{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-26-001109","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2026-06-30T12:03:55+00:00","discovered_at":"2026-06-30T12:05:07.473468+00:00","generated_at":"2026-06-30T12:05:15.769916+00:00","sec_items":["5.02","5.07","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vivani Medical receives HREC approval to initiate Phase 1 trial of NPM-139 semaglutide implant for obesity","bullets":["Received approval from Bellberry HREC in Australia to start SLIM-1 Phase 1 trial of NPM-139 semaglutide implant.","SLIM-1 trial initiation expected mid-2026; builds on prior Phase 1 success with NPM-119 exenatide implant in 2025.","Company plans SLIM-2 dose-ranging efficacy trial pending SLIM-1 results to accelerate NPM-139 development.","CEO cites strong market demand for miniature, reversible GLP-1 implant technology."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-26-001109","json":"https://secwatch.observer/filing/0001753926-26-001109.json","markdown":"https://secwatch.observer/filing/0001753926-26-001109.md","text":"https://secwatch.observer/filing/0001753926-26-001109.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392626001109/0001753926-26-001109-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392626001109/vani-20260624.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T12:05:15.769916+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"}