secwatch.observer — SEC 8-K summary
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Issuer:     Anteris Technologies Global Corp. (AVR)
CIK:        0002011514
Form:       8-K
Filed at:   2025-03-31T23:59:59+00:00
Accession:  0001140361-25-011072
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Anteris reaches 100 patients treated with DurAVR THV; strong one-year safety and efficacy data
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- Over 100 patients treated with DurAVR THV, including de novo, valve-in-valve, and bicuspid cases.
- 65 patients completed 30-day primary endpoints; safety and efficacy demonstrated.
- One-year data on 37 patients shows sustained large effective orifice areas and low mean pressure gradients.
- No valve or cardiovascular mortality at one year; excellent safety profile.
- Pivotal trial on track to commence Q3 2025, pending FDA approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125011072/0001140361-25-011072-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125011072/ef20046399_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-011072

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