FDA turns down Perth medtech

Artrya shares continued to drop this morning after the US Food and Drug Administration knocked back its AI-based coronary diagnostic product for commercial use. 

The Perth-based medtech told the market late on Thursday that its initial application with the agency had not received clearance for commercial use, triggering nearly a 50 per cent fall in its share price.

In response to the decision, the company said it planned to submit a new application for Salix Coronary Anatomy but may consider a “different pathway” subject to further discussions with the FDA.

Artrya listed on the ASX in a $40 million initial public offering in November last year at $1.35 per share, in a bid to commercialise Salix Coronary Anatomy, a software designed to scan and detect coronary artery disease in patients.

“Artrya is currently evaluating the details of the FDA's decision but anticipates being able to address the issues raised,” it said in a statement.

“Artrya will pursue additional commentary from FDA in regards to the outcomes of the 510(k) review to inform future application pathways for the Salix software.”

Its product is listed on the Australian Register of Therapeutic Goods and is planning commercial release of the product in the 2023 financial year.

The business was co-founded by managing director John Barrington and fellow director John Konstantopoulos in 2018.

Shares in Artrya were down 34.8 per cent at 12:17pm AEST to trade at 36 cents.