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Update on DrugSorb-ATR from CytoSorbents

CytoSorbents Corporation, recognized for its pioneering work in blood purification, recently announced important regulatory developments regarding its innovative product, DrugSorb-ATR. Operating out of Princeton, New Jersey, this company has positioned itself as a leader in the medical devices sector, especially in critical care and cardiac procedures. On August 20, 2025, CytoSorbents shared that it received a decision from the U.S. Food and Drug Administration (FDA) regarding their prior De Novo application for DrugSorb-ATR.

FDA Appeal Outcome

The FDA's recent appeal outcome was notable as it did not cite any safety concerns related to DrugSorb-ATR. However, the agency upheld its previous denial due to the lack of additional data to support the label indications the company seeks. The FDA, in its appeal decision, suggested a potential expedited path for market authorization under certain conditions, thus providing the company with a glimmer of hope.

Constructive FDA Engagements

CytoSorbents conducted a productive meeting with FDA officials to discuss the appeal's contents and strategize on the next steps. Following this engagement, CytoSorbents made the strategic decision not to pursue a final appeal to the FDA's Center for Devices and Radiologic Health (CDRH). The encouraging feedback from higher management indicated that a balanced approach could yield a faster De Novo grant with the requested label indication.

Going forward, the company plans on revising their De Novo application, which will now include additional real-world data enhancing the device's credibility and application efficacy. This new batch of data was previously unavailable during the original submission last year.

New Real-World Data Emphasizing Device Effectiveness

The newly gathered data emphasizes DrugSorb-ATR's ability to manage blood thinning in patients undergoing urgent coronary artery bypass graft (CABG) surgeries. These real-world scenarios support the device’s robust performance in clinical practices, reinforcing its benefit-risk ratio, a key determinant for regulatory evaluation.

Moreover, the FDA's understanding of the new submission suggests a focused review of only the open issues from the initial application, given their assurance regarding the absence of safety issues. This paves the way for an expedited review process aligned with the Breakthrough Device Designation previously awarded to DrugSorb-ATR.

Next Steps in Regulatory Submission

CytoSorbents plans to submit a request for a pre-submission meeting with the FDA next month, anticipating a formal meeting in the fourth quarter of 2025 to finalize the necessary documents for the new De Novo submission. Although the company aims to fast-track its progress, the standard regulatory decision will likely arrive around mid-2026 following an anticipated 150-day review process post-submission.

Leadership Insights

Dr. Phillip Chan, CEO of CytoSorbents, expressed optimism about the ongoing discussions with the FDA. He emphasized the importance of swiftly launching into the pre-submission phase to capitalize on the feedback received, leveraging the strengths of the original filing while presenting new data to substantiate their claims on DrugSorb-ATR’s impact on patient care.

Furthermore, CytoSorbents had previously initiated a Level 1 “Request for Reconsideration” with Health Canada. However, after consultations with their Canadian regulatory counsel, the decision was made to delay further review until clearer guidance from the FDA was attained. This indicates a cohesive strategy in navigating both U.S. and Canadian regulatory environments.

Commitment to Innovation and Patient Care

CytoSorbents remains focused on addressing the significant unmet medical needs in the intensive care domain. Their goal is not only to improve patient outcomes through innovative devices like DrugSorb-ATR but also to enhance operational efficiency, manage costs effectively, and secure marketing approval in both the U.S. and Canada.

The company’s commitment to patient safety and care enhancement remains paramount as it aims to navigate the complex regulatory landscape and ultimately provide effective solutions for patients undergoing critical surgeries.

For more insights and updates, industry enthusiasts can explore CytoSorbents’ range of transformative products and applications designed to set new standards in critical care and beyond.