Fresenius Kabi announced today it has signed a multiyear agreement under which the Mayo Clinic is expected to purchase 10,000 Ivenix large-volume infusion pumps for its hospitals and clinics in Minnesota, Arizona, and Florida. This is the largest contract for Ivenix pumps Fresenius Kabi has signed to date, testament of the stringent implementation of the company’s Vision 2026 strategy.

Fresenius Kabi announced today the launch of its tocilizumab biosimilar Tyenne^® referencing RoActemra^®** (tocilizumab) in the European Union. 

Tyenne^® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases.

Tyenne^® is Fresenius Kabi’s third approved biosimilar launched in Europe, offering patients and heath care providers a flexible range of user-friendly subcutaneous (prefilled syringe and autoinjector) and intravenous (vials) administration. 

* Tyenne^® (tocilizumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
** RoActemra^® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

• Company-wide research offers novel pathways for enhancing kidney patient care using data-driven insights and real-world evidence

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the presentation of over 60 company-affiliated research abstracts at the American Society of Nephrology’s (ASN) Kidney Week 2023 taking place November 2-5 in Philadelphia.  

“The scientific and medical breadth of research presented this year highlights the power of Fresenius Medical Care’s global scope and scale in creating data-driven insights that have the potential to improve patient care and outcomes,” said Dr. Frank Maddux, Global Chief Medical Officer and Member of the Management Board for Fresenius Medical Care. “Our presentations cover key topics including advances in machine learning and artificial intelligence in kidney care, using big data and real-world evidence to drive insights, advancing home dialysis, and research around hemodiafiltration (HDF) and hemodialysis (HD) therapies. We look forward to sharing our insights at this year’s conference.”   
 
Scientific and medical experts from across Fresenius Medical Care will present research related to many important topics in kidney disease care. A link to all Fresenius Medical Care-affiliated presentations can be found on our company’s website: https://fmcna.com/ASN-2023/. Highlights of this year’s presentations for the medical congress include:

• Artificial Intelligence and Data Science: 
  • Impact of Nationwide Utilization of a Machine Learning Model to Identify Home Therapy Candidates (November 2, 10:00 AM – 12:00 PM): Education on a machine learning predictive model which identifies in-center hemodialysis patients who would be good candidates for home therapy.
  • Comparative Prognostic Accuracy of Vascular Access Flow and Artificial Intelligence (AI)-Based Arteriovenous Fistula (AVF) Failure Risk Score (November 3, 10:00 AM – 12:00 PM): Presenting a risk score which accurately and reproducibly predicts AVF failure within 3 months that may offer a cheaper and automated alternative to Qa measurement.
• Data-Driven Global Insights:
  • Apollo DB: Characteristics of a Global Dialysis Database Across Major World Regions (November 2, 10:00 AM – 12;00 PM): Capturing data from over 40 countries, Apollo DB is an anonymized dialysis database that combines and harmonizes data from a global provider for research and quality improvement activities.
  • Characteristics of Global Dialysis Data from Multiple Providers in the New MONitoring Dialysis Outcomes (MONDO) Dataset (November 2, 10:00 AM – 12:00 PM): Research captured from 20 years of longitudinal patient data contributed to the new MONDO dataset, the most robust global dialysis dataset in the world.
  • Creatinine Clearance Predicts Longitudinal Phosphate Levels Irrespective of Achieved Urea Kt/V: A Peritoneal Dialysis-MONDO Analysis (November 4, 10:00 AM – 12:00 PM): Experts present a study designed to evaluate if CrCl predicts longitudinal PO4 irrespective of achieved Kt/V.
• Hemodiafiltration (HDF) and Hemodialysis (HD) Research:
  • Relative Blood Volume Monitoring Using Crit-Line and Hospital Admissions: A Retrospective Analysis of over 25,000 Patients Across 330 Dialysis Clinics (November 2, 10:00 AM – 12:00 PM): Presenting a comparison of hospital admissions among Fresenius Kidney Care (FKC) clinics with high utilization of RBV and propensity score matched (PSM) clinics not using RBV.
  • Real-World Effectiveness of Hemodialysis Modalities (November 2, 10:00 AM – 12:00 PM): A late-breaking abstract that provides real world evidence demonstrating comparison of patients treated with hemodialysis vs hemodiafiltration.
  • Dialyzer Performance and Associations in Self-Reported Pruritis and Fatigue: Results from the eMPORA III Trial (November 3, 10:00 AM – 12:00 PM): eMPORA III was a multi-center crossover trial with 4-week randomized treatment periods comparing dialyzer performance (FX CorAL 600 vs two comparable high-flux dialyzers) in post-dilution online hemodiafiltration (HDF).
  • Psychometric Validation of the CONVINCE Inter- and Intradialytic Symptoms Questionnaire (November 3, 10:00 AM – 12:00 PM): The CONVINCE Scientific Committee and CONVINCE Investigators present the survey developed based on the KDQOL symptoms scale with an adapted recall period of 7 days for interdialytic symptoms and extended inter- and intradialytic (IDS) items based on literature review and patient interviews.

