TriSalus Life Sciences Announces New CMS HCPCS Code for TriNav® Infusion System Mapping

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, announced today that the Centers for Medicare & Medicaid Services (CMS) has established a new Level II HCPCS code for the TriNav® Infusion System, effective April 1, 2025. This new code, C8004, provides reimbursement clarity for simulation angiograms—commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE).

The introduction of C8004 provides validation of TriNav's growing role in pre-treatment mapping for Transarterial Radioembolization, reinforcing its value in optimizing Y90 dose delivery.

"With this new code, Interventional Radiologists and Medicare patients have access to PEDD for radioembolization procedures with full reimbursement for both mapping and treatment," said Mary Szela, CEO of TriSalus. "Using PEDD technology for both the mapping and treatment procedures in radioembolization helps ensure accurate treatment planning and delivery which is crucial for delivering the radioactive microspheres to the tumor with precision."

Dr. Richard Marshall, who serves as Medical Director for TriSalus, stated:

"In my current practice, using the same catheter for both mapping and treatment helps enhance the accuracy of Y90 dose delivery. I can achieve a higher T:N ratio with the TriNav Infusion System, and I have seen that its high concordance between mapping and treatment allows better prediction of the dose which can improve personalized dosimetry."

HCPCS Code C8004 Details

• Description: Simulation angiogram utilizing a pressure-generating catheter (e.g., one-way valve, intermittently occluding), including all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary for subsequent therapeutic radioembolization of tumors.
• Effective Date: April 1, 2025
• Eligible Reporting Facilities: Hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs)
• Medicare Payment Rate: $11,341 under APC 5193

TriSalus' initial analysis indicates that the reimbursement level under C8004, combined with standard Medicare payment adjustments, will support continued adoption of TriNav for both mapping and treatment.

For more information, the full CMS Quarterly Update can be found [here].

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 to liver and pancreatic tumors. 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. Our ultimate goal is to transform the treatment paradigm for patients battling liver and pancreatic tumors. 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.

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.

https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update

View source version on businesswire.com: https://www.businesswire.com/news/home/20250326932769/en/

For Media Inquiries:

Jeremy Feffer, Managing Director

LifeSci Advisors

917.749.1494

[email protected]

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James Young

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