DENVER / Nov 11, 2024 / Business Wire / TriSalus Life Sciences^® Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), an oncology company dedicated to enhancing outcomes for patients suffering from liver cancer through its advanced delivery technology as well as an investigational immunotherapy, nelitolimod, has announced a strategic partnership with Geo-Med, LLC (“Geo-Med”), a certified Service-Disabled Veteran-Owned Small Business (SDVOSB), to expand availability of the TriNav Infusion System (“TriNav”) to U.S. Department of Veterans Affairs (VA) medical centers nationwide.

“Fittingly, on the day honoring our veterans, we announce this pivotal collaboration designed to expand access for U.S. veterans to our proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach. PEDD is enabled by TriNav, a promising technology with the potential to improve liver cancer outcomes,” said Mary Szela, Chief Executive Officer and President of TriSalus. “We are thrilled to partner with Geo-Med to increase access to TriNav for veterans battling liver cancer. This collaboration is closely aligned with our mission to enhance patient outcomes, particularly for those who have served our country.”

Geo-Med is a key supplier to the VA and the U.S. Department of Defense (DOD) medical facilities. Their deep expertise in providing high-quality medical products to the VA and DOD, along with their insight into VA procurement, will be instrumental in ensuring that TriNav reaches the veterans who need it most.

Hepatocellular carcinoma (HCC), the most common form of liver cancer, occurs up to five times more frequently in U.S. veterans than in the general population.¹ The PEDD method has been shown to improve therapeutic delivery to the tumor², while simultaneously decreasing non-target delivery³, offering a potentially more effective treatment option for veterans battling liver cancer.

Mike Locke, Chief Executive Officer of Geo-Med, added, “We are proud to collaborate with TriSalus to bring this innovative delivery technology to veterans. Liver cancer is a particularly aggressive disease, and by expanding access to TriNav, we’re providing veterans with the latest advancements in treatment.”

About TriSalus Life Sciences

TriSalus Life Sciences^® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutics delivery to liver and pancreatic tumors.

The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav^® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD 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 PEDD 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 PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.

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 trinavinfusion.com and trisaluslifesci.com. Please also follow us on X (formerly Twitter) and LinkedIn.

About Geo-Med, LLC

Geo-Med, LLC is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) providing medical, surgical, and pharmaceutical products to the VA and Department of Defense. With over two decades of experience, Geo-Med is dedicated to delivering high-quality healthcare products and improving the well-being of veterans and active military personnel.

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 may include, but are not limited to, statements regarding the consummation of the Offer and Consent Solicitation, the timing of the Expiration Date, the future effectiveness of the registration statement on Form S-4, the approval by the holders of Warrants of the Warrant Amendment and subsequent entry into the Warrant Amendment, the effects of the Offer on our capital structure and expected changes to the dilutive impact of the Warrants. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including, without limitation: the Company’s ability to successfully complete the Offer and Consent Solicitation; the number of holders of Warrants that approve the Warrant Amendment in the Consent Solicitation; the timing and results of the SEC review of the registration statement on Form S-4 filed on May 24, 2024, if any; the Company’s ability to attract and retain customers and expand customers’ use of the Company’s products; risks relating to market, financial, political and legal conditions; risks relating to the uncertainty of the projected financial and operating information with respect to the Company; risks related to future market adoption of the Company’s offerings; risks related to the Company’s marketing and growth strategies; risks related to the Company’s ability to acquire or invest in businesses, products or technologies that may complement or expand its products, enhance its technical capabilities or otherwise offer growth opportunities; the effects of competition on the Company’s future business; the risks discussed in the Company’s quarterly report on Form 10-Q for the period ended March 31, 2024 under the heading “Risk Factors”; and the risks discussed in the Company’s Registration Statement on Form S-4 filed on May 24, 2024, under the heading “Risk Factors” and other documents of the Company filed, or to be filed, with the SEC. If any of these risks materialize or any of the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company presently does not know of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans or forecasts of future events and views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by applicable law. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

¹ Richman, VA Research Currents, May 2017
² Titano, J. J. et al. End-hole Versus Microvalve Infusion Catheters in Patients Undergoing Drug-Eluting Microspheres-TACE for Solitary Hepatocellular Carcinoma Tumors: A Retrospective Analysis. Cardiovasc. Intervent. Radiol. 42, 560–568 (2019).
³ Pasciak, A. S., McElmurray, J. H., Bourgeois, A. C., Heidel, R. E. & Bradley, Y. C. The impact of an antireflux catheter on target volume particulate distribution in liver-directed embolotherapy: a pilot study. J. Vasc. Interv. Radiol. JVIR 26, 660–669 (2015).