Small Caps | Feb 15 2024
Dr Boreham's Crucible: Artrya
By Tim Boreham
ASX code: ((AYA))
Market cap: $20.4m
Shares on issue: 78,648,993
Chief executive officer: Mathew Regan
Board*: Bernard (Bernie) Ridgeway (chair), Kate Hill, Dr Jacque Sokolov
* Co-founder John Konstantopoulos resigned from board in February 2023 but remains executive in charge of commercial and strategy. CEO and co-founder John Barrington resigned in March 2023
Financials (December quarter 2023): revenue nil, net cash outflows $1.15m, cash of $15.15m, estimated quarters of funding available 13.18
Major shareholders: John Barrington 9.6%, John Konstantopoulos 8.95%, Richcab Pty Ltd (Dale McKenzie Superfund) 5.1%.
Moseyin’ up to the imposing doors of the Food and Drug Administration’s Washington HQ and exclaiming ‘whaddya think, dudes?” has never been an advisable approach to seeking approval of a drug or device.
Yet time after time, applicants fall short because they haven’t done their homework, including eliciting and interpreting the agency’s Delphic signals.
Heart device Artrya admits it didn’t follow the FDA-101 handbook when it sought approval for its algorithmic-based device, Salix coronary anatomy software, to detect the build-up of deadly plaque in coronary arteries.
In June last year, the FDA knocked back the device, even though it had been approved in Europe, the UK, New Zealand and - let’s not forget - Australia.
Artrya CEO Mathew Regan says the rejection was a case of a “young business trying to push forward” when it wasn’t ready.
“We probably didn’t engage with the FDA in the way we should have,” he says.
This time around the company engaged in a Q-submission pre-meeting, whereby management can seek the agency’s guidance. It has also engaged regulatory greybeards to navigate the process.
“We didn’t do that last time – we were winging it.”
Last time around, Artrya lodged approval for its Salix device under the 510k predicate route. But the addition of some artificial intelligence (AI) tweaks meant there was also a de novo element and the 510k route led to a dead-end.
The company is now targeting FDA approval by June, with an application expected to be lodged by the end of March.
Management is heartened that in December the FDA approved the ancillary Salix Ingest, which enables the secure exchange of data between clinical systems and Salix.
Who needs iron ore?
A bright idea emanating from the West, Artrya was founded by John Barrington and fellow Perth native Ioannis (John) Konstantopoulos in 2018.
The two Johns collaborated with the University of Western Australia, the Perth-based Harry Perkins Institute of Medical Research (of which Mr Barrington is a director) and the University of Ottawa Heart Institute.
In particular, the company was aided by one of the world’s leading researchers of vulnerable plaque, Harry Perkins’ Prof Girish Dwivedi.
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