CVS Health Corp. is making an at-home hemodialysis device and plans to conduct its first clinical trial this year, MarketWatch reports.
Here are nine things to know.
1. CVS will work with clinical research groups to conduct a trial of its new device, which is designed to be safe and simple for at-home use by patients with chronic kidney disease. The pharmacy company ultimately hopes to gain FDA clearance.
2. CVS will have exclusive rights to the device but a manufacturing partner will produce it.
3. CVS plans to begin the clinical trial late in the third quarter of this year, and "would be happy if we got to market in the middle-to-end of 2020," CVS's Alan Lotvin told MarketWatch. Mr. Lotvin is the kidney initiative leader and head of the specialty pharmacy business.
4. Dialysis after kidney failure typically requires patients to spend several hours at a dialysis clinic, three days a week.
CVS's at-home device is intended to facilitate longer, more frequent dialysis treatments, which has improved cardiac health, metabolic control and survival for patients in studies.
5. "In order to really make home hemodialysis viable, we needed a simpler device designed with patient use in mind, versus nurse use, and designed with the intent to be simpler, safer and easier without sacrificing effectiveness," Mr. Lotvin said.
6. CVS will likely partner with sellers of at-home products to develop solutions for peritonatal dialysis as well.
7. In addition to expanding home dialysis options, CVS aims to educate patients and aid early identification of kidney disease. It announced the initiative April 4, following a string of recent deal announcements in the healthcare industry — including Walmart's potential buyout of Humana, and Cigna's acquisition of Express Scripts.
In December 2017, CVS agreed to acquire Aetna for $69 billion.
8. When CVS prepares to launch its hemodialysis device, "presumably there's going to be a payer angle," Mr. Lotvin said. However, the company is "looking to work within existing systems."
9. Kidney disease affects an estimated 30 million Americans, and approximately 700,000 Americans have End State Renal Disease. Medicare patients treated with in-center hemodialysis have mortality rates up to 10 times higher than those of the general Medicare population, according to CVS.