Artrya’s A$15M Placement Priced at A$0.73 to Fund FDA Approvals

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.

  • A$15 million placement at A$0.73 per share with a 10.4% discount
  • Funds to accelerate FDA regulatory applications for Salix® Coronary Plaque and Flow products
  • Initiation of the flagship SAPPHIRE study to boost clinical credibility and US hospital adoption
  • Tranche two placement subject to shareholder approval in April 2025
  • Partnership with Sonic Healthcare Australia for radiology commercial implementation
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Capital Raise to Propel Regulatory and Commercial Milestones

Artrya Limited (ASX: AYA), an applied AI healthcare company focused on coronary artery disease diagnostics, has successfully secured A$15 million through a two-tranche placement priced at A$0.73 per share. This capital raise, announced on 14 February 2025, is designed to accelerate the company’s regulatory submissions and commercial expansion efforts, particularly in the United States market.

The placement price represents a 10.4% discount to the recent five-day volume weighted average price, reflecting a strategic balance between raising capital efficiently and rewarding investors. The first tranche of approximately 6.8 million shares will be issued under existing placement capacity, while the second tranche of nearly 13.75 million shares awaits shareholder approval at a general meeting scheduled for early April.

Focus on FDA Approvals and Clinical Validation

Artrya plans to deploy the proceeds to expedite regulatory applications for its Salix® Coronary Plaque (SCP) and Salix® Coronary Flow (SCF) products. These AI-driven software tools analyze coronary artery imaging to detect disease markers, aiming to improve early diagnosis and patient outcomes. The company expects FDA clearance for its Salix® Coronary Anatomy product imminently, with broader approvals targeted throughout 2025.

In parallel, Artrya will commence the SAPPHIRE study, a flagship clinical trial designed to validate the Salix® software’s efficacy across multiple US hospital centers. This study is critical for establishing clinical credibility and locking in new hospital partnerships, thereby accelerating commercial adoption in a competitive healthcare technology landscape.

Strategic Partnerships and Market Expansion

Alongside regulatory and clinical initiatives, a portion of the funds will support customer implementation costs, including a recently announced commercial agreement with Sonic Healthcare Australia Radiology. This partnership underscores Artrya’s commitment to integrating its AI platform into established healthcare workflows, enhancing scalability and market penetration.

CEO Mathew Regan highlighted the significance of this capital raise, describing it as a pivotal moment that will enable the company to capitalize on its patented AI platform’s potential. The successful placement, managed by Petra Capital, positions Artrya to advance its mission of improving coronary heart disease diagnosis through innovative technology.

Looking Ahead

While the first tranche of shares is expected to settle and be allotted by late February, the second tranche’s completion hinges on shareholder approval. Additionally, Petra Capital will receive options as part of their role in managing the placement, aligning incentives for continued support.

As Artrya navigates the regulatory landscape and clinical validation, investors will be watching closely for FDA decisions and the impact of the SAPPHIRE study on commercial uptake. The company’s ability to execute on these fronts will be crucial in defining its growth trajectory in the competitive medical technology sector.

Bottom Line?

Artrya’s A$15 million raise sets the stage for critical FDA approvals and US market expansion, but shareholder approval and clinical outcomes remain key hurdles.

Questions in the middle?

  • Will the FDA clearance for Salix® Coronary Anatomy in March 2025 proceed as expected?
  • How will the SAPPHIRE study results influence hospital adoption and revenue growth?
  • What are the risks if shareholder approval for the second tranche is delayed or denied?