As filed with the Securities and Exchange Commission on April 3, 2026

Registration No. 333-              

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM S-8

 

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 

MDXHEALTH SA

(Exact name of registrant as specified in its charter)

 

Belgium  Not Applicable
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

 

CAP Business Center

Zone Industrielle des Hauts-Sarts

4040 Herstal, Belgium

(Address of principal executive offices) (Zip Code)

 

May 2017 Stock Option Plan

2019 Stock Option Plan

2021 Share Option Plan

2022 Share Option Plan

2023 Share Option Plan

2024 Share Option Plan

2025 Share Option Plan

(Full title of the plan)

 

Michael McGarrity

Chief Executive Officer

MDxHealth, Inc.

15279 Alton Parkway — Suite 100

Irvine, CA 92618

(Name and address of agent for service)

 

+1 949-812-6979

(Telephone number, including area code,

of agent for service)

 

Copies to:

 

Mark Busch

Patrick Rogers 

K&L Gates LLP 

300 South Tryon Street 

Suite 1000 

Charlotte, North Carolina 28202 

Tel: (704) 331-7440 

 

Roel Meers
Baker McKenzie BV/SRL

Avenue du Boulevard 21

1210 Brussels

Belgium

+32 2 639 36 11 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐  Accelerated filer ☐
Non-accelerated filer ☒  Smaller reporting company ☐
  Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

 

 

 

 

EXPLANATORY NOTE

 

This Registration Statement on Form S-8 registers ordinary shares issuable under the Registrant’s May 2017 Stock Option Plan, dated June 19, 2017, 2019 Stock Option Plan, dated June 21, 2019, 2021 Share Option Plan, dated May 27, 2021, 2022 Share Option Plan, dated May 25, 2022, 2023 Share Option Plan, dated June 30, 2023, 2024 Share Option Plan, dated June 20, 2024, and 2025 Share Option Plan, dated June 27, 2025.

 

 

PART I

 

INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS

 

The information required by this Part I is omitted from this registration statement in accordance with Rule 428(b)(1) of the Securities Act of 1933, as amended (the “Securities Act”), and the Note to Part I of Form S-8. The documents containing the information specified in Part I of Form S-8 will be delivered to the participants in the plans covered by this Registration Statement as specified by Rule 428(b)(1) under the Securities Act.

 

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PART II

 

INFORMATION REQUIRED IN THE REGISTRATION STATEMENT

 

Item 3. Incorporation of Documents by Reference.

 

The following documents have been filed by MDxHealth SA (the “Registrant”) with the U.S. Securities and Exchange Commission (the “Commission”) and are incorporated herein by reference:

 

the Registrant’s Annual Report on Form 20-F for the fiscal year ending December 31, 2025, filed with the Commission on April 3, 2026;

 

the Registrant’s Reports on Form 6-K furnished to the Commission on February 11, 2026 and February 26, 2026 (other than the information included in Exhibit 99.1 therein); and

 

the description of our ordinary shares contained in Exhibit 2.1 to our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 3, 2026, including any amendment or report filed for the purpose of updating such description.

 

All reports and other documents filed by the Registrant pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date hereof, and prior to the filing of a post-effective amendment which indicates that all securities offered hereby have been sold or which deregisters all securities then remaining unsold, shall be deemed to be incorporated by reference herein and to be part hereof from the date of filing of such reports and documents. The Registrant is not incorporating by reference any reports or documents or portions thereof that are not considered to be “filed” with the Commission.

 

Any statement contained herein or in a document incorporated or deemed to be incorporated herein by reference shall be deemed to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated herein by reference modifies or supersedes such earlier statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.

 

II-1

 

Information subsequently furnished on Form 6-K shall not be deemed incorporated herein by reference unless such Form 6-K expressly provides to the contrary.

 

Item 4. Description of Securities

 

Not applicable.

 

Item 5. Interests of Named Experts and Counsel

 

Not applicable.

 

Item 6. Indemnification of Directors and Officers.

 

Under Belgian law, the directors of a company may be liable for damages to the company in case of improper performance of their duties. The Registrant's directors may be liable to the Registrant and to third parties for infringement of the Registrant's articles of association or Belgian company law and, under certain circumstances, pursuant to Belgian tort, bankruptcy, social security or tax laws. Under certain circumstances, directors may be criminally liable.

 

The Registrant maintains liability insurance for the Registrant's directors and officers, including insurance against liability under the Securities Act.

