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Fresenius Medical Care invests EUR 60 million in Unicyte (September 5, 2019)

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.



Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.4 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,996 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 339,550 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. 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 www.freseniusmedicalcare.com.

Unicyte AG is a regenerative medicine company with a focus on kidney & liver disorders, diabetes and oncology. Unicyte evolved from a long-term research collaboration of Italy’s University of Turin and Fresenius Medical Care. Unicyte is headquarted in Oberdorf NW, Switzerland, and is an independent affiliate of Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases.

For more information visit the company’s website at www.unicyte.ch.

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 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.

Unicyte AG to collaborate with Medical Center Hamburg-Eppendorf on innovative treatments for patients with kidney disorders (December 20, 2018)

Unicyte AG, a subsidiary of Fresenius Medical Care, has initiated a long-term research collaboration with Prof. Dr. Tobias B. Huber of Germany’s Medical Center Hamburg-Eppendorf (UKE) to explore the molecular and cellular mechanisms of kidney diseases.

Prof. Huber, Chair of the III. Department of Medicine at UKE, a major university hospital, is a leading expert on glomerular diseases. He will direct the research program, which aims to address various forms of kidney disease including diabetic nephropathy. The goals of the collaboration are to gain further insights into the process leading to the gradual decline in renal function and to identify genetic, signaling and soluble factors involved in the underlying mechanisms.

Unicyte, a leading regenerative medicine company with translational programs in the field of kidney disorders and other illnesses, is building on successful partnerships with other academic partners. These include a collaboration of 15 years’ standing with the University of Torino in Italy.

Dr. Olaf Schermeier, Fresenius Medical Care’s CEO for Global Research and Development, said: “As Unicyte’s organizational structure is designed to leverage the benefits of academia-industry partnerships, the collaboration with Prof. Huber offers a unique opportunity to help patients with kidney disorders by developing innovative treatment options based on a holistic understanding of renal dysfunction. I’m very excited about this collaboration with one of the leading hospitals in Europe, as it could lead to new treatment options that will complement current kidney care.”

Prof. Tobias B. Huber stated: “Because fundamental scientific questions concerning the pathomechanisms of kidney diseases remain to be answered, we will further explore the potential of new options for the treatment of kidney patients in pre-dialysis stages. The collaboration with Unicyte as industry partner will be fruitful in developing a therapy from pre-clinical research through to clinical practice. Our goal is to provide excellent new therapies, reduce the burden of disease, and significantly improve the lives of our patients.”



Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases of which around 3.2 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,872 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 329,085 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the company provides related medical services in the field of Care Coordination. 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 www.freseniusmedicalcare.com.

Unicyte AG is a regenerative medicine company with a focus on kidney & liver disorders, diabetes and oncology. Unicyte evolved from a long-term research collaboration of Italy’s University of Turin and Fresenius Medical Care. Unicyte is headquarted in Oberdorf NW, Switzerland, and is an independent affiliate of Fresenius Medical Care, the world's largest provider of products and services for individuals with renal diseases.

For more information visit the company’s website at www.unicyte.ch.

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 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.

Fresenius Medical Care achieves preclinical milestone in its regenerative medicine program for chronic kidney disease (July 30, 2018)


Unicyte AG, regenerative medicine unit of Fresenius Medical Care, appoints Jonathan Knowles to Scientific Advisory Board (December 2017)

Unicyte AG, regenerative medicine unit of Fresenius Medical Care, appoints Jonathan Knowles to Scientific Advisory Board

Unicyte AG, a pioneering leader in human liver stem cells and nano-extracellular vesicles, announced today the appointment of Prof. Jonathan Knowles to its Scientific Advisory Board.

The board works closely with Unicyte’s management team to accelerate the company’s regenerative stem cell and extracellular vesicles programs for treating diabetes, non-alcoholic fatty liver disease, diabetic nephropathy and cancer. In addition, it provides scientific advice for the collaboration between Unicyte and Italy’s University of Turin in order to foster innovation and new research programs.

