TriSalus Life Sciences® Announces Publication of Pre-Clinical Data Demonstrating Improved Delivery of Embospheres® to Liver Tumors using Pressure-Enabled Drug Delivery™ (PEDD™) via the TriNav® Infusion System

Rhea-AI Summary

TriSalus Life Sciences (NASDAQ: TLSI) has published research demonstrating the superior performance of their TriNav Infusion System using Pressure-Enabled Drug Delivery (PEDD) technology in delivering Embospheres to liver tumors. The study, published in the Journal of Vascular and Interventional Radiology, showed significant improvements compared to traditional microcatheters:

- 227% increase in Embospheres concentration within tumor tissue
- Improved tumor-to-normal ratio from 2.7 to 4.2
- 209% increase in peritumoral delivery

The research was conducted using a transgenic porcine liver tumor model, utilizing fluorescent imaging and deep-learning algorithms for precise quantification. These results support PEDD's potential to enhance therapeutic delivery while protecting healthy tissue in liver cancer treatments.

Positive

• 227% increase in tumor penetration of therapeutic agents (p=0.029)
• Improved tumor targeting with tumor-to-normal ratio increasing from 2.7 to 4.2
• 209% increase in peritumoral delivery (p=0.045)

Negative

• None.

Insights

Medical Research Analyst

The pre-clinical data demonstrates remarkable technical advancement in targeted drug delivery for liver cancer treatment. The 227% increase in Embosphere concentration within tumor tissue represents a quantum leap in delivery efficiency. The improvement in tumor-to-normal ratio from 2.7 to 4.2 is particularly significant as it indicates enhanced precision in targeting cancer cells while minimizing impact on healthy tissue.

The 209% increase in peritumoral delivery is important because the tumor microenvironment often acts as a barrier to treatment efficacy. This improved penetration could be particularly valuable for treating aggressive or resistant tumors. The validation through a transgenic porcine model, while preliminary, provides a strong foundation for potential clinical translation.

Think of PEDD technology as a high-pressure irrigation system that can reach areas traditional "watering" methods can't access. This could revolutionize how we deliver cancer treatments to solid tumors, potentially improving patient outcomes through better drug distribution and reduced side effects.

Market Research Analyst

From a market perspective, TriSalus is strategically positioning itself in the interventional oncology space, which is projected to see substantial growth. The PEDD technology's demonstrated superiority over traditional microcatheters could translate into significant market capture, particularly in the liver cancer treatment segment.

The data's publication in a peer-reviewed journal adds credibility and could accelerate market adoption among healthcare providers. While still pre-clinical, these results could pave the way for expanded applications and potential partnerships with pharmaceutical companies looking to enhance their drug delivery efficacy.

For investors, this represents a important technical validation that could drive future revenue growth through both direct sales and potential licensing opportunities. The technology's ability to improve existing treatments' effectiveness could make it an attractive addition to standard cancer treatment protocols, expanding the company's market reach.

DENVER--(BUSINESS WIRE)-- TriSalus Life Sciences^®, Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), TriSalus Life Sciences 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 the publication of research titled, “Pressure Enabled Drug Delivery (PEDD) Significantly Increases Intraarterial Delivery of Embolic Microspheres to Liver Tumors in a Porcine Model,” in the peer-reviewed Journal of Vascular and Interventional Radiology. The study, conducted in a transgenic tumor model, highlights the superior performance of the TriNav Infusion System in delivering Embospheres® into liver tumors when compared to delivery with a traditional microcatheter.

Key Findings:

• Improved Tumor Penetration: PEDD achieved a 227 % increase (p=0.029) in the concentration of fluorescently labeled Embospheres within tumor tissue compared to a traditional microcatheter.
• Improved Tumor Selectivity: The tumor-to-normal (T:N) ratio rose from 2.7 for a traditional microcatheter to 4.2 when delivered by PEDD, indicating more precise tumor targeting and reduced off-target delivery.
• Increased Peritumoral Delivery: Delivery to peritumoral regions increased by 209% (p=0.045), demonstrating PEDD's ability to overcome challenging tumor associated microenvironments.

“This study further validates the potential of TriNav using the PEDD approach to transform the treatment of liver tumors,” said Bryan F. Cox, Ph.D., Chief of Research for TriSalus. “By significantly enhancing therapeutic delivery and sparing healthy tissue, PEDD offers a promising advancement for patients whose outcomes may be limited by conventional delivery methods.”

The study was conducted using a transgenic porcine (Oncopig) liver tumor model, employing fluorescent imaging and advanced deep-learning algorithms to quantify therapeutic delivery with millimeter-scale resolution. Results showed the TriNav Infusion System using the PEDD approach markedly outperforms traditional microcatheters in delivering embolic microspheres into liver tumors.

These findings add to the growing body of clinical and real-world evidence supporting PEDD's ability to improve the delivery of therapeutic agents for patients with primary and metastatic liver cancers.

To read the full study, visit here.

About TriSalus Life Sciences

TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutic delivery to solid 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 as well as other solid tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of infusion into solid tumors. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to limit delivery to normal tissue, creating 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250109060433/en/

For Media Inquiries:

Jeremy Feffer, Managing Director

LifeSci Advisors

917.749.1494

jfeffer@lifesciadvisors.com

For Investor Inquiries:

James Young

Chief Financial Officer

847.337.0655

james.young@trisaluslifesci.com

Source: TriSalus Life Sciences

FAQ

What were the key results of TLSI's TriNav Infusion System study for liver tumors?

The study showed a 227% increase in Embospheres concentration within tumor tissue, improved tumor-to-normal ratio from 2.7 to 4.2, and a 209% increase in peritumoral delivery compared to traditional microcatheters.

How does TLSI's PEDD technology improve tumor targeting in liver cancer treatment?

PEDD technology improves tumor targeting by achieving a tumor-to-normal ratio of 4.2 compared to 2.7 with traditional microcatheters, indicating more precise tumor targeting and reduced off-target delivery.

What methodology did TLSI use in their liver tumor delivery study?

The study used a transgenic porcine (Oncopig) liver tumor model, employing fluorescent imaging and advanced deep-learning algorithms to quantify therapeutic delivery with millimeter-scale resolution.

What is the statistical significance of TLSI's TriNav delivery improvements?

The improvements showed statistical significance with p=0.029 for the 227% increase in tumor penetration and p=0.045 for the 209% increase in peritumoral delivery.