{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-23-001239","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2023-09-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.391618+00:00","generated_at":"2026-06-10T14:31:28.992002+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Vivani Medical provides update on FDA clinical hold for NPM-119 diabetes implant","bullets":["FDA placed full clinical hold on NPM-119 Phase 2a LIBERATE-1 study on Aug 18, 2023, due to CMC deficiencies.","Second complete response submitted Sept 15, 2023; FDA has 30 days to respond.","If hold lifted, trial start in 2023, interim data 1H2024, full top-line 2H2024.","If response deemed inadequate, Vivani will provide updated guidance."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-23-001239","json":"https://secwatch.observer/filing/0001753926-23-001239.json","markdown":"https://secwatch.observer/filing/0001753926-23-001239.md","text":"https://secwatch.observer/filing/0001753926-23-001239.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392623001239/0001753926-23-001239-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392623001239/g083757_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T14:31:28.992002+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"}