TriSalus Life Sciences Receives Expanded Reimbursement Authorization from CMS for TriNav Infusion System

• Transitional Pass Through Payment (TPT) Facilitates Patient Access to New and Innovative Products That Have Shown Substantial Clinical Improvement
• Expanded Coverage Allows for Reimbursement of Both Pre-Treatment Mapping and Treatment Procedures

DENVER & CHICAGO--(BUSINESS WIRE)-- TriSalus™ Life Sciences, an emerging immuno-oncology company committed to transforming outcomes for patients with liver and pancreatic tumors, today announced that the Centers for Medicare & Medicaid Services (CMS) has expanded authorization for transitional pass-through (TPT) payment for its TriNav™ Infusion System. The device may now be used with the procedure code (37242) for vascular embolization or occlusion in the artery, which is commonly used for pre-treatment mapping in Y-90 procedures.¹ This is in addition to the previously approved use of procedure code (37243) for vascular embolization or occlusion in organs.² The January 1, 2021 clarification confirms CMS will make transitional pass-through (TPT) payment when either code is appropriately reported in association with TriNav and TPT HCPCS Code C1982.

The Medicare TPT payment program is designed to foster innovation and increase access to cutting edge treatments that benefit patients. CMS believes the program is important for hospitals to receive TPT payment for products that offer substantial clinical improvement.

TriNav has now met the required criteria to receive transitional pass-through status for vascular embolization or occlusion of both organs and arteries.

“We’re pleased that CMS recognizes the innovative benefit of TriNav,” said Mary Szela, President and CEO of TriSalus. “TriNav is helping interventional radiologists eliminate the potential variables that may be created by the use of different devices for pre-treatment mapping and treatment. This is believed to help ensure consistency in the perfusion pattern between the two procedures for optimal dose delivery during the embolization. As we work to overcome some of the most significant challenges in cancer care, this expanded reimbursement allows providers to continue to pursue the benefit of using Pressure-Enabled Drug Delivery™ (PEDD™), which offers a unique mechanism for therapy delivery to selected sites in the peripheral vascular system, including hepatocellular carcinoma (HCC) and other solid tumors in the liver and pancreas.”

About the TriNav Infusion System

TriNav is a flexible, ultra-thin therapy delivery system with SmartValve™ technology, a self-expanding, nonocclusive one-way microvalve. This system for the Pressure-Enabled Drug Delivery approach, 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.

About TriSalus

TriSalus Life Sciences is a revenue generating, emerging immuno-oncology company dedicated to developing immunotherapy treatments for liver and pancreatic tumors using our novel delivery technologies to improve patient outcomes. TriSalus intends to pursue multiple solid tumor indications with investigational SD-101 and acquire other immuno-oncology agents to combine with its proprietary Pressure-Enabled Drug Delivery technology for the administration of therapeutics intravascularly into visceral organ solid tumors. In combination with checkpoint inhibitors, TriSalus’ focus is to reprogram the dominant immunosuppressive cell population in liver and pancreatic tumors. This innovative approach in development has the potential to leverage multiple mechanisms that can work together with the goal to overcome inherent immune suppression within the solid tumor microenvironment.

For more information, please visit www.trisaluslifesci.com.

¹ Centers for Medicare and Medicaid Services, Integrated Outpatient Code Editor (22.0.0), Final Summary of Data Changes, (Jan. 2021).
² Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payments Systems Final Rule, 85 Fed.Reg 249, 85866, 85988 (Dec. 29, 2020).

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