Recent Updates — TLSI

TriSalus Life Sciences, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its TriNav Advance device on September 22, 2026. This approval expands the company's Pressure-Enabled Drug Delivery (PEDD) portfolio by enabling access to small, distal vessels via compatible microcatheters while preserving enhanced therapeutic delivery and off-target protection. The device supports two configurations: telescoping for selective delivery to smaller vessels and high-flow for easy infusion through large lumens. TriSalus intends to initiate a limited market release of the TriNav Advance over the coming weeks. This regulatory milestone strengthens the company's comprehensive portfolio for liver embolization and broader embolization procedures beyond the liver, potentially catalyzing further physician adoption. TriSalus Life Sciences is an oncology-focused medical technology company that integrates novel drug delivery devices with standard-of-care therapies and investigational immunotherapeutics to treat solid tumors.

TriSalus Life Sciences reported second quarter 2026 financial results, generating $11.4 million in revenue and maintaining full-year guidance of $54 million to $57 million. The company expanded its commercial organization and raised $46.0 million in gross proceeds from an equity offering in the first quarter, ending Q2 with $46.3 million in cash. Operating losses widened to $9.8 million due to increased sales and marketing expenses, while net loss was $9.2 million, or $0.16 per share. TriSalus is an oncology-focused medical technology company that integrates novel drug delivery devices with standard-of-care therapies and investigational immunotherapeutics for solid tumors.