---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-036430"
form_type: "8-K"
ticker: "AVR"
cik: "0002011514"
company_name: "Anteris Technologies Global Corp."
filed_at: "2025-09-29T23:59:59+00:00"
generated_at: "2026-05-17T05:27:52.498382+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Anteris delays PARADIGM pivotal trial enrollment to Q4 2025 after FDA request

## Summary
- Patient enrollment in PARADIGM trial now expected Q4 2025, previously Q3 2025.
- FDA requested additional bench testing info; company submitted formal response to IDE.
- Regulatory submissions to European authorities are underway for multi-regional trial.
- Stockholders approved ASX waiver proposal (13.66M for, 2.60M against) at Sept 29 special meeting.

## SEC filing metadata
- accession: 0001140361-25-036430
- form_type: 8-K
- ticker: AVR
- cik: 0002011514
- company_name: Anteris Technologies Global Corp.
- filed_at: 2025-09-29T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 5.07, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2011514/000114036125036430/0001140361-25-036430-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2011514/000114036125036430/ef20054947_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-036430
- JSON: https://secwatch.observer/filing/0001140361-25-036430.json
- Plain text: https://secwatch.observer/filing/0001140361-25-036430.txt

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