Anteris Technologies Secures $320M and FDA Approval for Heart Valve Trials

Key Facts

1The company initiated the global pivotal PARADIGM Trial and received FDA IDE approval to start trials in the United States.

2The company completed aggregate capital raises totaling $320 million in early 2026, including a strategic investment from Medtronic, plc.

3DurAVR® THV clinical outcomes showed favorable 30-day and 1-year results for aortic stenosis patients.

Anteris Technologies Global Corp. (AVR) has reported its full-year 2025 financial results alongside significant corporate milestones. The company successfully initiated its global pivotal PARADIGM Trial after receiving IDE approval from the U.S. FDA to commence trials in the United States. Clinical data for the DurAVR® THV system demonstrated favorable outcomes for aortic stenosis patients at both 30-day and one-year intervals. Strengthening its balance sheet, Anteris completed capital raises totaling $320 million in early 2026, featuring a strategic investment from Medtronic. These developments mark a critical transition for the company toward the global commercialization of its proprietary heart valve technology.