Latest news with #HelenGiza
Yahoo
5 days ago
- Business
- Yahoo
Fresenius Medical starts US commercialisation of haemodiafiltration system
Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem. The full-scale commercial launch is anticipated by the company in 2026. FME secured the Food and Drug Administration's (FDA) 510(k) clearance last week for the updated HDF-capable system. In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments. The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations. The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter. Over the coming months, FMS' Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year. The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy. The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis. FME CEO Helen Giza said: 'Last week's FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US. 'Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.' "Fresenius Medical starts US commercialisation of haemodiafiltration system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
5 days ago
- Business
- Yahoo
Fresenius Medical starts US commercialisation of haemodiafiltration system
Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem. The full-scale commercial launch is anticipated by the company in 2026. FME secured the Food and Drug Administration's (FDA) 510(k) clearance last week for the updated HDF-capable system. In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments. The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations. The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter. Over the coming months, FMS' Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year. The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy. The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis. FME CEO Helen Giza said: 'Last week's FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US. 'Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.' "Fresenius Medical starts US commercialisation of haemodiafiltration system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Yahoo
09-03-2025
- Business
- Yahoo
Fresenius Medical Care AG (NYSE:FMS): On a Healing Path
We came across a bullish thesis on Fresenius Medical Care AG (NYSE:FMS) on ValueInvestorsClub by mimval. In this article, we will summarize the bulls' thesis on FMS. The company's shares were trading at $23.09 when this thesis was published, vs. the closing price of $23.98 on Mar 07. Patients connected to dialysis machines in a hospital ward, highlighting the company's dialysis and intravenous therapies. FMS provides dialysis and related services for individuals with renal diseases in Germany, the United States, and internationally. It has captured 40% of the market share with 80% of revenue coming from the Care Delivery segment and the remaining 20% from its med-tech manufacturing business called Care Enablement. The market potential for FMS is substantial and always increasing. It is estimated that 36 million Americans have chronic kidney disease and almost 135,000 new patients are added each year. 808,000 of those diagnosed are in the end-stage with 68% of them requiring dialysis. Many claim that the new anti-obesity drugs may reduce the need for dialysis, putting FMS 'stock price under pressure. However, the efficacy of these medications on kidney health is still speculative in nature. The recent spin-off from parent Fresenius SE has also worked in favor of the company. While the parent still owns a 32% stake, FMS should offer a leaner structure that would look to divest low-margin business and improve capital allocation. The management had announced a cost reduction of $650 million by 2025 and they have already managed to reduce expenses by $519 million till Q3-24. The possibility of selling the med-tech business to a strategic buyer cannot be discounted and this would free up capital for further business expansion. The CEO Helen Giza has also hinted at a share buyback program at the recently concluded J.P. Morgan Healthcare Conference. FMS is available at a discount when compared with its peer DaVita. DaVita trades at 10x its trailing 12-month EBITDA and 10x its FCF. FMS is available at 7x EBITDA and 8x FCF. Due to better capital allocation, favorable business mix and improved margins FMS should command EBITDA and FCF multiples of 9x and 12x. This translates into an intrinsic value of $35, providing a potential 45% upside. While we acknowledge the potential of FMS as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than FMS but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Bloomberg
25-02-2025
- Business
- Bloomberg
Fresenius Medical Care CEO Helen Giza on Trump Tariffs, Cost Cutting and Product Demand
Fresenius Medical Care expects profit growth to surge in 2025 as dialysis demand in its key US market continues to recover and it squeezes out more cost savings. Chief Executive Officer Helen Giza speaks on the company reducing its workforce by 8,200 employees and divesting 230 facilities in 2024. In the US, underlying same-market treatment growth remained positive, driven by an overall increase in patient volumes and higher reimbursement rates. The company is also preparing to roll out more advanced dialysis machines there. 'We're feeling really good about the momentum and seeing that really continue' in 2025, Giza says. She speaks to Lizzy Burden, Anna Edwards and Kriti Gupta on 'Bloomberg: The Opening Trade'. (Source: Bloomberg)
Yahoo
25-02-2025
- Business
- Yahoo
Dialysis firm FMC beats profit estimates in fourth quarter
(Reuters) -Fresenius Medical Care, the world's largest dialysis specialist, reported fourth quarter results above market expectations on Tuesday, citing positive development both in its care delivery and care enablement businesses. The results were boosted by positive volume and pricing effects, as well as savings from its FME25 turnaround program and portfolio optimization plan aimed at cutting costs and helping improve its leverage ratio. "The momentum we have created enables us to further raise our FME25 savings target from EUR 650 million to EUR 750 million," CEO Helen Giza said in a statement. FMC, which makes the bulk of its sales in the U.S. and employs most of its staff there, said its adjusted operating income grew 31% to 489 million euros ($512.3 million) in the final quarter of 2024, beating analysts' estimate of 481 million euros in a company-provided consensus. The adjusted figure is given at a constant currency basis and excludes the impact from divestitures closed in 2023 and special items such as costs related to the FME25 turnaround plan and the change in FMC's legal form, it said. Including those effects, the quarterly operating income fell 39% to 259 million euros. FMC also said it expected 2025 revenue to grow at a low single digit percentage rate and adjusted operating income to rise by a high teens to high twenties percentage, both in constant currency. Based on this, FMC narrowed its operating margin guidance for the year to a range of 11% to 12%, from the previously expected 10% to 14%. The company's shares were seen rising 2.7% in Lang & Schwarz pre-market indications, with a German trader saying that both results and the outlook were better than expected. ($1 = 0.9546 euros) Sign in to access your portfolio
