---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-040087"
form_type: "8-K"
ticker: "AVR"
cik: "0002011514"
company_name: "Anteris Technologies Global Corp."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:57:38.850397+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Anteris obtains FDA approval to initiate PARADIGM pivotal trial for DurAVR THV

## Summary
- FDA approved global IDE trial for DurAVR THV in severe aortic stenosis patients.
- PARADIGM is a prospective RCT enrolling ~1,000 patients 1:1 across US, Europe, Canada.
- Primary endpoint: all-cause mortality, all stroke, cardiovascular hospitalization at one year.
- Trial co-chaired by Dr. Michael J. Reardon (Houston Methodist) and Prof. Stephan Windecker (Bern).
- First patients already treated in Denmark; trial supports future PMA and parallel CE Mark approval.

## SEC filing metadata
- accession: 0001140361-25-040087
- form_type: 8-K
- ticker: AVR
- cik: 0002011514
- company_name: Anteris Technologies Global Corp.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/0001140361-25-040087-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/ef20058141_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-040087
- JSON: https://secwatch.observer/filing/0001140361-25-040087.json
- Plain text: https://secwatch.observer/filing/0001140361-25-040087.txt

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