 

The Belgian Companies and Associations Code includes a cap on liability for directors (including persons in charge of daily management) for any damages they cause due to mismanagement, including breaches of the articles of association and the Belgian Companies and Associations Code. This liability cap applies towards the company and third parties. For the Registrant, the cap currently amounts to €12,000,000.00 (subject to indexation). The cap applies irrespective of the number of claimants or defendants for the same (set of) facts. However, the cap does not apply to repetitive minor misconduct, serious error or cases of fraud or intent to harm. Furthermore, the cap does not apply to directors’ liability under the special liability regimes relating to payment of withholding tax, VAT and social security contributions, and in certain other technical cases provided for by the Belgian Companies and Associations Code.

 

Certain of the Registrant’s non-executive directors may, through their relationships with their employers or partnerships, be insured and/or indemnified against certain liabilities in their capacity as members of the Registrant’s board of directors.

 

Item 7. Exemption from Registration Claimed.

 

Not applicable.

 

II-2

 

Item 8. Exhibits.

 

Exhibit
Number
  Description
3.1  Articles of Association of MDxHealth SA (English Translation) (incorporated by reference to Exhibit 1.1 to the Registrant’s Annual Report on Form 20-F filed on April 3, 2026)
3.2  Corporate Governance Charter of MDxHealth SA (English Translation) (incorporated by reference to Exhibit 1.2 to the Registrant’s Annual Report on Form 20-F filed on April 3, 2026)
5.1  Opinion of Baker McKenzie BV/SRL*
23.1  Consent of BDO Réviseurs d’Entreprises SRL, Independent Registered Public Accounting Firm*
23.2  Consent of Baker McKenzie BV/SRL (contained in Exhibit 5.1)*
24.1  Power of Attorney (included on the signature page of this Registration Statement)*
99.1  May 2017 Stock Option Plan (English Translation) (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form F-1 filed on October 13, 2021)
99.2  2019 Stock Option Plan (English Translation) (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form F-1 filed on October 13, 2021)
99.3  2021 Share Option Plan (English Translation) (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form F-1 filed on October 13, 2021)
99.4  2022 Share Option Plan (English Translation) (incorporated by reference to Exhibit 99.8 to the Registrant’s Report on Form 6-K filed on April 28, 2022)
99.5  2023 Share Option Plan (English Translation) (incorporated by reference to Exhibit 99.8 to the Registrant’s Report on Form 6-K filed on April 26, 2023)
99.6  2024 Share Option Plan (English Translation) (incorporated by reference to Exhibit 99.8 to the Registrant’s Report on Form 6-K filed on May 16, 2024)
99.7  2025 Share Option Plan (English Translation) (incorporated by reference to Exhibit 99.5 to the Registrant’s Report on Form 6-K filed on May 2, 2025)
107  Filing Fee Table*

 

*Filed herewith

 

II-3

 

Item 9. Undertakings

 

(a)The undersigned Registrant hereby undertakes:

 

(1)To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i)to include any prospectus required by section 10(a)(3) of the Securities Act;

 

(ii)to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

 

(iii)to include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in the Registration Statement;

 

provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference into this Registration Statement.

 

(2)That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

(b)The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(c)Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

II-4

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Irvine, California, on April 3, 2026.

 

  MDxHealth SA
   
  By: /s/ Michael McGarrity 
    Michael McGarrity
    Chief Executive Officer and Director
    (Principal Executive Officer)

 

POWER OF ATTORNEY

 

Each person whose signature appears below constitutes and appoints Michael McGarrity and Joseph Sollee, and each of them, his/her true and lawful attorney-in-fact and agent, each of whom may act alone, with full power of substitution and resubstitution, for him/her and in his/her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement on Form S-8, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he/she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof. This power of attorney may be executed in counterparts.

 

Pursuant to the requirements of the Securities Act, this Registration Statement has been signed below by the following persons in the capacities indicated, in each case on April 3, 2026:

 

    Signature/Title
     
Dated: April 3, 2026   /s/ Michael McGarrity
    Michael McGarrity
    Chief Executive Officer and Director (Principal Executive Officer)
     
Dated: April 3, 2026   /s/ Ron Kalfus
    Ron Kalfus
    Interim Chief Financial Officer (Principal Financial and Accounting Officer)
     
Dated: April 3, 2026   /s/ Koen Hoffman
    Koen Hoffman (acting through Ahok BV)
    Chairman of the Board of Directors
     
Dated: April 3, 2026   /s/ Dr. Sanford Jay Siegel
    Dr. Sanford Jay Siegel  
    Director
     
Dated: April 3, 2026   /s/ Hilde Windels
    Hilde Windels (acting through Hilde Windels BV)
    Director
     
