TriSalus Life Sciences, Inc.
For the period ended Dec 31, 2025. Filed Mar 5, 2026.
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FY2025 · Filed Mar 5, 2026
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Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) and 15d-15(e) are designed only to provide reasonable assurance that information to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosure. As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial and accounting officer), of the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") have concluded that our disclosure controls and procedures were not effective as a result of the material weaknesses in our internal control over financial reporting previously identified, which one continues to exist as of December 31, 2025, as discussed below. Management’s assessment of the effectiveness of our disclosure controls and procedures is expressed at a level of reasonable assurance because management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined by Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Our management, including our CEO and CFO, assessed the effectiveness of our internal control over financial reporting as of December 31, 2025, based upon the framework presented in "Internal Control-Integrated Framework" (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"). Based upon our assessment, our management concluded that our internal control over financial reporting was not effective as of December 31, 2025, due to the material weakness discussed below.
Remediation of Previously Disclosed Material Weaknesses
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements would not be prevented or detected on a timely basis. In connection with our consolidated financial statements for the year ended December 31, 2024, management identified material weaknesses in our internal control over financial reporting with respect to (i) financial reporting, (ii) lease accounting (iii) maintenance and accuracy of our outstanding equity information and accounting for stock-based compensation, (iv) accounting for revenue, (v) accounting for accrued liabilities, including patent costs, (vi) accounting for the previous Business Combination, (vii) accounting for significant transactions, (vii) oversight and accounting of the valuation of financial instruments, and (ix) IT general controls.
During the year ended December 31, 2025, we have taken measures to address the material weaknesses identified in the 2024 Annual Report and enhance our internal control over financial reporting. We have:
hired additional accounting and financial reporting personnel with U.S. GAAP and SEC reporting experience to facilitate management level reviews, and financial reporting oversight;
designed and implemented review processes that ensure segregation of duties within the accounting and finance function;
adequately reviewed the assumptions and inputs into accounting estimates;
implemented protocols and controls over financial reporting and period end close processes;
established effective monitoring and oversight controls for non-recurring and complex transactions to ensure the accuracy and completeness of our financial statements and related disclosures;
reviewed and enhanced IT general controls over information systems relevant to financial reporting, including privileged access and segregation of duties; and
realigned existing personnel and added both internal and external personnel to strengthen management’s review and documentation over internal control over financial reporting.
As of December 31, 2025, one material weakness remains unremediated related to accounting for significant transactions. While management implemented revised processes and hired additional resources, sufficient time has not elapsed to demonstrate operating effectiveness. The material weakness will be considered remediated when the controls we have implemented operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. Our management will continue to monitor the effectiveness of the remediation plan and will make the changes it determines to be appropriate.
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2025, other than the remediation actions described above, there were no changes to our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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