{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-040087","form_type":"8-K","ticker":"AVR","cik":"0002011514","company_name":"Anteris Technologies Global Corp.","filed_at":"2025-11-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.305408+00:00","generated_at":"2026-05-17T00:57:38.850397+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Anteris obtains FDA approval to initiate PARADIGM pivotal trial for DurAVR THV","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-040087","json":"https://secwatch.observer/filing/0001140361-25-040087.json","markdown":"https://secwatch.observer/filing/0001140361-25-040087.md","text":"https://secwatch.observer/filing/0001140361-25-040087.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/0001140361-25-040087-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2011514/000114036125040087/ef20058141_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:57:38.850397+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}