offering, and the exercise of the Series A Right Warrant. The raise also allowed for the release of $5.0 million of restricted cash on the Company's balance sheet, and combined, provided increased liquidity of $11.8 million.

• Expanded our global footprint with the opening of our new regional sales subsidiary in Dubai, United Arab Emirates, providing a gateway into the Middle East and Africa.

• Appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy and execution for DrugSorb™-ATR in the U.S. and Canada.

• Appointed Melanie Grossman, CPA as Vice President and Corporate Controller.

The 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, 2025
Time:  4:30 PM ET
North American toll-free:  1-800-836-8184
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)

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.

Please Click to Follow Us on Facebook and X

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 

View original content to download multimedia:https://www.prnewswire.com/news-releases/cytosorbents-reports-first-quarter-2025-financial-results-and-provides-business-update-302455780.html

SOURCE Cytosorbents Corp