CTSO CytoSorbents Corporation

CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit (ICU) and during cardiac surgery through blood purification, and Converge Biotech, a prominent healthcare company with a strong critical care and infectious disease focus in India, are pleased to announce a new strategic collaboration where the two companies seek to expand their combined market reach in the sepsis and critical care markets in India with a broad synergistic product portfolio.

CytoSorbents is renowned for its flagship product, CytoSorb®, a blood purification technology that reduces “cytokine storm” and a broad range of inflammatory toxins that can otherwise lead to massive inflammation, organ failure and death in many critical illnesses that are very common in India such as sepsis and septic shock, lung failure, acute liver disease, trauma, burn injury, pancreatitis, and others. The therapy is also used to treat acute liver disease and trauma through the removal of harmful substances such as bilirubin and myoglobin, respectively. CytoSorb is used in 76 countries worldwide with more than a quarter million treatments administered to date.

Converge Biotech will leverage its extensive critical care sales force and strong hospital network to accelerate CytoSorb's market penetration in India, ensuring more healthcare facilities have access to this critical therapy. In doing so, CytoSorb will help Converge Biotech strengthen its existing intensive care unit (ICU) portfolio to now include the treatment of sepsis and other life-threatening diseases. With CytoSorbents' innovative technology and Converge's established critical care presence, the two companies plan to expand the availability of life-saving blood purification products to healthcare professionals throughout India, with the goal of improved patient outcomes in hospitals and ICUs across the country.

"We look forward to a great collaboration with Converge Biotech to make CytoSorb more broadly available to physicians across India to treat complex diseases like septic shock, acute respiratory distress syndrome, liver failure and many others," said Dr. Phillip Chan, Chief Executive Officer at CytoSorbents. "With our unique therapy and Converge Biotech’s local expertise, distribution capabilities, relationships within the Indian healthcare market, focused critical care sales team, complementary therapy portfolio, and market strength, we believe this partnership can help drive the growth of both companies for years to come in one of the fastest-growing critical care markets globally.”

"We are extremely excited to join forces with CytoSorbents and make CytoSorb therapy accessible to patients who urgently need it in India, helping to save more lives," said Arunkumar Bijjala, Managing Director of Converge Biotech. "Our mission has always been to provide innovative and life-saving therapies in the critical care space, and CytoSorb represents a highly impactful solution for sepsis and other critical illnesses that are major challenges for physicians in the ICU. This partnership will allow us to significantly expand our offerings and reinforce our position as a leading player in the critical care segment."

The collaboration signifies a new chapter, empowering both organizations to drive the adoption of advanced therapies for critical illnesses in India.

About Converge Biotech

Converge Biotech is a fast-growing pharmaceutical company in India specializing in the critical care segment. With a strong presence in ICU settings, Converge is committed to bringing innovative, life-saving therapies to patients in India and improving patient care outcomes.For more information on Converge, please visit www.convergebio.in

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, 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 250,000 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, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved 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 medical device application 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. In November 2024, the Company received its Medical 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 at www.cytosorbents.com or follow us on Facebook and X. 

CytoSorbents 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, 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.

CytoSorbents Company Contact:Peter J. Mariani, Chief Financial Officer305 College Road EastPrinceton, NJ 08540pmariani@cytosorbents.com

CytoSorbents Investor Relations Contact:Aman Patel, CFA ICR-Westwicke ir@cytosorbents.com

Converge Biotech Media ContactMr. Eswar Teja, Product Manager+91 99485 12050