Item 9A. Controls and Procedures
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 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 at the reasonable assurance
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level as of the end of the period covered by this Annual Report, as discussed above and as a result of the material weakness that existed in our internal control over financial reporting identified previously, which continues to exist as of December 31, 2024, as discussed below.
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, 2024, 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, 2024, due to the material weaknesses discussed below.
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 audited 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) a lack of sufficient number of trained resources with the appropriate skills and knowledge and with assigned responsibilities and accountability for the design and operation of internal controls over:
1. financial reporting,
2. patent costs,
3. certain R&D accruals,
4. certain general accruals,
5. accounting for leases under ASC 842,
6. accounting for revenue, and
7. accounting for significant transactions, including costs associated with the SEPA, the Exchange Warrants, and accounting for the OrbiMed Credit Agreement, including the Initial OrbiMed Commitment amount and the related derivative financial instruments;
(ii) inadequate controls over the accounting and financial reporting for the Business Combination;
(iii) inadequate internal controls over the valuation of the warrant and tranche rights and obligations and liabilities resulting from the series B-2 preferred stock financing, and the revenue base redemption liability associated with the Initial OrbiMed Commitment Amount;
(iv) inadequate design and implementation of controls over the conversion of data from our legacy stock-based compensation management system to our new system, over the assumptions used to calculate fair value of certain equity awards to support the recognition of stock compensation expense, and over the assumptions used to determine the achievement of the performance obligations of certain equity awards; and
(v) inadequate security management internal controls over certain IT applications supporting financial reporting, related to segregation of privileged IT user rights and to monitor elevated user activity.
Our management developed a remediation plan, and we have continued to take steps to remediate each of the material weaknesses described above. The remediation plan included hiring additional trained resources with requisite experience with complicated accounting issues, designing and enforcing processes that ensure adequate segregation of duties within the finance function and adequately reviewing the assumptions and inputs to accounting estimates and engaging outside expert consultants as needed. As of December 31, 2024 , we have hired additional trained resources with such requisite experience or selected outside expert consultants. We will continue to evaluate the existing finance function experience and expertise to identify additional resource needs to aid in the remediation of the material weaknesses. The material weaknesses will be considered remediated when our management designs and implements effective controls that 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.
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Changes in Internal Control over Financial Reporting
During the year ended December 31, 2024, it was determined that no change to our internal control over financial reporting occurred during the last fiscal quarter ended December 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None
Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections
None
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Part III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item and not set forth below will be set forth below will be set forth in the proposal headed Election of Directors and section headed Executive Officers contained in our definitive proxy statement for our 2025 annual meeting of shareholders to be filed with the Securities and Exchange Commission on or before April 30, 2025 ("the Proxy Statement"), pursuant to General Instructions G(3) of Form 10-K and is incorporated herein by reference.
We have adopted a Code of Business Conduct and Ethics that applies to all officers, directors and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or person performing similar functions. A current copy of the Code of Business Conduct and Ethics is available on the Governance section of our website at investors.trisaluslifesci.com. If we make any substantive amendments to the Code of Business Conduct and Ethics or grants any waiver from a provision of the Code of Business Conduct and Ethics to any executive officer or director that are required to be disclosed pursuant to SEC rules, we will promptly disclose the nature of the amendment or waiver on our website or in a current report on Form 8-K.
Item 11. Executive Compensation
The information required by this item will be set forth in the sections headed Executive Compensation and Non-Employee Director Compensation contained in the Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters
The information required by this item will be set forth in the sections headed Security Ownership of Certain Beneficial Owners and Management and Executive Compensation contained in the Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be set forth in the sections headed Certain Related-Person Transactions and Information Regarding the Board of Directors and Corporate Governance contained in the Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
Our independent registered public accounting firm is Grant Thornton, Chicago, IL, Auditor Firm ID: 248.
The information required by this item will be set forth in the proposal headed Ratification of Selection of Independent Registered Public Accounting Firm contained in the Proxy Statement and is incorporated herein by reference.
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Part IV
Item 15. Exhibit and Financial Statement Schedules
(a) The following documents are filed as part of this Form 10-K:
(1) Financial Statements:
Our audited Consolidated Financial Statements are listed in the “Financial Statements and Supplementary Data” under Part II. Item 8 of this Annual Report on Form 10‑K.
