This article is part of upstarta series about companies using new science and technology to solve their industry challenges.
Paul Hall is thinking about his pool. In his mind, he’s far away from the humble clinic in Orange, California, where he sits quietly as blood flows through a hemodialysis machine, removing toxins from it. Soon he’ll be watching his three grandchildren play around while he heals. Or watch TV. He will do it any time he likes.
“There is no place like home,” Mr. Hall, 64, said.
He has just a few classes left to train on using the Tablo hemodialysis system, a home dialysis product made by San Jose-based Outset Medical. When finished, he hopes to insert it into his Moreno Valley home.
The size of a college dorm refrigerator, this generation of hemodialysis machines looks nothing like the bulky machines first introduced to the domestic market in the 1960s. A touchscreen that uses 3-D animation to guide the user through each step is mounted on top of a box with a built-in water purification system.
After a 30-minute setup process, which included inserting two 14-gauge needles into his left arm, the machine complimented him: “Well done, Paul!”
Like most of the 780,000 Americans with end-stage renal disease, Mr. Hall requires dialysis or a transplant to survive. The number of people living with chronic kidney disease in the country is only expected to increase. It already affects about one in seven adults, according to the U.S. Kidney Data System’s 2022 annual report.
Transplant will not be mr. Hall first; the one for his oldest child failed about twenty years ago. Without working kidneys, excess fluid and toxic waste can build up and poison the body. According to the USRDS, about one in six patients on maintenance dialysis die each year. Others forget about treatment, most likely because of other life-limiting conditions such as advanced cancer or heart failure.
“The patient outcomes were definitely better, but still unacceptably poor,” Dr. Dr. said. Joseph Vassalotti, chief medical officer of the National Kidney Foundation.
The company that will become Outset Medical was founded in 2010; it launched commercially in 2018, when Tablo entered hospitals and clinics. The U.S. Food and Drug Administration approved Tablo for home use in March 2020, just like vulnerable people who need to quarantine due to the coronavirus pandemic.Later that year, the company went public with a virtual IPO
The only current alternative to a home hemodialysis system is the portable NxStage System One, manufactured by Germany-based Fresenius Medical Care. It was introduced to the home in 2005 and has recently launched an updated version, VersiHD.
Of the hemodialysis devices examined in the market analysis, the Tablo is the most expensive hemodialysis device on the market, according to market research by ECRI, a federally accredited nonprofit patient safety organization. The Tablo’s average price was $47,000, excluding service or operating costs, while the NxStage System One’s average price was $26,000.
Dialysis is really expensive. The Centers for Medicare and Medicaid Services wants to reduce spending and improve the quality of care for beneficiaries with end-stage renal disease. The agency is seeking to increase home dialysis and kidney donations through financial incentives for dialysis providers, physicians, health systems and kidney transplant programs.
The explicit need for home systems is another factor. Most dialysis patients go to the clinic for hemodialysis, with little flexibility for long distances, snow storms or car breakdowns. Patients often perceive themselves as having a poor quality of life, as cramps, insomnia, depression, and anxiety are common.
gentlemen. Hall missed a lot of life events, he said. While he didn’t complain, he noticed a difference when the clinic closed for the long holiday weekend.
“I can say how I feel after two days,” Mr. Hall said. “If it starts to get hard to breathe and I know I have fluid in my lungs, I want to get it off me.”
Home dialysis is not a novel idea, said Leslie Trigg, chief executive of Outset Medical. In the early 1970s, it was estimated that more than 30% of dialysis patients were treated at home. According to a review published in the journal Dialysis Symposium in 2017, they often have no choice because dialysis equipment cannot keep up with demand.
This changed in 1972 with the expansion of Medicare, which included coverage for patients with end-stage renal disease who required dialysis or kidney transplantation; in turn, funding from coverage supported the development of outpatient dialysis clinics. In the half century since, the number of dialysis patients has increased, as has for-profit center dialysis.
According to USRDS, about 14 percent of dialysis patients are now being treated at home, either on their own or with a care partner, and that number is growing. An estimated 2% of patients receive home hemodialysis. Most people have peritoneal dialysis, which involves injecting a dialysis solution into the lining of the abdomen to filter waste from the body. It is usually prescribed every day, and the day is much longer than hemodialysis.
gentlemen. Hall also tried for two years. He prefers the peritoneum and hopes he can start over now, but has an infection.
