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The study will involve around 100 UK kidney patients testing Kalium Health’s technology. The aim is to evaluate performance and usability of Kalium’s handheld potassium test compared to traditional hospital-based instruments restricted to professional use. A successful outcome will pave the way for the company’s planned regulatory approval and market entry.
Kalium Health spun out of the University of Cambridge with seed funding in 2020 and has developed an integrated hardware/software platform that provides a quantitative readout from a tiny drop of blood. The company is initially focusing on the accurate monitoring of blood potassium levels by clinicians and patients themselves to improve the management of chronic kidney diseases, which affect 800 million people worldwide.
Its digital blood testing technology provides clinical-grade results without the need to visit a clinic. This has the potential to optimise medications and diet and, critically, detect abnormal potassium levels before severe complications arise. Data can be integrated into third party apps and health records along with Kalium’s own digital platform.
Lucy Sreeves, executive director at Kidney Research UK, one of the first major investors, said: “Accurately measuring potassium levels is essential for people living with chronic kidney disease. Abnormal levels of potassium in the body are dangerous and potentially life-threatening, yet they can only currently be measured through inconvenient and costly visits to clinical settings for invasive blood draws. This clinical study is a significant milestone in the development of this new device to empower patients to measure their own potassium levels and we look forward to seeing the results later in 2024.”
Interim results will be available as soon as February, with full results available in the spring. Data analysis will be conducted in line with US FDA expectations to enable fast regulatory approval as the company progresses towards an initial US launch, tapping into a $100 billion annual spend on managing chronic kidney disease.
In November the company appointed US healthcare leader Ranndy Kellogg, president and CEO of Omron Healthcare, to its board and launched its latest investment offering. Kalium is in advanced discussions with several UK and US investors while also responding to interest from new investors.
Professor Fiona Karet, co-founder and chief medical officer at Kalium Health, said: “This clinical study is a major moment for us and marks a further de-risking of the business as we continue commercialisation. With patient recruitment now under way we will have interim results within the coming weeks. This study will provide us with valuable data to enable us to build an even stronger case for adoption, given the significant cost savings, efficiencies, and improved patient outcomes our technology can offer.”