"We are excited to welcome Prof. Jonathan Knowles to our Scientific Advisory Board, as he has not only the scientific expertise but also the experience of developing highly innovative technologies in both pharma and biotech companies," said Florian Jehle, CEO of Unicyte and Vice President, Technology & Innovation Management within Research & Development at Fresenius Medical Care.

Jonathan Knowles is Chairman of the Board of Directors of Immunocore Ltd. and of the Access Committee of Genomics England. He is a Visiting Professor of Translational Medicine at the University of Oxford and formerly a distinguished Professor of Personalized Medicine at the University of Helsinki and at EPFL Lausanne. As Head of Research from 1997 to 2009 he had oversight of Research and Development for the Roche Group. He also served as a director on the boards of Genentech and of Chugai Pharmaceuticals, and from 1987 to 1997 was Director of the Glaxo Institute for Molecular Biology. Jonathan Knowles holds a 1st class honors degree in Biology from the University of East Anglia in England and a PhD in Molecular Genetics from the University of Edinburgh in Scotland.

Jonathan Knowles said: “I am excited to join Unicyte’s Scientific Advisory Board and to support the company as it is anticipating first partnerships for commercialization. Unicyte has a unique adult stem cell platform that overcomes the cost constraints of many alternative approaches and has significant market potential, especially in large indications such as diabetes. Also, I am very interested in the therapeutic potential of extracellular vesicles, and Unicyte has a lead in this area.”

Unicyte originated from the long-standing research collaboration between Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, and Prof. Giovanni Camussi, a leading expert in nano-extracellular vesicles and stem cells at the University of Turin. Now an independent affiliate of Fresenius Medical Care, Unicyte has a broad preclinical pipeline focusing on kidney and liver disorders, diabetes and oncology, and will work with partners when needed to advance these therapeutic programs.

Dr. Daniel Gau, Unicyte’s Head of Business Development, said: “Prof. Knowles will make an outstanding and valued addition to our Scientific Advisory Board, helping Unicyte to identify new areas of focus and potentially disruptive therapies for the benefit of our patients.”

About Unicyte AG
Unicyte AG is a preclinical stage regenerative medicine company with a focus on kidney and liver disorders, diabetes and oncology. Unicyte evolved from a long-term research collaboration of Italy’s University of Turin and Fresenius Medical Care. Unicyte is headquartered in Oberdorf NW, Switzerland, and is an independent affiliate of Fresenius Medical Care, the world's largest provider of products and services for people with chronic kidney failure. For more information, visit Unicyte’s website at www.unicyte.ch.

About Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases, of which around 3 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,714 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 317,792 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

About the University of Turin / MBC Turin
The Molecular Biotechnology Center (MBC) at the University of Turin, active since September 2006, has the main objective to bring together investigators with different scientific backgrounds to facilitate an interdisciplinary approach to biomedical research. The Center is actively involved in biotechnological research in the field of biomedical sciences, with specific focus on the study of the molecular mechanisms at the basis of physiopathological processes that have a significant impact on human health, such as cardiovascular diseases, inflammation, cancer and stem cell biology. These research efforts are mainly based on the development of the most advanced molecular imaging technology, bioinformatic analysis and the generation of mouse and zebrafish models. For more information, visit http://www.mbc.unito.it/en.

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 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.

Unicyte AG, regenerative medicine unit of Fresenius Medical Care, appoints world-leading experts to Scientific Advisory Board (July 25, 2017)

Unicyte AG, a pioneering leader in human liver stem cells and nano-extracellular vesicles, announced today the formation of its inaugural Scientific Advisory Board with the appointments of Professors Giovanni Camussi, Camillo Ricordi and Paul Robbins.

