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Item 9A. Controls and Procedures

2026-03-05 compared with 2025-04-15 · 82 added, 102 removed, 157 unchanged (54% of the section changed)

2 unchanged sentences

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).

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.

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

2 unchanged sentences

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, 2024, due to the material weaknesses discussed below.

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 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:

financial reporting,

patent costs,

certain R&D accruals,

certain general accruals,

accounting for leases under ASC 842,

accounting for revenue, and

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;

(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.

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.

• 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;

• 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 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.

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.

Other Information

1 unchanged sentence

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.

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 no later than 120 days after the Company's fiscal year ended December 31, 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 and principal financial and accounting officer.

A current copy of the Code of Business Conduct and Ethics is available on the Governance section of our website at investors.trisaluslifesci.com.

12 unchanged sentences

(1) Financial Statements:

Our audited Consolidated Financial Statements are listed in the “Financial Statements and Supplementary Data” under Part II.

Our 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.

5 unchanged sentences

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.

4 unchanged sentences

001-39813 3.3 August 16, 2023

3.4 C ertificate of Amendment to Certificate of Designations, Preferences and Rights of Series A Convertible Pre ferre d Stock of TriSalus Life Sciences, Inc.

3.1 July 24, 2025

4.1 Specimen Common Stock Certificate

4 unchanged sentences

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

Incorporated by Reference

Exhibit Description Schedule/

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

4.4 Amendment No.

2 unchanged sentences

4.5 Description of Securities

Form 10-Q 001-39813 4.7 August 14, 2024

4.6 Substitute Warrant Certificate, dated August 15, 2024, by and between TriSalus Life Sciences, Inc, and OrbiMed Royalty & Credit Opportunities IV, LP.

2 unchanged sentences

Form S-3 001-39813 4.11 October 29, 2024

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

4.8 Warrant Certificate, dated February 18, 2025, by and between TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV, L.P.

4.10 April 15, 2025

4.9 Warrant Certificate, dated February 18, 2025, by and between TriSalus Life Sciences, Inc., and OrbiMed Royalty & Credit Opportunities IV Offshore, L.P.

4.11 April 15, 2025

10.1* TriSalus Life Sciences, Inc.

4 unchanged sentences

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

Surefire Medical, Inc.

10 unchanged sentences

Form 8-K 001-39813 10.18 August 16, 2023

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

Form of Early Exercise Stock Option Grant Notice and Form of Stock Option Agreement under Surefire Medical, Inc.

10 unchanged sentences

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

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

Amended and Restated Employment Agreement, dated November 11, 2022, by and between TriSalus Life Sciences, Inc.

1 unchanged sentence

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

Amended and Restated Executive Employment Agreement, dated March 2, 2023, by and between TriSalus Life Sciences, Inc.

6 unchanged sentences

Form S-4/A 333-269138 10.19 April 21, 2023

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

Amended and Restated Executive Employment Agreement, Dated January 6, 2025, by and between TriSalus Life Sciences, Inc.

and Jodi Devlin.

10.22 April 15, 2025

Strategic Collaboration Agreement, dated March 2, 2021, by and between Surefire Medical Inc.

7 unchanged sentences

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

10.26 April 15, 2025

Amendment No.

1 unchanged sentence

and Richard Marshak.

10.30 April 15, 2025

Amendment No.

1 unchanged sentence

and Richard Marshak.

10.31 April 15, 2025

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

10.23 S econd Amendment to Credit Agreement by and between TriSalus Operating Life Sciences, Inc., T riSalus Life Sciences, Inc.

and Orb iMed Royalty & Credit Opportunities IV, LP

10.1 May 15, 2025

A mendment No.

1 to 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

10.2 May 15, 2025

10.25 S ecurities Purchase Agreement dated April 30, 2025, by and among TriSalus Life Sciences, Inc.

and the persons party thereto

10.1 April 30, 2025

10.26 F orm of Registration Rights Agreement

10.2 April 30, 2025

10.27 T ender and Sup port Agreement, dated April 30, 2025, by and among TriSalus Life Sciences, Inc.

and the persons party thereto

10.3 April 30, 2025

E xecutive Employment Agreement by and between the Company and Da vid Patience, date d May 27, 2025

10.1 August 12, 2025

S ign-on Bonus Agreement by and between the Company and David Patience, dated May 27, 2025

10.2 August 12, 2025

C onsulting Agree ment, by and between the Company and David Patience, dated June 2, 2025

10.3 August 12, 2025

19.1 TriSalus Life Sciences, Inc.

Insider Trading Policy

19.1 April 15, 2025

21.1 List of Subsidiaries

21.1 April 15, 2025

23.1 Consent of Grant Thornton LLP, independent registered public accounting firm of TriSalus.

24.1 Power of Attorney (see signature page).

Incorporated by Reference

1 unchanged sentence

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

12 unchanged sentences

101.LAB Inline XBRL Taxonomy Extension Labels Linkbase Document.

Incorporated by Reference

Exhibit Description Schedule/

File Number Exhibits Filing Date

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.

5 unchanged sentences

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.

Form 10-K Summary

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.

/s/ Mary Szela

Chief Executive Officer

/s/ David Patience

David Patience

Chief Financial Officer

March 5, 2026

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.

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Mary Szela and David Patience, 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.

3 unchanged sentences

(Principal Executive Officer)

April 15, 2025

/s/ James Young

March 5, 2026

/s/ David Patience

Chief Financial Officer

(Principal Financial and Accounting Officer)

April 15, 2025

March 5, 2026

David Patience

/s/ Mats Wahlström

Director and Chairman of the Board April 15, 2025

Director and Chairman of the Board March 5, 2026

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/ Michael P.

Director March 5, 2026

/s/ Gary Gordon

Director April 15, 2025

Director March 5, 2026

/s/ Kerry Hicks

Director April 15, 2025

/s/ Liselotte Hyveled

Director April 15, 2025

Liselotte Hyveled

/s/ George Kelly Martin

Director April 15, 2025

George Kelly Martin

Director April 15, 2025

/s/ Sean Murphy Director April 15, 2025

/s/ William Valle Director April 15, 2025

Director March 5, 2026

/s/ William Valle Director March 5, 2026

William Valle

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures