The clock re-starts: 30 day FDA count down

Artrya announced today that it has submitted its answers to questions asked by the FDA as it reviews the company’s application forclearance for Salix Coronary Anatomy.

Artrya submitted its initial application through the FDA’s 510(k) process in September last year. Under the 510(k) process, the FDA has 90 days to approve or reject (or approve with restrictions) any application. As such, Venn Brown estimates there are around 30 days left on the clock, meaning the result of the application should be known by the end of the month (inline with management guidance).

As reported in our first half results note [2Q25 results - positive cost reduction & FDA approval remains on track],the information requested by the FDA was process-related, including questions around labelling and cyber security and were not about functionality or diagnostic efficacy.

This final submission is the first of the seven major (and two minor) catalysts we expect from Artrya over the coming 18 months that will fundamentally change the business, significantly reducing business and investment risk and changing how it’s viewed by the market, the first of which is FDA approval expected before the end of March.

Seven major catalysts will fundamentally change Artrya’s business & investment risk:

1.     Salix Coronary Anatomy FDA clearance (expectedby the end of March);

2.     The launch of US sales activities;

3.     Reporting its first US revenues;

4.     Submit FDA application for Salix Coronary Plaque (Venn Brown est. mid-CY25)

5.     Salix Coronary Plaque FDA clearance (Venn Brown est. 1H26);

6.     Launch of Salix Coronary Plaque;

7.     Submit FDA application for Salix Coronary Flow (SCF);

8.     Salix Coronary Flow FDA approval (Venn Brown est. 2H26); and

9.     Ongoing US customer wins

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The final submission comes on the back of the group’s $15 million capital raise completed two weeks ago and the signing of the 3-yearagreement with Sonic Healthcare, Australia’s second-largest radiology provider [see Artrya:Capital raise + Sonic Healthcare signs muti-year agreement].

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For more information about Artrya see Venn Brown’s initiation of coverage report: Salix:The future of cardiac imaging diagnostics.

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