Mobile Dialysis Startup to Begin Human Trials in 2022

Innovative Kidney Support: Mobile Hemodialysis Advances

Over the last year, a unique study has unfolded in Canada, involving three sheep outfitted with specialized jackets. These aren't fashion statements, but rather integral components of a groundbreaking animal trial.

Qidni Labs and the Pursuit of Portable Purification

The sheep are participants in research conducted by Qidni Labs, a Buffalo, New York-based startup dedicated to developing waterless and mobile blood purification systems. Founded in 2014, Qidni Labs has secured $1.5 million in funding and is currently preparing for a subsequent funding round.

The company previously received recognition at the 2019 KidneyX Summit for its innovative air removal system designed for a wearable renal therapy device.

Introducing Qidni/D: A New Approach to Hemodialysis

The jackets worn by the sheep represent a prototype of Qidni’s mobile hemodialysis machine, known as Qidni/D. This device is engineered to be considerably smaller and require less fluid than conventional hemodialysis setups, potentially enhancing patient mobility.

Morteza Ahmadi, founder and CEO of Qidni Labs, explains that while the ultimate vision is a fully mobile purification technology, this device serves as a crucial stepping stone.

The Prevalence of Chronic Kidney Disease

According to data from the CDC, approximately one in seven individuals in the United States lives with some form of chronic kidney disease. This condition can progress to kidney failure, often necessitating dialysis or a kidney transplant.

Diagnosis typically relies on the presence of symptoms such as weight loss, shortness of breath, or an irregular heartbeat.

Hemodialysis vs. Peritoneal Dialysis

Two primary dialysis methods exist: hemodialysis and peritoneal dialysis. Hemodialysis filters blood using a dialysate solution, while peritoneal dialysis involves introducing fluid into the body to absorb toxins before draining it.

Qidni/D is a hemodialysis machine designed to be compact enough to fit within a jacket, utilizing specialized cartridges and a gel-based system to minimize the amount of liquid required for treatment. (Images of the device have been reviewed by TechCrunch).

Promising Early Trial Results

Initial animal trials – the findings of which are awaiting publication in a peer-reviewed journal – demonstrated the device’s ability to reduce urea levels in sheep blood to levels comparable with an adequate dose of traditional dialysis.

Researchers reviewed study data via Zoom.

Study Details and Treatment Duration

The sheep involved in the study had no functional kidneys and were connected to the machine for periods ranging from four to eight and a half hours. Morteza Ahmadi suggests that four hours of treatment may be sufficient for effective blood cleansing.

Limitations and Future Research

It’s important to note that this is a preliminary animal study, and drawing definitive conclusions is premature. The study lacked an active control group, instead comparing urea and electrolyte removal to established standards from other dialysis studies.

While not conclusive, the results are encouraging and suggest that Qidni’s mobile dialysis machine design warrants further investigation.

“Based on this study’s data, we believe we could potentially replace daily dialysis,” Ahmadi states.

Next Steps: Human Trials and FDA Approval

The team plans to continue refining the technology through additional sheep-based studies this year, with the goal of initiating human trials in 2022. They aim to submit an application for FDA approval by the second half of 2023, contingent upon demonstrating safety and efficacy in clinical trials.

The Landscape of Kidney Treatment

The current kidney treatment landscape is largely dominated by dialysis, a demanding therapy. However, kidney transplantation offers a potential long-term solution for many patients.

Currently, a significantly larger proportion of individuals with end-stage renal disease receive dialysis compared to those who receive transplants. CDC estimates indicate that 786,000 Americans live with end-stage renal failure, with 71 percent undergoing dialysis and 29 percent having received transplants.

Challenges within the Dialysis Industry

The dialysis industry, particularly giants like Fresenius and DaVita – which control approximately 70 percent of the market – has faced scrutiny due to a controversial and complicated history of performance issues.

The financial burden of kidney treatment is also substantial, with dialysis and transplants accounting for around seven percent of Medicare’s budget. This complexity has spurred the development of alternative solutions, such as implantable kidneys.

Qidni/D: A Mobile Dialysis Solution

Qidni’s current product isn’t an artificial kidney designed for permanent implantation. Instead, it represents a more mobile approach to dialysis.

Qidni/D possesses unique characteristics that could prove disruptive, notably its compact size and reduced water requirements.

Water Conservation and Infection Control

The CDC reports that an average dialysis patient is exposed to 300 to 600 liters of water per week. This water is used in the dialysate solution to remove toxins from the blood. Qidni/D, in contrast, utilizes only one cup of water per treatment session, largely contained within the dialysate solution.

“To our knowledge, this is among the first instances of waterless technology being successfully applied to blood purification over an extended period in a large animal model,” Ahmadi explains.

Reducing the liquid components of dialysis could simplify the process, potentially making at-home dialysis more accessible (reducing stringent water safety requirements) and minimizing the risk of water-related infections.

A Step Towards the Future of Kidney Care

This innovation also represents a step towards the development of an implantable kidney, which would ideally require minimal external fluid. However, mobile dialysis remains Qidni’s primary focus.

The company’s next funding round, aiming to raise $2.5 million, will support testing their cartridge technology in small-scale human trials. The goal is to connect the device to existing dialysis machines, utilizing Qidni’s cartridges instead of conventional dialysate.

Ultimately, this research contributes to the pursuit of a machine that more closely mimics the function of a natural kidney, with the ultimate aim of eliminating the need for dialysis altogether.