TriSalus Life Sciences Wins FDA 510(k) Clearance for TriNav Advance; Shares Jump 17%

TriSalus Life Sciences Inc. (TLSI) said the U.S. Food and Drug Administration granted 510(k) clearance to TriNav Advance, expanding its Pressure-Enabled Drug Delivery (PEDD) portfolio for liver embolization procedures. The stock rose 17% in overnight trading following the announcement on September 22, 2026. The clearance adds a new device to TriSalus' oncology-focused interventional platform, which uses pressure to improve drug delivery during embolization. The company did not disclose financial terms or a commercial launch timeline. Westminster, Colorado-based TriSalus develops therapies for liver and pancreatic tumors. Shares of TLSI trade on the Nasdaq.