secwatch.observer — SEC 8-K summary
======================================

Issuer:     Anteris Technologies Global Corp. (AVR)
CIK:        0002011514
Form:       8-K
Filed at:   2025-11-03T23:59:59+00:00
Accession:  0001140361-25-040087
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Anteris obtains FDA approval to initiate PARADIGM pivotal trial for DurAVR THV
------------------------------------------------------------------------------

- FDA approved global IDE trial for DurAVR THV in severe aortic stenosis patients.
- PARADIGM is a prospective RCT enrolling ~1,000 patients 1:1 across US, Europe, Canada.
- Primary endpoint: all-cause mortality, all stroke, cardiovascular hospitalization at one year.
- Trial co-chaired by Dr. Michael J. Reardon (Houston Methodist) and Prof. Stephan Windecker (Bern).
- First patients already treated in Denmark; trial supports future PMA and parallel CE Mark approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/0001140361-25-040087-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/ef20058141_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-040087

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