TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today that the Company will present data from recent research findings at the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, to be held March 23-28, 2024, in Salt Lake City, Utah.

TriSalus will share data on the technical feasibility and safety of Pressure-Enabled Drug Delivery™ (PEDD) procedures in hypovascular tumors and initial data regarding our Pancreatic infusion technology, which is currently 510(k) cleared by the U.S. Food and Drug Administration (FDA) and in the Phase 1 clinical trial with nelitolimod in locally advanced pancreatic cancer.

The TriSalus approach seeks to address many of the key challenges associated with delivering therapeutics to pancreas tumors. In contrast to the liver, pancreas arteries feeding tumors are difficult to access and venous access affords anatomic advantages. Additionally, pancreatic tumors exhibit a dense, desmoplastic stroma that limits the delivery of therapeutics. The technology is designed to address these mechanical barriers and challenges by modulating pressure and flow, incorporating real-time pressure sensing capability to optimize safety and delivery.

“The presentations featuring our PEDD approach illustrates that TriSalus is committed to and focused on transforming how therapeutics are delivered into biologically challenging liver and pancreas tumors. Mechanical barriers present in the tumor microenvironment, including high intra-tumoral pressure, may limit the performance of many therapeutic classes including embolics and immunotherapy. We look forward to our continued partnership with the interventional radiology community to improve outcomes in a variety of solid tumor indications,” noted Steven C. Katz, MD, FACS, Chief Medical Officer.

Presentation details for SIR 2024 are as follows:

Presentation: Clinical Efficacy of Pressure-Enabled Transarterial Embolization of Hypovascular, Treatment-Refractory Metastases.

Presenting Author: Koustav Pal, MBBS, Postdoctoral Research Fellow at University of Texas MD Anderson Cancer Center

Date: Sunday, March 24, 2024

Time: 3:54 p.m. MT

Location: Salt Lake Palace Convention Center, Room 255C

Presentation: The PERIO-03 Trial: Technical Feasibility and Safety of a Novel Pancreatic Retrograde Venous Immunotherapy Infusion Intervention for Locally Advanced Pancreatic Ductal Adenocarcinoma.

Presenting Author: Rahul A. Sheth, MD, Associate Professor at University of Texas MD Anderson Cancer Center

Date: Sunday, March 24, 2024

Time: 4:21 p.m. MT

Location: Salt Lake Palace Convention Center, Room 255B

The presentations will be available on the publications page of the TriSalus website following the respective sessions.

About TriSalus Life Sciences

TriSalus Life Sciences is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with 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 that deliver a range of therapeutics, using its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach: 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 to 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 (SD-101), the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors, 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 SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically. The target for SD-101, 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 trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this report, including statements regarding the Company’s expected financial results for the three months ended December 31, 2023 and the full year ended December 31, 2023, the Company’s belief as to the factors causing the financial results, and the Company’s projected operating runway into the second quarter of 2024, are all forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “expect,” “may,” “potential,” “should,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, the risk that our reported financial results will differ from the estimates provided in this press release, the Company’s ability to achieve its projected growth or maintain its current levels of revenue, the Company’s ability to obtain additional liquidity, the Company’s ability to continue as a going concern, and other risk factors described in the Company’s filings with the Securities and Exchange Commission, including the section titled “Risk Factors”. See the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 14, 2023 and other filings made with the SEC for a discussion of important factors that may cause the Company’s actual results to differ materially from those expressed or implied by the Company’s forward looking statements. Moreover, the Company operates in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for the Company’s management to predict all risk factors nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Furthermore, if the Company’s forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

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