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          Fresenius Group Overview

          September 05, 2019

          Fresenius Medical Care invests EUR 60 million in Unicyte

          • Representative micrographs depicting renal histology of (from left): healthy mouse (control); mouse with fast progressing kidney disease; diseased mouse treated with Unicyte’s nEVs. Original magnification at x400.

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          Fresenius Medical Care, the world’s leading provider of dialysis services and products, plans to invest EUR 60 million in its independent affiliate Unicyte AG in a Series A financing round. Unicyte, a leading regenerative medicine company with translational programs in the field of kidney disorders and other diseases, will primarily use the capital to start clinical trials of its first product candidates in 2020 and to establish the required manufacturing processes.

          Over the last four years, Unicyte has created a unique set of proprietary technology platforms of human liver stem cells (HLSCs), HLSC-derived islets and nano-Extracellular Vesicles (nEVs). nEVs are stem cell-derived particles that support communication between cells.

          Unicyte succeeded in confirming the disease-modifying potential of its nEVs in various preclinical models of chronic kidney disorders. Combined results of these studies demonstrate nEVs’ efficacy and underlying mechanism of action in preventing renal fibrosis and its subsequent progression to end-stage renal disease.

          “Regenerative medicine could provide highly innovative therapies to chronic kidney disease patients and is becoming increasingly important for our industry. Driving regenerative therapies not only addresses the U.S. administration’s initiative to improve the prevention of end-stage renal disease, but can help us to significantly slow the progression of kidney disease and make the most innovative therapies available to our patients,” said Rice Powell, CEO of Fresenius Medical Care.

          Dr. Olaf Schermeier, Fresenius Medical Care’s CEO for Global Research and Development, said: “This continued investment in Unicyte shows our commitment to developing the best treatment options for our patients across the renal care continuum. At the same time, it puts Fresenius Medical Care at the forefront of innovation in the field of regenerative renal stem cell therapy.”

          “Based on our preclinical results, the commitment of Fresenius Medical Care is a strong driver for Unicyte’s next milestone, the start of clinical development with the required organizational structure. It will also provide a solid data package for our non-kidney product candidates to seek strategic partnerships as the next step,” said Florian Jehle, CEO of Unicyte.

          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 certain factors, including changes in business, economic and competitive conditions, regulatory reforms, 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.

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