TriSalus Life Sciences Announces CMS Reimbursement for the TriNav® Infusion System via Assignment of a New Technology Healthcare Common Procedure Coding System (HCPCS) Code

DENVER–(BUSINESS WIRE)–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, is pleased to announce today that the Centers for Medicare & Medicaid Services (CMS) has created a New Technology Healthcare Common Procedure Coding System (HCPCS) code for procedures involving the TriNav® Infusion System. This new code, HCPCS C9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 – Level 4 Endovascular Procedures. The new code will become effective on January 1, 2024, and may be reported by hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs).

“We want to thank the Centers for Medicare & Medicaid Services, our congressional supporters, our clinicians, and all the patients and hospitals that helped to ensure that patients continue to have uninterrupted access to this important technology,” said Mary Szela, Chief Executive Officer of TriSalus.

About the TriNav Infusion System

TriNav is a flexible, ultra-thin therapy delivery system with SmartValve technology, a self-expanding, nonocclusive one-way dynamic microvalve that opens and closes in synchrony with the patient’s heart to modulate pressure and flow. This system uses the Pressure-Enabled Drug Delivery approach and has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures. For more information, please visit www.trinavinfusion.com.

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 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 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. 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. SD-101 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 Twitter and LinkedIn.


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