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

Anteris Technologies Global Corp.

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.

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