TriSalus Life Sciences Announces FDA 510(k) Clearance for TriNav Advance

What Happened

• TriSalus Life Sciences, Inc. filed a Form 8-K on September 22, 2026, announcing that the U.S. Food and Drug Administration granted 510(k) clearance for its TriNav Advance device.
• The company stated that, with FDA clearance, it expects to commence commercialization of the TriNav Advance. A press release dated September 22, 2026, is attached as Exhibit 99.1 to the 8-K. The report was signed by Chief Financial Officer David Patience.

Key Details

• Filing date: September 22, 2026 (Current Report on Form 8-K).
• Regulatory milestone: FDA 510(k) clearance for the TriNav Advance device.
• Company action: TriSalus expects to commence commercialization following clearance.
• Disclosure: Press release attached as Exhibit 99.1; 8-K signed by CFO David Patience.

Why It Matters

• FDA 510(k) clearance permits TriSalus to market the TriNav Advance in the U.S., removing a key regulatory barrier to sales.
• This is a product and regulatory milestone that could enable future device revenue and broaden the company’s commercial activities; investors often view such clearances as de‑risking steps for medical device companies.
• The company has publicly signaled its intent to move to commercialization, so investors should watch for subsequent updates on launch timing, pricing, distribution, and any reported sales.