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From UK to USA: How we’re thinking about international growth

By Tom Collings, CEO, Kalium Health

If you have been following Kalium Health on X (formerly Twitter) or LinkedIn lately, you will have noticed that we’ve recently made some major announcements. We’ve opened up our next round to institutional investors, formalised our inaugural advisory board and appointed US healthcare leader Ranndy Kellogg to our Board. We’ve got tremendous momentum and it’s exciting to be part of something so special.

The uniqueness of our technology and the tremendous progress we have made over recent years has not gone unnoticed. We have attracted international media attention from the likes of MedTech Innovation News, Fierce Healthcare, European Pharmaceutical Manufacturer, and The Engineer, and industry recognition from OBN and others, which has helped to boost our profile and open up new opportunities.

Over the next three years we will complete clinical validation activities, enter the market and begin our scale-up. This is something I am immensely excited and optimistic about, and also something we’re also going into with our eyes wide open. I wanted to use this article to set out why we plan to launch in the USA – after all, while the opportunity is huge, the US commercial landscape is complex and we have had to work hard to develop our strategy.

Most UK-born healthcare companies want to enter the US market at some stage. It is undeniably attractive – the US has a population of over 330 million people, uses English as the primary business language and offers huge economic opportunities, with healthcare as a whole representing a $4.3 trillion a year market. However, these potential benefits don’t come easy: competition is intense, the market is notoriously complex and mistakes during the growth phase can cause costly delays.

Our decision to prioritise US market entry is based on many factors, including recent changes to US kidney care legislation and EU regulatory legislation, but can be summarised as falling into two camps – opportunity and capability.

Opportunity for huge impact

As CEO, my aims are to make sure Kalium Health develops the right technology for an evolving market and gets it into use as quickly as possible, so that the company not only generates economic value, but also helps to improve the lives of as many patients as we can.

Our proprietary, miniaturised blood sensing technology targets an unmet clinical need by focusing on accurate, quantitative monitoring of blood potassium levels to improve the management of chronic kidney disease (CKD). Treating CKD currently accounts for over 24% of US Medicare spend – it is a huge cost to the public and often a burdensome out-of-pocket cost for millions of Americans. This presents an enormous opportunity for us to create value in a market that often leads the way in innovation globally.

Our recent primary research with US physicians and health payers validated the use cases and market opportunities for us, with the broader shift towards value-based care and direct alignment with new cardiorenal medications providing strong tailwinds.

Our decision is also influenced by practical regulatory considerations, with the FDA route currently providing a more predictable and potentially quicker approval route than EU CE Marking or UK Conformity Assessment.

The market is right, the timing is right and there is a clear product fit.

Capability to deliver

However, there is a significant difference between wanting to enter a market and being able to do so successfully. This is why our decision to target the US market is based not just on this sizable and attractive opportunity, but also on a clearheaded assessment of our capabilities to enter it effectively.

We have developed a realistic three-year strategy that will see us establish US operations in Texas in 2024, file for FDA clearance in 2025 and begin clinical and commercial pilots with US care providers soon after. We have a detailed plan, backed by extensive market research, to achieve each of these objectives. The key to our success will be our team and the partners we choose to work with along the way.

It is our clear mission to help transform kidney care and the timeliness of our solution that has enabled us to attract and build a world class team, including the recent appointment of Ranndy Kellogg to our Board of Directors. We are delighted to be working with Ranndy, who is also President and CEO of Omron Healthcare USA and sits on the Board of AliveCor – both leaders in the field of patient-centric health monitoring.

Ranndy’s invaluable insight and extensive experience helps us set a realistic path to market entry and expansion. His expertise complements that of our newly formed advisory board, which includes US industry expert Bill Moffitt, former CEO at the hugely successful i-STAT Corporation, which was acquired by Abbott Laboratories.

Right technology, right timing, right team

Our decision to launch in the US is considered and deliberate. We have a clear opportunity and unmet clinical need and, while there will be challenges, we have an outstanding technology and a world class team with a track record of building successful US healthcare businesses.

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image: Andrea Piacquadio for Pexels


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