Kidney dialysis is a life-saving treatment that replaces kidney function in patients with kidney failure. The earliest form of dialysis dates to the 1940s, when Dutch physician Willem Kolff invented the first artificial kidney machine. However, it wasn't until the 1960s that dialysis became widely available and began to transform the lives of those with end-stage kidney disease (ESKD).
Chronic kidney disease (CKD) is a worldwide health crisis that imposes a significant burden on global healthcare systems. It is estimated that for people aged 65 through 74, one in five men and one in four women have CKD. In the US alone, approximately 786,000 Americans have ESKD and require kidney dialysis to stay alive. This incidence is increasing owing to an aging population as well as the growing prevalence of risk factors such as diabetes and hypertension.
Despite a rapid expansion in the provision of dialysis and over 2 million individuals currently receiving dialysis treatment to survive, only 10% of people globally who need treatment to live are actually receiving it. Socioeconomic factors define access to dialysis: more than 90% of patients who receive treatment come from affluent developed countries with universal health care. Globally, most people who develop ESKD forego treatment, resulting in millions of deaths every year.
Growth of patients is continuously outpacing the capacity of kidney replacement therapy (KRT), defined as dialysis or kidney transplant a | Global prevalence of chronic dialysis. b | Estimated worldwide need and projected capacity for KRT by 2030. pmp, per million population. Image from the ISN Global Kidney Health Atlas 2019.
The two types of dialysis - hemodialysis (HD) and peritoneal dialysis (PD) - both do the same thing, which is to clean the blood of wastes and excess fluids. In HD, blood is pumped out of the body through an artificial kidney and back, going in dirty and returning clean. PD uses the peritoneum (a thin membrane that lines the abdominal cavity) as a natural filter, pumping cleaning fluids through it via a catheter. Both forms of dialysis must be repeated frequently and can sometimes take 3-4 hours a session, several times a week.
Despite its importance, kidney dialysis has long faced significant challenges. Traditional in-center HD treatments can be physically and emotionally draining for patients, who may need to spend many hours a week in dialysis centers. Current in-home dialysis options include PD and home HD, but the machines are very heavy and bulky and require 10-20 liters of fluids for treatment, making it cumbersome for patients to use and limiting their mobility. Furthermore, dialysis can cause a host of complications, from infections to anemia to cardiovascular disease. For many patients, kidney transplantation is not a viable option, either because of a shortage of donor organs or other medical complications.
More recent market analyses of kidney dialysis show that while patients value longevity, they consider symptom burden reduction and achieving maximal functional and social rehabilitation to be even higher priorities. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value in the form of true patient-centered innovation that supports high-quality, high-value care.
A summary of initiatives to transform dialysis outcomes from both top-down and bottom-up efforts guided by priorities identified by patient needs. Image from Nature Reviews Nephrology : The current and future landscape of dialysis
In recent years, several innovations have emerged in the field of kidney dialysis that promise to make dialysis easier and more convenient, as well as improve patient outcomes. One key innovation is the development of portable dialysis machines. Below, we discuss the macro-trends in the dialysis market, especially the push for home dialysis, and highlight some of the technologies enabling this shift.
The Changing Landscape of Kidney Dialysis
Home dialysis has existed for decades. In fact, kidney dialysis started as a largely home-based HD treatment during the 1960s in the US. This changed when US Congress passed legislation in 1972, the Medicare End Stage Renal Disease Program, which greatly increased access to dialysis treatment but catalyzed the development of a for-profit outpatient in-center dialysis provider industry.
While most dialysis is conducted in-center, there is accumulating evidence supporting better clinical outcomes from home treatment, especially with PD. Home dialysis offers greater convenience for patients to plan dialysis around lifestyles. The option to dialyse more frequently can also reduce infection risk and the need for dietary restrictions, as well as improve blood pressure control and patients' quality of life. Additionally, home dialysis may be more cost-effective than in-center dialysis, as it can reduce the need for expensive hospital stays and transportation.
Current home HD machines on the market include the NxStage System One developed by NxStage Medical Inc, the Quanta SC+ by Quanta Dialysis Technologies, and the Tablo system by Outset Medical. Portable PD machines include the Baxter HomeChoice Pro PD system. Though relatively more compact, these machines are still very heavy, with HD machines weighing between 70-195 lbs and PD machines weighing an average of 25 lbs. In addition, copious amounts of water or large amounts of dialysate fluid (10-20 litres) are required for each session, and patients need sufficient space in the home to store their dialysate supplies. Patients, especially the elderly, find it cumbersome to manage the logistics of the current machines.