Dated: April 3, 2026   /s/ Michael Holder
    Michael Holder
    Director
     
Dated: April 3, 2026   /s/ Dr. Eric Bednarski
    Dr. Eric Bednarski
    Director
     
Dated: April 3, 2026   /s/ Donnie (Don) M. Hardison
    Donnie (Don) M. Hardison
    Director

 

II-5

 

SIGNATURE OF AUTHORIZED US REPRESENTATIVE OF REGISTRANT

 

Pursuant to the requirements of the Securities Act of 1933, as amended, the undersigned, the duly authorized representative in the United States of MDxHealth SA, has signed this registration statement on Form S-8 on April 3, 2026.

 

  MDxHealth, Inc.
   
  By: /s/ Michael McGarrity 
    Michael McGarrity
    Chief Executive Officer

 

II-6

 

Exhibit 5.1

 

Baker McKenzie BV/SRL
 
Bolwerklaan 21 Avenue du Boulevard - box 1
1210 Brussels
Belgium
Tel: +32 2 639 36 11
Fax: +32 2 639 36 99
www.bakermckenzie.com

 

April 3, 2026

 

MDxHealth SA

CAP Business Center

Zone Industrielle des Hauts-Sarts

Rue d’Abhooz 31

4040 Herstal

Belgium

 

Dear all,

 

RE:MDXHEALTH SA – ISSUANCE OF SHARES

 

1.Introduction

 

(a)We have acted as external Belgian law counsel to MDxHealth SA of CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium, registered under company number 0479.292.440 RLP Liège (division Liège) (the “Company”), on certain Belgian law matters in connection with the Company’s the Registration Statement (as defined below) filed with the United States Securities and Exchange Commission (the “SEC”) under the United States Securities Act of 1933, as amended (the “Securities Act”), in respect of the potential issuance by the Company of new ordinary shares without nominal value of the Company (the “New Shares”), with admission to trading and listing of the New Shares on the Nasdaq Capital Market, covered by the Registration Statement to which this opinion is an exhibit, such New Shares to be issued upon exercise of the following outstanding share options in the form of subscription rights (collectively, the “Share Options”, and such potential issuance of New Shares upon exercise of the respective Share Options the “Potential Issuance”):

 

(i)share options in the form of subscription rights issued by the Company on June 19, 2017 (the “2017 Share Options”),

 

(ii)share options in the form of subscription rights issued by the Company on June 21, 2019 (the “2019 Share Options”),

 

(iii)share options in the form of subscription rights issued by the Company on May 27, 2021 (the “2021 Share Options”),

 

 

Partners

Koen VANHAERENTS1*

Jean-François VANDENBERGHE1,9*

Roel MEERS1,9*

Luc MEEUS1,5,9*

Fiona CARLIN1,3,9*

Kurt HAEGEMAN1,9*

Dominique MAES1,9*

Michael VAN ACKER1,9*

Géry BOMBEKE1,9*

Elisabeth DEHARENG1,9

Geert BOVY1,9*

Gavin BUSHELL1,4,9*

Gregory LEBRUN1,9*

Dimitri VAN UYTVANCK1,9*

 

Davinia MARTENS1,9

Julie PERMEKE1

Joren JANSSEUNE1,9

Arne NAERT1,9

David HAVERBEKE1,9

Wouter VANDORPE1,9

Senior Counsels & Counsels

Jozef SLOOTMANS1,9

Alain HUYGHE1,9

Philippe LION1,9

Stéphane MARTIN9

Olivier VAN BAELEN1,9

Els JANSSENS1,9

Kim STAS1,9

Bram HOORELBEKE1,9

 

 

Veerle LERUT1

Benjamin PIRLET1,9

Jérôme DE RUYVER1,9

Sebastian TYTGAT1,9

Nastassja WALSCHOT1,9

William-James KETTLEWELL1,9

Ellen DEVLOO1,9

Pieter-Jan DENYS1,9

Kristoff COX1,9

Lisa WEINERT7,9

Nicolas CELIS1,9

Associates

Mario DEKETELAERE2

Olivier VAN DEN BROEKE2,9

Lien WILLEMS1,9 

Ellen HERINCKX1

Laura DECLERCQ1

Amaranta RUTZ1

Younes SEBBARH1,9

Eva CLAEYS1

Stéphanie DE POTTER1

Anne-Sophie CORNE1,9

Inès SILVESTRINI1,9

Arnaud FLAMAND1,9

Clémence ROUMA1

Eline KEGELS1

Stephanie VAN LAETHEM1

Anne-Marie GÜLGER1

Caroline MOUCHET1

Caroline SERBANESCU1

 

