{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-24-001110","form_type":"8-K","ticker":"VANI","cik":"0001266806","company_name":"Vivani Medical, Inc.","filed_at":"2024-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.653051+00:00","generated_at":"2026-06-01T04:32:59.776160+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA lifts clinical hold on Vivani Medical's NPM-119, clears IND for Phase 1 trial","bullets":["FDA cleared IND and lifted clinical hold for NPM-119 (exenatide), a six-month GLP-1 implant for type 2 diabetes.","LIBERATE-1 Phase 1 trial will assess safety, tolerability, and pharmacokinetics vs. Bydureon BCise; enrollment expected H2 2024.","First clinical application of NanoPortal implant technology; addresses medication non-adherence affecting ~50% of type 2 diabetes patients.","Lead program NPM-115 (high-dose exenatide) for chronic weight management showed preclinical weight loss comparable to semaglutide.","NPM-139 (semaglutide implant) in pipeline with potential once-yearly dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-24-001110","json":"https://secwatch.observer/filing/0001753926-24-001110.json","markdown":"https://secwatch.observer/filing/0001753926-24-001110.md","text":"https://secwatch.observer/filing/0001753926-24-001110.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1266806/000175392624001110/0001753926-24-001110-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1266806/000175392624001110/g084283_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:32:59.776160+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"}