secwatch.observer — SEC 8-K summary
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Issuer:     Anteris Technologies Global Corp. (AVR)
CIK:        0002011514
Form:       8-K
Filed at:   2025-10-28T23:59:59+00:00
Accession:  0001140361-25-039514
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Anteris enrolls & treats first patients in DurAVR THV global pivotal trial
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- First patients enrolled and successfully treated in PARADIGM Trial for DurAVR THV in severe calcific aortic stenosis.
- Procedure performed by Prof. Dr. Ole De Backer at Rigshospitalet, Copenhagen University Hospital, Denmark.
- Trial is a randomized controlled study (1:1 vs commercial TAVRs) enrolling ~1,000 patients in All Comers Cohort.
- Primary endpoint: all-cause mortality, all stroke, cardiovascular hospitalization at one year post procedure.
- Expands existing data set of 130 patients; plans to add sites across US, Europe, and Canada.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125039514/0001140361-25-039514-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125039514/ef20057756_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-039514

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