Arteriovenous Fistula

A dedicated session will highlight new advancements in hemodiafiltration therapy showcasing its potential to improve patient outcomes through enhanced toxin removal in dialysis treatments. Company-wide researchers and clinical experts share insights from large global databases, revealing crucial trends in kidney failure etiology, cardiovascular risks, and treatment modalities across different regions. Nearly 75 abstracts presented across a broad range of cutting-edge research, covering topics from the global impact of dialysis to advancements in kidney care technology, sustainability, and health equity. BAD HOMBURG, Germany , Oct. 21, 2024 /PRNewswire/ -- Fresenius Medical Care (FME), the world’s leading provider of products and services for individuals with renal diseases, today announced the presentation of nearly 75 company-affiliated research abstracts at the American Society of Nephrology’s (ASN) Kidney Week 2024 taking place October 24-27 in San Diego . “We are pleased to present research that exemplifies our ongoing commitment to advancing kidney care on a global scale,” said Frank Maddux , MD, Global Chief Medical Officer at Fresenius Medical Care. “This year’s abstracts highlight key innovations in treatment approaches, including high-volume hemodiafiltration, as well as the integration of artificial intelligence. We aim to leverage insights from Fresenius Medical Care’s global databases to improve patient outcomes and drive more equitable, sustainable care for people working to live meaningful lives with kidney disease worldwide.” Fresenius Medical Care has provided an educational grant to the American Society of Nephrology in support of an educational symposium during Kidney Week, The Role of Hemodiafiltration in the Management of Dialysis-Dependent Chronic Kidney Failure , on October 25, 2024 , 12:45 PM PDT - 01:45 PM PDT . In recent years, hemodiafiltration (HDF) has been increasingly recognized for the treatment of patients with kidney failure requiring dialysis. HDF uses enhanced convection in combination with diffusion to improve the removal of large solutes such as beta-2-microglobulin and kappa and lambda light chains. While HDF has been used in Europe widely for many years, beginning in 2025, Fresenius Medical Care will gradually introduce this therapy into its Fresenius Kidney Care dialysis clinics in the United States . In February 2024, Fresenius Medical Care received FDA 510(k) clearance for the company’s 5008X Hemodialysis System , an HDF and HighVolume HDF-capable dialysis machine in the U.S. At the ASN Kidney Week 2024, scientific and medical experts from across Fresenius Medical Care will present research related to many important topics in kidney disease care. Highlights of this year’s presentations include: Advancing High-Volume Hemodiafiltration (HVHDF) Mortality Risk on Hemodiafiltration Compared with High-Flux Hemodialysis: Real-World Evidence from a Large Brazilian Cohort : Patients undergoing online hemodiafiltration (HDF) have been associated with better survival compared to those on high-flux hemodialysis (HD). Recently, the use of HDF has grown markedly in Brazil , but there is no robust real-world Brazilian study on the impact of this dialysis modality on patient’s outcomes. Hemodiafiltration Is Associated with Lower Hospitalization Rates Compared with Hemodialysis in a Singapore Cohort : Hemodialysis (HD) patients suffer from high rates of hospitalization leading to significant morbidity, mortality, and costs. Hemodiafiltration (HDF) has been shown to improve patient outcomes. Adequate Convective Volume Can Be Achieved in Majority of Multiethnic Asian Patients Receiving Hemodiafiltration in Singapore : High-volume hemodiafiltration (HDF) has been shown to improve patient outcomes. However, there is a very common concern amongst healthcare practitioners about the feasibility of achieving optimal convective volume (CV) in Asian patients. Sustainability and Equity in Kidney Care High Prevalence and Inequities in Unmet Social Risk in Diverse Urban Patients on Hemodialysis : Health-related social risks (SR) are associated with adverse health outcomes amongst patients with kidney disease. We aimed to identify and analyze SR in a diverse population of hemodialysis (HD) patients. Survival Sex Differences among Pediatric and Young Adult Hemodialysis Patients in the Global MONDO Registry : For all age groups, women with ESKD on HD have higher rates of cardiovascular (CV) events compared to men, but their all-cause mortality is reduced. Survival in pediatric and young adult HD patients (pts) from across the globe is understudied. Canadian Wildfires of 2023 and Risk of Mortality and Hospitalization Among ESKD Patients : Climate change driven droughts are increasing frequency and intensity of wildfires, a significant source of air pollution. Smoke plumes from the 2023 Canadian wildfires travelled long distances and negatively impacted air quality across large swaths of eastern US. We investigated the association between exposure to 2023 Canadian wildfire-related air pollutants and risk of mortality and hospitalization among hemodialysis patients in New England, the Mid-Atlantic, and the Midwest U.S. Harnessing the Power of Global Databases to Drive Care Cardiovascular Morbidity Patterns in Patients on Dialysis Globally in Apollo Dial DB : Cardiovascular diseases (CVDs) affect most people with kidney failure but are undefined globally. We aimed to analyze CVD prevalence among dialysis patients treated in 40 countries across six continents, as represented in the first version of a global dialysis database called Apollo Dial DB. Profiles of Home Medication