Globally, only 9 countries (Canada, Netherlands, Iceland, Finland, Denmark, Australia, New Zealand, Mexico, and Hong Kong) report home dialysis for >20% of dialysis patients. Hong Kong has the highest penetration rates, with more than 70% of patients receiving PD at home. The primary reason for the popularity of PD in Hong Kong is the availability of resources, including trained healthcare professionals, for patient support. Hong Kong’s PD-First Policy also provides financial incentives for patients to choose PD over in-centre HD.
However, the market for home dialysis is growing. In the US, the percentage of patients receiving home dialysis grew from 8.9% in 2009 to 13.1% in 2019. Though many years away from matching Canada or Australia, it is closing in on the UK where 17.1% of patients utilize home dialysis.
Recent changes to US Medicare reimbursement policies may help boost these numbers. In 2019, the Centers for Medicare and Medicaid Services (CMS) introduced a new payment model for kidney care that aims to encourage the use of home dialysis and set a goal of having 80% of new ESKD patients receive home dialysis or a transplant by 2025. The model includes a payment bonus for providers who increase the number of patients using home dialysis, and also expands coverage for certain home dialysis supplies and services.
This new payment model could be a game-changer, and has motivated the largest dialysis providers in the US to expand their home dialysis options. Fresenius acquired NxStage Medical for $1.9 billion in 2019 and DaVita expanded its use of home dialysis machines supplied by Fresenius. DaVita is also tapping on Baxter’s automated PD system to grow its home dialysis program. Leading healthcare organizations, including payers and providers such as Anthem, CVS, Outset Medical, have joined forces to expand access to home dialysis.
This push has also increased innovation in the industry, from companies that develop and market home dialysis equipment and related technologies, as well as those that provide training and support for patients and healthcare providers.
Portable Devices for the Future of Kidney Dialysis
The development of next-generation portable dialysis machines represents an exciting area of innovation in the field of kidney dialysis. By offering patients greater flexibility and convenience, these machines which are smaller and more user-friendly than traditional dialysis equipment have the potential to improve health outcomes and concurrently enhance patients' quality of life. While there are still several challenges to overcome, the growing focus on patient-centered care and the changing reimbursement landscape is driving transformation in this area.
Many of the innovations are centered around reducing and recycling of dialysis fluid required per dialysis treatment, as well as miniaturizing the components of the device to increase portability.
Some companies developing next-generation portable HD devices include Seattle-based Kuleana Technology, whose devices contain a photo-oxidation technology that eliminates toxins without the continuous use of water. Their devices will not require connection to an external water source nor require complex sorbents, saving over 50 gallons of water per treatment. Nextkidney has developed a sorbent technology to regenerate dialysis fluid during HD. Their device, NeoKidney, only requires 5 litres of dialysate and fits into a cabin-sized luggage weighing 22lbs (10kg). Still in early development, QidniLabs is developing a waterless and wearable HD device called Qidni/D that has shown promising results in animal trials.
For PD, Singapore-based company AWAK, a Vickers portfolio company, is developing a portable and wearable device the size of a handbag. It is designed to enable patients to perform dialysis at home or on-the-go. This is enabled by their proprietary sorbent technology that regenerates dialysate, reducing it to 1-2 litres, making it easier to use and more cost-effective. Additionally, the regeneration technology used by the AWAK device reduces the risk of infection and improves treatment outcomes by maintaining a constant level of electrolytes and other solutes in the dialysate. AWAK’s device, which won Breakthrough Therapy designation by the US FDA, has already completed first-in-human studies with improved results compared to current PD devices.
Another enabling innovation is telehealth technology, which has made it possible for patients to receive remote monitoring and support from healthcare providers, further increasing the feasibility of home dialysis. This has also led to the use of artificial intelligence and machine learning to predict patient outcomes and adjust treatment plans accordingly. By analysing large amounts of data, AI systems can identify patterns and trends that may not be immediately apparent to doctors, leading to more personalized and effective treatment plans.
While these portable dialysis machines have the potential to improve patient outcomes with home dialysis, there are still some challenges that need to be overcome. For example, patients need additional training and support to learn how to use the machines effectively and safely, so networks of support and education programs need to be set up for home dialysis. In many countries, there needs to be involvement and engagement of health systems and policy makers to tweak insurance and reimbursement policies to improve accessibility of home dialysis.
It Is important to appreciate that “one size may not fit all”, and that dialysis modality selection is a complex decision made by the individual. But the potential benefits of these new technologies are vast, offering hope to millions of people suffering from kidney disease worldwide. With continued investment and development, the future of dialysis looks brighter than ever before, and patients may soon be able to receive more personalized, efficient, and effective treatments that greatly improve their quality of life.