This article is part of Upstarta series about companies using new science and technology to solve industry challenges.
Paul Hall thought about his swimming pool. In his mind, he was far from the nondescript clinic in Orange, California, where he sat quietly, his blood flowing through a hemodialysis machine, clearing it of toxins. Soon he would see his three grandchildren splashing about as he did his treatment. Or watch TV. And he would do it all at any hour he wanted.
“There’s no place like home,” said Mr Hall, 64.
He had just a few more sessions left to be trained in the use of the Tablo Hemodialysis System, a home dialysis product made by Outset Medical, based in San Jose. When he was done, he hoped to join him at his home in Moreno Valley.
This generation’s hemodialysis machines are the size of a college dorm fridge and are nothing like the hulking machines first introduced to the home market in the 1960s. A touchscreen, which uses 3D animation to guide users through each step, is mounted on 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 praised him, “Well done, Paul!”
Like most of the 780,000 Americans with end-stage kidney disease, Mr. Hall needs dialysis or a transplant to live. The number of people with chronic kidney disease in this country is only expected to grow. It already affects about one in seven adults, according to the United States Renal Data System’s 2022 annual report.
A transplant wouldn’t be Mr. Hall’s first; that of his oldest child fails about two decades ago. Without working kidneys, extra fluids 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 forego treatment, most likely because of other life-limiting conditions, such as advanced cancer or heart failure.
“The patient outcomes are definitely better, but still unacceptably poor,” said Dr. Joseph Vassalotti, medical director of the National Kidney Foundation.
The company that would become Outset Medical started in 2010; it was launched commercially in 2018, when Tablo entered hospitals and clinics. The Food and Drug Administration approved Tablo for home use in March 2020, just as vulnerable populations had to isolate themselves due to the coronavirus pandemic. Later that year, the company went public in a virtual IPO
The only current alternative to home hemodialysis systems is the portable NxStage System One, made by Fresenius Medical Care, which is headquartered in Germany. It was introduced to homes in 2005, with a newer version, VersiHD, following more recently.
Of the hemodialysis units examined in a market analysis, Tablo is the most expensive hemodialysis unit on the market, according to a market survey by ECRI, a federally certified nonprofit patient safety organization. Tablo costs an average price of $47,000, excluding service or operational costs, compared to $26,000 for the NxStage System One.
Dialysis is indeed expensive. The Centers for Medicare & Medicaid Services hope to reduce its spending and improve the quality of care for its beneficiaries with end-stage kidney disease. Through financial incentives for dialysis providers, physicians, health systems and kidney transplant programs, the agency is seeking to increase home dialysis and kidney donation.
The obvious need for home systems is another factor. A majority of dialysis patients travel to hemodialysis clinics, with little flexibility for long distances, snow storms or car breakdown. Patients often rate themselves as having a low quality of life because cramps, insomnia, depression, and anxiety are all common.
mr. Hall has missed so many life events, he said. And while he doesn’t complain, he notices a difference when clinics close for long holiday weekends.
“After two days I can see how I feel,” Mr. Hall said. “When it gets harder to breathe and I know there’s fluid in my lungs, I want that off me.”
Home dialysis is not a new idea, said Leslie Trigg, Chief Executive of Outset Medical. By the early 1970s, it was estimated that more than 30 percent of dialysis patients had completed their treatment at home. Often they were left with little choice, with dialysis units failing to meet demand, according to a 2017 review in Seminars in Dialysis magazine.
In 1972, this changed with the expansion of Medicare, which included coverage for people with end-stage kidney disease who required dialysis or a kidney transplant; in turn, that funding of coverage fueled the growth of outpatient dialysis clinics. In the half century since, the patient population for dialysis has grown, as has in-center for-profit dialysis.
Now about 14 percent of dialysis patients treat at home, alone or with a healthcare partner, and that number is growing, according to the USRDS. An estimated 2 percent are undergoing home hemodialysis. Most do peritoneal dialysis, in which dialysis solution is infused into the lining of the abdomen to filter the waste from the body. It is usually prescribed daily, and for significantly longer periods per day than hemodialysis.
mr. Hall also tried this for two years. He preferred peritoneal and wished he could be back on top by now, but got an infection.
