SOZO uses bioimpedance spectroscopy (BIS) technology to manage and monitor a person’s fluid status, body composition and hydration in a clinical or at-home setting.
This initial study will monitor up to 30 patients with chronic heart failure in a clinical setting for 30 days, and is expected to be completed in the calendar year 2017.
If successful, SOZO is expected to provide an early warning system for cardiac decompensation with the potential to optimise patient care and significantly reduce hospital readmissions.
The real-world data generated will be used to form the basis for the design of a larger scale trial expected to be initiated by late 2017.
CHF is among the most expensive diseases in the U.S with an estimated 6.5 mln people suffering from heart failure, with more than 850,000 new patients diagnosed each year.
Heart failure currently costs the U.S. circa US$31bn per year, and is estimated to increase to US$70bn by 2030.
The company obtained CE (European Conformity) mark for SOZO in June 2017 and plans to initiate the European launch of SOZO in key commercial sites in calendar year 2017.