The board will work closely with Unicyte’s management team to accelerate the company’s lead candidate programs for treating diabetes, non-alcoholic fatty liver disease, diabetic nephropathy and renal cancer. In addition, it will provide scientific advice for the collaboration between Unicyte and Italy’s University of Turin, in order to foster innovation and new research programs. "We are thrilled to establish a Scientific Advisory Board for Unicyte with some of the world's leading experts in regenerative medicine, diabetes, metabolic disease and aging as we move our therapeutic programs toward clinical validation," said Florian Jehle, CEO of Unicyte and Vice President, Technology & Innovation Management within Research & Development at Fresenius Medical Care. Unicyte originated from the long-standing research collaboration between Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, and Professor Camussi, a top expert in nano-extracellular vesicles and stem cells at the University of Turin. Now an independent affiliate of Fresenius Medical Care, Unicyte has a broad preclinical pipeline focusing on kidney and liver disorders, diabetes and oncology, and will work with partners when needed to advance these therapeutic programs. The three new members of the Scientific Advisory Board are all highly respected scientists, with international reputations for their research and extensive work on important scientific bodies:

  • Giovanni Camussi is Professor and Chairman of Nephrology in the Internal Medicine and Medical Sciences departments at the University of Turin’s School of Medicine and Biotechnology. His research focuses on the purification and characterization of stem cell-derived nano-extracellular vesicles and the characterization of their coding and non-coding RNA (ribonucleic acid) molecules. In particular, he has investigated the paracrine action of nano-extracellular vesicles.
  • Camillo Ricordi is Professor of Surgery and Director of the Diabetes Research Institute and the Cell Transplant Program at the University of Miami. He led the team that performed the first series of successful clinical islet allotransplants to reverse diabetes, a procedure now used worldwide by laboratories performing clinical islet transplants.
  • Paul D. Robbins is Professor of Molecular Medicine at the Scripps Research Institute in Jupiter, Florida and Director of its Center on Aging. His research focuses on developing therapeutic approaches to extend health and reduce frailty using mouse models of aging.
Dr. Daniel Gau, Unicyte’s Head of Business Development, said: “Our Scientific Advisory Board comes at the right time to endorse our leading position in the fields of human liver stem cells and nano-extracellular vesicles, as we are anticipating first partnerships for future commercialization. At the same time, the board will guide Unicyte in identifying new areas of focus and potentially disruptive therapies, for the benefit of our patients.”

About Unicyte AG
Unicyte AG is a preclinical stage regenerative medicine company with a focus on kidney and liver disorders, diabetes and oncology. Unicyte evolved from a long-term research collaboration of Italy’s University of Turin and Fresenius Medical Care. Unicyte is headquartered in Oberdorf NW, Switzerland, and is an independent affiliate of Fresenius Medical Care, the world's largest provider of products and services for people with chronic kidney failure. For more information, visit Unicyte’s website at www.unicyte.ch.

About Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases, of which around 3 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,654 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 310,473 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

About the University of Turin / MBC Turin
The Molecular Biotechnology Center (MBC) at the University of Turin, active since September 2006, has the main objective to bring together investigators with different scientific backgrounds to facilitate an interdisciplinary approach to biomedical research. The Center is actively involved in biotechnological research in the field of biomedical sciences, with specific focus on the study of the molecular mechanisms at the basis of physiopathological processes that have a significant impact on human health, such as cardiovascular diseases, inflammation, cancer and stem cell biology. These research efforts are mainly based on the development of the most advanced molecular imaging technology, bioinformatic analysis and the generation of mouse and zebrafish models. For more information, visit http://www.mbc.unito.it/en.

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 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.

Unicyte AG to co-sponsor the Extracellular Vesicles Gordon Research Conference (August 21-26, 2016)

Under the chair of Peter Quesenberry and Giovanni Camussi, the Extracellular Vesicles Gordon Research Conference focused on cutting edge research on the molecular, cellular and clinical translational aspects of the structure and function of extracellular vesicles and RNA.

