{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-24-001628","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2024-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.426091+00:00","generated_at":"2026-05-31T01:27:02.965841+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vivani Medical gets Australian approval to start first-in-human GLP-1 implant trial LIBERATE-1","bullets":["Approval from Bellberry HREC and TGA acknowledgement for LIBERATE-1 trial in obese/overweight subjects.","Trial will evaluate safety, tolerability, and PK of exenatide NanoPortal implant in 24 participants.","Preclinical data suggests comparable efficacy to semaglutide with twice-yearly dosing.","Enrollment expected Q4 2024; data projected in 2025; Australian R&D incentives may defray costs.","Data intended to support regulatory submissions in the US and other geographies."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-24-001628","json":"https://secwatch.observer/filing/0001753926-24-001628.json","markdown":"https://secwatch.observer/filing/0001753926-24-001628.md","text":"https://secwatch.observer/filing/0001753926-24-001628.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392624001628/0001753926-24-001628-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392624001628/vani-20240926.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:27:02.965841+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"}