Pemphigus, Benign Familial

New expanded indication will increase home hemodialysis device options available to patients with end-stage kidney disease BEVERLY, Mass., Sept. 19, 2023 /PRNewswire/ -- Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion of the Quanta™ Dialysis System, a compact and easy-to-use hemodialysis device. The Quanta Dialysis System is currently indicated for use in chronic and acute care settings. The new submission seeks to expand use to include self-care, in-home hemodialysis. Continue Reading A new FDA 510(k) was submitted for indication expansion of the Quanta Dialysis System for self-care, in-home hemodialysis. The pending FDA clearance will increase the number of home hemodialysis device options available to patients with end-stage kidney disease. According to the U.S. Renal Data System, there are over 490,000 people in the U.S. who use hemodialysis to treat their end-stage kidney disease (ESKD). Home hemodialysis (HHD), which replaces the thrice-weekly commute to a dialysis clinic to receive treatment, accounts for 2% of the total hemodialysis population.i Studies suggest that HHD has many benefits over traditional in-center dialysis such as improvements to quality of life, health outcomes and access to care. In response to the benefits of HHD, the Centers for Medicare and Medicaid Services (CMS) established a program to encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries.ii "The FDA submission for in-home use of the Quanta Dialysis System represents a significant milestone for Quanta in our journey to make dialysis more accessible to every patient in every setting," said Alejandro Galindo, Quanta Chief Executive Officer. "The Quanta Dialysis System is already providing patients in the U.K. with the freedom and flexibility that HHD offers. With clearance of this 510(k), patients in the U.S. will have more control over their care, and choice in where, when and how they receive treatment." This submission, pending regulatory clearance from the FDA, would make the Quanta Dialysis System the third device in the United States indicated for HHD in patients with end-stage kidney disease (ESKD). FDA clearance for the expanded indication is expected in 2024. Quanta's 510(k) submission is supported by clinical data from its Home Run™ study, a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for HHD. Full results from the study will be shared this November during a poster presentation at the upcoming American Society of Nephrology (ASN) Kidney Week in Philadelphia, Pennsylvania. About End-Stage Kidney Disease End-stage kidney disease is the final stage of chronic kidney disease, where kidney function has declined enough to the point where the kidneys can no longer function on their own. With fully functioning kidneys, waste and excess fluids from the blood are filtered and then excreted in urine. For those with ESKD, the kidneys lose their filtering abilities and dangerous levels of fluid, electrolytes and waste build up in the body. Approximately 800,000 people in the United States are living with ESKD, 71% of which rely on dialysis to manage the disease, while the remaining 29% have a functioning kidney transplant. About Quanta Dialysis Technologies Quanta Dialysis Technologies is committed to making dialysis accessible to every patient in every setting with its Quanta Dialysis System. As a portable device with performance comparable to larger, traditional machines, the Quanta Dialysis System is a modular and powerful solution that provides the clinical versatility needed to deliver dialysis care across multiple settings. With a simple-to-use and intuitive user interface, it is designed to be operated by a broad range of users to bring dialysis directly to patients. The Quanta Dialysis System is commercially available in the United Kingdom for home and hospital use. In the United States, it is FDA-cleared (K222067) for use in chronic and acute care settings, with treatment types including intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), prolonged intermittent renal replacement therapy (PIRRT), slow continuous ultrafiltration (SCUF), and continuous venovenous hemodialysis (CVVHD). To learn more about Quanta and its products, visit quantadt.com. Media Contact: Melinda Freson [email protected] i United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022. ii Centers for Medicare and Medicade Services. ESRD Treatment Choices (ETC) Model. SOURCE Quanta Dialysis Technologies

WALTHAM, Mass., Aug. 23, 2023 /PRNewswire/ -- 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. Continue Reading 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 Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed. © 2023 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, NxStage, the triangle logo, VersiHD, PureFlow and Nx2me are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.9 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,050 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 344,000 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 AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release. Media Contact Leif Heussen T +49 6172 608-4030 [email protected] Emanuela Cariolagian T +1 800 723-2384 [email protected] Contact for analysts and investors Dr. Dominik Heger T +49 6172 609-2601 dominik.heger@fmc-ag.com SOURCE Fresenius Medical Care Holdings, Inc.

