TriSalus Life Sciences Reports $33.2 Million Net Loss and 59% Revenue Growth in 2024

TriSalus Life Sciences, Inc. reported a net loss of $33.2 million for the year ending December 31, 2024, compared to a net loss of $63.6 million in 2023. Revenue increased significantly, rising from $18.5 million in 2023 to $29.4 million in 2024, a 59% increase. This growth was attributed to increased sales volumes of the TriNav Infusion System, the company's primary revenue generator. However, research and development expenses decreased by 40.7% to $17.7 million, while sales and marketing expenses increased by 51.7% to $25.8 million, reflecting increased headcount to support TriNav's growth.

The company's financial performance was significantly impacted by several factors. The expiration of transitional pass-through payments (TPT) from CMS at the end of 2023 was offset by the implementation of a new, permanent HCPCS code (C9797) for TriNav procedures in January 2024, and a second code (C8004) in April 2025. The company also experienced a significant change in fair value of warrant, SEPA, and revenue base redemption liabilities, resulting in an $8.7 million improvement compared to 2023. Furthermore, the company made three milestone payments totaling $3 million to Dynavax Technologies Corporation under the Dynavax Agreement, related to the development of nelitolimod.

Strategic developments during the year included the expansion of TriSalus' PEDD device portfolio with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter, targeting a larger vessel market and potentially expanding into uterine fibroid embolizations (UFEs). A new registry study, PROTECT, was initiated to explore the use of TriNav in thyroid disease treatment. The company also continued its Phase 1 and 1b clinical trials for nelitolimod across multiple cancer indications, with data from the pancreatic cancer trial anticipated by the end of 2025. The company raised $15.1 million through the sale of common stock under a standby equity purchase agreement (SEPA) and a private placement. A term loan facility of up to $50 million was secured with OrbiMed, with $25 million drawn in April 2024 and an additional $10 million in February 2025.

Operational developments included an increase in employee headcount to 110 by December 31, 2024, and the expansion of the sales organization. The company also highlighted the successful completion of a Health Economic and Outcome Research (HEOR) study demonstrating TriNav's performance in complex patients. The company's estimated total addressable market for PEDD technology in the U.S. exceeds $1.6 billion annually. However, the company's 10-K filing also notes substantial doubt about its ability to continue as a going concern due to its limited operating history, significant accumulated deficit, and ongoing need for additional capital.

The company's outlook remains contingent upon several factors, including continued market acceptance of TriNav, successful clinical trials for nelitolimod, securing additional funding, and navigating the complexities of the regulatory environment. The company acknowledges significant risks related to its financial condition, reliance on TriNav, the uncertain outcome of nelitolimod development, intense competition, and the complexities of regulatory compliance. The company's ability to achieve profitability and long-term success depends on successfully addressing these risks.