Artrya Ltd (ASX:AYA) continues to progress with regulatory processes, clinical studies and market entry activities in multiple jurisdictions despite not receiving clearance for commercial use of the Salix Coronary Anatomy (SCA) product from the US Food and Drug Administration (FDA).
While the company evaluates the details of the FDA's decision from its initial 510(k) application, it is confident it will be able to address the issues raised and could consider a different pathway based on its discussion with the regulatory body.
In the meantime, there are many positives for the medical technology company with regulatory processes underway in other markets that are independent of FDA clearance.
Artrya also has a healthy bank balance, with cash at call and on deposit expected to be approximately $36 million at June.
Commercial release in Australia
In Australia, Salix is already listed on the Australian Register of Therapeutic Goods (ID 347719), with commercial release of SCA planned for FY23.
Artrya intends to expand the number of SCA commercial users during the 2023 financial year and commence Salix Coronary Flow (SCF) pilots later that year with regulatory applications to follow.
US clinical partnership
Artrya’s first US hospital clinical partnership with Heart Center Research, LLC, a division of Huntsville Heart Center, is expected to be finished in October, with the company now looking for further business development opportunities with other prospective clinical partners.
The company will present at the Association for Medical Imaging Management conference in Phoenix and the Society of Cardiovascular Computed Tomography in Las Vegas in July to bring further awareness to what it is trying to achieve in the med-tech field.
CE Mark/UKCA audits in the UK
Artrya passed CE Mark/UKCA audits in March and June this year and has now passed the Technical File Review.
The company is progressing with the UKCA regulatory applications and expects to complete workflow research with a UK National Health Service Trust Hospital during the 2023 financial year. The results of this study will inform sales and marketing activities with more than 1,200 other NHS Trust hospitals throughout the United Kingdom.
About Artrya
Artrya is an applied artificial intelligence healthcare company that works alongside clinicians to improve the diagnosis of coronary artery disease and develop a holistic overview of a patient at risk. Artrya has developed deep learning algorithms that will streamline how heart disease care is delivered. Artrya USA Inc. is a wholly owned subsidiary of Artrya Limited.