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

TriSalus Life Sciences, Inc.

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.

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