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Advancing and Personalizing Kidney Disease Care

Annual Medical Report 2024

Mission

We provide the best possible care. Sustainably in diverse healthcare systems. For a growing number of patients around the world.

Ģý achieves optimal sustainable clinical, quality and technological standards in patient care through our commitment to developing innovative products and therapies.

The unique position of Ģý builds on many years of professional experience and continual innovation. Accordingly, the focus of our research and development effort is to maintain the technological and clinical edge needed to create innovative products and enhanced therapies. Our employees are united in our commitment to providing high-quality products and services and bringing the optimal sustainable medical and professional practices to patient care.

WeĢýre setting new standards of care by generating high-quality patient outcomes based on a deep understanding of medicine, science, engineering, and patient care.

Helen Giza

Chief Executive Officer, Chair of the Management Board

Letter from the CEO

Evolving the standard of kidney disease care is a vital part of our
patient-centric mission at Ģý.
Life can be complex for people living with kidney disease, with unique
challenges for each individual. Addressing this requires a personalized
care approach designed to improve health outcomes that enable greater
independence and quality of life.

Ģý is the world leader in engineering the medical
devices and technologies that make diverse kidney therapies possible.
The size, scale, and expertise of our Care Enablement business is
pioneering the renal care of tomorrow with high-quality MedTech
innovations.

Our Care Delivery business is dedicated to being the kidney care
provider of choice for patients, physicians and payors across the
healthcare spectrum. Supported by our Global Medical Office, weĢýre
setting new standards of care by generating high-quality patient
outcomes based on a deep understanding of medicine and science.

I am proud to introduce you to this yearĢýs Annual Medical Report, where
we discuss our work in evolving the standard of kidney disease care.
It features insights from some of the foremost experts working in the
field of renal care. They are insights that are powering solutions for
individuals and families who want more and better-quality time to enjoy
the precious gift of life.

When it comes to caring for patients and families, it takes all of us.
Thank you for joining us in leading the way for those who need it most.

Helen Giza
Chief Executive Officer,
Chair of the Management Board

Ģý the Global Medical Office

Franklin W. Maddux, MD, FACP

Global Chief Medical Officer, Member of the Management Board

Franklin W. Maddux oversees the delivery of high-quality, value-based care for the worldĢýs most expansive kidney care organization. His distinguished career encompasses more than three decades of experience as a physician, expert nephrologist, technology entrepreneur, and healthcare executive.

Dr. Maddux joined ĢýĢýs (FME) North America region in 2009 after the company acquired Health IT Services Group, a leading electronic health record (EHR) software company, which he founded. He developed one of the first laboratory electronic data interchange programs for the U.S. dialysis industry and later created one of the first web-based EHR solutions, now marketed under Acumen Physician Solutions.

He previously served as chief medical officer and senior vice president for Specialty Care Services Group and is the former president of VirginiaĢýs Danville Urologic Clinic, where he was a practicing nephrologist for nearly two decades. His writings have appeared in leading medical journals, and his pioneering healthcare information technology innovations are part of the permanent collection of the National Museum of American History at the Smithsonian Institution.

An alumnus of Vanderbilt University, Dr. Maddux earned his medical degree from the School of Medicine at the University of North Carolina at Chapel Hill, where he holds a faculty appointment as clinical associate professor.

Lorien Dalrymple, MD, MPH

Senior Vice President, Global Head of Population Health and Medicine

Board certified in nephrology, Dr. Dalrymple received her Bachelor of Science in Psychology from Duke University, Medical Degree from the University of Colorado, and Master of Public Health from the University of Washington. She completed her Internal Medicine Residency and Nephrology Fellowship at the University of Washington.

Prior to joining Ģý in 2016, she was an Associate Professor of Medicine at the University of California Davis. She has undertaken numerous research studies related to kidney disease and the associated complications and is a member of the Kidney Medicine editorial board. She served as a co-chair of the National Quality Forum Renal Standing Committee and co-chaired the Kidney Health Initiative ESKD Data Standards project. In addition, she has served on multiple Technical Expert Panels convened by the Centers for Medicare and Medicaid Services.

