Fresenius Medical Care Collaborates with Coordination of National Institutes of Health and Specialty Hospital to Extend Access to Innovative Dialysis Therapy in Mexico
Fresenius Medical Care (NYSE:FMS), the global leader in renal disease products and services, has expanded its High-Volume Hemodiafiltration (HighVolumeHDF) therapy in Mexico through a partnership with CCINSHAE. The two-year contract includes installing 150 Fresenius Medical Care 5008S CorDiax systems across seven CCINSHAE centers in Mexico City.
The program now treats 240 new uninsured CCINSHAE patients and 410 regular insured patients. Clinical studies, including the CONVINCE Trial, showed HighVolumeHDF therapy reduces all-cause mortality by 23% compared to standard high-flux hemodialysis. Following FDA clearance of its 5008X CAREsystem in May 2025, Fresenius plans to launch HighVolumeHDF in the U.S. market by 2026.
Fresenius Medical Care (NYSE:FMS), leader mondiale nei prodotti e servizi per le malattie renali, ha ampliato la sua terapia di Emodiafiltrazione ad Alto Volume (HighVolumeHDF) in Messico grazie a una collaborazione con CCINSHAE. Il contratto biennale prevede l'installazione di 150 sistemi Fresenius Medical Care 5008S CorDiax in sette centri CCINSHAE a Citt脿 del Messico.
Il programma ora tratta 240 nuovi pazienti non assicurati CCINSHAE e 410 pazienti assicurati regolari. Studi clinici, incluso il trial CONVINCE, hanno dimostrato che la terapia HighVolumeHDF riduce la mortalit脿 per tutte le cause del 23% rispetto all'emodialisi ad alto flusso standard. Dopo l'approvazione FDA del suo 5008X CAREsystem nel maggio 2025, Fresenius prevede di lanciare HighVolumeHDF nel mercato statunitense entro il 2026.
Fresenius Medical Care (NYSE:FMS), l铆der mundial en productos y servicios para enfermedades renales, ha ampliado su terapia de Hemodiafiltraci贸n de Alto Volumen (HighVolumeHDF) en M茅xico mediante una asociaci贸n con CCINSHAE. El contrato de dos a帽os incluye la instalaci贸n de 150 sistemas Fresenius Medical Care 5008S CorDiax en siete centros CCINSHAE en Ciudad de M茅xico.
El programa ahora atiende a 240 nuevos pacientes no asegurados de CCINSHAE y a 410 pacientes asegurados regulares. Estudios cl铆nicos, incluido el ensayo CONVINCE, demostraron que la terapia HighVolumeHDF reduce la mortalidad por todas las causas en un 23% en comparaci贸n con la hemodi谩lisis de alto flujo est谩ndar. Tras la aprobaci贸n de la FDA de su sistema 5008X CARE en mayo de 2025, Fresenius planea lanzar HighVolumeHDF en el mercado estadounidense para 2026.
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Fresenius Medical Care (NYSE:FMS), leader mondial des produits et services pour les maladies r茅nales, a 茅tendu sa th茅rapie d'h茅modiafiltration 脿 haut volume (HighVolumeHDF) au Mexique gr芒ce 脿 un partenariat avec CCINSHAE. Le contrat de deux ans pr茅voit l'installation de 150 syst猫mes Fresenius Medical Care 5008S CorDiax dans sept centres CCINSHAE 脿 Mexico.
Le programme traite d茅sormais 240 nouveaux patients non assur茅s CCINSHAE et 410 patients assur茅s r茅guliers. Des 茅tudes cliniques, dont l'essai CONVINCE, ont montr茅 que la th茅rapie HighVolumeHDF r茅duit la mortalit茅 toutes causes confondues de 23% par rapport 脿 l'h茅modialyse 脿 haut flux standard. Apr猫s l'autorisation de la FDA de son syst猫me 5008X CARE en mai 2025, Fresenius pr茅voit de lancer HighVolumeHDF sur le march茅 am茅ricain d'ici 2026.
