Core Viewpoint - Fresenius Medical Care is advancing its high-volume hemodiafiltration (HVHDF) kidney replacement therapy in the U.S. following FDA clearance for its updated 5008X CAREsystem, marking a significant step in the company's commercialization strategy for 2025 and a full-scale launch in 2026 [1][2][7] Company Developments - The updated 5008X CAREsystem received FDA 510(k) clearance, enabling Fresenius Medical Care to enhance patient care through improved dialysis technology [2][4] - The company plans to deploy the new system in a first wave of Fresenius Kidney Care clinics throughout 2025, with broader implementation expected in 2026 [2][3] - The 5008X CAREsystem features the Fresenius Clinical Data Exchange® (CDX), which allows for direct access to medical information systems at the chairside, optimizing clinic workflows and reducing clutter [2][4] Industry Context - Hemodiafiltration is already the standard treatment in many regions, including Europe, Latin America, and Asia, and the company aims to establish this standard in the U.S. [2] - The CONVINCE study demonstrated a 23% reduction in mortality rates for patients using high-volume hemodiafiltration compared to traditional high-flux hemodialysis, highlighting the potential benefits of this therapy [5][8] Market Potential - There are approximately 160,000 in-center hemodialysis machines in the U.S. that could be replaced with the new standard of care, indicating a significant market opportunity for Fresenius Medical Care [3]
Fresenius Medical Care Begins Broader U.S. Commercialization of 5008X™ CAREsystem, Achieves Key Milestones in Efforts to Introduce High-Volume Hemodiafiltration Dialysis Therapy to Individuals with Kidney Disease in the U.S.