Three sheep in Canada last year have worn their kidneys on their sleeves. Or rather in jackets on the fluffy back.
These three sheep are part of an ongoing animal study conducted by Buffalo, New York-based startup Qidni Labs, a company tracking 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 to another round of funding. Qidni Labs was also one Award winners at the KidneyX Summit 2019 for the development of an air suction system for a portable kidney therapy device.
The jackets are a prototype of Qidni’s mobile hemodialysis machine called Qidni / D. The idea behind Qidni / D is that it is significantly smaller than a traditional hemodialysis setup and requires fewer fluids, which allows patients to be more mobile.
“We see this device and technology as a bridge to blood purification technology that enables patients to be mobile, although we do not expect this to be the first product,” says Morteza Ahmadi, founder and CEO of Qidni. Laboratories.
According to CDC, roughly one in seven people in the US has some type of chronic kidney disease. Over time, this can lead to kidney failure. From this point onwards, it is recommended that patients start dialysis or have a transplant. This threshold is usually symptom-based; People may experience weight loss, shortness of breath, or an irregular heart rate, to name a few symptoms.
There are two main types of dialysis: hemodialysis or peritoneal dialysis. Hemodialysis passes blood through a filter and a fluid called dialysate, while peritoneal dialysis brings fluid into the body that absorbs toxins and then drains them away. Qidni / D is a hemodialysis machine that fits in a sheep’s jacket and uses its own cartridges and a gel-based system to reduce the amount of fluid required for dialysis. (Biomedarticles has verified images of the device).
In an early animal experiment – the results of which have not yet been published in a peer-reviewed journal – the device was able to keep the urea level in sheep blood around the threshold of one adequate dose of traditional dialysis. Biomedarticles reviewed data from the study on Zoom.
These sheep had no functioning kidneys and were on the machine for between four and eight and a half hours. Morteza adds that data so far suggests four hours of treatment should be enough to purify the sheep’s blood.
This is only a small animal study so it is difficult to draw massive conclusions from it. For example, it did not contain an active control arm 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 nowhere near enough to suggest that the technology is ready for the market, but the company’s internal staff see it as a good sign that the design of Qidni’s mobile dialysis machine will withstand further tests.
“We can say that in this study, based on the data, we could replace daily dialysis,” he says.
The team will further optimize the technology in further sheep-based studies this year and aims to begin human studies in 2022. The overall goal is to apply for FDA approval by the second time, provided clinical studies can demonstrate safety and efficacy by mid-2023.
The renal treatment landscape is dominated by dialysis, which is a troublesome treatment – although a kidney transplant could in many cases alleviate that burden.
Currently, far more people with end-stage kidney disease require dialysis than a kidney transplant. The CDC estimates that 786,000 people in the United States are living with end-stage kidney failure, of whom 71 percent are on dialysis and 29 percent have received a transplant.
The dialysis industry and in particular Fresenius and DaVita, the two giants that are about 70 percent the industry also has one controversial and complicated story of poor performance.
The renal treatment landscape is also remarkable because it is covered by Medicare, but it remains expensive. Dialysis and transplants make approx seven percent of the Medicare budget. Because of this complex landscape, startups are pursuing alternatives such as implantable kidneys.
Qidni’s current product is not an artificial kidney as it could live forever in a participant’s body and replace a non-functioning organ. Rather, it is a more mobile version of dialysis. Qidni / D, the blood purification device, is currently the focus of the company.
However, Qidni / D has some unique elements that could make it as “disruptive” as Morteza hopes. Namely its small size and its low water requirement.
During an average week of dialysis, the average person is approx 300 to 600 liters of water, according to the CDC. Some of this water is used in the dialysate solution, which helps wash toxins out of the blood. Per Morteza, Qidni / D only uses one Cup of water per treatment session, most of which is contained in the dialysate solution.
“To our understanding, this is likely one of the first times in the world that waterless technology is useful for blood purification in a large animal model over a long period of time,” he says.
Removing the liquid components of dialysis can streamline an already arduous process. On the one hand, Morteza hopes that dialysis at home will be more accessible as a result (less stringent requirements for water safety) and that the risk of infection will be limited (waterborne infections sometimes occur during dialysis).
It’s also a small step towards an implantable kidney that ideally doesn’t require large amounts of external fluid – although mobile dialysis is still Qidni’s main focus. The company’s upcoming round will focus on testing its cartridge technology in small human trials.
“In this round of funding, we would raise $ 2.5 million, and that should bring us to a point where we can test this technology on a small group of patients who are using our own cartridges instead of existing dialysate on an existing one Dialysis machine is connected. ”He says.
It is ultimately a step towards a machine that works more like the organ it is supposed to mimic, although the holy grail for patients is a solution that eliminates dialysis in the first place.