AVR Price sensitive 27 Feb 2026, 9:31 AM

2025 Financial Results and Corporate Update

Anteris Technologies Global Corp

Anteris Reports 2025 Financial Results and Provides Corporate Update

Key points

  • Initiated the global pivotal PARADIGM Trial for DurAVR® THV
  • Received FDA Investigational Device Exemption approval to initiate PARADIGM Trial in the US
  • Reported favorable 30-day and 1-year DurAVR® THV clinical outcomes

Full summary

Anteris Technologies Global Corp. reported financial results for the full year ended 31 December 2025 and provided a corporate update. Key highlights include: Initiated the global pivotal PARADIGM Trial, building on experience from successfully treating 130 patients with the DurAVR® THV; Received FDA Investigational Device Exemption (IDE) approval in the fourth quarter of 2025 to initiate the PARADIGM Trial in the United States; Reported favorable 30-day (100 patients) and 1-year (65 patients) DurAVR® THV clinical outcomes from rolling cohorts of small annuli, symptomatic severe aortic stenosis patients; Completed the first 'double DurAVR®' implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions; Strengthened operational infrastructure and advanced quality management system buildout while advancing manufacturing scale-up to support clinical activities, including ISO 13485 certification for DurAVR® THV production; Appointed two new independent directors to the Board of Directors; Received approval from the Company's stockholders for ASX Limited's grant of a waiver from ASX Listing Rule 7.1; Completed aggregate capital raises totalling US$320 million in early 2026, including a strategic investment from Medtronic, plc to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV System.

Guidance

The Company's net operating cash outflows for the year ended 31 December 2025 were US$77.8 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial.

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