Benjamin E. Hippen, MD, FASN, FAST

Global Head of Clinical Affairs, Global Medical Office
Chief Medical Officer, Care Delivery

Dr. Hippen oversees the global clinical care delivery programs for Ģý, ensuring we deliver exceptional care and support to all patients under our care. Dr. Hippen specializes in ethical, organizational, and public policy issues in nephrology and transplantation. His contributions have advanced patient care initiatives and influenced broader clinical leadership, integrating transplantation into the dialogue among practicing nephrologists and within our Care Delivery framework.

Dr. Hippen received an undergraduate degree from Rice University and completed his medical school and internal medicine residency training at the Baylor College of Medicine. Thereafter, he completed a general nephrology and transplant nephrology fellowship at the University of Alabama in Birmingham. After completing his nephrology and transplant training, Dr. Hippen joined Metrolina Nephrology Associates, P.A. in Charlotte, North Carolina, a 40-nephrologist private practice, where he served as the medical director of two in-center hemodialysis facilities and, for several years, served as the medical director of a home therapies facility. During his time in Charlotte, he became a Clinical Professor of Medicine at the UNC Chapel Hill School of Medicine. Prior to joining Ģý in September 2021, Dr. Hippen served terms on the Ethics Committee and Membership and Professional Standards Committees of the Organ Procurement and Transplantation Network, served on the Board of Directors and was the chair of the Medical Advisory Board of ESRD Network 6, and served on the founding physician practice board of InterWell Health. Consonant with his ongoing research interests in ethical, organizational, and public policy issues in nephrology and transplantation, Dr. Hippen is the author of more than 70 peer-reviewed articles, essays, reviews, and book chapters.

Robert J. Kossmann, MD, FACP, FASN

Executive Vice President, Global Head of Medical Affairs, Chief Medical Officer, Care Enablement

Dr. Kossmann served as executive vice president and chief medical officer for FME North America from 2019 to 2021 and chief medical officer for FMEĢýs Renal Therapies Group, the companyĢýs medical equipment and renal pharmaceuticals division, from 2014 to 2019.

Dr. Kossmann has held a variety of leadership roles where he has provided guidance to the nephrology field, including as former president of the Renal Physicians Association (RPA); a founding member of RPAĢýs Nephrology Coverage Advocacy Program (now Policy Advocacy Leadership program); a nephrology advisor to the American Medical AssociationĢýs Relative Value Scale Update Committee; and founder of the New Mexico Renal Disease Collaborative Group.

A practicing nephrologist for two decades, Dr. Kossmann trained in nephrology at the University of Washington in Seattle and holds his bachelorĢýs and Doctor of Medicine degrees from Case Western Reserve University in Cleveland, Ohio.

Manuela Stauss-Grabo, PhD

Senior Vice President, Head of Clinical Research

Dr. Manuela Stauss-Grabo joined Ģý in 2013 and has since made significant contributions to the field of clinical research in nephrology. With over 20 years of experience, she currently serves as the Senior Vice President of Global Clinical Research in the Global Medical Office (GMO), where she leads a dedicated team focused on advancing the understanding and treatment of kidney disease. Dr. Stauss-GraboĢýs extensive background in biology and clinical research equips her with a unique perspective on the complexities of kidney health. Her leadership is instrumental in designing and implementing clinical studies that generate robust evidence, ultimately aimed at improving patient outcomes. She is passionate about bridging the gap between scientific research and practical application, ensuring that findings translate into effective therapies for patients suffering from kidneyrelated conditions. Under her guidance, the Ģý Clinical Research team, a global team of researchers, manages a diverse portfolio of national and international clinical studies. The team is responsible for overseeing all phases of researchĢýfrom strategic concept development to detailed planning and executionĢýensuring that each study adheres to the highest standards of quality, safety and compliance.

