6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

For the month of January 2023

Commission File Number 001-40996

MDXHEALTH SA

(Translation of registrant’s name into English)

CAP Business Center

Zone Industrielle des Hauts-Sarts

4040 Herstal, Belgium

+32 4 257 70 21

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

MDXHEALTH SA

On January 9, 2023, MDxHealth SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1.

The information in the attachedExhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities ExchangeAct of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemedincorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, exceptas otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

2

Exhibit 99.1

NEWS RELEASE – INSIDE AND REGULATED INFORMATION

9 JANUARY 2023, 4PM ET / 22:00 CET

MDxHealth Reports Preliminary 2022 Revenues

and Reaffirms 2023 Revenue Guidance

IRVINE, CA, and HERSTAL, BELGIUM – January 9, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today reported preliminary 2022 revenues and reaffirmed its 2023 revenue guidance. The Company expects to report 2022 revenues of approximately $37 million, with a year-end cash balance of $15.5 million. The Company is also reaffirming its previously issued 2023 revenue guidance of $65-$70 million.

Michael K. McGarrity, CEO of mdxhealth, commented: “In 2023, we are focused on operating execution and believe that improved reimbursement, along with our expanded diagnostic product offering will drive growth as reflected in our guidance. With the recent acquisition from Exact Sciences of the Genomic Prostate Score® (GPS) test (formerly Oncotype DX GPS), we believe mdxhealth is now a leader in the field of personalized diagnostic solutions focused exclusively on urology, and that our expanded menu will provide our urology customers with a more comprehensive offering of clinically actionable diagnostics to support a clear pathway for patients suspected of or diagnosed with prostate cancer. We are committed to building value for all of our stakeholders including patients, customers and shareholders.”

About mdxhealth**^®^**

Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis and prognosis of urologic cancers and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Plano, Texas. European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

2023Reporting Calendar

Financial information and auditor review

The preliminary unaudited financial data for the year ended December 31, 2022 set forth above is derived from preliminary internal financial reports. The Company has not yet finalized its complete results of operations for the year ended December 31, 2022. The Company and its auditors may identify items that would require the Company to make adjustments, some of which could be material, to the preliminary unaudited financial data set forth above.

For more information:

This press release contains forward-lookingstatements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of whichinvolve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases suchas “potential,” “expect,” “will,” “goal,” “next,” “potential,”“aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions.Forward-looking statements contained in this release include, but are not limited to, statements regarding the acquisition of OncotypeDX® GPS prostate cancer business from Exact Sciences including statements regarding the anticipated benefits of the acquisition; statementsregarding expected future operating results; statements regarding product development efforts; and statements regarding our strategies,positioning, resources, capabilities and expectations for future events or performance. Such statements and estimates are based on assumptionsand assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct.Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materiallydifferent. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results,product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Importantfactors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statementsinclude, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effectson our operations, and the demand for our products; our ability to successfully and profitably market our products; the acceptance ofour products and services by healthcare providers; the willingness of health insurance companies and other payers to cover our productsand services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and complywith applicable regulations; the possibility that the anticipated benefits from our business acquisitions like our acquisition of theOncotype DX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; andthe amount and nature of competition for our products and services. Other important risks and uncertainties are described in the RiskFactors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission.MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in itsexpectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless requiredby law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets ofMDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under theU.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securitieslaws.

NOTE: The mdxhealth logo, mdxhealth,Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealthSA. All other trademarks and service marks are the property of their respective owners.