ARTICLE SUMMARY:
A kidney care start-up’s scaled-down dialysis device will offer patients newfound freedom from the tribulations of end-stage renal disease.
Since the introduction of modern hemodialysis more than 60 years ago, the process of blood filtration has undergone mostly cosmetic changes to the machines that perform it but very little fundamental innovation. In patients with end-stage kidney disease (ESKD, also known as end-stage renal disease or ESRD) the organs can no longer effectively remove excess water and toxins, such as urea and intermediate metabolites, from the bloodstream and need dialysis for mechanical support. To prepare patients for the therapy, doctors must create an arteriovenous fistula or graft in the arm, which can take six weeks or more to mature and is prone to infection or obstruction.
Around 10% of US ESKD patients are fortunate enough to make it onto the kidney transplant list at all, and still they may wait up to five years to find a donor if a family member is not an immediate match. During this waiting period, many patients’ health declines to the point that they are removed from the list, so for nearly 1 million Americans and roughly 3.5 million patients worldwide, dialysis is the only option for survival.
The dialysis process is extremely taxing on the body, with toxins and water building up between sessions that occur two to three times per week for about four hours at a time, leaving patients in a state of constant fatigue. Between generally low energy levels and the time commitment of these sessions, most aspects of patients’ lifestyles suffer, from work to social life, leading to a gradually accumulating loss of independence, mobility, and experiences. On the whole, ESKD care costs the US healthcare system more than $50 billion annually, representing about half of global expenditure on the disease.
In 2019, an executive order mandated that much of dialysis in the US be moved out of dedicated centers and into the home and other healthcare settings, which for patients translated to more time spent seated attached to a machine. Nephrodite CEO Nikhil Shah, DO, MPH describes what dialysis patients go through as “a never-ending cycle of pain and fatigue.” Shah is a urologic surgeon by training with an emphasis on transplantation; as his focus shifted to urologic oncology, he trained for his residency and fellowship with a group that pioneered the use of surgical robotics for cancer treatment.