---
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"
generated_at: "2026-06-01T04:32:59.776160+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Vivani Medical's NPM-119, clears IND for Phase 1 trial

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001753926-24-001110
- JSON: https://secwatch.observer/filing/0001753926-24-001110.json
- Plain text: https://secwatch.observer/filing/0001753926-24-001110.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.