Drugstore chain CVS Health said on Wednesday that it plans to test a device that would let more people undergo kidney dialysis at home, a play for the $35 billion market for end-stage kidney care.
More than 30 million Americans have kidney disease -- nearly the population of California -- and the prognosis is dicey for the 100,000 who begin dialysis each year. Roughly a quarter of those patients die within a year of starting treatment.
CVS is starting human trials on a dialysis machine designed by DEKA Research & Development, a company founded by Dean Kamen, inventor of the two-wheeled Segway personal transporter. The idea is to simplify dialysis, the process of cleaning toxins from blood, making it more accessible.
"DEKA designed this device with patients in mind to help make home dialysis safe and simple," Kamen said in a statement.
In the final stage of kidney disease, the organ no longer functions on its own, requiring frequent dialysis or a transplant. Experts say home dialysis would encourage longer and more frequent treatments, which research has shown yields better outcomes than going to an outpatient dialysis clinic, where hemodialysis is commonly done three times a week.
"We have been working to fundamentally disrupt the kidney care market and rapidly innovate in an area that has stagnated for decades," said Alan Lotvin, a physician and executive vice president and chief transformation officer at CVS, which has 9,900 retail locations across the country.
The company plans a clinical pilot involving up to 70 patients at as many as 10 sites in the U.S. to evaluate the new device, and is working with the U.S. Food and Drug Administration on the project. "The duration of the trial is expected to last 24 to 36 months with the timing of the FDA review remaining a significant variable," emailed a CVS spokesperson. "Our hope is the device would be on the market by the end of 2021."
The announcement comes a week after President Donald Trump signed an executive order intended to upgrade kidney care with a goal to greatly increase the number of patients who get dialysis at home.
"We applaud the administration for taking bold steps toward advancing kidney care as they are helping to rethink how to make kidney transplant and home dialysis mainstays of therapy," Lotvin said in a statement
Currently, 88% of Americans with end-stage renal disease start dialysis at a medical center, U.S. Health and Human Services Secretary Alex Azar said in March. In some countries, more than 80% of patients get dialysis at home, he added.
CVS' foray into renal care follows its purchase last year of health insurer Aetna for about $69 billion. The enlarged company is seeking to widen its reach into health-care services, with plans to outfit 1,500 of its locations with clinics and wellness rooms.
The venture is a potentially lucrative one. About 37 million adults in the U.S. have chronic kidney disease, and end-stage treatment consumes about 7% of claims to Medicare, or $35 billion. The federal health insurance program spent $113 billion overall treating kidney disease in 2016 -- one of every five dollars spent in Medicare.