Katia DEHON1

Raphaël HENDRICKX1

Dieter GEUENS1

Tim MEYNEN1

Guillian BACLIN1

Alexandra STOICA2,9

Associated with the Brussels Bar

E-List

Victor SAINT-CAST7

 

B-List

Tom JENKINS4,8,9

Roma MCCOOL4

 

1 – Advocaat / Avocat, Member of the Brussels Bar | 2 – Advocaat, Member of the Antwerp Bar | 3 – Barrister, Inn of Court, Northern Ireland | 4 – Solicitor (England and Wales) | 5 – Attorney, Member of the New York Bar | 6 – Rechtsanwalt, Member of the Düsseldorf Bar | 7 – Avocat, Member of the Lille Bar | 8 – Solicitor of the High Court of Hong Kong | 9 – BV/SRL | * – Shareholder/Director of Baker McKenzie BV/SRL

 

 

(iv)share options in the form of subscription rights issued by the Company on May 25, 2022 (the “2022 Share Options”),

 

(v)share options in the form of subscription rights issued by the Company on June 30, 2023 (the “2023 Share Options”),

 

(vi)share options in the form of subscription rights issued by the Company on June 20, 2024 (the “2024 Share Options”), and

 

(vii)share options in the form of subscription rights issued by the Company on June 27, 2025 (the “2025 Share Options”).

 

(b)For the purposes of this opinion letter (the “Opinion Letter”):

 

(i)we have reviewed only the documents referred to in paragraph 3 (Documents Reviewed); and

 

(ii)we have completed only the searches and enquiries referred to in paragraph 4 (Searches and Enquiries);

 

and we have not examined any other documents relating to or affecting, and have not made any other searches or enquiries regarding the Company or any of the persons to whom Share Options have been granted and other holders of Share Options (each such person or holder a “Share Option Holder”).

 

(c)Nothing in this Opinion Letter should be construed as implying that we are familiar with, or have made independent review or investigation of factual matters such as, the affairs of the Company or any of the Share Option Holders, and this Opinion Letter is based solely on the investigations and subject to the limits stated in this Opinion Letter. We do not assume any responsibility for advising you of the (subsequent) discovery of information not previously known to us with respect to any matters described in this Opinion Letter.

 

(d)The opinion in this Opinion Letter is limited to the matters stated herein and does not extend to, and is not to be read as extending by implication to, any other matter in connection with the Potential Issuance, the Share Options, or otherwise.

 

2.Belgian Law Opinion

 

(a)This Opinion Letter is limited to matters of Belgian law as in force, and as construed in published Belgian case law, as at the date of this Opinion Letter. Consequently:

 

(i)we have made no investigation of foreign law, and do not express or imply any opinion on foreign law (including, but not limited to, the laws of the United States of America) or on European Union law as it affects any jurisdiction other than Belgium;

 

(ii)we do not assume any responsibility for advising you of any changes in law or otherwise after the date of this Opinion Letter with respect to any matters described in this Opinion Letter; and

 

(iii)we express no opinion on matters of taxation, matters of antitrust and competition, matters of fact or matters of accounting.

 

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(b)As Belgian law counsel we are not qualified or able to assess the true meaning and purport of the terms or any agreements, documents and legal acts (rechtshandelingen / actes juridiques) subject or expressed to be subject to any applicable law other than Belgian law, including, but not limited to, the Registration Statement, and we have made no investigation of such meaning and purport. Our review of agreements, documents or legal acts (rechtshandelingen / actes juridiques) subject or expressed to be subject to any law other than Belgian law, including, but not limited to, the Registration Statement has therefore been limited to the terms of such documents as they appear to us on their face.

 

(c)We do not admit we are “experts” within the meaning of the Securities Act, or the rules and regulations of the SEC promulgated thereunder, with respect to any part of the Registration Statement or otherwise.