• Powerful Cloud-Based Data Asset to Drive Improvements in Care Quality and Patient Outcomes as the Largest Multinational, Longitudinal Database of its kind
• Achievement Part of Company’s Long-Term AI Strategy and Ongoing Digital Transformation Efforts 

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the phase-one completion of the company’s first anonymized global dialysis dataset—coined the Apollo database project—the foundation of the company’s long-term AI aspirations. Intended to advance patient care quality and outcomes by making kidney disease care more personalized and precise, the database provides a highly sophisticated view into the clinical care provided to more than 540 thousand dialysis patients, the largest multinational, longitudinal database of its kind.

“Artificial intelligence is only as good as the data that powers it,” says Frank Maddux, MD, Global Chief Medical Officer and Member of the Management Board. “The Apollo database is not only helping advance our understanding of kidney disease and dialysis therapies through data-driven insights. It also provides data that is high quality, relevant and timely, three vital data attributes that are crucial to achieving AI aspirations at scale.” 

Phase one of the Apollo Database project harmonizes data from across the company’s global clinical systems into the cloud, aggregating data from 40 countries across 6 continents on more than 350 patient treatment parameters. It includes information from more than 540 thousand dialysis patients, more than 140 million dialysis treatments, and more than 34 million laboratory assessments. 

The database provides full anonymization of data and a streamlined pathway for global analytics all while adhering to the complex set of global, regional and local privacy requirements, including HIPAA and GDPR.

“The data created across Fresenius Medical Care’s global clinical footprint is unmatched in its breadth and depth, and is one of the company’s greatest competitive advantages,” said Stuart McGuigan, Global Chief Information Officer of Fresenius Medical Care. “Reimagining our digital infrastructure has been a key part of our organizational transformation, and the achievement of the Apollo Database project is an important benchmark in not just our digital transformation, but in our long-term AI strategy.” 

The Apollo Database project will be featured in numerous research presentations by Fresenius Medical Care experts at this year’s American Society of Nephrology Kidney Week conference—one of the world’s largest and most influential gatherings of kidney disease physicians and experts—happening November 2-5 in Philadelphia, Pennsylvania in the U.S. 

“Dialysis care generates a large amount of data that can be used for secondary purposes, but multinational datasets are scarce due to the fundamental need for adherence to varying complex data protection regulations around the world, as well as the challenges in harmonization of data from different clinical systems,” said Len Usvyat, PhD, Head of Clinical Advanced Analytics for Fresenius Medical Care. “This important data tool increases the speed and robustness of the company’s analytical capabilities and provides greater consistency in generating data-driven clinical insights. The knowledge gained from these efforts have the potential to improve not just the practice of medicine, but more importantly the quality of life for people with kidney disease.”

The project is coordinated by the Global Medical Office in collaboration with the company’s Digital Technology & Innovation, Care Delivery and Care Enablement teams. The project is already powering more than 15 clinical improvement projects, such as a global feasibility assessment of the expanded use of an Anemia Control Model, an artificial intelligence model being used in many countries to optimize use of erythropoietin stimulating agents and iron therapies in dialysis patients. 
 

