---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-038166"
form_type: "8-K"
ticker: "AVR"
cik: "0002011514"
company_name: "Anteris Technologies Global Corp."
filed_at: "2025-10-15T23:59:59+00:00"
generated_at: "2026-05-17T03:47:46.406671+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Anteris gets Danish clearance to start DurAVR THV global pivotal trial

## Summary
- Danish Medicines Agency clears Anteris to initiate DurAVR THV PARADIGM Trial for severe calcific aortic stenosis.
- Patient recruitment at Danish centers expected in 4Q 2025; trial to enroll ~1000 patients, 1:1 vs. commercial TAVR.
- IDE under FDA review; U.S. approval expected soon to allow U.S. sites in the trial.
- Study co-chairs Dr. Michael Reardon and Prof. Stephan Windecker; CMO Chris Meduri cites potential to transform care.
- Company calls approval a watershed moment, beginning commercialization planning for PMA and CE Mark.

## SEC filing metadata
- accession: 0001140361-25-038166
- form_type: 8-K
- ticker: AVR
- cik: 0002011514
- company_name: Anteris Technologies Global Corp.
- filed_at: 2025-10-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2011514/000114036125038166/0001140361-25-038166-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2011514/000114036125038166/ef20056802_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-038166
- JSON: https://secwatch.observer/filing/0001140361-25-038166.json
- Plain text: https://secwatch.observer/filing/0001140361-25-038166.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.