Fresenius Medical Care (NYSE:FMS), der weltweit f眉hrende Anbieter von Produkten und Dienstleistungen f眉r Nierenerkrankungen, hat seine High-Volume-Hemodiafiltration (HighVolumeHDF)-Therapie in Mexiko durch eine Partnerschaft mit CCINSHAE ausgeweitet. Der Zweijahresvertrag umfasst die Installation von 150 Fresenius Medical Care 5008S CorDiax-Systemen in sieben CCINSHAE-Zentren in Mexiko-Stadt.
Das Programm behandelt nun 240 neue nicht versicherte CCINSHAE-Patienten und 410 regul盲r versicherte Patienten. Klinische Studien, darunter die CONVINCE-Studie, zeigten, dass die HighVolumeHDF-Therapie die Gesamtmortalit盲t um 23% gegen眉ber der Standard-Hochfluss-H盲modialyse reduziert. Nach der FDA-Zulassung seines 5008X CAREsystems im Mai 2025 plant Fresenius, HighVolumeHDF bis 2026 auf dem US-Markt einzuf眉hren.
- Clinical studies demonstrate 23% reduction in all-cause mortality with HighVolumeHDF therapy
- Expansion of treatment access to 240 new uninsured patients in Mexico
- FDA 510(k) clearance received for 5008X CAREsystem, enabling U.S. market entry
- Two-year contract secured for installation of 150 new treatment systems
- Significant investment required for system installations and expansion
- Extended timeline for full U.S. commercial launch (2026)
- Limited initial rollout to only 7 out of 10 CCINSHAE centers in Mexico
Insights
FMS expands innovative dialysis therapy in Mexico while preparing for US launch; positive for treatment access and business growth.
Fresenius Medical Care's partnership with Mexico's CCINSHAE represents a strategic expansion of their High-Volume Hemodiafiltration (HighVolumeHDF) therapy. The two-year contract has enabled installation of 150 Fresenius 5008S CorDiax systems across seven CCINSHAE centers, providing treatment to 240 new uninsured patients and 410 insured patients.
The clinical significance here is substantial. HighVolumeHDF isn't just another dialysis variant鈥攖he CONVINCE Trial demonstrated a
From a business perspective, this Mexican partnership serves as a strategic foothold as Fresenius develops its broader North American strategy. The company has secured critical FDA clearances for its 5008X Hemodialysis System (February 2024) and the hemodiafiltration-capable 5008X CAREsystem (May 2025), setting the stage for US commercialization later in 2025 and full-scale launch in 2026.
This expansion follows a proven playbook鈥擧ighVolumeHDF is already established in Europe, Latin America, and Asia Pacific. The Mexican implementation demonstrates Fresenius's ability to navigate partnerships with public health systems while serving both insured and uninsured populations. By doubling patient numbers through various entry channels (new diagnoses, transitions from peritoneal dialysis, and transplant program entries), Fresenius is validating their market penetration strategy before the crucial US launch.
- 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,
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
"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
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.听听
"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." 听听听
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
In the
In the future, the company wants to bring HighVolumeHDF therapy 鈥� already widely used in
In May 2025, , a key benchmark enabling the next steps in the company's broader commercialization efforts across the
Coordination of National Institutes of Health and Specialty Hospitals (CCINSHAE) is part of the Public Healthcare system in
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听.
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
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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FAQ
What are the clinical benefits of Fresenius Medical Care's HighVolumeHDF therapy?
How many patients are currently receiving HighVolumeHDF treatment through the CCINSHAE partnership in Mexico?
When will Fresenius Medical Care (NYSE:FMS) launch HighVolumeHDF therapy in the United States?
What is the scope of the CCINSHAE partnership in Mexico?
In which countries is Fresenius Medical Care's HighVolumeHDF therapy currently available in the Americas?