Dr. Stauss-Grabo received her Diploma in Biology from the Julius-Maximilians-University in Wuerzburg, Germany as a major in Biochemistry and completed her doctoral thesis titled ĢýInvestigations on the Pharmacokinetics of the Ivy Saponin Alpha-HederinĢý under the supervision of Prof Dr. Manfred Haake at the Institute of Pharmaceutical Chemistry, Philipps-Universität Marburg, Germany. This pioneering research provided the first comprehensive description of how alpha-hederin, a key saponin found in Hedera helix (common ivy), is processed in the body. The studyĢýs findings were significant, as they laid the groundwork for understanding the medicinal properties of ivy extracts, which have long been used in traditional medicine for respiratory conditions in many countries worldwide.

Dr. Stauss-Grabo is committed to fostering collaboration among stakeholders in the healthcare community, including researchers, clinicians, and regulatory bodies. Her efforts not only enhance the scientific rigor of clinical trials but also promote innovative approaches to tackling kidney disease on a global scale. Through her work at Ģý, Dr. Stauss-Grabo continues to make a profound impact on the lives of patients by driving forward initiatives that aim to enhance treatment options and improve overall health outcomes in nephrology.

Stefano Stuard, MD, PhD

Senior Vice President, Global Clinical Officer Hemodiafiltration

Dr. Stefano Stuard joined Ģý in 2010 as a Medical Director in FMEĢýs NephroCare business in the Europe, Middle East, and Africa (EMEA) region. Dr. StuardĢýs career includes more than 14 years in clinical governance roles with ĢýĢýs EMEA and Latin America regions. In his most recent role, he supported NephroCare medical leadership in his role as Chief Clinical Officer for the EMEA countries. Dr. Stuard has long been a champion of online hemodiafiltration as a kidney replacement therapy, overseeing its steady growth in NephroCare clinics. By June 2024, more than 61 percent of patients in our European Union clinics were treated by High-Volume Hemodiafiltration.

In his current role, Dr. Stuard will focus on educating nephrologists in FMEĢýs Care Delivery business segment and will support many of the aspects of our development of a comprehensive plan to make HDF therapy a standard of care. Dr. Stuard previously served as vice president and head of the EMEA Center of Excellence for Clinical and Therapeutic Governance and as a director/consultant for nephrology and dialysis departments in Italian public and private hospitals. He has published over 220 scientific publications in peer-reviewed journals. Dr. Stuard received his PhD in nephrology from the University of Bologna (Italy). He received his Doctor of Medicine and surgery as well as a post-graduate specialization in nephrology, magna cum laude, from the University of Chieti (Italy). He received an award from the European Society of Artificial Organs for his contribution in the field of artificial organs. Dr. Stuard is also a member of European Renal Association Kidney Relief in Disasters Task Force.

Len Usvyat, PhD

Senior Vice President, Head of Renal Research Institute

Len supports advanced analytics and data-driven functions within FME to advance the Global Medical Office agenda and support the Care Delivery and Care Enablement organizations. These functions include real-world evidence generation activities as well as applied data science efforts across various parts of the enterprise. LenĢýs team supports these functions through data analytics and data engineering, research and publications, as well as project management and administrative efforts. The team integrates advanced analytics into the clinical care of people with kidney disease, supports generation of clinical evidence to meet regulatory requirements and post-market surveillance of the FME products portfolio, uses real-world data to examine the clinical and cost-effectiveness of FME products, and generates insights that can be used in improving care of people with kidney disease worldwide.

Len chairs FMEĢýs Predictive Analytics Steering Committee, co-leads Global Advanced Analytics Alignment days, serves on the Steering Committee for the Apollo database, and works closely with the global MONitoring Dialysis Outcomes (MONDO) initiative, an international consortium of dialysis providers.

Len has published more than 100 manuscripts in peer-reviewed journals. He holds a masterĢýs degree from the University of Pennsylvania and a doctorate from the University of Maastricht in the Netherlands.

Extended GMO Executive Team

Syuhada Ahmad, MD

Senior Director, Global Medical Office Operations

Dr. Syuhada Ahmad leads GMO Operations within Population and Health Medicine. She earned her medical degree from Moscow Medical Academy, Russia, and has extensive experience in clinical quality, medical affairs, hospital operations, risk management, health informatics, and accreditations.

Dr. Ahmad oversees and drives a diverse array of medical projects in the Global Medical Office and GMO Enterprise Risk Management. She collaborates with stakeholders and leaders across the organization, providing strategic leadership and fostering essential partnerships for the success of medical risk, compliance, and operations programs.

Dr. Ahmad began her career with Ģý in Malaysia, moved to Hong Kong a few years later, and is now based in Bad Homburg, Germany.

Ryan A. Jimenez, EdM, APR

Senior Vice President, Head of Medical Communications

Ryan Jimenez joined FME in 2016 as vice president of Medical Office Relations for North America, where he led the development of the regionĢýs Medical Office communications strategies and capabilities.

With corporate communications, he led the development of the companyĢýs video broadcast network, including the creation of the Medical Office Live series of broadcast events across North America as executive producer.

He previously served as regional communications director for Four Seasons Hotels and Resorts, leading global communications campaigns in North America, EMEA, Latin America, and Asia, and is the former senior producer and global communications director for CNNĢýs Larry King Live.

He was appointed by California Governor Arnold Schwarzenegger as communications director for the office of First Lady Maria Shriver and began his career in hospital communications at Catholic Healthcare West in the United States.

Ryan received his bachelorĢýs degree from the Annenberg School of Communications and Journalism at the University of Southern California and holds his masterĢýs degree in organizational behavior and ethics from Harvard University.

Shelly Nash, DO, FACOOG, FACMI

Chief Medical Information Officer, Clinical Health Information Technology

A double board-certified physician, Shelly Nash is a seasoned physician executive with broad experience in informatics, advanced analytics, population health intelligence, enterprise-level care innovation and digital innovation. She has been part of large health systems, technology companies, in private practice as a physician, as well as a teaching attending at inner city Chicago hospitals. She truly believes that technology can improve the care of patients and the experience of providing care for clinicians if we are able to advance the field of informatics and become more patient and clinician-centric in our design of applications.

The Global Medical Office
Emeriti Program

The GMO Emeritus / Emerita program is a distinction awarded to retiring Medical Officers who have the equivalent of 10 years full-time service to FME. They are nominated by the Global Chief Medical Officer and approved by the Management Board for meritorious service to the mission of the company and distinguished contributions to healthcare and society. Medical Officers Emeriti remain connected to FME through ongoing participation in thought leadership and scientific inquiry. Emeriti Officers can be called upon as advisors and subject-matter experts.

Date of Induction
Bernard Canaud, MD, PhDDecember 31, 2022
Allan Collins, MD, FACPFebruary 17, 2022
Adelheid Gauly, PhD, MBAJune 14, 2022
Michael J. Lazarus, MDMarch 17, 2022
Dugan Maddux, MD, PhDJune 30, 2022
Norma Ofsthun, PhDApril 28, 2022
Thomas J.R. Roy, PhDJuly 31, 2022
Ted Toffelmire, MD, FRCPC, FACPDecember 1, 2023

Achieving the best health outcomes, with the greatest independence, and highest quality of life, requires diverse therapies that can meet each personĢýs complex and unique needs.

Franklin W. Maddux, MD, FACP
Global Chief Medical Officer, Member of the Management Board

Disclaimer

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. The opinions expressed in the document are of the authors only and in no way reflect the European CommissionĢýs opinions.

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).

Advancing and Personalizing Kidney Disease Care:

Advancing and Personalizing Kidney Disease Care:

2024 ANNUAL MEDICAL REPORT

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