CVS Announces Home Dialysis Machine Trials

July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers

On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes.

The HemoCare device was designed by DEKA Research & Development Corp., a New Hampshire-based company founded by Dean Kamen, the inventor of the Segway personal transporter. The machine includes simplified touch-screen controls, new automated safety features, and other improvements over standard home dialysis systems.

DaVita Inc. and Fresenius Medicare Care AG together control more than 70% of the dialysis market in the U.S. Most patients must undergo treatment three times a week to remove toxins from their blood, and currently only about 12% of patients begin dialysis treatment at home.

CVS’s 70-patient safety and efficacy trial will be conducted at up to 10 kidney centers in the U.S. CVS hopes to complete the trial and obtain regulatory clearance from the U.S. Food and Drug Administration to allow the HemoCare to be marketed by the end of 2021. The drugstore chain has not yet finalized financial models of how it will sell or rent the device to patients, but the U.S. dialysis market is large enough that CVS may achieve substantial revenues even if it captures only a fraction of the market.

CVS diversified its business last year by acquiring health insurer Aetna Inc. The company also plans to shift up to 1,500 of its stores to care-focused “HealthHUBs,” with expanded walk-in medical clinics and other health services, by the end of 2021.

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