• 510(k) application with FDA progressing, clearance expected by end-March 2025
• Negotiations with major radiology groups in Australia, agreements with US healthcare systems
• Successful $5M placement to strengthen balance sheet

Artrya Limited (ASX: AYA), a medical technology company focused on commercializing its AI platform for coronary artery disease, has released its Q2 FY25 activities report. Key highlights include:- 510(k) application with the FDA is progressing, with the company responding to additional information requests from the regulator. Artrya remains confident of clearance by the end of March 2025.- The company is in negotiations with two major radiology groups in Australia to use its Salix® Coronary Anatomy product. Artrya also continues to make progress integrating its technology with healthcare systems in the US, including Northeast Georgia Health System, Tanner Health, and Cone Health.- Artrya completed a successful $5 million placement at $0.42 per share, strengthening its balance sheet with $4.7 million in net proceeds. This will support product development, clinical work, regulatory approvals, and other commercialization efforts as the company awaits FDA clearance.- The company has also focused on cost efficiencies, with the average monthly cash outflow decreasing from $1.4 million to $1.2 million. Artrya will strategically increase spending where it can accelerate future FDA clearances.- Artrya's CEO Mathew Regan expressed excitement about the company's upcoming milestones, including the anticipated FDA clearance and the potential to immediately commercialize Salix® Coronary Anatomy in the US.

Artrya CEO Mathew Regan stated the company has an 'exciting few months ahead' as it prepares to roll out its technology globally, including in the US once FDA clearance is granted. The company is also in advanced negotiations with two of Australia's largest radiology groups and plans to submit additional products for regulatory clearance within the calendar year.