Approximately 1 million Americans suffer from liver cirrhosis, primarily as a result of viral hepatitis, alcoholism, or increasingly, non-alcoholic steatophepatitis (“NASH”). Cirrhosis due to NASH, which arises from fatty liver disease, is increasing rapidly due to the epidemic of obesity that is frequently accompanied by diabetes. The first sign that liver cirrhosis has progressed into a medically serious condition is often the appearance of ascites fluid in the abdomen, detected by ultrasound. This signals that liver status has changed from “compensated” to “decompensated” and the patient is now at increased risk of serious medical complications.

In most patients, early-stage ascites can be controlled with a salt-restricted diet and pharmacologic therapy using diuretics (“water pills”). However, in about 10% of patients with ascites, the ascites gets much worse and eventually does not respond to diuretic therapy, or the patients can no longer tolerate this therapy. This stage is called “refractory ascites” and these patients are frequently hospitalized with life-threatening infections, kidney failure, and other complications such as hepatorenal syndrome (“HRS”) which has a life expectancy of only a few weeks unless it can be reversed. If they are not lucky enough to receive a liver transplant, which is the only definitive cure, they face a mortality rate of about 50% with 12-24 months.