{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-038166","form_type":"8-K","ticker":"AVR","cik":"0002011514","company_name":"Anteris Technologies Global Corp.","filed_at":"2025-10-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.303847+00:00","generated_at":"2026-05-17T03:47:46.406671+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Anteris gets Danish clearance to start DurAVR THV global pivotal trial","bullets":["Danish Medicines Agency clears Anteris to initiate DurAVR THV PARADIGM Trial for severe calcific aortic stenosis.","Patient recruitment at Danish centers expected in 4Q 2025; trial to enroll ~1000 patients, 1:1 vs. commercial TAVR.","IDE under FDA review; U.S. approval expected soon to allow U.S. sites in the trial.","Study co-chairs Dr. Michael Reardon and Prof. Stephan Windecker; CMO Chris Meduri cites potential to transform care.","Company calls approval a watershed moment, beginning commercialization planning for PMA and CE Mark."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-038166","json":"https://secwatch.observer/filing/0001140361-25-038166.json","markdown":"https://secwatch.observer/filing/0001140361-25-038166.md","text":"https://secwatch.observer/filing/0001140361-25-038166.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2011514/000114036125038166/0001140361-25-038166-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2011514/000114036125038166/ef20056802_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:47:46.406671+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"}