End-stage renal disease (ESRD) is the most severe form of chronic kidney disease that is an incurable health failure. ESRD is a widespread health issue in developed countries and the patients have only two options: either receive permanent renal replacement therapy or undergo surgery to receive a kidney transplant. There are approximately 3.4 million patients worldwide suffering from ESRD that need artificial methods to replace regular kidney functions in their organism. Currently there are no technologies available that would give adequate feedback in real-time on all the important parameters of treatment quality. Optofluid Technologies (OFT) has set out to introduce an online dialysis monitor that utilizes optical techniques. It has developed a prototype that is able to measure all the important uremic biomarker groups in order to provide detailed feedback on the treatment efficiency. A successful SMEI P1 project has been implemented to carry out a detailed feasibility study and OFT is ready to finalize the development in order to bring the novel device to the market. In order to accomplish this OFT is looking to validate the product performance in clinical setting. To ensure the success of the development EU leading hospitals from 5 different member states have been included to carry out the clinical studies. In addition, the leading experts on uremic biomarkers from the EUTox working group will be involved to ensure effective commercialization and communication activities looking to achieve a fast and widespread market acceptance. The planned project will have a wide-spread economic and social impact by influencing all the key stakeholders – scientific and medical community, patients and dialysis equipment manufacturers. As a result of the development project, OFT will generate revenues of up to 73MEUR by 2023.

Chronic kidney disease is a worldwide and ever-growing health crisis in which end-stage patients largely depend on intramural dialysis, placing a heavy burden on their life and on European health care systems. KIDNEW develops groundbreaking and modular technology to enable an implantable artificial kidney with better functional kidney replacement therapy (KRT) than currently available, without need for immunosuppressive drugs and at reduced costs. It provides proof of concept on three breakthrough technologies: 1. Solid-state miniature ultra-high flux silicon (Si)-based filter with a high-density of uniform nanopores through novel block copolymer self-assembly, and with novel hemocompatible biomimetic polymer polymer brush coating connected to a photonic clotting monitoring sensor and (thrombolytic) cleansing tool; 2. Solid-state bioreactor-grown kidney tubule cell monolayers on novel biomimetic Si-wafer based membrane with bioimpedance-based monolayer integrity monitoring and monolayer repair functionality using growth-factors; 3. Solid-state integrated functional biohybrid filter and tubule exchange units stacked in parallel in a multichip to demonstrate functional implantable KRT in goats. An implantable bioartificial kidney will provide more effective, more physiological, and economical sustainable KRT than dialysis. Eco-friendliness of proposed technologies, in line with the EU Green Deal, has recently been highlighted by the European Kidney Health Alliance. On the short to mid-term, the filter and/or tubule unit may enter niche-markets for extracorporeal use, in complementing rather than replacing current dialysis solutions. KIDNEW brings together scientists from the fields of clinical and regenerative nephrology (UMC Utrecht, NL), regenerative pharmacology (University Utrecht, NL), chip technology (Imec NL and Imec BE), optical sensing (Optofluid Technologies OÜ, EE), blood compatible coatings (CNRS, FR), and membrane technology (Me-Sep, PL).

End-stage renal disease (ESRD) is the most severe form of chronic kidney disease that is an incurable health failure. ESRD is a widespread health issue in developed countries and the patients have only two options: either receive permanent renal replacement therapy or undergo surgery to receive a kidney transplant. There are approximately 3.1 million patients worldwide suffering from ESRD that need artificial methods to replace regular kidney functions in their organism. The main objective of the project is to validate the uremic biomarkers in a clinical research setting by developing a diagnostic medical device in the form of a novel on-line dialysis sensor that offers a unique method for the biomarker detection. At the heart of the development is technology developed by Optofluid Technologies (OFT) that is free of the flaws of current dialysis monitoring methods such as estimating only urea based biomarkers and will offer enhanced possibilities for dialysis monitoring and quality assessment. This enables the developed sensor to outperform all the current monitoring methods on the market and fully utilize the possibilities of modern dialysis methods resulting in higher treatment efficiency and ultimately disrupting the dialysis equipment market and replacing previous technologies. The market demand has been proven by attracting business inquiries from the leading dialysis equipment producers. Negotiations with selected partners are underway. A successful commercialization will help to improve clinical decisions by clinicians leading to better treatment. Besides enhanced treatment quality, the novel OFT´s technology will significantly reduce the environmental impact of the treatment, reduce the healthcare costs of ESRD patients and improve the patients’ life-quality. In order to guarantee a successful commercialization OFT has a team of experts with previous experience in business development and medical technology.

In 2017, on a world scale the total number of individuals with chronic kidney disease, acute kidney injury, and those on renal replacement therapy exceeded 850 million, a truly concerning figure that is twice the estimated number of people with diabetes worldwide and >20 times higher than the number of individuals affected by AIDS/HIV worldwide. The socioeconomic impact of kidney disease is huge and is anticipated to even further grow in the coming years. Awareness of the magnitude and the risks of this condition have remained low at the population level. Therefore, kidney disease has been, until recently, largely overlooked by health authorities and governments in most countries with as the result accumulation of major unmet needs in personalized medicine in kidney disease. The aim of PICKED (PersonalIzed medicine in Chronic KidnEy Disease) is to equip a generation of 10 doctoral candidates (DC) with interdisciplinary skills for the development of pathways to implement personalized medicine in chronic kidney disease and their complications on the level of its detection, progression and treatment. We anticipate that these DCs will significantly contribute to the increasing possibilities to stratify patients with kidney disease and the development of successful intervention procedures with potential to substantially impact the lives of over 10% of the European population. PICKED will realize this aim by coordinating the efforts of 10 beneficiaries and 8 associated partners across 7 European countries and 3 sectors, with lead supervisors covering a large range of disciplines ranging from biomarker-research to research into the legal, ethical and quality of life aspects for the implementation of personalized medicine in kidney disease.