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CytoSorbents Provides Update on FDA Status of DrugSorb-ATR

CytoSorbents Corporation, publicly traded under NASDAQ as CTSO, is a pioneer in treating critical conditions requiring intensive care and cardiac surgery through advanced blood purification technologies. Recently, the company updated stakeholders regarding its efforts to gain U.S. Food and Drug Administration (FDA) market authorization for its innovative device, DrugSorb-ATR.

Recent Developments

On August 14, 2025, CytoSorbents announced that the FDA had rendered a decision on the company’s appeal concerning the De Novo market authorization for DrugSorb-ATR. This decision followed an April 25, 2025, denial letter which stated that additional information was necessary to support CytoSorbents' desired labeling indication for the device, classified as an FDA Breakthrough Device. Notably, the FDA concluded that there were no safety issues related to the device, marking a critical point in the company’s pursuit of regulatory approval.

The July 2025 meeting provided an opportunity for CytoSorbents' management and FDA officials to engage in discussions aimed at resolving outstanding issues identified during the previous review. Although the denial decision was upheld, the FDA proactively proposed potential pathways to move forward in the authorization process, fostering ongoing dialogue with the agency.

Moving Forward

Dr. Phillip Chan, CEO of CytoSorbents, expressed a mixed sentiment regarding the FDA's decision. He recognized the progress made in addressing previous concerns while also acknowledging the challenges that lie ahead. The company aims to continue productive interactions with the FDA to delineate a clear path towards bringing DrugSorb-ATR to the market, ultimately aiding the critical care of patients undergoing coronary artery bypass graft (CABG) surgery.

DrugSorb-ATR is designed specifically for patients who face life-threatening conditions due to the use of blood-thinning medications during surgery. By addressing perioperative bleeding—one of the significant risks associated with this demographic—CytoSorbents believes this device will substantially enhance surgical safety and patient outcomes. The urgency of this innovation cannot be understated, especially considering the alarming volume of patients who may experience severe bleeding complications due to existing anticoagulant therapies.

Broader Implications of the Device

The need for DrugSorb-ATR stems from the increasing prevalence of heart disease and the corresponding rise in surgeries requiring effective management of blood thinners. CytoSorb-ATR’s technology leverages biocompatible, highly porous polymer beads, facilitating the active removal of harmful substances from the bloodstream. This mechanism not only diminishes the risk of perioperative complications but also aids in the management of various critical conditions such as sepsis, traumatic injuries, and organ failures.

CytoSorbents’ flagship product, CytoSorb®, has already achieved significant global traction, with nearly 300,000 units utilized worldwide across multiple applications. While CytoSorb is approved in the European Union, DrugSorb-ATR is in the investigational phase and awaiting U.S. and Canadian regulatory clearance.

Conclusion

As CytoSorbents navigates the complexities of FDA regulations, the company remains steadfast in its commitment to provide life-saving innovations to healthcare systems. The adherence to FDA's guidance indicates a collaborative approach that could lead to successful market entry for DrugSorb-ATR, potentially transforming care for countless patients facing surgical interventions. The company anticipates future updates as discussions with the agency progress, standing poised to tackle the critical issues that remain on the road to market authorization.

For further updates, stakeholders and interested readers are encouraged to visit CytoSorbents' official page for detailed insights and announcements regarding their product developments and regulatory statuses.