 

3.Documents Reviewed

 

For the purposes of this Opinion Letter we have examined the following documents:

 

(a)an electronic version of a copy of the Company’s registration statement on Form S-8 relating to the New Shares, to be filed with the SEC (the registration statement at the time it becomes effective, including all information deemed to be a part thereof, including the amendments, exhibits and schedules thereto, at the time such registration statement becomes effective, is herein referred to as the “Registration Statement”);

 

(b)an excerpt of the deed of incorporation of the Company as published in the Annexes to the Belgian Official Gazette on January 23, 2003 (the “Deed of Incorporation”);

 

(c)an electronic version of a copy of the amended and restated articles of association of the Company as filed in the legal entity file (dossier van de rechtspersoon/dossier de la personne morale) on October 20, 2025, electronically certified by the Royal Federation of Belgian Notaries (Koninklijke Federatie van het Belgisch Notariaat/Fédération Royale du Notariat Belge) on April 1, 2026, (as available through the Fednot Database (as defined below));

 

(d)an electronic version of a signed copy of the following documents:

 

(i)in relation to the 2017 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on June 19, 2017 in relation to, amongst other things, the issuance of the 2017 Share Options and the approval of the terms and conditions of the 2017 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 583, 596 and 598 of the old Belgian Companies Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 596 and 598 of the old Belgian Companies Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(i);

 

(ii)in relation to the 2019 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on June 21, 2019 in relation to, amongst other things, the issuance of the 2019 Share Options and the approval of the terms and conditions of the 2019 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 583, 596 and 598 of the old Belgian Companies Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 596 and 598 of the old Belgian Companies Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(ii);

 

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(iii)in relation to the 2021 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on May 27, 2021 in relation to, amongst other things, the issuance of the 2021 Share Options and the approval of the terms and conditions of the 2021 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(iii);

 

(iv)in relation to the 2022 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on May 25, 2022 in relation to, amongst other things, the issuance of the 2022 Share Options and the approval of the terms and conditions of the 2022 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(iv);

 

(v)in relation to the 2023 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on June 30, 2023 in relation to, amongst other things, the issuance of the 2023 Share Options and the approval of the terms and conditions of the 2023 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(v);

 

(vi)in relation to the 2024 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on June 20, 2024 in relation to, amongst other things, the issuance of the 2024 Share Options and the approval of the terms and conditions of the 2024 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(vi); and

 

4

 

(vii)in relation to the 2025 Share Options: (A) the minutes of the extraordinary general shareholders’ meeting of the Company held on June 27, 2025 in relation to, amongst other things, the issuance of the 2025 Share Options and the approval of the terms and conditions of the 2025 Share Options, and (B) the report of the board of directors of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, and the report of the statutory auditor of the Company, prepared in accordance with articles 7:180 and 7:191 of the Belgian Companies and Associations Code, each of the aforementioned reports as submitted to the extraordinary general shareholders’ meeting of the Company referred to in this paragraph 3(d)(vii).

 

4.Searches and Enquiries

 

We have carried out the following searches and enquiries using the registration number of the Company with the Crossroads Bank for Enterprises as it appears in this Opinion Letter:

 

(a)we obtained a “full extract of the details of a registered entity (legal person)” issued by the Crossroads Bank of Enterprises in relation to the Company and referring to the circumstances in existence on March 30, 2026 (the “CBE Excerpt”);

 

(b)on March 30, 2026, we carried out an on-line search in the Central Insolvency Register available on www.regsol.be (the “Regsol Search”) in relation to the Company which did not show any bankruptcy, public judicial reorganisation or transfer under judicial authority files opened in respect of the Company;

 

(c)on March 30, 2026, we carried out an on-line search and review of the Annexes to the Belgian Official Gazette relating to the Company up to six years prior to the date of this Opinion Letter (the “Publications”). The most recent publication available in the Annexes to the Belgian Official Gazette was publication number 25364751 dated October 22, 2025.

 

5.Assumptions

 

For the purposes of this Opinion Letter, we have assumed (without making any investigation) that:

 

(a)all copy documents reviewed by us conform to the originals, and all originals are genuine, complete and up-to-date;

 

(b)all signatures, stamps and seals on any documents submitted to us are genuine;

 

(c)the executed documents submitted to us have been signed by the persons whose names are indicated thereon as being the names of the signatories and we have assumed the legal capacity (bekwaamheid/capacité) of the natural persons executing such documents;

 

(d)in the case of draft versions or (or draft updates to) any of the documents reviewed by us, the final and executed versions of such documents are identical in all aspects to such drafts and are duly executed;

 

(e)the Registration Statement will become effective and will be filed in the form referred to in this Opinion Letter;

 

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(f)the Publications give a true, complete and not misleading summary of the matters reflected in the documents on which such excerpts are based and such matters have not been revoked or amended by subsequent decisions by the Company (or its board of directors, general shareholders’ meeting, or any of its other competent bodies or representatives) which were not published in the Annexes to the Belgian Official Gazette;

 

