Renal

A study by Wysowski and colleagues from the FDA (US Food and Drug Administration) studied hyperkalemia prevalence using NHANES III survey data.  An analysis of the data shows a staggering number of people with chronic kidney disease (CKD) have mild to severe hyperkalemia.  For instance, in patients with Stage 3 CKD, it is estimated that 21% or nearly 2 million patients suffer from hyperkalemia.  The incidence becomes even more prevalent as a patient's kidney disease progresses.  For patients with late and end-stage CKD (Stages 4 and 5) the incidence of hyperkalemia is over 50% - approximately 400,000 patients.  

In the case of patients with end stage renal disease (ESRD) both hemodialysis and peritoneal dialysis can assist in the removal of dangerous toxins such as potassium.  However, poor compliance with treatment sessions, inadequate control of recommended diets and continued disease progression are major contributors to the high incidence of hyperkalemia in this patient population. 

The unmet medical need and potential ifor a product like ZS-9 in the renal market alone exceeds $500MM.