CVS Health launched a long-awaited trial to test out its at-home dialysis device designed to provide more frequent and thorough treatments compared to those offered in the clinic.
The nationwide pharmacy chain and benefit manager announced its plans to move into device development in April 2018 with the goal of securing FDA approval and market access by the end of next year.
"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," Alan Lotvin, M.D., CVS Health’s chief transformation officer, 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, and we are working closely with the U.S. Food and Drug Administration as we evaluate this device," Lotvin said.
The clinical trial, starting first in a more controlled setting, will include up to 70 participants at up to 10 medical sites in the U.S., according to the company’s kidney care division. Following training with the device, the patients and their caregivers will then transition to home-based treatment.
The hemodialysis device itself was developed in collaboration with Deka Research and Development, founded by Dean Kamen, famously known as the inventor of the Segway. Kamen also invented the first wearable drug infusion pump known as the AutoSyringe under his first medical device company, and later helped lead Deka’s development of the HomeChoice peritoneal dialysis system for Baxter International.
CVS’ HemoCare Hemodialysis System aims to clean a person’s blood more often than the typically thrice-weekly procedures performed in commercial clinics following research results indicating longer, more frequent treatments can result in better outcomes.
"Deka designed this device with patients in mind to help make home dialysis safe and simple," said Kamen. "CVS Health is uniquely positioned to redefine identification, education and treatment for chronic kidney disease, making them our ideal partner."
President Donald Trump recently issued an executive order to better incentivize at-home dialysis treatments as well as to create new payment models for kidney transplants. The government said it hopes to save about $4.2 billion in overall treatment costs by moving patients to transplants sooner compared to having them on prolonged, center-based dialysis.
"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," Lotvin said.
The order also aims to encourage the development of artificial organs with the goal of doubling the total number of available kidneys by 2030. Currently, more than 100,000 people with renal disease are waiting for a kidney transplant.