TriSalus gets FDA clearance for TriNav Advance
FDA 510(k) clearance for TriNav Advance expands TLSI’s PEDD device portfolio and liver embolization coverage with a limited market release planned.
Rhea-AI Filing Summary
TriSalus Life Sciences, Inc. (TLSI) announced that the U.S. FDA has granted 510(k) clearance for its TriNav® Advance device, the newest addition to its Pressure-Enabled Drug Delivery™ (PEDD) portfolio. The device expands access to small, distal vessels via use with compatible microcatheters while maintaining PEDD’s enhanced drug delivery and off‑target protection. With this clearance, the company expects to begin a limited market release over the coming weeks, broadening its coverage of liver-directed and other embolization procedures and offering interventional radiologists more flexibility across complex anatomies.
Positive
- FDA 510(k) clearance for TriNav® Advance strengthens TriSalus’ PEDD device portfolio and supports entry into a broader range of embolization procedures, including complex liver-directed cases.
- TriNav® Advance offers greater procedural flexibility by enabling use with compatible microcatheters for distal vessels or in high‑flow configuration, potentially increasing physician adoption of TriSalus’ technology.
Negative
- None.
Insights
Analyzing...
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
FDA pathway: 510(k) clearance
Number of FDA-cleared PEDD devices: 3 devices
TriNav Advance configurations: 2 configurations
+2 more
5 metrics
FDA pathway
510(k) clearance
Regulatory clearance granted for TriNav Advance
Number of FDA-cleared PEDD devices
3 devices
TriNav Infusion System, TriNav Infusion System LV, and Pancreatic Retrograde Venous Infusion System
TriNav Advance configurations
2 configurations
Telescoping with a microcatheter and high-flow without an additional microcatheter
Clearance date
September 22, 2026
Date FDA 510(k) clearance for TriNav Advance was announced
Completed Phase 1 trials for nelitolimod
3 trials
Clinical development status of investigational immunotherapeutic nelitolimod
Key Terms
510(k) clearance, Pressure-Enabled Drug Delivery™ (PEDD), embolization procedures, Toll-like receptor 9 agonist, +1 more
5 terms
510(k) clearance regulatory
"announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance"
A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.
Pressure-Enabled Drug Delivery™ (PEDD) medical
"newest addition to its Pressure-Enabled Drug Delivery™ (PEDD) portfolio"
embolization procedures medical
"supports a broader range of embolization procedures beyond the liver"
Toll-like receptor 9 agonist medical
"nelitolimod, a class C Toll-like receptor 9 agonist"
A toll-like receptor 9 (TLR9) agonist is a type of drug that activates TLR9, a sensor on certain immune cells that recognizes specific DNA patterns and turns on an immune response. Think of it like pressing a doorbell that wakes up parts of the immune system; in drug development this approach is used to boost vaccines or cancer immunotherapies, so progress in trials, safety data, or approvals can materially affect a biotech company's prospects and valuation.
Pressure-Enabled Regional Immuno-Oncology™ (PERIO) medical
"during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How many FDA-cleared devices does TLSI now have in its PEDD platform?
TriSalus states that it has three FDA-cleared devices using its Pressure-Enabled Drug Delivery™ approach: two TriNav® Infusion Systems for hepatic arterial infusion of liver tumors and one Pancreatic Retrograde Venous Infusion System for pancreatic tumors.
What is nelitolimod in TriSalus’ pipeline?
Nelitolimod is described as an investigational immunotherapeutic, a class C Toll-like receptor 9 agonist, designed to address the immunosuppressive tumor environment. TriSalus has completed three Phase 1 clinical trials and plans to explore partnership opportunities for further development.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 22, 2026
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
| (Address of principal executive office) | (Zip Code) | |||||||
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below): | |||||
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c)) | |||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
| Item 8.01 | Other Events. | |||||||
On September 22, 2026, TriSalus Life Sciences, Inc. (the “Company”) issued a press release announcing that it has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its TriNav Advance device. With FDA clearance, the Company expects to commence commercialization. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. | |||||||
| (d) Exhibits: | ||||||||
| Exhibit Number | Description | |||||||
99.1 | Press Release dated September 22, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 22, 2026 | TriSalus Life Sciences, Inc. | ||||||||||
| By: | /s/ David Patience | ||||||||||
| Name: | David Patience | ||||||||||
| Title: | Chief Financial Officer | ||||||||||
TriSalus Life Sciences Receives FDA Clearance for TriNav® Advance, Strengthening Comprehensive Pressure-Enabled Drug DeliveryTM (PEDDTM) Portfolio for Liver Embolization
WESTMINSTER, Colo. – September 22, 2026 – TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard-of-care therapies and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TriNav® Advance, the newest addition to its Pressure-Enabled Drug Delivery™ (PEDD) portfolio.
TriNav® Advance expands TriSalus' portfolio of PEDD devices, adding access to small, distal vessels, via a compatible delivery microcatheter, while preserving PEDD's enhanced therapeutic delivery and off-target protection. Interventional radiologists can now pair TriNav Advance with a compatible microcatheter of their choice, giving them flexibility across a broader range of procedures and anatomies.
With this addition, TriSalus offers a complete portfolio addressing liver-directed therapy cases and its indication supports a broader range of embolization procedures beyond the liver. The Company intends to initiate a limited market release of the TriNav Advance device over the coming weeks.
TriNav Advance can be used in two configurations to match vessel anatomy and treatment goals:
•Telescoping: Used with a compatible microcatheter, with the TriNav Advance SmartValve positioned proximal to the delivery site - enabling selective delivery to smaller, distal vessels while maintaining the benefits of PEDD.
•High-flow: Used like a standard TriNav device, without an additional microcatheter, for easy infusion through a large lumen.
“TriNav® Advance enhances our Pressure-Enabled Drug Delivery™ portfolio in support of the full range of liver embolization procedures,” said Mary Szela, President and Chief Executive Officer of TriSalus. “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.”
“The TriNav® Advance clearance marks a seminal moment for TriSalus Life Sciences, enabling us to expand our impact, particularly in cases involving tortuous anatomies,” said Richard Marshall, M.D., Chief Medical Officer of TriSalus. “We believe that physicians can now optimize therapeutic delivery in difficult cases while limiting exposure to unaffected anatomical structures, which has been central to what makes PEDD clinically meaningful. This is a natural extension of the technology into cases we haven’t been able to fully address before.”
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-
Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company has completed three Phase 1 clinical trials and will begin exploring partnership opportunities for development.
Forward Looking Statements
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
For Media Inquiries:
Andrea Marasso
Vice President, Marketing
andrea.marasso@trisaluslifesci.com
For Investor Inquiries:
David Patience
Chief Financial Officer
investor.relations@trisaluslifesci.com
Chief Financial Officer
investor.relations@trisaluslifesci.com
Source: TriSalus Life Sciences, Inc.