CytoSorbents Appeals to FDA for De Novo Review of DrugSorb™-ATR Approval
CytoSorbents Appeals FDA Decision for DrugSorb™-ATR
CytoSorbents Corporation, a prominent player in blood purification technologies, recently announced its appeal to the U.S. Food and Drug Administration (FDA) concerning the De Novo request for its DrugSorb-ATR device. The company, well-regarded for addressing critical conditions in intensive care and cardiac surgery, filed this appeal on June 18, 2025. The action stems from the FDA's earlier denial letter issued on April 25, 2025, which highlighted certain deficiencies that need to be resolved before the device's approval for U.S. commercialization.
The DrugSorb-ATR device is designed specifically to mitigate bleeding risks in patients undergoing coronary artery bypass grafting (CABG) surgery who have recently discontinued the antiplatelet medication Brilinta® (ticagrelor). This medication is widely used to prevent blood clots but poses a significant risk of bleeding when surgeries are necessary shortly after its administration.
In its denial letter, the FDA noted outstanding issues that CytoSorbents must address. In response, the company has proactively communicated with the FDA's review team to discuss and clarify these deficiencies. The decision to pursue a supervisory review through the appeals process underscores CytoSorbents' commitment to ensuring that its device meets regulatory requirements efficiently.
The appeals process provides a platform for CytoSorbents to engage directly with senior officials at the FDA, allowing the company to present insights from leading cardiac surgeons who can offer expertise and critical consultation to aid in addressing the FDA's concerns. Dr. Phillip Chan, the CEO of CytoSorbents, expressed confidence in the DrugSorb-ATR submission and emphasized the importance of making the device accessible to patients who need urgent CABG surgery while on Brilinta.
The administrative appeals process is designed to facilitate a structured dialogue between the company and the FDA, culminating in a formal hearing. A decision is typically rendered within approximately 60 days from filing the appeal, which positions CytoSorbents to receive feedback in a timely manner.
Meanwhile, the company's DrugSorb-ATR application is also under a comprehensive review by Health Canada, although the review process has faced delays due to a backlog. Nevertheless, CytoSorbents remains optimistic about achieving a regulatory decision in 2025.
CytoSorbents’ innovative blood purification technologies leverage highly porous polymer beads that efficiently remove toxic substances from blood. This technology is essential not only for reducing postoperative bleeding but also for addressing inflammatory agents and toxins in various critical conditions, including sepsis and traumatic injuries. Their lead product, CytoSorb®, is already CE marked in the European Union and has been utilized in over 270,000 treatments across more than 70 countries.
Establishing the DrugSorb-ATR device in the market aligns with CytoSorbents’ mission to enhance patient outcomes in critical care settings. This pursuit, together with the FDA’s Breakthrough Device Designation status, highlights the urgent medical need that CytoSorbents aims to fill.
As the company navigates through this regulatory landscape, it emphasizes its dedication to advancing healthcare solutions that save lives. CytoSorbents is committed to engaging with regulatory authorities to respond to concerns, ensuring that their innovative solutions can be brought to market swiftly and effectively.
For more detailed information about CytoSorbents Corporation and its product offerings, visit their official website. The company continues to foster partnerships and collaborations that could enhance its mission to address life-threatening conditions with cutting-edge medical technology.