TriSalus Life shares surge 29% on FDA device clearance
TriSalus Life Sciences (TLSI) has seen its shares jump 29% following the company's announcement of receiving FDA clearance for the TriNav Advance device. The FDA's 510(k) clearance for TriNav Advance allows TriSalus to expand its Pressure-Enabled Drug Delivery (PEDD) device portfolio with a new tool for small, distal vessel access.
The device offers two modes of operation: telescoping mode, designed for selective delivery to smaller vessels using a compatible microcatheter, and high-flow mode, which functions similarly to existing TriNav devices but without an additional microcatheter. This addition broadens the company's portfolio to include liver-directed therapy cases and extends its reach to various embolization procedures, not just liver-related ones.
TriSalus plans to start a limited market release of the TriNav Advance over the coming weeks. CEO Mary Szela highlighted that the new device strengthens the company's PEDD portfolio, improving its capabilities for a wider range of liver embolization procedures. CMO Richard Marshall noted that the FDA clearance will enable TriSalus to tackle more complex cases, particularly those involving intricate anatomies, while minimizing impact on healthy structures.
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