DENVER / Nov 07, 2024 / Business Wire / TriSalus Life Sciences^® Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), a leader in oncology innovations integrating advanced delivery technology to transform treatment for liver and pancreatic tumors, today announced the launch of the TriNav^® LV Infusion System and TriGuide™ Guiding Catheter. These new devices are designed to optimize therapeutic delivery, enhancing treatment options and potentially improving outcomes for patients.

Highlights of the Launch:

• Expanded Patient Access: The TriNav LV Infusion System is tailored for larger vessels (3.5-5.0 mm), increasing the number of patients eligible for TriSalus' proprietary Pressure-Enabled Drug Delivery (PEDD™) technology.
• Comprehensive Device Portfolio: This launch marks an expansion of TriSalus’ PEDD device offerings, now covering vessel sizes from 1.5 mm to 5.0 mm, giving interventional radiologists a broader range of treatment options and increasing the Total Addressable Market (TAM).
• Innovative Design for Ease of Access: The new TriGuide Guiding Catheters, uniquely equipped with a larger inner diameter, lubricious inner lining, and reverse curve design, are the first of their kind to support femoral access for the TriNav LV Infusion System, enhancing procedural efficiency.
• High Satisfaction Among Early Users: In a limited market release, physicians reported a 97% satisfaction rate with the TriNav LV Infusion System, underscoring its clinical effectiveness and ease of use.
• Reimbursement Compatibility: The TriNav LV Infusion System is eligible for the same HCPCS codes—C9797 for procedures and C1982 for devices—as the existing TriNav products, supporting seamless integration into current billing structures.

"We are thrilled to introduce TriNav LV, an infusion system developed in direct response to customer feedback for a larger-diameter PEDD device suited for lobar therapeutic delivery in patients with larger vessels," said Mary Szela, Chief Executive Officer and President of TriSalus. "This launch is a testament to our commitment to meeting clinician needs and marks the first of several innovative products we plan to introduce over the next 12 to 18 months. Our focus remains on advancing our pipeline to make a significant difference in patient outcomes and to drive progress in cancer 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 the PEDD method are commonly present as well. Nelitolimod delivered by the PEDD method 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.