Use in Patients on Dialysis Globally : Global patterns of medication use in dialysis are undefined. This project aims to provide a real-world view of home medication use in dialysis using a global dialysis dataset from 40 countries. The most common prescribed medications administered at home by patients were compared by modality. Changes in Fluid Overload during the First 6 Months of Dialysis among More than 13,000 Patients : Fluid overload (FO) is a recognized risk factor for mortality in dialysis patients; however, less has been reported on factors related to changes in FO. Whole-body bioimpedance spectroscopy (BIS) has been validated for hydration assessment. We used Body Composition Monitor (BCM) data, a whole-body BIS, to evaluate changes in the degree of FO during the first 6 months of hemodialysis (HD) or hemodiafiltration (HDF) and characteristics associated with those changes using Apollo Dial DB. Leveraging Artificial Intelligence (AI), Computational Medicine, and Advanced Analytics for Patient Care Arteriovenous Fistula Failure Prediction Using Single Treatment Information : Predicting the natural course of AVF complications with technical surveillance has been an elusive task. We developed a machine learning algorithm assessing the risk of failure of AVF using information collected by the dialysis machine in a single treatment. Validation of a Cloud-Based Convolutional Neural Network Classifying Arteriovenous Access Aneurysms in a Multicenter Study : Arteriovenous (AV) access aneurysms may become life-threatening, e.g., in the event of ruptures. We developed an artificial intelligence classification application (ACA) that categorizes aneurysms using AV access images. This study prospectively evaluates ACA’s classification of AV aneurysms against physicians specializing in access care. Joint Modeling of Longitudinal Ferritin Trajectories and COVID-19 Infections in Native American, Hispanic, and White Patients on Hemodialysis : American Indians/Alaska Natives (AIAN) and Hispanic individuals in the U.S. are overrepresented in the hemodialysis (HD) population and were hardest hit by COVID-19. Early in the pandemic, hyperferritinemia was linked to COVID-19 infections. Joint modeling learns from both longitudinal and time-to-event data for predictive accuracy and dynamic estimation. We investigated the predictive utility of ferritin w/ COVID-19 infection in a cohort of AIAN, Hispanic and White HD patients. For more information about Fresenius Medical Care’s presence at ASN Kidney Week 2024, please visit . 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 4.1 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,757 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 311,000 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 . 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. Media contact Kirsten Stratton T +1 781 929 8096 kirsten.stratton@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 View original content to download multimedia: SOURCE Fresenius Medical Care Holdings, Inc.

Ionis Pharmaceuticals has announced positive results from a phase 2b study of fesomersen, an investigational antisense medicine designed to reduce the production of Factor XI for the prevention of thrombosis, in patients with end-stage renal disease (ESRD) on haemodialysis. The RE-THINC ESRD study was conducted by Bayer, which partnered with Ionis in 2015 to develop the drug. However, the companies have now terminated the agreement, with the rights and licences granted to Bayer under the collaboration being returned to Ionis. The trial met its primary endpoint, demonstrating no increase in the incidence of the composite of major bleeding and clinically relevant non-major bleeding with 24 weeks of treatment. The study also demonstrated dose-dependent and sustained median reductions in steady-state Factor XI levels of 53.1%, 72.2% and 86.6% in the 40mg, 80mg, and 120mg doses of fesomersen, respectively, administered once every four weeks. Incidences of dialysis circuit clotting and arteriovenous access thrombosis also diminished significantly with decreasing Factor XI levels, the company reported, both of which were exploratory efficacy endpoints. Thrombosis occurs when blood clots block the blood vessels, which can obstruct blood flow and prevent sufficient oxygen flow to tissues and organs. Current anti-thrombotic treatments include anticoagulants such as warfarin, Factor Xa inhibitors and thrombin inhibitors. Despite these therapies proving effective at lowering the risk of thrombosis, they can place patients at a significant risk of bleeding because they target factors required for normal coagulation, Ionis reported. Fesomersen is an investigational antisense medicine designed by Ionis to reduce the production of Factor XI, a clotting factor produced in the liver that, in high levels, can increase the risk of thrombosis. Alternatively, individuals deficient in Factor XI have a lower incidence of thrombosis-related events and little to no increase in bleeding risk, making Factor XI an attractive target for an anti-thrombotic medicine. Commenting on the positive results, Richard Geary, executive vice president and chief development officer at Ionis, said: "We are very pleased with the efficacy and safety data seen in the phase 2b study of fesomersen in patients with ESRD, which we believe supports continued advancement of this potential novel anti-thrombotic therapy for patients with renal and cardiovascular diseases. "We thank Bayer for their partnership in the development of fesomersen. We are focused on getting fesomersen into the hands of a new partner to deliver it to the market and patients in need.”