(2) Financial Statement Schedules:
None.
(3) Exhibits
The exhibits filed as part of the Annual Report on Form 10-K are listed in Item 15(b).
(b) Exhibits
The following exhibits are filed as part of this Annual Report on Form 10-K:
Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
2.1# Agreement and Plan of Merger, dated as of November 11, 2022, by and among MedTech Acquisition Corporation, MTAC Merger Sub, Inc., and TriSalus Life Sciences, Inc.
Form 8-K 001-39813 2.1 November 14, 2022
2.2 First Amendment to Agreement and Plan of Merger, dated as of April 4, 2023, by and among MedTech Acquisition Corporation, MTAC Merger Sub, Inc., and TriSalus Life Sciences, Inc.
Form 8-K 001-39813 10.1 April 5, 2023
2.3 Second Amendment to Agreement and Plan of Merger, dated as of May 13, 2023, by and among MedTech Acquisition Corporation, MTAC Merger Sub, Inc., and TriSalus Life Sciences, Inc.
Form 8-K 001-39813 10.1 May 13, 2023
2.4 Third Amendment to Agreement and Plan of Merger, dated as of July 5, 2023, by and among MedTech Acquisition Corporation, MTAC Merger Sub, Inc., and TriSalus Life Sciences, Inc.
Form 8-K 001-39813 10.1 July 6, 2023
3.1 Second Amended and Restated Certificate of Incorporation of TriSalus Life Sciences, Inc.
Form 8-K 001-39813 3.1 August 16, 2023
3.2 Amended and Restated Bylaws of TriSalus Life Sciences, Inc.
Form 8-K 001-39813 3.2 August 16, 2023
3.3 Form of Certificate of Designations, Preferences, and Rights of Series A Convertible Preferred Stock of TriSalus Life Sciences, Inc.
Form 8-K
001-39813 3.3 August 16, 2023
4.1 Specimen Common Stock Certificate
Form 8-K 001-39813 4.1 August 16, 2023
4.2 Specimen Warrant Certificate
Form 8-K 001-39813 4.2 August 16, 2023
4.3 Warrant Agreement, dated December 17, 2020, by and between MTAC and Continental Stock Transfer & Trust Company.
Form 8-K 001-39813 4.1 December 23, 2020
4.4 Form of Amended and Restated Registration Rights Agreement, by and among TriSalus Life Sciences, Inc., MedTech Acquisition Sponsor LLC, and certain former stockholders of TriSalus Life Sciences, Inc.
Form 8-K 001-39813 10.1 November 14, 2022
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Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
4.5 Registration Rights Agreement, dated April 30, 2024, by and between TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV, LP .
Form 10-Q 001-39813 4.4 May 15, 2024
4.6 Amendment No. 1 to Warrant Agreement, dated June 26, 2024, by and between the Company and Continental Stock Transfer & Trust Company.
Form 8-K 001-39813 10.1 June 27, 2024
4.7 Description of Securities
Form 10-Q 001-39813 4.7 August 14, 2024
4.8 Substitute Warrant Certificate, dated August 15, 2024, by and between TriSalus Life Sciences, Inc, and OrbiMed Royalty & Credit Opportunities IV, LP.
Form S-3 001-39813 4.1 October 29, 2024
4.9 Substitute Warrant Certificate, dated August 15, 2024, by and between TriSalus Life Sciences, Inc, and OrbiMed Royalty & Credit Opportunities IV Offshore , LP.
Form S-3 001-39813 4.1 October 29, 2024
4.10 Warrant Certificate, dated February 18, 2025, by and between TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV, L.P.
4.11 Warrant Certificate, dated February 18, 2025, by and between TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV Offshore, L.P.
10.1* TriSalus Life Sciences, Inc. 2023 Equity Incentive Plan
Form 8-K 001-39813 10.21 August 16, 2023
10.2* TriSalus Life Sciences, Inc. 2023 Employee Stock Purchase Plan
Form 8-K 001-39813 10.24 August 16, 2023
10.3* Letter Agreement, dated December 17, 2020, by and among MedTech Acquisition Corporation, its officers and directors and MedTech Acquisition Sponsor LLC.
