CytoSorbents Provides Regulatory Update for DrugSorb-ATR

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) received a denial letter from the FDA on April 25, 2025, regarding its De Novo Request for DrugSorb-ATR, a breakthrough device designed to reduce bleeding severity in coronary artery bypass grafting (CABG) patients who recently stopped taking Brilinta®. The FDA identified remaining deficiencies that need to be addressed before authorization.

The company has met with the FDA and will continue discussions to resolve the issues. If no resolution is reached, CytoSorbents plans to file a formal appeal within 60 days. Despite this setback, the company remains confident in obtaining a final regulatory decision in 2025 for this device, which addresses an unmet medical need affecting tens of thousands of U.S. patients annually.

Positive

• DrugSorb-ATR maintains FDA Breakthrough Device designation
• Company still expects final regulatory decision in 2025
• No competing therapies currently available in the U.S. market

Negative

• FDA denied De Novo Request for DrugSorb-ATR
• Additional deficiencies must be addressed before authorization
• Potential delay in commercialization timeline if formal appeal is needed

PRINCETON, N.J., May 1, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device.  DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.

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, 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.   CytoSorbents has since met with the FDA and will continue to have interactive conversations with the agency to try to resolve the remaining issues.  However, if these conversations do not lead to a resolution, a formal appeal will be filed within 60 days. 

"We remain deeply committed to bringing DrugSorb-ATR to market as an important solution to address the serious, unmet medical need of preventing life-threatening bleeding in CABG patients treated with Brilinta®," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.  "With no therapies currently available in the U.S., tens of thousands of patients remain at risk every year.  We will continue working closely with FDA and believe we can resolve the remaining issues in a timely manner and still anticipate a final regulatory decision in 2025." 

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, and 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 270,000 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.  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 authorization for the DrugSorb-ATR medical device 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 MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada.  DrugSorb-ATR has not been authorized for commercialization in the U.S. or Canada. 

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 remaining deficiencies in the FDA denial letter and/or 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.

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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

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SOURCE Cytosorbents Corp

FAQ

What was the FDA's decision on CytoSorbents' DrugSorb-ATR device?

The FDA issued a denial letter on April 25, 2025, for CytoSorbents' De Novo Request for DrugSorb-ATR, citing deficiencies that need to be addressed before authorization.

What is the purpose of CTSO's DrugSorb-ATR device?

DrugSorb-ATR is designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the blood thinner Brilinta®.

What are CytoSorbents' next steps after the FDA denial?

CytoSorbents is continuing discussions with the FDA to resolve remaining issues and will file a formal appeal within 60 days if no resolution is reached.

When does CTSO expect a final regulatory decision for DrugSorb-ATR?

Despite the setback, CytoSorbents still anticipates receiving a final regulatory decision for DrugSorb-ATR in 2025.

How many patients could benefit from DrugSorb-ATR in the US?

According to the company, tens of thousands of patients annually remain at risk without any currently available therapies in the U.S.