Training is required for all home dialysis candidates and the person assisting them, and the company or home care organization usually visits the home during the initial period.
But even with these measures, there are other considerations.
“It’s not for everyone,” says Dr. Mark Sarnak, chief of nephrology at Tufts Medical Center. “Some people have needle phobia. Some people may not have the eyesight to do peritoneal dialysis. Some people may be too sick.”
And not everyone is familiar with the technology, has the support of family members (if needed) or the extra space to store the supplies or the machine. Others prefer to have a trained professional oversee the treatment.
In order for Mr. Hall to do his three-hour Tablo treatment, he connects one needle to an arterial line to allow blood to flow through the machine’s dialyzer, otherwise known as an artificial kidney. The other he attaches to the venous line, returning his cleansed blood. The most challenging for him, however, is the end of the treatment, when he must remove the needles and apply just the right amount of pressure to prevent significant blood loss. His ex-wife and daughter have trained to help.
There are benefits to having easy access to home dialysis. Traditionally in a clinic a lot of fluid is removed in a short time and many patients feel exhausted afterwards. With peritoneal dialysis and more frequent hemodialysis, “it’s much gentler,” said Dr. Sarnak, the lead author of a recent statement from the American Heart Association. According to the statement, there are also potential cardiovascular benefits with more frequent hemodialysis.
(However, the risk of infection may increase with a higher frequency. And while it is uncommon, infection is also a risk for patients on peritoneal dialysis.)
The FDA needs a healthcare partner while taking Tablo – another potential barrier for patients wanting to switch to home use; the clinic that monitors the patient at home confirms the availability of one, according to Outset Medical. (NxStage System One should be used alone, but if patients use it at night while sleeping, a healthcare partner is encouraged.)
Another problem is that home dialysis has not reached all needy populations. According to the USRDS, black and Hispanic patients, who suffer disproportionately from kidney disease, are less likely to receive home dialysis than white patients
There may be more options on the horizon. One of Quanta Dialysis Technologies, already approved for chronic and acute settings, is in home clinical trials. Another, from CVS and Deka Research & Development Corp., is in the final phase of a clinical trial.
At the beginning of this year, 2,300 Outset systems were used in hospitals, rehabilitation centers and long-term care facilities. But the company’s home rollout has been slow, with an estimated 300 devices being used by patients at home or at training locations, according to the company’s latest public figures.
The research on Tablo is promising, doctors say, but limited because of the small sample size and relatively short-term follow-up. dr. Michael Aragon, a nephrologist based in Fort Worth, Texas, helped to oversee Tablo’s home safety and efficacy research before joining the company as Chief Medical Officer. The study found that 28 patients with end-stage renal failure who completed the study had adequate toxins removal on Tablo, and the device was considered safe both at home and in the clinic.
During Mr. Hall’s trial treatment at the clinic, he also had to learn how to solve problems. Two hours later, when the leaves of a tree on the machine gradually turned green to indicate time remaining, an alarm went off. The machine had tried to measure his blood pressure, but it failed. A nurse moved the cuff. (Although uncommon, loss of consciousness from a drop in blood pressure is a risk at home or at the center.)
Several reports of bleeding, loss of consciousness, and deaths related to the Tablo have been reported to the FDA’s database of adverse events over the past four years. Ms Trigg said none of the side effects affecting patients had been assessed by the company as related to Tablo.
NxStage System One also has its own share of similar side effects, although a Fresenius Medical Care spokesperson said no injuries or deaths were ruled out as the fault of the machine’s equipment.
Ismael Cordero, senior project officer for device evaluations at ECRI, the security organization, reviewed reports from both companies. Any potential hazards, he said, become “even more concerning when the devices are used outside of a clinical setting.”
Carly Kempler, an FDA spokeswoman, said the database has limitations and that “if the FDA becomes aware of information that reveals a safety issue with a medical device, the FDA will take action as necessary.”
mr. Hall hopes to get another transplant. Meanwhile, he finally treats himself at home, with the help of his family. While the first Tablo he received had issues, its replacement works flawlessly.
No longer commuting to the clinic, he’s happy with the choices each day brings – simple ones like early morning or evening treatment? “That’s a great feeling to know that I can work around whatever comes next,” he said.
