Fresenius Medical Care (FME) Expert Call summary

Overview of high-volume HDF and clinical benefits

• High-volume HDF combines diffusion and convection to remove a broader range of toxins, closely mimicking natural kidney function and maintaining albumin levels.

• Post-dilution, high-volume HDF (≥23L/session) is the most efficient form, preferred for optimal volume management and clinical outcomes, with proven benefits in clinical studies and over a decade of use in Europe.

• Clinical trials, especially the CONVINCE trial, demonstrated a 23% reduction in all-cause mortality and improved patient-reported outcomes, including cognitive function, compared to high-flux hemodialysis.

• Real-world data from over 85,000 patients across 23 countries confirmed a 22% reduction in all-cause mortality, a 31% reduction in cardiovascular mortality, reduced inflammation, and better anemia and mineral-bone disease management.

• HDF has grown at a 13% annual rate internationally, is available in over 90 countries, and is recommended as a first-line option by NICE in England.

US market introduction and strategy

• The Coral (FX CorAL) dialyzer and 5008X machine have received US approval, with a significant HDF launch planned for late 2025; first US patients were treated in June 2024.

• Physician education and support are key to adoption, with protocols developed for both new and existing dialysis patients.

• The 5008X machine offers operational advantages, such as no required disinfection between treatments, reducing labor costs.

• No current plans for higher reimbursement or add-on payments in the US; clinical benefits are expected to drive adoption.

• FME leverages its integrated care delivery and enablement capabilities, with an installed base of 160,000 machines in the US, to introduce HDF as a new standard of care.

Competitive landscape and reimbursement

• Currently, the 5008X is the only FDA-approved HDF machine in the US, though global competitors exist.

• In Europe, HDF penetration varies by country, often influenced by reimbursement policies; the CONVINCE trial is expected to drive broader adoption.

• US adoption is anticipated to be market-driven, with no expected reimbursement caps as seen in some European countries.