liberDi announced today that it has received regulatory clearance from the US Food and Drug Administration (FDA) for its digital dialysis clinic, which allows patients to perform dialysis at home or at the workplace, by themselves, monitored by their physician using the advanced telemedicine capabilities of the system.
liberDi CEO, Hezkiah Tsoory remarked, that “receiving FDA clearance for our state of the art digital dialysis clinic technology, is a huge achievement for liberDi. This is a big step forward in liberDi’s journey to improve the quality of life of people on dialysis. liberDi’s system is designed to provide these patients with ease of use, freedom of movement, automatic catheter connection flush technology and patient monitoring, while performing their daily dialysis activities from the comfort of their home or workplace. liberDi frees people from spending half of their lives in dialysis centres, which is a disruptive technology in the dialysis market.”
One out of 10 people in the world experience kidney disease. In advanced stages of the disease, dialysis is the most common treatment. Dialysis is a life-support treatment which extends average life expectancy by five to 10 years. Approximately 90% of patients spend half of their remaining lifetime dialysing in clinics. liberDi’s system is positioned to replace traditional full-service, in-clinic care, with a self-care system suitable for many people on or requiring dialysis.
liberDi conducted two initial clinical studies to demonstrate the safety and effectiveness of the portable peritoneal dialysis system on patients requiring dialysis. For this, 42 subjects used the system for dialysis under the supervision of three medical centres in Israel. The studies’ results endorse that liberDi’s digital dialysis clinic is safe to use and feasible for an automatic peritoneal dialysis exchange. liberDi also performed a human factor validation study evaluating all user groups: people requiring dialysis and their caregivers, as well as healthcare professionals such as nephrologists and dialysis nurses. The study simulated a real-world environment and proved that anyone can operate the system following a single 90- minute proper training session.
liberDi’s chairman, Caroll Neubauer, former CEO of B Braun USA, added that “we are excited to start 2023 with FDA clearance allowing liberDi to bring its Digital Dialysis Clinic to the US market to improve treatment as well as the quality of life to dialysis patients and their families.”
Edwina Brown (Imperial College London, London, UK), president of the International Society for Peritoneal Dialysis (ISPD), said: “This represents an exciting development for peritoneal dialysis and is the first for some years. It makes at-home peritoneal dialysis easier and quicker (due to the pump in the device), and with remote monitoring available for the dialysis centre it will make dialysis at home more accessible for the many people globally who develop kidney failure. The team developing liberDi should be congratulated.”