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 Città 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 mortalità 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), líder mundial en productos y servicios para enfermedades renales, ha ampliado su terapia de Hemodiafiltración de Alto Volumen (HighVolumeHDF) en México mediante una asociación con CCINSHAE. El contrato de dos años incluye la instalación de 150 sistemas Fresenius Medical Care 5008S CorDiax en siete centros CCINSHAE en Ciudad de México.
El programa ahora atiende a 240 nuevos pacientes no asegurados de CCINSHAE y a 410 pacientes asegurados regulares. Estudios clínicos, incluido el ensayo CONVINCE, demostraron que la terapia HighVolumeHDF reduce la mortalidad por todas las causas en un 23% en comparación con la hemodiálisis de alto flujo estándar. Tras la aprobación de la FDA de su sistema 5008X CARE en mayo de 2025, Fresenius planea lanzar HighVolumeHDF en el mercado estadounidense para 2026.
Fresenius Medical Care (NYSE:FMS)는 신장 질환 제품 및 서비스 분야의 글로벌 선두주자로서, CCINSHAE와의 파트너십을 통해 멕시코에서 고용량 혈액여과 투석(HighVolumeHDF) 치료를 확대했습니다. 2년 계약에는 멕시코시티 내 7개 CCINSHAE 센터에 150대의 Fresenius Medical Care 5008S CorDiax 시스템 설치가 포함됩니다.
이 프로그램은 현재 240명의 신규 무보험 CCINSHAE 환자와 410명의 정기 보험 환자를 치료하고 있습니다. CONVINCE 임상시험을 포함한 연구 결과, HighVolumeHDF 치료는 표준 고유량 혈액투석 대비 전체 사망률을 23% 감소시키는 것으로 나타났습니다. 2025년 5월 FDA 승인을 받은 5008X CARE 시스템 출시 후, Fresenius는 2026년까지 미국 시장에 HighVolumeHDF를 선보일 계획입니다.
Fresenius Medical Care (NYSE:FMS), leader mondial des produits et services pour les maladies rénales, a étendu sa thérapie d'hémodiafiltration à haut volume (HighVolumeHDF) au Mexique grâce à un partenariat avec CCINSHAE. Le contrat de deux ans prévoit l'installation de 150 systèmes Fresenius Medical Care 5008S CorDiax dans sept centres CCINSHAE à Mexico.
Le programme traite désormais 240 nouveaux patients non assurés CCINSHAE et 410 patients assurés réguliers. Des études cliniques, dont l'essai CONVINCE, ont montré que la thérapie HighVolumeHDF réduit la mortalité toutes causes confondues de 23% par rapport à l'hémodialyse à haut flux standard. Après l'autorisation de la FDA de son système 5008X CARE en mai 2025, Fresenius prévoit de lancer HighVolumeHDF sur le marché américain d'ici 2026.
Fresenius Medical Care (NYSE:FMS), der weltweit führende Anbieter von Produkten und Dienstleistungen für 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 regulär versicherte Patienten. Klinische Studien, darunter die CONVINCE-Studie, zeigten, dass die HighVolumeHDF-Therapie die Gesamtmortalität um 23% gegenüber der Standard-Hochfluss-Hämodialyse reduziert. Nach der FDA-Zulassung seines 5008X CAREsystems im Mai 2025 plant Fresenius, HighVolumeHDF bis 2026 auf dem US-Markt einzuführen.
- 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—the 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—HighVolumeHDF 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.
"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
In the
In the future, the company wants to bring HighVolumeHDF therapy – already widely used in
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
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 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
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
Media contact
Emanuela Cariolagian
T +1 213 706 0051
Emanuela.cariolagian1@freseniusmedicalcare.com
Christine Peters
T +49 160 60 66 770
christine.peters@freseniusmedicalcare.com
Contact for analysts and investors
Dr. Dominik Heger
T +49 6172 609 2601
dominik.heger@freseniusmedicalcare.com
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SOURCE Fresenius Medical Care Holdings, Inc.
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?
