Fresenius Medical Care Collaborates with Coordination of National Institutes of Health and Specialty Hospital to Extend Access to Innovative Dialysis Therapy in Mexico

• High-Volume Hemodiafiltration is used for the first time in seven out of 10 CCINSHAE centers in Mexico
• In Mexico, 240 CCINSHAE patients are now being treated; more than 410 regular patients also treated
• Fresenius Medical Care is committed to expanding HighVolumeHDF therapy to all markets where it is not already present, including the United States

BAD HOMBURG, Germany, July 3, 2025 /PRNewswire/ -- Fresenius Medical Care (FME), the world's leading provider of products and services for individuals with renal diseases, will extend High-Volume Hemodiafiltration (HighVolumeHDF) access for patients in seven out of 10 centers in Mexico, by partnering with the country's Coordination of National Institutes of Health and Specialty Hospitals (CCINSHAE) to develop a pilot program that provides low-income patients without medical coverage in Mexico with access to hemodialysis therapies.  

Fresenius Medical Care Mexico and CCINSHAE signed a two-year contract to enable the installation of the Fresenius Medical Care 5008S CorDiax technology in participating renal treatment centers in CCINCSHAE Centers in Mexico City (CDMX) and its metropolitan area, for a total of 150 systems in all.

"The groundbreaking pilot program, with its mission to provide chronic kidney disease patients with access to high quality treatments that were previously out of their reach, represents an important advancement in CKD in Mexico," said Edgar Robles, Fresenius Medical Care Mexico's Managing Director of Care Enablement Commercial Operations.

This technology provides standard hemodialysis as well as HighVolumeHDF, a therapy that has demonstrated improved patient well-being while increasing cost-effectiveness in most health care systems.

The initiative between Fresenius Medical Care and the CCINSHAE has recently provided HighVolumeHDF treatment to 240 new CCINSHAE patients who do not have public or private medical coverage. Further 410 regular patients, who are covered by public or private medical insurance, already started receiving HighVolumeHDF last year.

Some of these patients were part of the hemodialysis (HD) program in CCINSHAE centers and transitioned to HighVolumeHDF, while others were new patients assigned to CCINSHAE centers for various reasons, including new diagnoses, transitions from peritoneal dialysis to hemodiafiltration or patients entering the transplant program, thus doubling the number of patients via these other sources.  

"Fresenius Medical Care is committed to providing access to innovative therapies such as HighVolumeHDF," continued Robles. "Our approach is to raise quality standards in dialysis, which also improves the quality of life of patients, and simplifies operational procedures and provides efficient hemodialysis solutions for healthcare professionals."    

High-Volume Hemodiafiltration is backed by multiple clinical studies, including the international, randomized and controlled CONVINCE¹ Trial, which compares high-volume hemodiafiltration with standard high-flux hemodialysis. The study reported a 23% reduction rate on average of all-cause mortality for patients treated with High-Volume Hemodiafiltration compared to those treated with the more commonly used high-flux hemodialysis.  

In the Americas, Fresenius Medical Care's HighVolumeHDF therapy is currently used in Argentina, Brazil, Canada, Caribbean Islands, Chile, Colombia, Ecuador, Mexico, Panama, Peru, and Uruguay.

In the future, the company wants to bring HighVolumeHDF therapy – already widely used in Europe, Latin America, and Asia Pacific – for people living with kidney diseases in the U.S. In February 2024, Fresenius Medical Care announced it was the first company to receive U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.

In May 2025, the company received FDA 510(k) clearance for the updated version of its new, hemodiafiltration-capable 5008X CAREsystem with additional features, a key benchmark enabling the next steps in the company's broader commercialization efforts across the U.S. later this year, followed by a full-scale commercial launch in 2026.

Coordination of National Institutes of Health and Specialty Hospitals (CCINSHAE) is part of the Public Healthcare system in Mexico (Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad).

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 4.2 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,675 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 299,000 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).

For more information visit the company's website at www.freseniusmedicalcare.com.

The CONVINCE study was exclusively supported by the European Commission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population (grant no 754803).

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.

¹Blankestijn PJ et al., CONVINCE Scientific Committee Investigators, Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure, N Engl J Med 2023 Aug 24;389(8):700-709

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SOURCE Fresenius Medical Care Holdings, Inc.