Artrya progresses FDA application ahead of US commercial launch

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Medical technology company Artrya (ASX:AYA) says it has made progress on its application to the US FDA for its Salix Coronary Anatomy solution.

The company said it established a roadmap with the FDA during a Q-Submission meeting in June 2023. It said it had addressed the FDA's feedback on the regulatory strategy, product definition, intended use, product performance testing, and clinical validation requirements.

In December 2023, it received FDA 510(k) registration and listing of its Medical Device Data System (MDDS), Salix Ingest. Salix Ingest manages the secure private data exchange between clinical systems and the company. The company said the data exchange system clearance is a crucial step in the process of receiving FDA 510(k) clearance for Salix Coronary Anatomy.

Artrya CEO Mathew Regan said, “While FY23 provided some challenges for Artrya, we have worked hard to streamline our business operations ensuring we have the right mix of capability, costs and capacity, and I’m pleased to report we have made substantial progress over the first half of FY24 putting us on track to launch our products in the US and Australia over coming months.

“We have diligently worked through an extensive program of work with the US regulatory authorities to ensure we fulfil all requirements and can deliver a quality application leading to FDA approval of our Salix Coronary Anatomy solution. We have seen early success with our efforts with the FDA approving Salix Ingest, the medical device and data security system underpinning our entire tech platform. “

FDA approval will allow us to move rapidly into the expanding US market, where a favourable medical insurance regime allows clinicians to access US$800-$1000 in reimbursement for coronary plaque assessment from a CCTA (Coronary Computed Tomography Angiography) scan. Clinicians will also be reimbursed US$800-$1000 for non-invasive blood flow or Fractional Flow Reserve from a CCTA scan, presenting a significant opportunity for Artrya as we move to commercialise our non-invasive blood flow solution, Salix Coronary Flow.

“In anticipation of FDA clearance, we have laid the groundwork for launch in the US with a strategic partnership with Northeast Georgia Health Ventures and Northeast Georgia Health System that sees our product tested and integrated into five major hospitals. Importantly, this collaboration will see our Salix Coronary Flow solution further developed. “In parallel, we are running pilots in Australia as the precursor to first sales, and continuing to build our credibility within the global clinical community by publishing critical studies on how AI can be leveraged for accurate plaque and heart assessment.

"We continue to carefully manage costs as the strategic changes we implemented last year extend our runway as we move towards commercialisation this year."