The week after President Donald Trump signed a landmark executive order meant to overhaul the current kidney care system, CVS Health has launched a clinical trial for HemoCare, an at-home hemodialysis device.
President Trump’s executive order shifts incentives and payments for dialysis away from in-clinic treatments and towards at-home dialysis.
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According to data from CMS, around 88 percent of end stage renal disease patients in 2016 started treatment with in-center dialysis. The administration’s actions aim to switch that proportion to at-home dialysis by 2025.
HemoCare aims to bolster CVS Health’s efforts in kidney care within this new paradigm, with an eye towards clinical research that has linked improved patient outcomes with longer treatments provided in the home.
Most at-home dialysis is currently done through peritoneal dialysis, a treatment that uses an stomach membrane called the peritoneum as a filter to clean the patient’s blood.
CVS Health’s new device would open up the at-home market for hemodialysis, which uses an artificial kidney device to perform the procedure and has traditionally been difficult to provide outside of a clinical setting. HemoCare is designed to simplify the hemodialysis process for at-home patients.
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“We’re working now to change the kidney care paradigm by bringing to market programs and tools to improve early detection of kidney disease and provide comprehensive education and support to help delay the transition to dialysis,” CVS Executive Vice President Alan Lotvin said in a statement.
“For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options.”
CVS is starting a trial to test safety and efficacy for the device through a multisite study of up to 70 patients ahead of a planned FDA submission. The HemoCare device was developed in collaboration with DEKA Research & Development Corp., an engineering and technology company started by Segway inventor Dean Kamen.
Last year, CVS announced an initiative to grow out its business in dialysis and the treatment of kidney disease through its CVS Kidney Care division, building on assets the pharmacy chain acquired when it purchased specialty infusion company Corum back in 2014 for $2.1 billion.
Outside of its efforts in dialysis, CVS Health has also invested in analytics meant to help identify early indications of kidney disease and educate them about how to manage their condition.
Fresenius Medical Care and DaVita, the two companies which currently dominate the dialysis market have been making moves to shift their business towards home dialysis.
Last year, Davita said it trained more than 13,000 new home dialysis patients and Fresenius closed its $2 billion acquisition of home hemodialysis device maker NxStage Medical earlier this year.