SOUTH SAN FRANCISCO, Calif., May 16, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new findings from analyses of claims data and electronic health records related to heart failure (HF) and hypertrophic cardiomyopathy (HCM) were shared in two poster presentations at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21). One poster presented data on spending for hospitalized Medicare patients with HF underscoring the economic burden of their healthcare, and an additional poster presented demographics and clinical characteristics of patients with hypertrophic cardiomyopathy. “Together these analyses highlight the severity, complexity and burden associated with each of heart failure and hypertrophic cardiomyopathy as well as the high costs associated with managing the cycle of hospitalization and readmission for patients with heart failure,” said Robert I. Blum, President and Chief Executive Officer of Cytokinetics. “Our collaborative research initiatives with leading teaching institutions and health economics experts continue to inform our understanding of the clinical and economic burden and underscore how potential new therapies may improve health outcomes.” High Spending Among Medicare Patients Hospitalized with Heart Failure and Substantial Payments for Post-Acute Care This analysis builds upon a previously presented analysis conducted in collaboration with Yale University School of Medicine examining payments spanning index hospitalization through 30-days post-discharge for Medicare beneficiaries with HF. Using Medicare fee-for-service administrative claims data, patients hospitalized with HF from 2016-2018 were identified with the following primary discharge diagnoses (ICD-10 codes): systolic HF (50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease (HHD) with HF (I11), and HHD with HF and chronic kidney disease (I13). The total estimated mean Medicare 30-day payments for HF care were approximately $16.5 billion over the 3-year study period, with little change in spending year to year. This new analysis of the same dataset examined 90-day post-discharge spending and found that the total estimated Medicare 90-day payments were approximately $27 billion over the 3-year study period. The index hospitalization accounted for 35% of the total mean 90-day payments. The remaining 65% of payments occurred in the post-acute care period (mean $11,374), driven by payments for readmission including observation stays (36% of post-acute care payments; mean $6,828) and skilled nursing facilities (27% of post-acute care payments; mean $5,192). Overall, 36% of Medicare patients hospitalized with HF were readmitted within 90 days. These results further emphasize the high cost of HF related health care, not only for initial hospitalization but for readmission and ongoing care. Retrospective Observation of Patients with Obstructive HCM Finds Increase in Cardiovascular Comorbidities and Medication Use Over 2-Year Follow-Up In a retrospective analysis of demographics and clinical characteristics of adult patients with obstructive HCM (oHCM), the first to examine a national sample using longitudinal medical and pharmacy claims data, patients were identified using claims data from the HealthCore Integrated Research Database (HIRD®), a database representing over 50 million people who are commercially insured or Medicare Advantage members in the United States, between January 1, 2012 to January 31, 2020. Patient characteristics and outcomes were reported for the 12-month period before the index date (the earliest diagnosis of oHCM) and a 2-year follow-up. Of the 1,841 patients identified with oHCM, 52% were male and the average age was 63.2 years. Cardiovascular comorbidities were common at the 2-year follow-up, including hypertension (64%), coronary artery disease (31%), atrial fibrillation (26%), HF (24%), and diabetes (21%). Between the 12-month baseline and 2-year follow up the percentage of patients with diagnostic procedures and myocardial imaging increased, as did the use of HCM-related medications (p < 0.01) including β-blockers (59% vs 70%), calcium channel blockers (29% vs 33%), anticoagulants (14% vs 22%), and antiarrhythmics (all: 6% vs 10%; disopyramide: 1% vs 3%). At the 2-year follow-up, 144 patients (8%) had received an implantable cardioverter-defibrillator for sudden death prevention and 123 patients (6%) underwent septal reduction procedures (5% myectomy; 1% alcohol septal ablation), with the mean time from initial evaluation to procedure being 218 days and 97 days, respectively. The results from this analysis, may help characterize the population of patients with oHCM and understand their disease progression to better support current treatment approaches and inform development of novel therapies to address this unmet need. About Cytokinetics Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is engaging with regulatory authorities in preparation for a U.S. NDA submission of omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with HF. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is also developing CK-274, a next-generation cardiac myosin inhibitor, for the potential treatment of HCM. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is preparing for the potential advancement of reldesemtiv to a Phase 3 clinical trial in ALS. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness. For additional information about Cytokinetics, visit  and follow us on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the timing and likelihood of regulatory approval for omecamtiv mecarbil, Cytokinetics'  research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics'  ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission. Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Communications, Investor Relations(415) 290-7757