TriSalus Life Sciences Unveils TriNav® XP Infusion System to Expand PEDD Capabilities

TLSI
November 19, 2025

TriSalus Life Sciences announced the launch of its TriNav® XP Infusion System, a pressure‑enabled drug delivery device that can accommodate embolic particles up to 700 µm and treat vessels between 1.5 mm and 3.5 mm. The XP system features a more flexible distal tip and SmartValve® technology, which clinical studies have shown improves drug distribution and reduces non‑target exposure.

The XP platform extends TriSalus’s existing TriNav line, which was limited to smaller beads for liver embolization. By supporting larger beads, the XP system unlocks higher‑volume embolization procedures such as uterine fibroid and thyroid nodule treatments, potentially increasing the company’s addressable market and revenue per procedure. Analysts estimate that the expanded product line could add an additional $5–$7 million in annual revenue once the system gains traction in these new indications.

TriSalus’s Q3 2025 financials provide context for the launch: revenue rose 57% year‑over‑year to $11.6 million, driven by strong demand for its core PEDD products, while operating losses widened to $3.2 million. The company’s cash balance of $22.7 million gives it a runway to invest in commercialization and to reach EBITDA positivity by the first half of 2026, a target that management reiterated in its earnings call.

The SmartValve® technology, validated in multiple peer‑reviewed studies, offers clinicians deeper, more uniform drug delivery, a key differentiator against competitors that rely on passive flow‑based systems. TriSalus is also exploring additional indications—such as genicular artery embolization for knee osteoarthritis—where the XP’s larger bead capacity could provide therapeutic advantages.

Analysts at Maxim Group and Lake Street have maintained “Buy” ratings, citing the company’s robust revenue growth and the strategic value of the TriNav XP. The positive market reaction is driven by the 57% YoY revenue increase in Q3 2025 and the reaffirmed 50% revenue growth guidance for the full year, which reinforce confidence in TriSalus’s growth trajectory.

CEO Mary Szela emphasized that the TriNav XP “extends the reach of our PEDD approach with SmartValve technology, giving clinicians greater flexibility to treat patients in a range of embolization procedures.” She reiterated the company’s commitment to achieving profitability by early 2026, underscoring the strategic importance of the new product line to the firm’s long‑term financial goals.

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