Anteris Advances DurAVR THV with $320M Capital Raise and PARADIGM Trial Launch

Event summary

  • Anteris raised $320M in early 2026, including strategic investment from Medtronic, to support the PARADIGM Trial and global commercialization of the DurAVR THV System.
  • The company initiated the global pivotal PARADIGM Trial in 2025, receiving FDA IDE approval in Q4 2025 to commence the trial in the U.S.
  • Anteris reported favorable 30-day (100 patients) and 1-year (65 patients) clinical outcomes for the DurAVR THV in small annuli, symptomatic severe aortic stenosis patients.
  • The company completed the first 'double DurAVR' implant, replacing both mitral and aortic valves in a single patient.

The big picture

Anteris is positioning itself as a next-generation player in the structural heart market, challenging established TAVR incumbents with its biomimetic DurAVR THV. The $320M capital raise, including Medtronic's strategic investment, underscores the potential of Anteris' technology. The company's focus on clinical evidence and manufacturing scale-up reflects the high-stakes nature of gaining market share in the competitive TAVR space.

What we're watching

Trial Execution
The pace at which Anteris enrolls and completes the PARADIGM Trial will determine the timeline for FDA approval and commercial launch.
Competitive Positioning
Whether Anteris can differentiate DurAVR THV against established TAVR competitors in the head-to-head PARADIGM Trial.
Capital Deployment
How effectively Anteris utilizes the $320M capital raise to scale manufacturing and support global commercialization efforts.