ARTICLE SUMMARY:
CloudCath is eliminating the barriers to home-based peritoneal dialysis to allow more people needing renal replacement therapy to enjoy treatment in the comfort of their own home. Excerpted from our recent feature article.
For many patients with end-stage renal disease (ESRD) who require renal replacement therapy, peritoneal dialysis (PD) is a preferred alternative to in-center hemodialysis. Recently, several home hemodialysis companies have entered the market with systems that ameliorate some of the drawbacks of the brick-and-mortar service model, but they have only acquired a small share of the home dialysis market due to cost concerns and challenges with self-cannulation and other ease of use issues.
Despite its clinical and quality-of-life advantages, and even though CMS, the major payor for this population, is working toward incentives for home-based therapy with value-based models like Kidney Care Choices (KCC), PD is underutilized. Penetration rates vary across global geographies, but the US has one of the lowest. Only about 14% of ESRD patients receive home-based renal replacement therapy.
Start-up CloudCath aims to identify and remove the barriers that prevent patients from receiving the benefits of PD. One barrier is historical and financial, but the greater challenge is safety; an infection known as peritonitis can occur from environmental bacteria during PD fluid exchanges or at the exit site and catheter tunnel. CloudCath has created a solution, CloudCath Connect PD, that monitors for potential infection, notifying care providers early, even while patients are asymptomatic. The early warning system is wrapped into a care management platform that supports clinicians and patients.
At the core of the CloudCath System is an optical sensor, which daily measures fluid turbidity correlating to the concentration of white blood cells in dialysate fluid. The company’s algorithms also analyze the rate of change of turbidity. The goal is to alert care providers to a potential infection at its origination, when it can often be easily treated with an antibiotic. If the system flags infection, it notifies both the patient and the treating physician by text or email, according to their choice. In the clinic, the treating physician will confirm the infection, and begin treatment. The system also serves as a treatment monitor, since if turbidity levels don’t decrease, that’s a sign that something isn’t right; perhaps that particular antibiotic isn’t working and should be switched.
There is no other such monitoring system on the market for this application. CloudCath Connect PD can identify potential infections four days earlier than conventional care, according to a soon-to-be published study called CATCH, by lead authors Rajnish Mehrotra, MD (University of Washington), a nephrologist and the president-elect of the International Society of Peritoneal Dialysis, and nephrologist Glenn Chertow, MD (Stanford University). A second study called ACT will demonstrate how the use of the CloudCath System reduces all-cause hospitalizations, among other clinical improvement endpoints. Again, hospitalizations risk the termination of PD, if the patient’s catheter is removed in the process. And, since peritonitis can cause scarring of the peritoneal membrane, avoiding infection and scarring also supports long-term use of PD.
In February 2022, the company gained FDA clearance of the CloudCath System as a remote patient monitoring system, and it is now commercial in the US.