{"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","discovered_at":"2026-05-14T18:03:35.517731+00:00","generated_at":"2026-06-12T14:43:24.474189+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA requests additional dose study for TriSalus SD-101; NDA likely beyond 2025","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-086578","json":"https://secwatch.observer/filing/0001104659-23-086578.json","markdown":"https://secwatch.observer/filing/0001104659-23-086578.md","text":"https://secwatch.observer/filing/0001104659-23-086578.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T14:43:24.474189+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}