---
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"
generated_at: "2026-06-11T02:14:57.459334+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "medium"
source: SEC EDGAR
---

# Vivani's NPM-119 trial on clinical hold; submits Complete Response to FDA

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: medium
- sec_items: 1.01, 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001753926-23-001153
- JSON: https://secwatch.observer/filing/0001753926-23-001153.json
- Plain text: https://secwatch.observer/filing/0001753926-23-001153.txt

## Key facts
- Material Agreements
  Vivani Medical, Inc. amended Amendment with Cortigent, Inc. valued at $1,500,000 (effective 2023-08-25).
  - Action: amendment
  - Agreement: credit facility
  - Counterparty: Cortigent, Inc.
  - Value: $1,500,000
  - Effective: 2023-08-25
  source text: 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_url: https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/0001753926-23-001153-index.htm

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