- Positive Phase 2b data from RE-THINC ESRD study of fesomersen in patients on hemodialysis presented at Kidney Week 2022 - Ionis to regain rights to fesomersen from Bayer CARLSBAD, Calif., Nov. 4, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from the Phase 2b RE-THINC ESRD study of fesomersen (formerly IONIS-FXI-LRx), an investigational antisense medicine designed to reduce the production of Factor XI (FXI) for the prevention of thrombosis, were presented by Bayer at the American Society of Nephrology's (ASN) Kidney Week 2022. The RE-THINC ESRD study evaluated fesomersen in patients with end-stage renal disease (ESRD) on hemodialysis. In the study, fesomersen achieved its primary endpoint, demonstrating no increase in the incidence of the composite of major bleeding and clinically relevant non-major (CRNM) bleeding with 24 weeks of treatment. Fesomersen also achieved dose-dependent and sustained median reductions in steady-state FXI levels of 53.1%, 72.2% and 86.6% in the 40 mg, 80 mg, and 120 mg doses of fesomersen, respectively, administered once every 4 weeks. Incidences of dialysis circuit clotting and AV-access thrombosis diminished significantly with decreasing FXI levels, both of which were exploratory efficacy endpoints. Fesomersen showed favorable safety and tolerability with 48 weeks of treatment in this study. "We are very pleased with the efficacy and safety data seen in the Phase 2b study of fesomersen in patients with ESRD, which we believe supports continued advancement of this potential novel anti-thrombotic therapy for patients with renal and cardiovascular diseases," said Richard S. Geary, Ph.D., executive vice president and chief development officer at Ionis. "We thank Bayer for their partnership in the development of fesomersen. We are focused on getting fesomersen into the hands of a new partner to deliver it to the market and patients in need." About the RE-THINC ESRD Study RE-THINC ESRD (NCT04534114) is a randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics and pharmacodynamics of multiple doses of fesomersen in 307 patients with end-stage renal disease on hemodialysis. Study participants were randomized to each of 3 dose cohorts or placebo administered subcutaneously every four weeks for up to 48 weeks. The RE-THINC ESRD study was conducted by Bayer, which licensed fesomersen from Ionis. About Thrombosis Thrombosis is the formation of blood clots inside blood vessels. Blood clots can obstruct blood flow to prevent sufficient oxygen flow to tissues and organs. In addition, clot fragments can break off from the blood clot and travel to occlude other parts of the circulation. Thrombosis is responsible for many heart attacks and strokes and is the leading cause of morbidity and mortality worldwide. Current anti-thrombotic treatments include anticoagulants such as warfarin, Factor Xa inhibitors and thrombin inhibitors. Although these therapies are effective at lowering the risk of thrombosis, they can place patients at significant risk of bleeding because they target factors required for normal coagulation. About Fesomersen Fesomersen, (formerly IONIS-FXI-LRx) is an investigational antisense medicine designed by Ionis to reduce the production of Factor XI, a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of blood clot formation inside blood vessels (thrombosis), which can cause heart attacks and strokes. Alternatively, individuals deficient in Factor XI have a lower incidence of thrombosis-related events and little to no increase in bleeding risk. This makes Factor XI an attractive target for an anti-thrombotic medicine because of the potential to separate anti-thrombotic activity from bleeding risk. Although currently available anticoagulants reduce the risk of thrombosis, these anticoagulants are associated with increased bleeding risk at therapeutic doses, which can lead to major, sometimes fatal, bleeding events. About Ionis Pharmaceuticals, Inc. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming a leading, fully integrated biotechnology company. To learn more about Ionis, visit and follow us on Twitter @ionispharma. Ionis' Forward-looking Statements This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of Ionis' technologies, fesomersen and other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to, those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2021, and the most recent Form 10-Q quarterly filing, which are on the Securities and Exchange Commission. Copies of these and other documents are available from the Company. In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to Ionis Pharmaceuticals and its subsidiaries. Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc. Company Codes: NASDAQ-NMS:IONS