Periodic Reporting for period 1 - Warrick X1 (Safe home-based portable peritoneal dialysis system that offers simpler dialysis and improved quality of life for patients)
Reporting period: 2019-09-01 to 2020-08-31
End Stage Renal Disease (ESRD), the fifth and last stage of Chronic Kidney Disease (CKD), is recognized as a major public health problem and occurs where kidneys are no longer capable of filtering waste products from the blood. With kidney function at less than 10%, a kidney transplant or an external means of filtering of the body waste through a Renal Replacement Therapy (RRT) is needed. This condition in Europe affects 358,000 dialysis patients, 12% of the global number. This builds up an economic burden consuming 2% of EU’s healthcare budget, with reimbursement costs up to 40,000-80,000 €/year per individual. RRT can be performed in two ways: Haemodialysis (HD), and Peritoneal Dialysis (PD). Despite technological advances, dialysis devices still present relevant issues, such as: discomfort and lack of portability, with 89% of dialysis patients having to go to specialized centres to receive the treatment; high risk of infection: 0.24-1.66 episodes/patient/year in PD; low compliance with treatment protocols (53%) due to the lack of automatization of the devices; time consuming treatments, taking 40 mins twice a day for PD, and 4 hours and 3 times per week for HD patients. liberDi overcomes these limitations offering Warrick X1, a truly automated and portable (up 80% lighter and 50% smaller) dialysis machine. PD dialysis machine. Dialysis can be performed in 20 mins anywhere at any time, thus giving ESRD patients the freedom to live a normal life. Thanks to the advanced automated flow control and disinfection system, the device represents a safe and cost-effective solution (over 30% savings of annual dialysis expenses). The IoT based technology and intuitive visual instructions help patients and their physicians to continuously and remotely keep track of the therapy.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
Within the first reporting period, liberDi has finalised the design of the Warrick X1 system optimising the height, weight and performance; and produced the first devices for use in trials. Vigorous testing of the Warrick X1 system has been performed in-house to ensure the safety for use in trials with humans. The associated software has also been upgraded. A Human Factor usability study has started from which the results will be used for the CE submission.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
The expected outcome of the project is to successfully upgrade the system, demonstrate and effectively communicate the functionality and advantages of the system through clinical validation. The results will be used to apply for the CE Mark certification and enable commercialisation in Europe. Warrick X1 will enable to significantly improve the quality of life of ESRD patients, allowing them to conduct a normal life at an affordable price. Warrick X1’s development will boost economic growth and create jobs within liberDi.