(g)there have been, and there will be, no amendments or supplements to the documents referred to under paragraph 3 (Documents Reviewed) in the form as examined by us, such documents (or the matters documented therein and thereby) have not been or will not be terminated, rescinded, declared null and void, or revoked, and there are no and will not be dealings, agreements or arrangements, actions or events between, by or involving any of the parties to such documents which supersede any of such documents (or the matters documented therein and thereby), or which otherwise affect the opinion given in this Opinion Letter;

 

(h)the Deed of Incorporation of the Company refers to a valid notary deed, of which the contents are complete and accurate, and which is not void or otherwise affected by any defects for which a court might dissolve the Company;

 

(i)the seat (zetel/siège) of the Company is located in Belgium since its incorporation, and the Company’s sole operational headquarters (exploitatiezetel/siège d’exploitation) are located at the place of its registered office;

 

(j)the articles of association of the Company have not been amended since the restatement referred to in paragraph 3(c), and accurately restate the original articles of association and the subsequent amendments thereto;

 

(k)(i) the board reports referred to under paragraph 3 (Documents Reviewed) above and the granting of the Share Options have been approved by duly appointed directors in accordance with the Company’s articles of association and Belgian law, (ii) the respective directors of the Company who passed such approval complied with the applicable provisions of, as relevant, article 523 of the old Belgian Companies Code or article 7:96 of the Belgian Companies and Associations Code (as well as article 1.8, §6 of the Belgian Civil Code) dealing with conflicts of interest of directors (as the case may be), (iii) insofar as needed and applicable, the respective directors of the Company who passed such approval complied with the applicable provisions of, as relevant, article 524 of the Belgian Companies Code or article 7:97 of the Belgian Companies and Associations Code dealing with related party transactions (as the case may be), and (iv) such approvals have not been amended, revoked, varied or declared null and void, and remain in full force and effect;

 

(l)each of the resolutions of the general shareholders’ meetings of the Company referred to, set out or implied in the documents referred to under paragraph 3 (Documents Reviewed) above (i) accurately record resolutions that were duly passed at a properly convened and quorate meeting of genuine shareholders of the Company, conducted in accordance with its articles of association and Belgian law and on the basis of reports of the board of directors (as applicable) duly approved by duly appointed directors, (ii) do not reflect any untruthful statements, and (iii) have not been amended, revoked, varied or declared null and void, and remain in full force and effect;

 

(m)the directors of the Company have satisfied themselves that the Share Options were issued and granted for the purpose of carrying out the business of the Company as set out in its articles of association, and that the issuance and grant of the Share Options are of benefit to the Company, and their conclusions in this respect are not unreasonable;

 

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(n)with respect to each Share Option Holder:

 

(i)in case of a legal entity, it has been duly incorporated and is validly existing as a legal entity under all laws applicable to that Share Option Holder;

 

(ii)it has all requisite power and capacity (corporate and otherwise) and has all requisite corporate benefit, in each case as relevant, to subscribe for, hold and exercise the Share Options that it holds, and to perform its obligations thereunder;

 

(iii)no other action by, and no notice to or filing with, any governmental, administrative or other authority or court on behalf of or by such party is required in order to enable it (as relevant) to validly subscribe for, hold and exercise the Share Options that it holds;

 

(iv)(as relevant) it has duly authorised and approved the subscription, holding and exercise of the Share Options that it holds; and

 

(v)(as relevant) each of the agreements to which it is a party in connection with the subscription for or acquisition of Share Options constitutes a valid and binding agreement or undertaking of said Share Option Holder, enforceable against it in accordance with the terms and conditions of such Share Options;

 

(o)none of the Share Option Holders or the Company is or will be subject to any contractual restrictions, restrictions imposed by any court, arbitral panel or governmental, administrative or other authority that do not have general (erga omnes) application or similar restrictions binding upon it which would (i) restrict its ability to enter into, assume or perform its obligations under the Share Options (except, in relation to the Company, as may be set out in its articles of association), or (ii) have any implication on the opinion given in this Opinion Letter;

 

(p)none of the Share Option Holders has:

 

(i)resolved to enter into liquidation, been dissolved, been annulled as a legal entity, filed an application for or been subject to proceedings for judicial reorganisation, filed an application for bankruptcy or been declared bankrupt; or

 

(ii)ceased to pay its debts as they fall due or is subject to measures such as the appointment of a provisional administrator or the sequestration of assets,

 

and none of them has taken, or become subject to, similar proceedings or measures in any applicable jurisdiction ;

 

(q)each of the Share Option Holders and the Company has complied, and will continue to comply, with the requirements of good faith (goede trouw/bonne foi) and public policy (openbare orde/ordre public), and there has been and will be no mistake of fact (dwaling/erreur), fraud (bedrog/dol), duress (geweld/violence), or abuse of circumstances (misbruik van omstandigheden/abus de circonstances) in relation to the Share Options;

