The company secured FDA Investigational Device Exemption approval in Q4 2025 and launched its global pivotal PARADIGM Trial after treating 130 patients with the DurAVR THV, including de novo cases, complex anatomies and valve-in-valve procedures. Initial outcomes showed favourable 30-day results in 100 patients and one-year results in 65, alongside the first double DurAVR implant in mitral and aortic positions and the appointment of two independent directors.

In early 2026 Anteris completed aggregate capital raises totaling $320 million, featuring a strategic investment from Medtronic to underwrite PARADIGM Trial execution and advance global commercialization of the DurAVR THV system. Stockholder approval was obtained for an ASX waiver, strengthening the balance sheet for upcoming clinical and manufacturing milestones.

Anteris advanced its operational infrastructure and quality management system buildout, achieving ISO 13485 certification to support scale-up of DurAVR THV production. These efforts include expanded manufacturing capabilities, enhanced regulatory compliance and bolstered field-based clinical teams in preparation for broader commercial rollout.

For the year ended December 31, 2025, the company recorded net operating cash outflows of $77.8 million, reflecting increased clinical, regulatory and manufacturing activities. Research and development expenses totaled $69.1 million, driven by trial preparations and manufacturing scale-up, while selling, general and administrative expenses amounted to $26.1 million.