DENVER--(BUSINESS WIRE)--Jun. 4, 2025-- TriSalus Life Sciences®, Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), which seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, is excited to announce the launch of the TriNav® FLX Infusion System, the latest addition to the TriNav Portfolio. TriNav FLX, with enhanced trackability, significantly expands our existing portfolio of TriNav products, offering Interventional Radiologists enhanced trackability and more options to select the right product for the right patient¹.

The TriNav FLX Infusion System retains the same trusted Pressure-Enabled Drug Delivery^TM (PEDD^TM) benefits as existing products but introduces an important advancement in design - The new system features twice the length of more flexible material at the distal end, allowing for easier navigation through more tortuous vessels. This enhancement is particularly beneficial for procedures where precise control and flexibility are required due to challenging peripheral vascular anatomy.

Key features of the TriNav FLX Infusion System include:

• Enhanced Trackability: The more flexible distal end provides improved navigation through challenging pathways.
• Reduction in Force: In benchtop models, the TriNav FLX demonstrated a 28% reduction in force during navigation compared to the standard TriNav design.¹

“We’re excited to further expand our TriNav portfolio with the introduction of the TriNav FLX Infusion System,” said Mary Szela, CEO of TriSalus Life Sciences. “With TriNav FLX, we now offer a comprehensive suite of advanced technologies designed to support Interventional Radiologists in navigating a wide range of peripheral vessel sizes and complexities. Our continued investment in portfolio innovation underscores our commitment to making Pressure-Enabled Drug Delivery accessible to more patients. Importantly, TriNav FLX is also eligible for reimbursement under HCPCS Code C8004 for simulation—or mapping—as well as C9797 for treatment procedures. This dual coverage allows clinicians to use TriNav FLX for both planning and delivery in radioembolization, supporting greater precision and continuity of care.”

For more information about the TriNav Infusion System portfolio, including indications, contraindications, and instructions for use, visit https://trinavinfusion.com/

About TriSalus Life Sciences

TriSalus Life Sciences® is a growing, oncology focused medical technology business bringing disruptive drug delivery technology with the goal of improving therapeutic delivery for the treatment of both oncologic and non-oncologic conditions. Additionally, we are exploring the integration of our technology with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of liver and pancreatic indications. We have developed an innovative organ-specific platform that is designed to overcome two of the most significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) the immunosuppressive properties of liver and pancreatic tumor immune cells. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.

In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

https://trinavinfusion.com/

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,” “believe” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding TriSalus’s business, the commercial potential of its TriNav Infusion System, TriSalus’s proprietary PEDD approach, the potential therapeutic benefits and commercial potential of Nelitolimod, and TriSalus’s technologies and other products in development. Such statements are subject to certain risks and uncertainties, including, but not limited to, those inherent in the process of developing and commercializing medical devices that are safe and effective for human use, discovering, developing and commercializing medicines that are safe and effective to use as human therapeutics, and the endeavor of building a business around such medical devices and medicines.

TriSalus’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although TriSalus’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by TriSalus. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning TriSalus’s products and programs are described in additional detail in TriSalus’s annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission (the “SEC”) and available at the SEC's website ( www.SEC.gov ). These forward-looking statements are made as of the date of this press release, and TriSalus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

1. Internal Test Report REP-0498; 28% reduction in forces to track through a benchtop tortuous model vs. TriNav

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For Media Inquiries:
Jeremy Feffer, Managing Director
LifeSci Advisors
917.749.1494
jfeffer@lifesciadvisors.com

For Investor Inquiries:
Dan Giordano
Vice President, Finance
815.405.6184
dan.giordano@trisaluslifesci.com

Source: TriSalus Life Sciences