Brisbane - Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR) reported today that DurAVR Transcatheter Heart Valve (THV), a new class of aortic valve replacement (AVR) and the world's only biomimetic, single-piece transcatheter aortic valve, was used to successfully treat patients as part of the DurAVR THV Early Feasibility Study (EFS or the Study) in the United States.

The EFS is an essential step towards receiving FDA approval in the US and commercialisation of this innovative medical technology.

Dr Azeem Latib, Director of Interventional Cardiology, Director of Structural Heart Interventions at Montefiore Health System, New York, and Study National Principal Investigator (IC), performed the first group of US DurAVR THV procedures. This first group of severe aortic stenosis patients treated with DurAVR THV had intraoperatively, post-implant EOAs of 2.2cm2, and average mean gradients of 4mmHg.

Dr Latib commented: 'Having previously travelled to Europe with Anteris to implant patients with DurAVR THV, I am delighted to note that the post-procedure patient outcomes seen in US patients at my centre corroborate with data reported from previous cohorts. The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis. We look forward to many more cases in the near future'.

The EFS Study is evaluating the safety and feasibility of DurAVR THV in the treatment of subjects with symptomatic severe native aortic stenosis (AS). Enrolling 15 subjects at 7 Heart Valve Centers of Excellence within the United States. Dr Mike Reardon, Chair of Cardiovascular Research at the Houston Methodist DeBakey Hospital, is the Study Chair. This is an FDAdesignated category B study and approved by CMS for reimbursement. The primary endpoint at 30 days post-implantation of this Study will assess safety and device feasibility.

About Anteris Technologies Ltd (ASX: AVR)

Anteris Technologies Ltd (ASX: AVR) is a structural heart company committed to designing, developing, and commercialising innovative medical devices. Founded in Australia, with a significant presence in Minneapolis, USA, a MedTech hub, Anteris is science-driven, with an experienced team of multidisciplinary professionals delivering transformative solutions to structural heart disease patients.

The Company's lead product, DurAVRTM, is a transcatheter heart valve (THV) for the treatment of aortic stenosis. DurAVRTM THV has been designed in partnership with the world's leading interventional cardiologists and cardiac surgeons and is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is uniquely shaped to mimic the performance of a healthy human aortic valve. DurAVRTM THV is made using ADAPT tissue, Anteris' patented anti-calcification tissue technology. ADAPT tissue has been used clinically for over 10 years and distributed for use in over 50,000 patients worldwide.

The ComASURTM Delivery System is designed to provide controlled deployment and accurate placement of the DurAVRTM THV with balloon-expandable delivery, allowing precise alignment with the heart's native commissures to achieve desired valve positioning. Anteris Technologies is set to revolutionise the structural heart market by delivering clinically superior solutions that meet significant unmet clinical needs.

Contact:

Malini Chatterjee

Tel: +1 917 330 4269

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