{"schema_version":"secwatch.filing_event.v1","accession":"0001214659-25-005814","form_type":"8-K","ticker":"EBRCZ","cik":"0001347123","company_name":"EBR Systems, Inc.","filed_at":"2025-04-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.038946+00:00","generated_at":"2026-05-23T15:21:18.694297+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves EBR Systems' WiSE CRT System for commercial distribution in US","bullets":["FDA approved WiSE CRT System for left ventricular endocardial pacing; target initial US addressable market ~$3.6B.","Indicated for previously untreatable (failed CS lead) and high-risk upgrade patients aged ≥22.","Limited market release in late 2025; full commercial launch expected early 2026.","Post-approval study of 320 patients over 5 years required; NTAP/TPT reimbursement effective Oct 1, 2025.","Contraindications include triple anticoagulant therapy and allergy to procedural agents."],"urls":{"canonical":"https://secwatch.observer/filing/0001214659-25-005814","json":"https://secwatch.observer/filing/0001214659-25-005814.json","markdown":"https://secwatch.observer/filing/0001214659-25-005814.md","text":"https://secwatch.observer/filing/0001214659-25-005814.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347123/000121465925005814/0001214659-25-005814-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347123/000121465925005814/e4132508k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T15:21:18.694297+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"}