Form 8-K 001-39813 10.1 December 23, 2020
10.4* Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan.
Form 8-K 001-39813 10.15 August 16, 2023
10.5* Form of Stock Option Grant Notice and Form of Stock Option Agreement under Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan (Pre-2020) .
Form 8-K 001-39813 10.16 August 16, 2023
10.6* Form of Early Exercise Stock Option Grant Notice and Form of Stock Option Agreement under Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan (for grants prior to 2020).
Form 8-K 001-39813 10.17 August 16, 2023
10.7* Form of Stock Option Grant Notice and Form of Stock Option Agreement under Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan (for grants after 2020).
Form 8-K 001-39813 10.18 August 16, 2023
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Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
10.8* Form of Early Exercise Stock Option Grant Notice and Form of Stock Option Agreement under Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan (for grants after 2020).
Form 8-K 001-39813 10.19 August 16, 2023
10.9* Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Agreement under Surefire Medical, Inc. 2009 Amended and Restated Equity Incentive Plan.
Form 8-K 001-39813 10.20 August 16, 2023
10.10* Form of Stock Option Grant Notice and Form of Stock Option Agreement under 2023 Equity Incentive Plan.
Form 8-K 001-39813 10.22 August 16, 2023
10.11* Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Agreement under 2023 Equity Incentive Plan.
Form 8-K 001-39813 10.23 August 16, 2023
10.12* Form of Indemnification Agreement by and between the Company and its directors and executive officers .
Form 8-K 001-39813 10.25 August 16, 2023
10.13* Amended and Restated Non-Employee Director Compensation Policy.
10.1 Standby Equity Purchase Agreement, by and between TriSalus Life Sciences, Inc. and YA II PN, LTD.
Form 8-K 001-39813 99.1 November 14, 2023
10.15## Asset Purchase Agreement, dated as of July 31, 2020, by and between Dynavax Technologies Corporation and Surefire Medical Inc. d/b/a TriSalus Life Sciences.
Form S-4/A 333-269138 10.13 April 21, 2023
10.16*## Amended and Restated Employment Agreement, dated November 11, 2022, by and between TriSalus Life Sciences, Inc. and Mary Szela.
Form S-4/A 333-269138 10.14 April 21, 2023
10.17*## E xecutive Employment Agreement, by and between the Company and James Young, dated January 6, 2025 .
Form 8-K 001-39813 10.1 January 4, 2025
10.18*## Amended and Restated Executive Employment Agreement, by and between the Company and Sean Murphy , dated January 6, 2025 .
Form 8-K 001-39813 10.2 January 4, 2025
10.19*## Amended and Restated Executive Employment Agreement, dated March 2, 2023 , by and between TriSalus Life Sciences, Inc. and Richard Marshak.
Form S-4/A 333-269138 10.17 April 21, 2023
10.20*## Executive Employment Agreement, dated November 11, 2022, by and between TriSalus Life Sciences, Inc. and Jennifer L. Stevens.
Form S-4/A 333-269138 10.18 April 21, 2023
10.21*## Executive Employment Agreement, dated November 4, 2022, by and between TriSalus Life Sciences, Inc. and Bryan F. Cox, Ph.D.
Form S-4/A 333-269138 10.19 April 21, 2023
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Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
10.22*## Amended and Restated Executive Employment Agreement, Dated January 6, 2025, by and between TriSalus Life Sciences, Inc. and Jodi Devlin .
10.23*## Strategic Collaboration Agreement, dated March 2, 2021, by and between Surefire Medical Inc. d/b/a TriSalus Life Sciences and The University of Texas M.D. Anderson Cancer Center.
Form S-4/A 333-269138 10.2 April 21, 2023
10.24*## Office/Warehouse Lease, dated February 4, 2014 between Colorado Industrial Portfolio LLC and Surefire Medical, Inc., as amended.
Form S-4/A 333-269138 10.3 July 6, 2023
10.25## Credit Agreement, dated April 30, 2024, by and between TriSalus Operating Life Sciences, Inc., TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV, LP.
