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Fresenius Medical Care, the world’s largest provider of dialysis products and services, today announced that the company has extended the end-date under the merger agreement with NxStage Medical, Inc. (“NxStage”) to account for the interruption of the Federal Trade Commission’s (“FTC”) review of the transaction during the recent U.S. government shutdown. The merger agreement’s end-date has been extended to August 6, 2019, or such earlier date on which there has been 60 consecutive days of full funding of the FTC’s operations.

Fresenius Medical Care has already signed a consent decree that was proposed by the Staff of the FTC and that remains subject to approval by the FTC Commissioners. Under the terms of the consent decree, Fresenius Medical Care would divest the NxStage bloodlines business to B. Braun Medical to address the comments from FTC Staff.

Fresenius Medical Care, the world’s largest provider of dialysis products and services, today announced the launch of its 4008A dialysis machine, which was especially designed to meet the needs of emerging markets. With the launch of the 4008A, the company is aiming to improve accessibility to life-sustaining dialysis treatment for patients in these countries who are living with end-stage renal disease (ESRD).

The 4008A dialysis machine incorporates Fresenius Medical Care’s high therapy standards while minimizing costs for health care systems. It has primarily been deployed in India, with other countries across the Asia-Pacific region to follow. Worldwide, there is an urgent and growing need for patients with ESRD to receive access to dialysis. A systematic review of worldwide access to treatment estimated that almost two million people in Asia with ESRD who needed dialysis were not receiving it – a treatment gap that is double the number of patients actively being treated. Worldwide use of dialysis is projected to more than double by 2030, with the most growth in Asia, but the number of people without access to dialysis is expected to remain substantial.¹

In response to this need, Fresenius Medical Care has developed the 4008A, which provides life-sustaining medical benefits and safety standards at a cost-effective price. Dr. Olaf Schermeier, Chief Executive Officer for Global Research and Development at Fresenius Medical Care, emphasized the importance of the 4008A launch: “Our global Research and Development team is in constant dialogue with physicians, nursing staff and patients. We put the benefit for our patients at the center of any new development. That is why we have developed this new high-quality dialysis platform that may allow for better cost effectiveness, and brought it to the market in record time.”     

Harry de Wit, CEO of Fresenius Medical Care Asia–Pacific, said: “At Fresenius Medical Care, we are proud of the work we do every day to improve the lives of people living with chronic kidney disease. The launch of the 4008A is a demonstration of our continuing commitment to help ensure that life-changing dialysis is brought within reach of the increasing number of patients who need urgent access to this treatment.”

Importantly, the 4008A offers a high level of safety and handling standards, including essential cleaning functions and battery back-up. The machine is designed to be robust and easily handled, making it ideal for demanding infrastructure and remote locations.

The use of ultrapure dialysis fluid is standard in all treatments with the 4008A machine. Evidence suggests that using ultrapure dialysis fluid provides significant medical benefits to patients – for example, through better preservation of residual renal function, which is the ability of the patient’s own kidneys to eliminate water and uremic toxins.² This has been shown to lower mortality and potentially improve quality of life in people with ESRD.^3,4,5 In addition, the use of ultrapure dialysis fluid could also contribute to reduced inflammation for dialysis patients, potentially helping to reduce their cardiovascular risk and morbidity.^6,7

The dialysis machine and the dialyzer are the two most important products in hemodialysis. While the dialyzer filters the patient’s blood, the dialysis machine pumps it and monitors its circulation outside the body. The machine is also used to maintain the composition of the dialysis solution and introduce anticoagulants into the blood. Dialysis treatments generally last three to six hours, and are commonly carried out three times a week.

More than half of all dialysis machines used worldwide are made by Fresenius Medical Care.

References
¹ Liyanage T et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. www.thelancet.com Published online March 13, 2015 http://dx.doi.org/10.1016/S0140-6736(14)61601-9.
² Schiffl H et al. Ultrapure dialysis fluid slows loss of residual renal function in new dialysis patients. Nephrol Dial Transplant 2002;17: 1814–1818.
³ Shafi T., Jaar B., Plantinga L. Association of Residual Urine Output With Mortality, Quality of Life, and Inflammation in Incident Hemodialysis Patients: The Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis 2010; 56:348-358.
⁴ Termorshuizen F., Dekker F.Van Manen J. Relative Contribution of Residual Renal Function and Different Measures of Adequacy to Survival in Hemodialysis Patients: An analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol 2004; 15: 1061–1070.
⁵ Obi Y., Rhee C., Mathew A. Residual Kidney Function Decline and Mortality in Incident Hemodialysis Patients. J Am Soc Nephrol 2016; 27: 3758–3768.
⁶ Sitter Tet al. Dialysate related cytokine induction and response to recombinant human erythropoietin in haemodialysis patients.Nephrol Dial Transplant 2000; 15: 2107–1211.
⁷ Lederer SR, Schiffl H. Ultrapure Dialysis Fluid Lowers the Cardiovascular Morbidity in Patients on Maintenance Hemodialysis by Reducing Continuous Microinflammation. Nephron 2002; 91: 452–455.