P0664CKDSENS, A NOVEL HEALTHCARE PLATFORM FOR CHRONIC KIDNEY DISEASE
Authors: Xipell Font Marc , Banon Elisenda , Falcó Josep Lluís , Koster Raphael , Berenguel Miguel , Teruel Josep Joan , Vera Cecilia , Blasco Miquel , Maduell Francisco , Borràs Berta , Carrera Francisco , Novell Marta , Maceira Adrià , Campistol Plana Josep Maria 
Published: June 2020

Abstract

Background and Aims
The 10% of the global adult population, more than 730 million people, suffers from some degree of chronic kidney disease (CKD). From that population, a 30% is suffering from an advanced stage of the disease. Approximately 38 million of the European population is affected by an advanced stage renal disease with 1 million of new cases every year. These patients require close monitoring, which increase the burden of the disease. New tools and methods are required to improve the patients’ well-being, the perception and management of their disease, decrease the impact of the complications, as well as to delay of the progression of the disease.

Method
Seven partners have joined in the CKDSens consortium and are contributing to the project with different expertise and technical resources (medical, technological, educational, business and management): CreatSens Health SL, Hospital Clínic de Barcelona – Fundació Privada Clínic per a la Recerca Biomèdica, Genesis Biomed, Eurecat, Universitat de Barcelona, Universidad Politécnica de Madrid, and Madopa. This consortium is a novel and unique technological platform, combining in vitro diagnostic devices and software components, that connects patients with CKD and healthcare professionals to improve the well-being of people and the efficiency of the healthcare system by monitoring relevant biomarkers out of the hospital in a simple and cost- effective connected paper-based sensors. The proposal aims to increase the quality of life of CKD patients through early diagnostics, real time monitoring and personalization of therapies.

Results
The CKDSens consortium is developing a novel technological platform for real-time and low-cost diagnostics for two key biomarkers in renal diseases (creatinine and potassium), which include a new point-of-care device that allows monitoring by remote control these biomarkers. The technology has been patented for both biomarkers, and it has been transferred to CreatSens, a spinoff from Universitat Rovira i Virgili. The product integrates paper-based sensors in a drop of blood analysis, wireless connectivity and a digital platform as data analytics. The aim of the consortium is to validate the use of a new medical device as a product that can fit and truly generate value and business. Through that perspective, the optimization, manufacturing and validation of the tool and the business case will be performed as a first step, while usability, end user interaction and regulatory pathway will be developed in the second step. CKDSens will afford a novel approach to embed healthcare in daily life and routine. This new strategy implies production and commercialization for prevention and diagnose where markets are well known and validated. The aim is to mimic a well-known business model such as glucometer, translating this one into renal diseases. CKDSens has risen funding for this purpose through a grant of the European Institute of Innovation and Technology (EIT Health, ID Project 19579), and it is working to have validated this device at the end of the year. This requires also a clinical validation, which will be performed in a clinical trial in the second half of the year.

Conclusion
CKDSens consortium has been created as a novel technological platform to develop and validate a new medical device for a remote control of patients with CKD, in order to increase the quality of life of CKD patients through early diagnostics, real time monitoring and personalization of therapies. It is expected to have this device designed and validated by the end of the year 2020 and ready for further commercialization.