MORE INFO

Fresenius Medical Care establishes regenerative medicine subsidiary, to continue successful work with University of Turin

Fresenius Medical Care, the world’s largest provider of dialysis products and services, has established a subsidiary focusing on regenerative medicine. Unicyte AG will pursue research into kidney and liver diseases, diabetes and cancer, and will work with additional partners when needed to advance these projects.

Fresenius Medical Care has collaborated with the University of Turin since 2003. The first, groundbreaking result of their joint research under the direction of Prof. Giovanni Camussi, Scientific Director of the university’s Torino Stem Cell Project, was the isolation and characterization of a human stem cell population from an adult liver. These liver stem cells are easy to isolate, capable of being multiplied without limit and transferrable into various other cell types, making them a potential option for regenerative medicine.

Further important discoveries were functional pancreatic islets (which mimic the function of pancreatic cells) for the treatment of diabetes, and stem cell-derived extracellular vesicles (particles that support communication between cells) for the treatment of kidney and liver diseases as well as cancer. The first research results were converted recently into preclinical development projects.

On the basis of the successful partnership with Prof. Camussi, a leading expert on extracellular vesicles and stem cell research, Unicyte is continuing the joint research. The company will pursue the development projects up until the stage of clinical studies on humans. The long-term goal is to improve the lives of kidney and liver disease, diabetes and cancer patients.

On the basis of the successful partnership with Prof. Camussi, a leading expert on extracellular vesicles and stem cell research, Unicyte is continuing the joint research. The company will pursue the development projects up until the stage of clinical studies on humans. The long-term goal is to improve the lives of kidney and liver disease, diabetes and cancer patients.

Dr. Olaf Schermeier, Fresenius Medical Care’s CEO for Global Research and Development, said: “We are very excited to be extending our successful collaboration with Prof. Camussi and the University of Turin. This is the right point in time to focus the outstanding scientific research on indications where there is great medical need.”

Florian Jehle, CEO of Unicyte and Vice President, Technology & Innovation Management at Fresenius Medical Care, said: “The establishment of Unicyte AG is the logical step to translate the existing research collaboration on stem cells and extracellular vesicles into clinical programs. In this way, Fresenius Medical Care is bundling its regenerative medicine research for selected indications.”

Prof. Camussi, Scientific Director of the Torino Stem Cell Project, stated: "The expectations for stem cell research have grown in recent years, but a rigorous scientific process is essential to developing targeted therapies while maintaining ethical standards. To develop sound clinical applications, our research must be reproducible and scientifically verifiable.”

About Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases of which more than 2.8 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,432 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 294,043 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of additional medical services in the field of care coordination. For more information visit the Company’s website at www.freseniusmedicalcare.com.

About University of Turin / MBC Turin
The Molecular Biotechnology Center (MBC) at the University of Turin, active since September 2006, has the main objective to bring together investigators with different scientific backgrounds to facilitate an interdisciplinary approach to biomedical research. The Center is actively involved in biotechnological research in the field of biomedical sciences, with specific focus on the study of the molecular mechanisms at the basis of physiopathological processes that have a great impact on human health, such as cardiovascular diseases, inflammation, cancer and stem cell biology. These research efforts are mainly based on the development of the most advanced molecular imaging technology, bioinformatic analysis and the generation of mouse and zebrafish models. For more information, visit http://www.mbc.unito.it/en. 

About Unicyte AG
Unicyte AG is a preclinical stage regenerative medicine company with a focus on oncology, diabetes, and liver & kidney disorders. Unicyte evolved from a long-term research collaboration of Italy’s University of Turin and Fresenius Medical Care. Unicyte is headquarted in Oberdorf NW, Switzerland, and is an independent affiliate of Fresenius Medical Care, the world's largest provider of products and services for individuals with renal diseases. For more information visit the company’s website at www.unicyte.ch.

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 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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