Mobile dialysis startup eyes human trials in 2022 following encouraging animal study

This past year, three sheep in Canada have been wearing their kidneys on their sleeves. Or more aptly, in jackets on 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 was founded in 2014, has raised $1.5 million and is currently in the due diligence process leading up to another round of funding. Qidni Labs was also an award winner at the 2019 KidneyX 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 Qidni/D is that it will be significantly smaller than a traditional hemodialysis setup and use fewer fluids, allowing patients to be more mobile.

“We see this device, and this technology, to be a bridge to a blood purification technology that allows the patients to be mobile, although we do not anticipate that to be the first product,” says Morteza Ahmadi, the founder and CEO of Qidni Labs.

Per the CDC, about one in seven people in the US have some type of chronic kidney disease. Over time, that could progress kidney failure, at which point it’s recommended that patients start dialysis or receive a transplant. That threshold is typically symptom based; people might experience weight loss, shortness of breath or an irregular pulse to name a few symptoms.

There are two major types of dialysis: hemodialysis or peritoneal dialysis. Hemodialysis passes blood through a filter and a liquid called dialysate, whereas peritoneal dialysis inserts fluid into the body, which absorbs toxins, then drains it out. Qidni/D is a hemodialysis machine that can fit into a sheep sized jacket, and uses its own cartridges and gel-based system to cut down on the amount of liquid needed to perform dialysis. (ProWellTech reviewed images of the device).

In an early animal trial – the results of which have not yet been published in a peer-reviewed journal – the device was able to reduce levels of urea in sheep’s blood at the threshold of an adequate dose of traditional dialysis. ProWellTech reviewed data from the study over Zoom.

These sheep had no functioning kidneys, and were hooked up to the machine for between four and eight and a half hours. Morteza adds that the data so far suggests that four hours of treatment should be sufficient to cleanse the sheep’s blood.

This is just one small animal study, so it’s hard to draw massive conclusions from it. It didn’t include an active control arm, for instance, and instead compared the amount of urea and electrolytes removed from the sheep’s blood to published standards from other studies on dialysis.

The study alone is far from enough to suggest that the technology is ready for market, but those within the company are taking it as a good sign that the design of Qidni’s mobile dialysis machine bears further testing.

“We can say that in this study, we could replace daily dialysis based on the data,” he says.

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.

The kidney treatment landscape is dominated by dialysis, which is an onerous treatment – despite the fact that a kidney transplant, in many cases, could relieve that burden.

At the moment, far more people with end stage renal disease are on dialysis than receive kidney transplants. The CDC estimates that 786,000 people in the US live with end stage renal failure, of which 71 percent are on dialysis and 29 percent have received transplants.

The dialysis industry, and in particular Fresenius and DaVita, the two giants that control about 70 percent of the industry, also has a controversial and complicated history of poor performance.

The kidney treatment landscape is also notable because it’s covered by Medicare, however, it remains expensive. Dialysis and transplants make up about seven percent of Medicare’s budget. Because of this complex landscape, startups have been pursuing alternatives like implantable kidneys.

Qidni’s current product is not an artificial kidney in that it could live forever in the body of a participant and replace a non-functional organ. Rather, it’s a more mobile take on dialysis. Qidni/D, the blood purification device, is the company’s main focus for the time being.

That said, Qidni/D does have some unique elements that may make it as “disruptive” as Morteza hopes it will be. Namely, its small size, and low water requirements.

During an average week of dialysis treatment, the average person is exposed to about 300 to 600 liters of water, per the CDC. Some of that water is used in the dialysate solution that helps to leach toxins out of the blood. Per Morteza, Qidni/D uses just one cup of water per treatment session, most of which is contained with the dialysate solution.

“In our understanding, this is probably one of the first times in the world that waterless technology is useful for blood purification over a long period of time in a large animal model,” he says.

Removing the liquid components of dialysis may streamline an already onerous process. Morteza, for one, hopes that this would make at-home dialysis more attainable (fewer stringent water safety requirements) and limit risks of infection (water-related infections sometimes occur during dialysis).

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

“In this round of funding we would be raising $2.5 million, and that should take us to a point that we can test this technology in a small group of patients, connected to an existing dialysis machine using our own cartridges instead of existing dialysate,” he says.

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.