• Achieved successful U.S. IPO on Nasdaq, raising $88.8m
• Continued preparations to initiate DurAVR® Transcatheter Heart Valve's pivotal study
• Generated additional positive patient data to support IDE submission for DurAVR® THV

Anteris Technologies, a global structural heart company, reported its financial results for the full year ended December 31, 2024, and provided a corporate update. Key highlights include: Achieved a successful U.S. Initial Public Offering ('IPO') onto Nasdaq raising $88.8m (AUD $139.3m) before costs and commissions; Continued preparations to initiate the DurAVR® Transcatheter Heart Valve's ('THV') randomized global pivotal study, with the request for Investigational Device Exemption ('IDE') on track for submission to the U.S. FDA in Q1 2025; Generated additional positive patient data to support IDE submission for the DurAVR® THV, with 86 cases treated to date; Performed the first two cases of the DurAVR® THV's European Early Feasibility Study ('EU-EFS') at Structural Heart Copenhagen in Denmark; Increased awareness of the DurAVR® THV system through multiple high-profile presentations at key medical conferences; Finalized design optimization of the balloon-expandable ComASUR® delivery system and expanded manufacturing scale-up; and concluded 2024 with a strong cash position of $70.5m (AUD $113.3m).

In 2024, Net Sales were $2.7 million relating to sales of tissue products. The Net Loss after Income Tax of $76.0 million was driven by operating expenses, primarily related to research and development to support the planned launch of the Pivotal Trial in 2025 and increased selling, general and administrative expenses.

Anteris is preparing to submit an IDE application to the FDA in the first quarter of 2025 to commence the Pivotal Trial for the DurAVR® THV system. The Pivotal Trial is expected to include up to 80 sites across the U.S. and other key markets, with an estimated 1,000 to 1,200 patients having severe, calcific aortic stenosis.