{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-23-001153","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2023-08-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.391352+00:00","generated_at":"2026-06-11T02:14:57.459334+00:00","sec_items":["1.01","7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"medium","headline":"Vivani's NPM-119 trial on clinical hold; submits Complete Response to FDA","bullets":["FDA placed LIBERATE-1 study on clinical hold Aug 11, citing insufficient CMC information to assess human subject risks.","Vivani submitted Complete Response on Aug 25; FDA has 30 days to respond.","If hold lifted, Phase 2a trial expected to start Oct 2023, interim results 1H2024, top-line 2H2024.","If CR inadequate, timeline delayed by ~one quarter.","Cortigent subsidiary to repay $1.5M and issue $2M promissory note at 5% under amended funding agreement."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-23-001153","json":"https://secwatch.observer/filing/0001753926-23-001153.json","markdown":"https://secwatch.observer/filing/0001753926-23-001153.md","text":"https://secwatch.observer/filing/0001753926-23-001153.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/0001753926-23-001153-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/g083730_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T02:14:57.459334+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":[{"claim_id":"4ca0ff43d626eb371ca3566eba8baef842ca1e41","claim":"Vivani Medical, Inc. amended Amendment with Cortigent, Inc. valued at $1,500,000 (effective 2023-08-25).","evidence_excerpt":"On August 25, 2023, the Company and Cortigent, Inc. (\"Cortigent\"), a wholly owned subsidiary of the Company entered into an Amendment 1 (the \"Amendment\") to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the \"TFSSA\").","evidence_source":"SEC 8-K Item 1.01/1.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/0001753926-23-001153-index.htm","confidence":0.9,"family_label":"Material Agreements","details":[{"label":"Action","value":"amendment"},{"label":"Agreement","value":"credit facility"},{"label":"Counterparty","value":"Cortigent, Inc."},{"label":"Value","value":"$1,500,000"},{"label":"Effective","value":"2023-08-25"}],"fact_type":"material_agreement"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}