DigitalHealth.London Accelerator company, Cibiltech, has announced that the first patient in the UK has been enrolled to the CIBIL (Clinical Impact of the iBox as an early Intervention tool) clinical trial.
“The CIBIL study aims to provide clinical and health economic evidence to allow further deployment of Predigraft in Europe and in the United Kingdom. It opens the way to a large adoption of AI-based medical device softwares”, states Stephane Tholander, CEO of Cibiltech.
Predigraft is a CE-marked class IIa medical device under EU MDR 2017/745, offering physicians and hospitals an easy-to-use platform that simplifies access to data and decision making. Predigraft embeds the iBox algorithm, a unique AI-based technology predicting individual long term kidney allograft survival.
Cibiltech has successfully recruited 177 patients so far, with eight actively recruiting sites in four countries (France, Germany , Spain and the UK). In total, 18 centers in seven countries will participate in this international study.
Victoria Hemzacek, Strategic Development Manager at Cibiltech, said, “The DigitalHealth.London Accelerator programme truly provides tailor-made support. The team has supported us to strengthen our evidence from the CIBIL trial with real world evidence pilot studies and to demonstrate the savings Predigraft could achieve for the NHS by reducing patients returning to dialysis.”