Periodic Reporting for period 1 - LPPDS (A portable peritoneal dialysis system for home use that monitors for infection)
Période du rapport: 2018-08-01 au 2018-11-30
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.
liberDi undertook a full analysis of both the technical and business potential of the Warrick X1, concluding that it would be highly valuable for the medical industry. liberDi reviewed the results achieved with the preclinical trials and the ongoing First in Human Study (FIH) to determine the engineering required optimise and upgrade the system. liberDi defined the remaining engineering activities to be performed to scale-up the production of Warrick X1, achieve clinical validation and CE mark, and achieve the first commercial sale. liberDi also utilised the feasibility study to validate the regulatory pathway, scout missing stakeholders in the value chain and reach out to potential customers.
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.