Artrya : Quarterly Activity Report and Appendix 4C for Q4 FY22

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ASX ANNOUNCEMENT

MARKET RELEASE

26 July 2022

Quarterly Activity Report and Appendix 4C for Q4 FY22

Highlights:

• First US clinical partnership commenced with Huntsville Heart Center
• Dr Jacob Agris M.D. PhD appointed as new Chief Medical Officer
• Initial FDA application not approved, however opportunity to re-apply
• NZ Medsafe regulatory registration received for Salix Coronary Anatomy
• Continued testing with Australian pilots
• Scientific award at global SCCT conference
• Strong cash position with $35.6 million held as of 30 June 2022

Artrya Limited (ASX: AYA), ("Artrya" or the "Company"), a medical technology company focused on commercialising its patented artificial intelligence platform, is pleased to release its Quarterly Activity Report and Appendix 4C Cash Flow Report for the quarter ended 30 June 2022.

Market Entry & Development

United States

Clinical Partnership

In May 2022, the Company announced its first U.S. clinical partnership with Alabama-based Huntsville Heart Center Inc, a national leader in coronary computed tomography angiography (CCTA) that treats more than 80,000 cardiac patients per year.

Heart Center Research, LLC, a division of Huntsville Heart Center, is conducting the study to determine the efficacy of Artrya' s technology. This multi-scanner retrospective study compares the performance of Artrya Salix Coronary Anatomy (SCA) against the interpretation of multiple expert readers. Study results are expected during Q2FY23 and will inform further product development, regulatory applications and scientific publications.

FDA Application

The US Food and Drug Administration advised in June 2022 that the Company's 510(k) application was not approved as the SCA product was determined to be not substantially equivalent to the selected predicate device. In providing feedback, the FDA invited resubmission of a further 510(k) application.

Based on the feedback provided, the Company is confident in addressing the issues raised in future submissions.

An international regulatory advisory firm was commissioned to undertake an external review of the Company's regulatory processes. The firm has relevant FDA experience in medical device applications and in working with Artrya. This review has now been completed and the recommendations arising are being

Artrya Limited

ACN 624 005 741

1257 Hay Street West Perth WA 6005 PO Box 567 West Perth WA 6872 www.artrya.com

T: +61 8 6478 7816

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implemented. In particular, internal regulatory capabilities are being enhanced with the appointment of senior personnel in the United States.

An internal review is also being completed in Q1FY23 to determine specific pathways for future applications. Based on this review, management will make a decision regarding whether to pursue a 510(k) or De Novo FDA application.

In the interim, market development activities will continue in the US to ensure Artrya's technology is in the hands of users and potential customers prior to an FDA approval.

Australia

Testing of the Salix Coronary Anatomy product continued at the three existing pilot sites during the quarter, informing ongoing software development. A further pilot site commenced during the quarter and additional sites will be brought on during Q2FY23. The Company is planning for commercial release of the product in FY23.

Current SCA performance in reporting calcium score, stenosis and vulnerable plaque biomarker low attenuation plaque volume is as follows:

1. Stenosis >50% 93%

Salix Coronary Flow (SCF) research with a pilot site has been agreed and is subject to final ethical approval. The research is expected to commence during the first half of FY23.

New Zealand

On the basis of the Australian regulatory approval (ARTG 347719), the Salix Coronary Anatomy product received NZ Medsafe registration in July 2022. This will allow the company to commercialise the product in the New Zealand market.

United Kingdom

An experienced marketing executive was appointed during the quarter to manage the UK National Health Service 2+2-year Framework Agreement that introduces Artrya to 1,250 Trust Hospitals in the United Kingdom.

A research protocol has been developed with a National Health Service Trust Hospital to undertake a study assessing the efficacy of the Salix Coronary Anatomy product in the NHS environment. It is expected the study will commence in the first half of FY23. This study is independent of regulatory approval processes.

The results of this study, along with the economic model already developed, will support UK sales and marketing activities.

Artrya passed CE Mark/UKCA regulatory audits in March and June 2022 and in June also passed the Technical File Review. The Company is progressing with the UKCA regulatory applications.

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Clinical Research & Publication

Research and publication of product performance results provides evidence of the clinical accuracy with which SCA detects and reports coronary artery disease biomarkers.

Three studies were submitted for publication and conferences during the quarter.

Artrya research was recognised at the world's leading scientific conference for cardiac CT, being the Society of Cardiovascular Computed Tomography held in Las Vegas, USA this month. The research paper, titled 'Comprehensive assessment of coronary artery disease on CCTA using deep learning methods' won Best Abstract Award, attracting considerable interest. The research evaluated the feasibility and accuracy of a novel artificial intelligence algorithm developed by Artrya for rapidly identifying coronary artery blockages and coronary plaque that increase the risk of heart attack.

The high accuracy results achieved by Artrya SCA algorithms highlight the opportunity of artificial intelligence to improve the diagnosis of coronary artery disease.

Artrya and Envision Medical Imaging delivered a joint presentation to the Association for Medical Imaging Management conference, also held in the US in July 2022.

Senior Appointments

Dr Jacob Agris M.D. PhD was appointed during the quarter as the Company's new Chief Medical Officer.

Dr Agris will oversee the Company's medical activity, clinical development, research studies and global regulatory strategy.

His knowledge as a practising physician, along with his experience leading AI development in health care and navigating regulatory approvals, brings significant credentials to the Artrya leadership team.

As research is key to driving Artrya's innovation, former CMO Professor Girish Dwivedi was appointed Chief Scientific Officer, leveraging his world-renowned research expertise in coronary plaque.

During the quarter, Dr John (Jack) Lewin, former CEO of the American College of Cardiology representing over 40,000 cardiologists across the United States, was appointed to the Artrya Clinical Advisory Board.

The Company intends to appoint a further Director to the Australian Board this quarter to add clinical knowledge, US market understanding and regulatory experience to the current skill set.

COVID-19

The Company is managing the impact of a resurgence in COVID and it is noted the latest omicron subvariant may limit access to Australian medical centres in some jurisdictions. Staff absences due to illness and working from home have had a minor impact on research and development activities and it is noted that marketing may be curtailed if restrictions are strongly supported or mandated by state governments.

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Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity