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End-stage renal disease (ESRD) is the final stage of chronic kidney disease, meaning by that point a person's kidneys are only functioning at 10 to 15 percent of their normal capacity. It's a serious condition, and one not only affects almost 750,000 patients in the U.S., but which also accounts for nearly 7 percent of Medicare’s budget, despite affecting fewer than 1 percent of Medicare patients.
Perhaps even worse are the current ways the disease is tested, relying on what is known as "the newspaper test," where patients are asked to read a newspaper through a collection bag of spent peritoneal dialysate. If they can't read it, then they're advised to seek medical attention. Not exactly the most sophisticated, or accurate, way to diagnose a life threatening disease.
CloudCath is a company that provides a system that enables real-time monitoring for patients undergoing catheter-based treatments, such as peritoneal dialysis, which is used to remove excess fluid and toxins for people with kidney failure. The company monitors these patients, and alerts medical personnel if there's a problem, with hope of staging earlier intervention, thereby reducing further complications that can lead to hospitalization and other problems.
"There's an increasing push to move dialysis therapy into the home. For example, a July 2019 White House executive order on kidney care, the Advancing American Kidney Health Initiative, proposed that 80 percent f new patients with ESRD be treated with either kidney transplantation or home dialysis by 2025, a significant increase from current rates, which are below 20 percent," Aly ElBadry, co-founder and CEO of CloudCath, told me.
"We see CloudCath's technology as a key piece of that puzzle in driving wider dialysis adoption by patients and nephrologists. In many cases kidney transplant is not feasible, and that's where we can play a role in driving longer, safer reliance on home dialysis."
CloudCath's device integrates into the patient’s drain line, remotely monitoring the spent dialysate fluid on every dialysis cycle by measuring and quantifying the fluid properties. The data is transmitted to the company's cloud in real time, where its algorithms can then notify healthcare providers when there is a potential problem. Through CloudCath’s monitoring platform, healthcare providers can log in and access real-time data from their patients throughout their treatment.
"Our solution seamlessly integrates with all models of at-home PD systems, analyzing spent dialysate and alerting healthcare providers of any changes that could indicate a potential infection much earlier than the current standard of care," said ElBadry.
"Our clinical advisory board estimates that our solution could cut the number of infection-driven hospitalizations by 75 percent."
Last week, the company announced that it raised a $12 million Series A financing led by Capital Integral with participation from FundRx, The Capital Partnership, Coconut Tree Investments, Stanford University’s StartX Fund, and additional strategic and individual investors. This round brings its total funding to $15.2 million.
The new funding will be used to commercialize CloudCath’s first product, and to support the development of additional applications for its technology, including urinary catheters.
CloudCath is currently seeking FDA approval, which it expects to receive this year, after which it plans to launch a large post-market study of around 750 to 1000 patients, while it seeks a home dialysis provider to partner with.
"We anticipate that the Series A funds will be enough to carry us through commercialization of our first product and FDA clearance of our second product," said ElBadry.
Ultimately, he told me, success for the company will come in being able to improve the lives of patients.
"We hope our technology will help reduce the rate of hospitalizations for catheter-based infections. We are also hoping that the data we collect on infections can help with the development of antibiotics to combat these infections."
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