CVS Health Announces Clinical Trial for New Home Hemodialysis Device

CVS Health announced the initiation of a clinical trial designed to evaluate the safety and efficacy of the HemoCare™ Hemodialysis System for administration of home hemodialysis. The device includes safety features and is designed to make home hemodialysis simple for patients. Home hemodialysis helps facilitate longer, more frequent dialysis treatments as compared to in-center treatments, and published clinical research has found that longer, more frequent hemodialysis treatments result in better health outcomes in appropriate patient populations. The clinical trial of up to 70 patients will be conducted at up to ten sites in the United States.

"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," said Alan Lotvin, M.D., Executive Vice President and Chief Transformation Officer, CVS Health. "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, and we are working closely with the U.S. Food and Drug Administration as we evaluate this device."

Currently, hemodialysis, which uses a machine to clean a patient's blood, is most commonly administered in a dialysis center three times per week. However, an expanding body of scientific literature indicates that clinical outcomes for hemodialysis patients can be improved if treatments are longer in duration, which can be challenging to achieve via in-center dialysis.

During the trial, investigators will measure the safety and performance of the HemoCare Hemodialysis System. In the initial phase of the trial conducted at medical facilities, clinical study subjects and their caregivers will receive training on the system and will then transition to home-based dialysis. Primary study endpoints include adverse events as well as regular tests to measure the dose efficacy of dialysis delivered by the device. The HemoCare Hemodialysis System was developed in collaboration with DEKA Research & Development Corp.

"DEKA designed this device with patients in mind to help make home dialysis safe and simple," said Dean Kamen, founder of DEKA Research & Development Corp. "CVS Health is uniquely positioned to redefine identification, education and treatment for chronic kidney disease, making them our ideal partner."

The clinical evaluation of the HemoCare Hemodialysis System and the early kidney disease identification and stratification programs are solutions of CVS Kidney Care, a CVS Health company. CVS Kidney Care is developing a series of comprehensive solutions for all commercial and government payers that are focused on improving health and outcomes for people living with chronic kidney disease (CKD) and end stage renal disease (ESRD).

In addition, CVS Kidney Care aligns with the core objectives of the recently announced Advancing Kidney Health initiative. Led by the U.S. Department of Health and Human Services' (HHS), the new effort aims to help improve early detection of and expand treatment options for kidney disease while working to reduce unnecessary health care costs for both patients and payers.

"We have been working to fundamentally disrupt the kidney care market and rapidly innovate in an area that has stagnated for decades, and 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," said Dr. Lotvin. "CVS Kidney Care is uniquely positioned to help deliver on the core tenets of this new HHS initiative in a way that no one else can, and we look forward to working together to help transform the kidney treatment experience for millions of Americans."

More than 37 million Americans have kidney disease, and nearly 700,000 have ESRD. Of those with ESRD, more than 500,000 of these patients are on active dialysis and more than 120,000 new ESRD cases are diagnosed each year. Financially, this disease represents a huge cost burden, costing Medicare $35 billion annually related to dialysis patient care. Despite this high level of spending, outcomes for dialysis patients are poor, with one in six dialysis patients dying in the first year after starting treatment.

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