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PRINCETON, N.J., July 29, 2025 /PRNewswire/ -- (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report second quarter 2025 financial results and recent business highlights after the market close on Thursday, August 7, 2025.

CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session starting at 4:30PM ET the same day.听

Conference Call and Webcast Details:
Date: Thursday, August 7, 2025
Time: 4:30 PM ET
North American toll-free: 1-800-836-8184
International toll: 1-646-357-8785
Live webcast link:

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

About CytoSorbents Corporation (NASDAQ: CTSO)

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.听 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, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure.听 In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.

CytoSorbents' lead product, , is approved in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used cumulatively to date.听 CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber.听 Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for and removal in cardiothoracic surgery procedures.听 CytoSorb has also received in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure.听 CytoSorb is not yet approved or cleared in the United States.

In the听U.S.听补苍诲听Canada,听CytoSorbents听is developing the DrugSorb鈩�-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.听 It has received two听FDA Breakthrough Device Designations:听 one for the removal of听ticagrelor听and another for the removal of the听direct oral anticoagulants (DOAC) apixaban and rivaroxaban听in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.听 In听September 2024, the Company听submitted a De Novo Request to the听U.S.听FDA听requesting marketing authorization for the DrugSorb-ATR medical device to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was听accepted for substantive review in听October 2024.听 On听April 25, 2025, the FDA issued a De听Novo Denial Letter听for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted and the device authorized for听U.S.听commercialization.听 The Company believes these items can be most effectively and expeditiously resolved through the formal appeals process, which facilitates engagement with FDA senior leadership and our external surgical experts.听On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the Company's request for supervisory review (administrative appeal) under 21 CFR 10.75. The Company continues to believe that remaining deficiencies in its De Novo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.听

In听November 2024, the Company received its MDSAP听certification and submitted its Medical Device License (MDL) application to听Health Canada.听 On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. 听As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company plans to file a Level 1 "Request for Reconsideration" with the Medical Devices Directorate Bureau Director following completion of the Company's review with the U.S. FDA.

DrugSorb-ATR has not been authorized for commercialization in the听U.S.听or Canada.听

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued听U.S.听and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY庐, CytoSorb-XL鈩�, HemoDefend-RBC鈩�, HemoDefend-BGA鈩�, VetResQ庐, K+ontrol鈩�, DrugSorb鈩�, ContrastSorb, and others. For more information, please visit the Company's website at听https://ir.cytosorbents.com/听听or follow us on听Facebook听补苍诲听X.听

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 remaining deficiencies in the FDA denial letter and the Health Canada Notice of Refusal and/or successfully appeal the FDA's and Health Canada'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.

U.S. Company Contact:听
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
[email protected]听

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD听
ICR Healthcare听
[email protected]

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SOURCE Cytosorbents Corp