A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications.
The digital therapeutic (DTx) – called CirrhoCare – has been shown in pilot testing to allow early diagnosis of new complications (decompensation events), with fewer and shorter hospital readmissions compared to a control group with standard follow-up over a three-month period.
CyberLiver’s chief executive Ravi Kumar said the breakthrough designation will help the company expedite the development of the DTx and move forward with finding partnerships to bring it into clinical use.
CirrhoCare makes use of sensors used to monitor variables like heart rate, temperature, hydration levels and cognition, as well as other indicators of complications such as ascites, hepatic encephalopathy and hypovolaemia.
The sensors are coupled with a mobile app to gather data and a brain dysfunction monitoring app, plus a proprietary algorithm which collates the data onto a clinician dashboard, and the platform allows direct, two-way communication between patient and healthcare professional.
In the recently-published pilot study, 20 cirrhotic patients discharged from hospital following acute decompensation were randomised to CirrhoCare, with another group of 20 matched patients used as a control arm.
Re-hospitalisation due to cirrhosis complications was reduced by 38% in the CirrhoCare managed patients, whilst unscheduled therapeutic paracentesis to treat ascites was reduced by 80%.
There were also trends towards improved cirrhosis prognostic markers measured using the MELD score and the CLIF-AD scores, whilst 85% of CirrhoCare users complied with the programme and feedback was positive.
“These preliminary results…reaffirm that CirrhoCare is feasible for community management of decompensated cirrhosis patients,” said lead investigator Prof Raj Mookerjee, a consultant hepatologist at University College London.
“They demonstrate the potential to reduce re-hospitalisations, whilst enabling management of these patients at-home, with a data-driven, physician-assistance tool, that enables prompt intervention to clinical alerts, thereby reducing the morbidity in these patients.”
CyberLiver said it is currently fundraising a Series A round to extend its pivotal clinical studies to the US in 2023 with the aim of achieving FDA approval in the 2024/2025 timeframe.
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