#United States #Princeton #CytoSorbents #DrugSorb-ATR #FDA Denial

CytoSorbents Corporation Provides Key Update on DrugSorb-ATR

Introduction
CytoSorbents Corporation, a prominent player in blood purification therapies, recently provided a significant update regarding its investigational device, DrugSorb-ATR. This latest device is aimed at reducing the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgeries, particularly in the context of treatment with antiplatelet drug Brilinta (ticagrelor).

FDA Interaction
On April 25, 2025, the U.S. Food and Drug Administration (FDA) issued a denial letter concerning CytoSorbents’ De Novo Request for DrugSorb-ATR. The letter highlighted various deficiencies that the company must address before the device can be authorized for commercialization in the United States. Following this development, CytoSorbents has engaged in discussions with the FDA to rectify the highlighted issues, with CEO Dr. Phillip Chan expressing the company’s commitment to navigating these regulatory challenges promptly. If satisfactory resolutions are not achieved through ongoing discussions, CytoSorbents plans to file a formal appeal within the next 60 days.

Addressing Unmet Medical Needs
Dr. Chan emphasized the critical nature of the product, stating the urgent need for solutions that prevent life-threatening bleeding in patients treated with Brilinta. With no current therapies in the U.S. market specifically targeting this issue, CytoSorbents aims to bring DrugSorb-ATR to patients already at risk, underscoring the necessity of timely intervention in potentially life-threatening situations.

Innovative Blood Purification Technology
CytoSorbents has established itself as a leader in blood purification technologies, boasting a myriad of applications that address severe health crises. The company’s proprietary systems utilize highly porous polymer beads designed to remove toxins and unwanted substances effectively from blood via pore capture and surface adsorption. These features make its devices particularly suitable for utilization in numerous clinical settings, including intensive care and cardiac surgery.

Going Forward
Despite the hurdles with FDA authorization, CytoSorbents remains optimistic about overcoming these challenges and anticipates a decision on the regulatory front within 2025. It is important to note that the company's flagship product, CytoSorb, has already seen successful deployment across the European Union and is operational in 70 countries globally, underscoring its efficacy in critical care settings. With more than 270,000 devices utilized to date, the company’s experience lays a strong foundation for the potential success of DrugSorb-ATR in the U.S. market.

Conclusion
As CytoSorbents continues its proactive engagement with the FDA regarding the approval of DrugSorb-ATR, the company showcases its unwavering commitment to addressing significant medical needs in high-risk surgical procedures. The forthcoming discussions with the FDA will be crucial as CytoSorbents aims to secure a place for this innovative medical technology in the fight against life-threatening bleeding.

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