TriSalus Life Sciences Gets FDA Clearance for Drug Delivery Device

Dow Jones

Sep 23

TriSalus Life Sciences said it received Food and Drug Administration 510(k) clearance for a new pressure-enabled drug delivery device.

Shares surged 26% to $6.21 on the news after Tuesday's closing bell. The stock closed down 1% at $4.93 and is down 29% this year.

The oncology company said the FDA greenlit TriNav Advance, the latest addition to the company's PEDD portfolio. The new device has access to small, distal vessels using a microcatheter and completes the company's portfolio addressing liver-directed therapy cases, TriSalus said.

The company will launch a limited market release of the device in the coming weeks.

"TriNav Advance enhances our Pressure-Enabled Drug Delivery portfolio in support of the full range of liver embolization procedures," Chief Executive Mary Szela said. "We are proud of the range of tools we offer to physicians and believe TriNav Advance will catalyze further adoption across these procedures. We're excited to broaden our portfolio in a way that can meaningfully benefit both physicians and patients."

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