Artrya CEO outlines plans to launch AI-powered heart disease solution in US and Australia

SYDNEY, AUSTRALIA: Artrya Limited, a company that develops artificial intelligence (AI) solutions for heart disease diagnosis and treatment, has announced its progress and goals for the next fiscal year.

The company’s CEO, Mathew Regan, said he has focused on three key areas: launching Salix, its flagship product, in the US market; commercializing Salix in Australia and the Research Use Only markets; and streamlining its business operations.

Salix is an AI-powered software that analyzes Coronary Computed Tomography Angiography (CCTA) scans and provides detailed information on the anatomy and plaque composition of the coronary arteries. Salix aims to help clinicians diagnose and treat coronary artery disease, which is the leading cause of death worldwide.

Regan said that the company had a meeting with the US Food and Drug Administration (FDA) in June, which gave them a clear and detailed roadmap for regulatory approval.

He said that the FDA feedback and guidance has been critical to how they develop Salix for their 510(k) product, which is a type of premarket submission that demonstrates that the device is safe and effective.

“We are diligently working through this roadmap, and I am confident we will be cleared for approval in the US by the end of FY24,” Regan said.

He added that one of his key goals is that Artrya becomes the ‘ideal’ FDA applicant, as its product roadmap involves interacting with the FDA for several more applications over the next few years. He said that all of its products share a common code base, and advancements with Salix will flow through to other products they develop.

Regan also highlighted the importance of the strategic agreement they recently signed with Northeast Georgia Hospital Ventures (NGHV), a subsidiary of Northeast Georgia Health System, one of the largest healthcare providers in the US. He said that the agreement with NGHV is pivotal, as it allows them to conserve cash and expedite the development-to-commercialization trajectory into the US market with a major player.

“And of course, this collaboration opens the door for potential future investments in North America,” Regan said.

He also emphasized the immense market opportunity in the US for its product, driven by the scale of heart disease, which kills one person every 34 seconds, and enhanced by a new Medicare reimbursement code released for plaque assessment that helps clinicians interpret CCTA scans.

“Clinicians who use our Salix solution will have access to reimbursement of US$900-1,000 leveraging our novel plaque assessment post FDA approval,” Regan said.

Regan said that Australia benefits greatly from having a home-grown product, as it means the technology becomes available here first. He said that typically, software products developed overseas take many years to reach Australian shores, so it’s a great source of pride that Australians will benefit from its products.

He said that one critical step in getting its product to market is real world clinical testing, which is the rationale behind its push to pilot Salix with a top-five diagnostic group in Australia. He said that pilots allow for clinicians to test the speed, accuracy, and usability of its Salix Coronary Anatomy solution against standard methods. He said that pilots are important for product validation as well as to get real world feedback from clinicians.

“Pilots also help us to understand how Salix integrates into client’s systems and workflow. We will be strategic with who we engage with during our early commercialization as we conduct further pilots and introduce our first clients during FY24,” Regan said.

He also said that as well as expanding its homegrown market, they have focused on promoting Salix into the global Research Use Only market, as this enhances clinical credibility of its unique product by placing it into the hands of clinicians that form its growing network of key thought and opinion leaders globally.

Regan said that a significant part of his role has been to streamline costs while increasing its internal team capability, including bringing in additional skills in software and AI development along with experienced global regulatory affairs and clinical operations specialists from Verily, an Alphabet Inc Life Sciences organisation (Google). He said that he is confident they now have the right mix of people and capabilities to move Artrya forward.

He said that FY2023 saw an average monthly net cash burn of $1.26 million and a closing cash position at 30 June of $20.1 million. He said that they are confident they will see their first revenue in FY2024.

“Our focus over the next year is to execute on our strategy and deliver on our milestones. We have a clear vision of becoming a global leader in AI-powered solutions for heart disease, and we are excited to share our journey with you,” Regan concluded.

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