---
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"
generated_at: "2026-06-10T14:31:28.992002+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Vivani Medical provides update on FDA clinical hold for NPM-119 diabetes implant

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001753926-23-001239
- JSON: https://secwatch.observer/filing/0001753926-23-001239.json
- Plain text: https://secwatch.observer/filing/0001753926-23-001239.txt

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