Form 10-Q 001-39813 10.1 May 15, 2024
10.26## First Amendment to Credit Agreement and Registration Rights Agreement by and between TriSalus Operating Life Sciences, Inc., TriSalus Life Sciences, Inc., OrbiMed Royalty & Credit Opportunities IV, LP., and OrbiMed Royalty & Credit Opportunities IV Offshore, LP.
10.27## Second Amendment to Lease of Space dated July 17, 2024, by and between TriSalus Life Sciences, Inc. and BPAZ Holdings 14, LLC.
Form 10-Q 001-39813 10.2 August 14, 2024
10.28# Form of Dealer Manager and Solicitation Agent Agreement.
Form S-4 333-279691 10.28 May 24, 2024
10.29 Form of Tender and Support Agreement, by and between the Company and Supporting Stockholders.
Form S-4 333-279691 10.29 May 24, 2024
10.30* Amendment No. 1 to Amended and Restated Executive Employment Agreement, dated January 24, 2024, by and between TriSalus Life Sciences, Inc. and Richard Marshak.
10.31* Amendment No. 2 to Amended and Restated Executive Employment Agreement, dated January 6, 2025, by and between TriSalus Life Sciences, Inc. and Richard Marshak.
19.1 TriSalus Life Sciences, Inc. Insider Trading Policy
21.1 List of Subsidiaries
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Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
23.1 Consent of Grant Thornton LLP, independent registered public accounting firm of TriSalus.
23.2 Consent of KPMG LLP, independent registered public accounting firm of TriSalus.
24.1 Power of Attorney (see signature page).
31.1 Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification of the Principal Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2 Certification of the Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1 TriSalus Life Sciences, Inc. Incentive Compensation Recoupment Policy.
Form 10-K 001-39813 97.1 April 11, 2024
101.INS Inline XBRL Instance Document – the instance documents does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.SCH Inline XBRL Taxonomy Extension Schema Document With Embedded Linkbase Documents.
101.DEF Inline XBRL Taxonomy Extension Schema Document.
101.LAB Inline XBRL Taxonomy Extension Labels Linkbase Document.
136
Incorporated by Reference
Exhibit Description Schedule/
Form
File Number Exhibits Filing Date
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page
(formatted as Inline XBRL and contained in Exhibit 101)
________________________
* Indicates management contract or compensatory plan or arrangement.
## Certain portions of this Exhibit have been omitted in accordance with Regulation S-K Item 601(b)(10)(iv) because they are not material and are the type of information that the Registrant treats as private or confidential. The Registrant agrees to furnish supplementally an unredacted copy of the Exhibit, or any section thereof, to the SEC upon request.
+ Certain of the exhibit and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request; provided, however, that the Registrant may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act, as amended, for any schedule or exhibit so furnished.
^ The certifications attached as Exhibits 32.1 and 32.2 are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-K), irrespective of any general incorporation language contained in such filing.
Item 16. Form 10-K Summary
None.
137
SIGNATURES
Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized, on the 15th day of April, 2025.
TriSalus Life Sciences, Inc.
By: /s/ Mary Szela
Name: Mary Szela
Title: Chief Executive Officer
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Mary Szela and James Young, and each of them, his or her true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ Mary Szela
Chief Executive Officer and Director
(Principal Executive Officer)
April 15, 2025
Mary Szela
/s/ James Young
Chief Financial Officer
(Principal Financial and Accounting Officer)
April 15, 2025
James Young
/s/ Mats Wahlström
Director and Chairman of the Board April 15, 2025
Mats Wahlström
/s/ Arjun "JJ" Desai
Director April 15, 2025
Arjun "JJ" Desai
/s/ Andrew von Eschenbach
Director April 15, 2025
Andrew von Eschenbach
/s/ Gary Gordon
Director April 15, 2025
Gary Gordon
/s/ Kerry Hicks
Director April 15, 2025
Kerry Hicks
/s/ Liselotte Hyveled
Director April 15, 2025
Liselotte Hyveled
/s/ George Kelly Martin
Director April 15, 2025
George Kelly Martin
/s/ David J. Matlin
Director April 15, 2025
David J. Matlin
/s/ Sean Murphy Director April 15, 2025
Sean Murphy
/s/ William Valle Director April 15, 2025
William Valle
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