ROBOTIC PROCESS AUTOMATION

 Mobile Dialysis Startup Eyes Human Trials In 2022

This past year, three sheep in Canada have been wearing their kidneys on their sleeves. Or more aptly, in jackets of their fluffy backs.

These three sheep are part of an ongoing animal study run by the Buffalo, New York-based startup Qidni Labs, a company pursuing waterless and mobile blood purification systems. Qidni labs were also a winner of the KidneyX 2019 Summit for developing an air removal system for a wearable renal therapy device. 

The jackets are a prototype of Qidni’s mobile hemodialysis machine called Qidni/D. The idea behind it is that the machine is significantly smaller than the traditional hemodialysis setup and it uses fewer fluids, allowing patients to be more free and mobile.

As per the records many people in the world are facing some type of chronic kidney disease and over time this disease could progress into kidney failure, at which point the patients are recommended to undergo dialysis or receive a transplant. 

There are mainly two types of dialysis: 

• Hemodialysis 

• Peritoneal dialysis. 

Hemodialysis passes blood through a filter and a liquid called dialysate, whereas peritoneal dialysis inserts fluid into the body, which absorbs the toxins and drains them out. 

The Qidni/D machine uses a hemodialysis machine that uses its own cartridges and gel-based system to cut down on the amount of liquid needed to perform dialysis.

In an early animal trial- the device was able to reduce levels of urea in sheep’s blood at the threshold of an adequate dose of traditional dialysis. These sheep had no functioning kidneys and were hooked up to the machine for between four and eight and a half hours. The data so far suggests that four hours of treatment should be sufficient to cleanse the sheep’s blood.

The team will continue to tweak the technology in more sheep-based studies this year, and is aiming to begin human trials in 2022. The overall goal is to file for FDA approval, provided that clinical studies can demonstrate safety and efficacy, by the second half of 2023. 

At the moment, far more people with end-stage renal disease are on dialysis than receive kidney transplants. The dialysis industries have a controversial and complicated history of poor performance and are very expensive. During an average week of dialysis treatment, the average person is exposed to about 300 to 600 liters of water, but Qidni/D uses just one cup of water per treatment session. Thus, making at-home dialysis more attainable and limits the risk of infection because of water.

It’s also a small step towards creating an implantable kidney, which would, ideally, not require massive amounts of external fluid – through mobile dialysis remains Qidni’s current focus. The company’s upcoming round will be focused on testing their cartridge technology in small human trials. 

It’s ultimately a step towards a machine that functions more like the organ it’s supposed to mimic, though the holy grail for patients is a solution that ends the need for dialysis in the first place.