 

(r)none of the Share Option Holders or the Company is or will be seeking to achieve any purpose not apparent from (as relevant) the Share Options which might render the Share Options illegal or void, and the Share Options have been or will be issued and acquired (as relevant), for bona fide commercial reasons and on arms’ length terms by each of the parties thereto;

 

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(s)the obligations of Share Option Holders or the Company under the Share Options are or will be binding and enforceable upon them under any applicable law (other than Belgian law), and the exercise and performance by the Company and each relevant Share Option Holder of its rights and obligations under the relevant Share Options is or will be lawful in any place of exercise or performance (other than Belgium);

 

(t)any factual circumstances, statements and matters set out in or implied by any of the documents referred to in paragraph 3 (Documents Reviewed) are true, accurate and complete;

 

(u)there are no provisions of the laws of any jurisdiction outside Belgium which would have any implication for the opinion given in this Opinion Letter and, insofar as the laws of any jurisdiction outside Belgium may be relevant, such laws have been or will be complied with;

 

(v)for the purpose of the opinion referred to in paragraph 6 (Opinion) in so far as it relates to the actual issuance of the New Shares to be issued upon exercise of the Share Options, (i) such Share Options have been or will be validly granted to the initial beneficiaries of such grants in accordance with their respective terms and conditions and applicable laws, (ii) at the moment of their exercise, such Share Options will be validly outstanding, will not have expired and will not have been cancelled in accordance with their respective terms and conditions and applicable laws, (iii) such Share Options will be validly exercised in accordance with their respective terms and conditions and applicable laws, (iv) the applicable exercise price of such Share Options and the issue price of the New Shares underlying such Share Options will be duly and fully paid up, (v) the relevant underlying New Shares will be duly subscribed for, (vi) the issuance of the relevant underlying New Shares and the corresponding capital increase will be duly recorded by means of a notarial deed before a Belgian notary public as required by Belgian law, and (vii) such notarial deed and an excerpt therefrom will be duly filed and registered as required by Belgian law;

 

(w)the undertakings and agreements contained in the Share Options and agreements pursuant to which such Share Options are granted, subscribed for, or acquired are and will be duly performed and complied with by all parties thereto;

 

(x)the issuance of the Share Options, the Potential Issuance and the (other) transactions contemplated by the Potential Issuance do not or will not require the publication of a prospectus in accordance with Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time , and/or the Belgian act of July 11, 2018 on the offering of investment instruments to the public and the admission of investment instruments to the trading on a regulated market, as amended from time to time.

 

6.Opinion

 

Based upon and subject to the assumptions, qualifications and limitations set out in this Opinion Letter, having regard to such legal considerations as we have deemed relevant, and subject to any matters, documents or events not disclosed to us, we express the following opinion insofar as Belgian law is concerned: the New Shares, when duly authorized and issued and fully paid up upon exercise of the relevant Share Options in accordance with the respective terms and conditions of such Share Options will be validly issued, fully paid up and non-assessable (meaning that a holder of the relevant New Shares will not by reason of merely being such a holder, be subject to assessment or calls by the Company or its creditors for further payment on such securities).

 

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7.Qualifications

 

The opinion expressed in this Opinion Letter is subject to the following qualifications:

 

7.1Reliance on searches and enquiries

 

The searches and enquiries referred to in paragraph 4 (Searches and Enquiries) may not be up-to-date and do not constitute conclusive evidence of the matters stated therein.

 

7.2Construction of certain terms

 

(a)In this Opinion Letter Belgian legal concepts which are expressed in English are to be construed in accordance with the Belgian legal concepts to which they refer.

 

(b)When used in paragraph 6 (Opinion), the terms “legal” and “validly” are references to the legal character of the relevant obligation, and the terms “binding” and “enforceable” mean that the relevant obligation or instrument is of a type and form enforced by Belgian courts. None of these means that such an obligation or instrument will be enforced in accordance with its terms in every circumstance, and they are not to be construed as a prediction of the outcome of litigation.

 

7.3Excluded matters

 

We do not express an opinion regarding:

 

(a)(i) any laws of any jurisdiction (including, but not limited to, Belgium and the European Union) imposing economic or trade sanctions or similar restrictive measures or regarding anti-terrorism, anti-money laundering, anti-bribery or anti-tax evasion measures, (ii) any regulations enacted, administered, imposed or enforced by any relevant sanctions authority or (iii) the extent, scope, legality or enforceability of any person’s obligation to comply with any of such laws or regulations;

 

(b)the admission to trading and listing of the New Shares on any market or other trading facility for securities; and

 

(c)the accuracy or completeness of any statements or warranties of fact set out in documents referred to in paragraph 3 (Documents Reviewed) (except for the representations and warranties as to which we are expressing an opinion), which statements and warranties we have not independently verified.

 

8.Disclosure, Reliance and Liability

 

(a)This Opinion Letter is issued by Baker McKenzie BV/SRL, a Belgian limited liability company (BV/SRL), and not by or on behalf of Baker & McKenzie International (a Swiss Verein) (“BMI”) or any of its other member or associated firms (together with BMI, the “Other Baker McKenzie Entities”). In this Opinion Letter the expressions “we”, “us”, “our” and like expressions should be construed accordingly.

 

(b)No Other Baker McKenzie Entity or any directors, shareholders, members, partners, lawyers, employees, contractors or consultants of Baker McKenzie BV/SRL or any Other Baker McKenzie Entity will be liable (whether contractually or non-contractually) to any person under or in connection with this Opinion Letter or in connection with the Potential Issuance.

 

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(c)This Opinion Letter may only be relied upon by the Company in connection with the Registration Statement. This Opinion Letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in it. Nothing in this Opinion Letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in any document.

 

(d)We consent to the filing of this Opinion Letter as an exhibit to the Registration Statement and to the reference to us in the Registration Statement. In giving this consent, we do not concede that we are within the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the SEC thereunder.

 

(e)This Opinion Letter may only be relied upon, and be disclosed, on condition that it is construed in accordance with Belgian law and that any dispute arising out of or in connection with it is brought before a Belgian court.

 

*          *          *

 

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Yours faithfully,   
    
BAKER McKENZIE BV/SRL   
    
/s/ Michael Van Acker  /s/ Roel Meers
Partner
Michael.VanAcker@bakermckenzie.com
  Partner
Roel.Meers@bakermckenzie.com

 

 

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Exhibit 23.1

 

Consent of Independent Registered Public Accounting Firm

 

MDxHealth SA

Herstal, Belgium

 

We consent to the incorporation by reference of our report dated April 2, 2026 relating to the consolidated financial statements of MDxHealth SA, which appear in MDxHealth SA’s Annual Report on Form 20-F for the year ended December 31, 2025, as filed with SEC on April 3, 2026, in this Registration Statement on Form S-8.

 

BDO Réviseurs d’Entreprises SRL

On behalf of it,

/s/ Bert Kegels

 

Zaventem, Belgium

April 3, 2026

Filing Fee Exhibit
S-8 EX-FILING FEES 0001872529 Fees to be Paid N/A 0001872529 1 2026-03-30 2026-03-30 0001872529 2026-03-30 2026-03-30 iso4217:USD xbrli:pure xbrli:shares

Ex-Filing Fees

CALCULATION OF FILING FEE TABLES

S-8

MDxHealth SA

Table 1: Newly Registered Securities

                                       
Security Type   Security Class Title   Notes   Fee Calculation
Rule
  Amount Registered   Proposed Maximum Offering
Price Per Unit
  Maximum Aggregate Offering Price   Fee Rate   Amount of Registration Fee
                                       
Equity   Ordinary Shares, no par value per share   (1)   Other   7,410,000   $ 2.3336   $ 17,291,976.00   0.0001381   $ 2,388.03
                                       
Total Offering Amounts:   $ 17,291,976.00         2,388.03
Total Fee Offsets:                
Net Fee Due:             $ 2,388.03

 

__________________________________________
Offering Note(s)

(1) 1a. Represents shares issuable under the Registrant’s May 2017 Stock Option Plan, 2019 Stock Option Plan, 2021 Share Option Plan, 2022 Share Option Plan, 2023 Share Option Plan, 2023 Share Option Plan, 2024 Share Option Plan and 2025 Share Option Plan.

1b. Pursuant to Rule 416(a) of the Securities Act of 1933, as amended (the “Securities Act”), this Registration Statement also covers such indeterminate number of additional Ordinary Shares of the Registrant as is necessary to eliminate any dilutive effect of any future share consolidation, share dividend or similar transaction.

1c. Proposed Maximum Offering Price Per Unit is estimated solely for the purpose of calculating the registration fee pursuant to Rules 457(c) and 457(h) of the Securities Act and based on the average of the high and low prices for the Registrant’s Ordinary Shares on March 31, 2026, as reported on The Nasdaq Capital Market.