Artrya (ASX:AYA): Newly FDA 510(k) approved, and so its all systems go!

3 and a half years after listing and nearly 7 years after its founding, Artrya (ASX:AYA) achieved the aspiration of most ASX medtechs, in obtaining FDA approval. Its Salix suite of products aims to improve the detection and treatment of Coronary Artery Disease (CAD), which is a major cause of heart attacks.

Entering the US was always this company’s ambition, but it could only be a pipe dream until the green light was obtained. But now, the world’s largest healthcare market is its oyster…at least in theory.

How Artrya reached this point

Artrya began in mid-2018 and listed on the ASX in November 2021, raising $40m at $1.35 per share. It was (and remains) chaired by Bernie Ridgeway, who some may remember from his time as the boss of Imdex. The company’s flagship Salix product is the Salix Coronary Anatomy (SCA) which uses AI to provide clinicians with the rapid reporting of vulnerable plaque.

Vulnerable plaque is one of the strongest predictors of heart attacks, but it’s difficult and time-consuming to identify manually, even if you have enough physicians (which isn’t always the case). SCA generates a personalised 3D heart model depicting the extent of plaque and other biomarkers.

SCA just needs an internet connection, there’s no hardware required and a full report is available within 15 minutes. It can be installed remotely and can come with the option of a single flat fee per image scanned.

The word plaque may make you think of plaque on your teeth and it is a similar concept when thinking of plaque on the heart – it is fat and calcium that is attached to the wall of a coronary artery. But is doesn’t just ‘stick’ and stay there, it can rupture and cause sudden blockages, meaning it is one of the strongest predictors of future heart attacks.

What’s next?

The company made its submission to the FDA in September 2024. It was not an entirely smooth process as the FDA made some queries on its application. But these were obviously addressed to the regulator’s satisfaction, because the green light came last Friday (March 28 2025). So now, the US market is its oyster.

SCA was already approved by the TGA, but the US is a larger market – someone suffers a heart attack every 40 seconds. For those wondering the market size, it is US$4.4bn according to the company as judged by the 4.4m CCTA scans done in the country. 6.2% year on year growth is projected over the next few years. Moreover, the US has attractive reimbursement rates (i.e. starting from US$950) and minimal competition – there has been little to no innovation for detecting CAD in decades.

The company already has strategic agreements with 3 US hospital groups which have already worked to integrate Salix into its workflows in anticipation of approval. With the green light, it can be rolled out into these groups’ network of hospitals, which mostly lie in the Southeast of the country.

Artrya also has deals with healthcare providers in Australia, led by Sonic – a very recent three-year deal announced where Salix will be integrated in all Sonic centres that scan for coronary heart disease condition, using Cronary Computed Tomography Angiography (CCTA). Artrya also anticipates FDA approval of other Salix products including Salix Coronary Plaque and Salix Coronary Flow.

Conclusion

Investors in Artrya have had their patience rewarded. But the hard work for the company is only just beginning. The challenge now is for the company to roll out SCA into the US market with its current partners and potential new ones. With a market cap of still under $100m, we think that price won’t last for long.

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