---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-086578"
form_type: "8-K"
ticker: "TLSI"
cik: "0001826667"
company_name: "TriSalus Life Sciences, Inc."
filed_at: "2023-08-02T23:59:59+00:00"
generated_at: "2026-06-12T14:43:24.474189+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA requests additional dose study for TriSalus SD-101; NDA likely beyond 2025

## Summary
- TriSalus received FDA written responses on July 31, 2023 for PERIO-01 Type B meeting regarding SD-101 for metastatic uveal melanoma.
- FDA acknowledged tolerable safety profile of SD-101 via PEDD with TriNav device, no delivery concerns.
- FDA requested additional dose optimization study (40-50 patients) before registrational trial; Phase 2 initiation planned for 2023.
- Potential NDA submission for SD-101 in uveal melanoma with liver metastases now expected beyond 2025.
- TriSalus also considering separate HCC study with SD-101 plus Y90 radioembolization, prioritization based on H2 2023 data.

## SEC filing metadata
- accession: 0001104659-23-086578
- form_type: 8-K
- ticker: TLSI
- cik: 0001826667
- company_name: TriSalus Life Sciences, Inc.
- filed_at: 2023-08-02T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1826667/000110465923086578/0001104659-23-086578-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1826667/000110465923086578/tm2322654d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-086578
- JSON: https://secwatch.observer/filing/0001104659-23-086578.json
- Plain text: https://secwatch.observer/filing/0001104659-23-086578.txt

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