Fresenius Medical Care Recent Study Validates Innovative Anemia Therapy Software Improves Clinical Outcomes for Hemodialysis Patients

• This randomized controlled study demonstrates that patients achieved a higher percentage of target hemoglobin levels
• Patients receiving anemia management assistance via the software tools saw a 25% reduction in erythropoiesis-stimulating agent (ESA) usage
• The software's physiology-based model and predictive controller were associated with improved hemoglobin fluctuations and variability, offering a higher likelihood of more stable hemoglobin levels compared to standard care protocols

Bad Homburg (October 24, 2024) -- Fresenius Medical Care (FME), the world’s leading provider of products and services for individuals with renal diseases, today announced innovative results from a multicenter, randomized controlled trial in the United States that highlights the potential benefits of personalized anemia therapy for patients undergoing hemodialysis. The study, “Effects of Individualized Anemia Therapy on Hemoglobin Stability,” published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrates that the use the anemia therapy assistance software, attained improved hemoglobin stability and reduced the use of erythropoiesis-stimulating agents (ESAs) among hemodialysis patients participating in the study1.

This innovative approach, which is part of the company’s ongoing commitment to improve patient outcomes, is powered by a physiology-driven mathematical model designed to deliver personalized treatment recommendations. The results showed a 25% improvement in hemoglobin target attainment for patients receiving individualized therapy compared to standard care. The findings are significant because maintaining target hemoglobin levels with less variability in patients can help reduce the risk of developing cardiovascular problems.

"This study exemplifies how data-driven insights can lead to more personalized treatments,” said Dr. Frank Maddux, MD, Chief Global Medical Officer of Fresenius Medical Care. “By integrating cuttingedge computational techniques, we are paving the way for more precise, patient-centered care, which not only improves clinical outcomes but also enhances quality of life for people on dialysis. Our commitment is to continue developing innovative solutions that transform kidney care worldwide."

The study, conducted by Dr. Doris H. Fuertinger and colleagues, enrolled 96 patients from five Fresenius Kidney Care clinics across the United States. Patients were randomized into two groups: one receiving personalized anemia treatment recommendations from the software, and the other following standard protocols. Over a 26-week period, patients in the personalized therapy group achieved greater hemoglobin stability, experienced fewer fluctuations, and required significantly less ESA, reducing their dose on average by 25%. Additional key findings suggest hemoglobin variability was significantly lower in the personalized therapy group, contributing to more stable patient
outcomes.

"This prospective, randomized controlled study highlights the value of physiological models and computer-aided individualization of therapy to improve clinical outcomes for people on dialysis," said Dr. Fuertinger, Head of Computational Medicine, Fresenius Medical Care. “By harnessing the power of these technologies, we are able to provide clinicians with actionable insights that may enable more precise and efficient therapy management.”

The study underscores FME’s vision of transforming renal care by designing cloud-based technologies and predictive analytics that can potentially integrate into daily clinical practice. As healthcare moves toward greater personalization, the company is committed to utilizing these advanced tools to optimize patient care and support clinicians in making data-driven decisions.

“We are proud to be at the forefront of this important research by developing novel approaches to treat end-stage renal failure," said Dr. Katarzyna Mazur-Hofsaess, member of the Management Board of Fresenius Medical Care and responsible for the segment Care Enablement. “Our commitment to new technology continues to support the individualization of care for people living with kidney disease.”

¹ Fuertinger, Doris H., et al. "Effects of Individualized Anemia Therapy on Clinical Outcomes in Patients Undergoing Hemodialysis." Clinical Journal of the American Society of Nephrology, vol. 19, no. 9, 2024, pp. 1100-1110.

About Fresenius Medical Care:
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 4.1 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,757 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 311,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

Disclaimer: 
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this release.