All home dialysis candidates and those helping them need to be trained, and a company or home health agency usually visits the home during the initial stages.
But even with these measures, there are other considerations.
“It’s not for everyone,” said Dr. Mark Sarnak, chief of the Division of Nephrology at Tufts Medical Center. “Some people have needle phobia, some people may not have the vision to do peritoneal dialysis, and some people may be too sick.”
Not everyone is happy with the technology, without family support (if needed), or extra space to store supplies or machinery. Others prefer to receive supervised treatment by a trained professional.
For Mr. To complete his three-hour Tablo treatment, he attached a needle to an arterial line that passed blood through the machine’s dialyzer, also known as an artificial kidney. He connects the other to the venous line through which his clean blood returns. However, the most challenging part for him was the end of treatment, at which point he had to pull out the needle and apply just the right amount of pressure to avoid massive blood loss. His ex-wife and daughter were trained on how to help.
Easy access to home dialysis has many benefits. Traditionally, in clinics, large amounts of fluid are drained in a short period of time, and many patients feel exhausted afterwards. With peritoneal dialysis and more frequent hemodialysis, “it’s much gentler,” says Dr. Sanak, lead author of a recent statement from the American Heart Association. More frequent hemodialysis also has potential cardiovascular benefits, according to the statement.
(However, the risk of infection may increase with frequency. Although less common, infection is also a risk for peritoneal dialysis patients.)
The FDA needs a care partner when using Tablo—another potential hurdle for patients looking to switch to home use; clinics that oversee patients at home confirm one is available, according to Outset Medical. (The NxStage System One can be run on its own, but a care partner is encouraged if the patient uses it while sleeping at night.)
Another problem is that home dialysis does not yet cover all those who need it.Black and Hispanic patients disproportionately affected by kidney disease are less likely to initiate home dialysis than white patients, according to USRDS
More options may be on the horizon. One from Quanta Dialysis Technologies has been approved for use in chronic and acute settings and is currently undergoing home clinical trials. Another company from CVS and Deka Research & Development Corp. is in the final stages of clinical research.
Earlier this year, 2,300 of Outset’s systems were used in hospitals, rehabilitation facilities and long-term care facilities. But the company’s latest public figures show the company’s home rollout has been slow, with an estimated 300 devices being used by patients at home or in training settings.
Doctors say Tablo’s study is promising but limited by its small sample size and relatively short follow-up. PhD. Before joining the company as chief medical officer, Fort Worth, Texas-based nephrologist Michael Aragon helped oversee Tablo’s home safety and efficacy trials. The trial found that the 28 patients with end-stage renal failure who completed the study were sufficiently cleared of toxins on the Tablo that the device is considered safe at home and in the clinic.
During Mr. Hall’s test treatments at the clinic, he also had to learn how to troubleshoot. Two hours later, an alarm goes off as the leaves of a tree on the machine gradually turn green to show the time remaining. The machine tried to measure his blood pressure, but couldn’t. The nurse repositions the cuff. (Although this is uncommon, loss of consciousness due to a drop in blood pressure is a risk at home or in the center.)
Over the past four years, several reports of bleeding, loss of consciousness and death related to Tablo have been reported in the FDA’s adverse event database. Mrs. The company has not ruled that adverse events affecting patients were related to Tablo, Trigg said.
There were similar adverse events with the NxStage System One, although a Fresenius Medical Care spokesman said no injuries or deaths were ruled to be a malfunction of the machine.
Ismael Cordero, senior program officer for device evaluations at safety group ECRI, reviewed the two companies’ reports. Any potential danger “becomes even more of a concern when these devices are used outside of a clinical setting,” he said.
FDA spokeswoman Carly Kempler said the database has limitations and “if FDA becomes aware of information that indicates a medical device has a safety issue, FDA will take appropriate action.”
gentlemen. Hall hopes to have another transplant. Meanwhile, with the help of his family, he finally treats himself at home. Although the first Tablo he received failed, its replacement went smoothly.
No longer commuting to the clinic, he’s happy to have options every day – simple options like early morning treatment, or evening? “It’s a great feeling to know I can fix any problem,” he said.