secwatch.observer — SEC 8-K summary
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Issuer:     Anteris Technologies Global Corp. (AVR)
CIK:        0002011514
Form:       8-K
Filed at:   2025-09-29T23:59:59+00:00
Accession:  0001140361-25-036430
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 5.07, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125036430/0001140361-25-036430-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125036430/ef20054947_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-036430

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer