Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has reported a net operating cash outflow of US$77.8 million for the year ended December 31, 2025, as it increased spending across clinical, regulatory and manufacturing work to support its global pivotal PARADIGM trial.
The structural heart company said research and development expenses totalled US$69.1 million in 2025, reflecting manufacturing and quality scale-up work, higher R&D headcount, PARADIGM preparatory activities and clinical costs linked to enrolling additional patients, alongside expansion of its field-based clinical team and medical affairs activities.
Selling, general and administrative expenses were US$26.1 million.
“2025 was a pivotal year for Anteris, advancing DurAVR® with disciplined execution, strengthening our clinical foundation, and positioning the company for long-term leadership in structural heart," Wayne Paterson, vice chairman and chief executive officer of Anteris, said.
"We converted strategy into measurable progress, reinforcing our competitive position and accelerating our path toward commercial readiness. The progress achieved in 2025 has strengthened our foundation and sharpened our trajectory toward becoming a leader in next-generation TAVR. We remained focused on what matters most; advancing clinical evidence, strengthening our balance sheet, and building sustainable long-term value.”
PARADIGM planned at ~1,000 patients; US IDE approved in Q4 2025
Operationally, Anteris initiated the global pivotal PARADIGM trial during 2025 and received US Food and Drug Administration Investigational Device Exemption approval in the fourth quarter of 2025 to begin the study in the United States.
The company said PARADIGM is designed as a prospective randomised controlled trial comparing its DurAVR THV to commercially available transcatheter aortic valve replacements, with approximately 1,000 patients expected to be enrolled in an “All Comers Randomized Cohort” under 1:1 randomisation.
Anteris said the trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at 1 year post-procedure. It added the trial is actively recruiting, with the first patients enrolled and implanted during the fourth quarter of 2025.
As part of its clinical update, the company said it has now treated 130 patients with DurAVR, spanning de novo aortic stenosis cases, complex anatomies and valve-in-valve patients. It also reported favourable 30-day outcomes in 100 patients and 1-year outcomes in 65 patients from rolling cohorts of small annuli symptomatic severe aortic stenosis patients.
Anteris also highlighted completion of its first “double DurAVR” implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions, and said it progressed manufacturing scale-up to support clinical activities, including ISO 13485 certification for DurAVR THV production.
On the corporate side, the company said it appointed David Roberts and Gregory Moss as new independent directors and noted shareholder approval for ASX’s grant of a waiver from ASX Listing Rule 7.1.
Anteris also disclosed aggregate capital raises totalling US$320 million in early 2026, including a strategic investment from Medtronic, to support execution of PARADIGM and progress the company toward global commercialisation.