Fresenius Kabi has been named the 2023 Supplier Partner of the Year by Vizient, Inc., the largest U.S. provider of healthcare performance improvement services. This recognition reflects Fresenius Kabi’s commitment to collaboration and innovation to enhance quality of care and patient safety. 

This is Fresenius Kabi’s second time being named Vizient’s Supplier Partner of the Year. 

Fresenius Kabi and its license partner Formycon announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for FYB202, an Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara^®*, a human monoclonal antibody for the treatment of immune-mediated disorders. 

Fresenius Kabi is the commercialization partner. The acceptance of the MAA for review marks another milestone in the company’s Vision 2026 growth strategy.

For more information, please see the website of Fresenius Kabi. 

* Stelara^® is a registered trademark of Johnson & Johnson

Fresenius Kabi announced today it has signed an agreement with Virginia Oncology Associates (VOA) under which VOA will purchase the Ivenix Infusion System to deliver medications for its patients. VOA specializes in treating people with cancer and blood disorders. It is part of the national US Oncology network.

Fresenius Kabi and VOA have agreed to work together to integrate the Ivenix Infusion System with VOA’s electronic medical record (EMR) system.  

Contact

T: +49 (0) 6172 608-4030
leif.heussen@fresenius.com

Documents

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Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for Versi®HD with GuideMe Software, a completely reinvented self-guided interface for the company’s VersiHD chronic home hemodialysis (HHD) system. VersiHD with GuideMe Software aims to transform the experience of HHD for patients and nurses.

As the established leader in HHD, NxStage from Fresenius Medical Care, draws on its experience of over 30 million patient treatments at home over nearly two decades, serving patients in more than 45,000 homes with a broad diversity of water sources across the U.S.

VersiHD with GuideMe Software provides graphical walk-through guidance that aims to enhance ease of use and confidence for both patients and nurses. It is designed to improve patient training time, ease the transition to home, and make the training experience easier for new users.

“With over 13,000 HHD patients in the U.S. alone, we are excited to amplify the innovation NxStage offers with advanced technologies, like VersiHD with GuideMe Software,” said Dr. Katarzyna Mazur-Hofsäß, CEO of Fresenius Medical Care’s Care Enablement segment. “We are committed to providing cutting-edge solutions to improve the health and well-being of dialysis patients by challenging the standard of home dialysis with the design of industry-leading products.”

“We expect VersiHD with GuideMe Software to further simplify home hemodialysis for patients during training and at home,” said Dr. Brigitte Schiller, Senior Vice President, Medical Officer, Home Therapies at Fresenius Medical Care. “As a result of this software upgrade, patients and their care partners will have additional support to be confident with the therapy at home.  VersiHD with GuideMe Software will support Fresenius Medical Care’s mission of advancing access to home therapies to more patients.”

NxStage has had many significant innovations over the years guided by patient input starting with the first portable HHD machine, NxStage System One™, in 2005 followed by the introduction of the PureFlow™ DI Water Purification System in 2006. Nx2me Connected Health®, the first Connected Health platform for HHD followed in 2014. The NxStage System One was the first machine to receive FDA clearance for Nocturnal HHD indication in 2014 and also the first to receive FDA clearance for Solo HHD indication in 2017. In 2017, NxStage introduced the VersiHD touchscreen cycler. Over 95% of HHD patients in the U.S. use the NxStage HHD system.

VersiHD with GuideMe Software will initially be available in selected markets in 2023. Existing VersiHD systems will be upgradeable to GuideMe Software. For more information about VersiHD with GuideMe Software, please visit www.nxstage.com/hcp/versihdguideme.

Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Gadobutrol Injection, a gadolinium-based contrast agent for used in MRIs.¹ It is the latest addition to Fresenius Kabi’s new radiology portfolio that offers hospitals a range of cost-effective contrast agents. The second product, Plerixafor Injection, a hematopoietic stem cell mobilizer is the newest addition to the company’s large generic injectable oncology medicine portfolio. 

¹ Gadobutrol Injection Package Insert, January 2023
 

Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025. 

FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders. 

* Stelara® is a registered trademark of Johnson & Johnson