CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2024 Product Revenue

PRINCETON, N.J., Jan. 03, 2025 (GLOBE NEWSWIRE) --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 preliminary, selected, unaudited fourth quarter and full-year 2024 financial results and business updates.

“We are pleased with our topline performance in the quarter. Our strong year-over-year growth represents solid execution in our core international business, and underscores the importance of CytoSorb®, our flagship product, in addressing a diverse range of critical care and cardiac surgery indications,”commentedDr. Phillip Chan, Chief Executive Officer of CytoSorbents.“This strong top-line close to 2024, as well as our return to more normalized product gross margins, positions us well to drive improved efficiencies in our core business as we prepare to enter the North American market with DrugSorb-ATR to reduce the severity of perioperative bleeding in CABG surgery due to Brilinta®, pending FDA and Health Canada approvals.”

The results disclosed in this press release are preliminary and unaudited. The Company expects to report full, audited results for the fourth quarter and year ended December 31, 2024, on March 6, 2025.

Management will host in-person investor meetings in San Francisco alongside the 43rd Annual J.P. Morgan Healthcare Conference being held January 13-16, 2025, in San Francisco, CA.ICR Healthcareis coordinating meetings on the Company’s behalf. To schedule a meeting with Dr. Phillip Chan, Chief Executive Officer, and Peter J. Mariani, Chief Financial Officer, please send requests to ICR Healthcare at ir@cytosorbents.com.

CytoSorbents Corporationis 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, ECMO, heart-lung machines). 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 in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis 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.

CytoSorbents’ lead product,CytoSorb®, is approved in the European Union and distributed in 76 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 thefirst cytokine adsorber. Additional CE mark extensions were granted forbilirubin and myoglobin removalin clinical conditions such as liver disease and trauma, respectively, and forticagrelorandrivaroxabanremoval in cardiothoracic surgery procedures. CytoSorb has also receivedFDA Emergency Use Authorizationin the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.

In the U.S. and Canada, CytoSorbents is developing theDrugSorb™-ATRantithrombotic 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 receivedtwo FDA Breakthrough Device Designations: one for theremoval of ticagrelorand another for theremoval of the direct oral anticoagulants (DOAC) apixaban and rivaroxabanin a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Companysubmitted a De Novo medical device application to the U.S. FDArequesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which wasaccepted for substantive review in October 2024. In November 2024, the Company received itsMedical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. 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 athttps://ir.cytosorbents.com/or follow us onFacebookandX.

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, 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.