secwatch.observer — SEC 8-K summary
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Issuer:     TriSalus Life Sciences, Inc. (TLSI)
CIK:        0001826667
Form:       8-K
Filed at:   2023-08-02T23:59:59+00:00
Accession:  0001104659-23-086578
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1826667/000110465923086578/0001104659-23-086578-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1826667/000110465923086578/tm2322654d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-086578

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