Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of July 2024

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 ☐

MDXHEALTH SA

On July 8, 2024, MDxHealth SA (the “Company”) reported preliminary results of revenues for the second quarter and first half of 2024 of approximately $22.2 and $42.0 million, respectively. The Company also reported that its cash balance as of June 30, 2024, was $21.3 million. The Company has not completed its quarter end closing procedures and the Company’s independent registered public accounting firm has not yet reviewed the results. Further commentary on the Company’s actual second quarter and first half of 2024 financial results will be provided as part of its 2024 Interim Report. Accordingly, these preliminary results are subject to change pending finalization, and actual results could differ materially as the Company finalizes such results.

On July 8, 2024, the Company reported Lieve Verplancke, representative of Qaly-Co Sàrl, resigned from the Company’s Board of Directors, effective July 7, 2024, and that Sanford J. Siegel, M.D. was appointed to Company’s Board of Directors, effective July 7, 2024, to fill the vacancy resulting from the resignation.

On July 8, 2024, the Company issued two press releases related to the above, copies of which are attached hereto as Exhibit 99.1 and Exhibit 99.2.

Information Incorporated by Reference

This Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Nos. 333-268885 and 333-280606) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished; provided, however, the information in the attached Exhibit 99.1 and Exhibit 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

Exhibit No.		Description of Exhibit
99.1		Press Release, dated July 8, 2024
99.2		Press Release, dated July 8, 2024

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.

	MDXHEALTH SA

Date: July 8, 2024	By:	/s/ Michael McGarrity
		Name:	Michael McGarrity
		Title:	Chief Executive Officer

Exhibit 99.1

Mdxhealth Appoints Sanford J. Siegel, M.D. to Board of Directors

IRVINE, CA, and HERSTAL, BELGIUM – July 8, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a commercial-stage precision diagnostics company, today announced the appointment of Sanford J. Siegel, M.D. to its Board of Directors. Dr. Siegel will be taking the seat of Lieve Verplancke M.D., who is stepping down from the Board of mdxhealth.

Dr. Siegel has more the 45 years of experience as a practicing urologist and over 35 years of executive leadership experience. Dr. Siegel currently serves as the Chairman of the Board of United Urology Group, having previously served as its Chief Executive Officer. United Urology Group, which was acquired by Audax in 2016, was formed under Dr. Siegel’s leadership and is one of the nation’s leading urology networks. Previously, Dr. Siegel served as the President and Chief Executive Officer of Chesapeake Urology Associates, which he founded in 1999. Dr. Siegel is a founding member of the Large Urology Group Practice Association (LUGPA), which was formed in 2008. He was a board member of the Urology Care Foundation (UCF) from 2016 until 2023 and The Urology Times. As a recognized leader in the field of medicine, Dr. Siegel has been honored with official citations for outstanding commitment and leadership from both the Governor and the General Assembly of Maryland. Dr. Siegel earned his medical degree from the University of Maryland School of Medicine and completed his specialty training in urology at Temple University Hospital in Philadelphia. He has been certified by the American Board of Urology and as Fellow of the American College of Surgeons.

Michael K. McGarrity, CEO of mdxhealth, commented: “We are very happy and honored to welcome Dr. Sanford Siegel onto our Board of Directors. Dr. Siegel is an exceptionally accomplished individual who has achieved remarkable success as a leading urologist, entrepreneur, and public health advocate. As mdxhealth continues to grow, Dr. Siegel will provide us with invaluable insights and guidance on how best our leading menu of precision diagnostic solutions can be fully leveraged by urology practices to ensure patients receive the critical diagnostic information necessary for determining the most appropriate course of treatment.”

“I am pleased to join the mdxhealth Board of Directors, which is a company that is helping to shape the future of prostate cancer diagnosis,” said Dr. Siegel. “As with most areas of cancer, the key to improving treatment outcomes is ensuring that patients have access to the most advanced diagnostics earlier in the course of their disease so that treatment options can be determined in a more timely and effective manner. As a practicing urologist who has treated thousands of patients with prostate cancer, I believe mdxhealth is well positioned to deliver this critically important technology to urologists, which should ultimately lead to improved patient care.”

Koen Hoffman, Chairman of mdxhealth, commented: “On behalf of the Board of Directors, I would like to welcome Sandy Siegel and thank Lieve Verplancke for her valued service to mdxhealth. Over the years she has contributed to our progress with the utmost professionalism and expertise.”

About mdxhealth

For more information:

info@mdxhealth.com

LifeSci Advisors (IR & PR)

US: +1 949 271 9223

ir@mdxhealth.com

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “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 expected future operating results; and our strategies, positioning, resources, capabilities and expectations for future events or performance. Such statements and estimates are based on assumptions and 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 materially different. 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. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with global macroeconomic conditions; our ability to successfully and profitably market our products; the acceptance and reimbursement of our products and services by healthcare providers and payers; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors 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 its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS and Monitor mdx are trademarks or registered trademarks of MDxHealth SA. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark, and all other trademarks and service marks, are the property of their respective owners.

Exhibit 99.2

MDxHealth Reports Preliminary Q2 and Half Year 2024 Revenues
and Raises 2024 Revenue Guidance

IRVINE, CA, and HERSTAL, BELGIUM – July 8, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH), a commercial-stage precision diagnostics company, today reported preliminary Q2 and half year 2024 revenues and cash. The Company expects to report Q2 and half year 2024 revenues of approximately $22.2 and $42.0 million, respectively, representing year-over-year growth of 32% and 34%, respectively, and representing sequential growth from Q1 of 12%. The Company is raising its full-year 2024 revenue guidance from $83-85 million to $85-87 million.

The Company’s cash balance as of June 30, 2024, was $21.3 million.

Michael K. McGarrity, CEO of mdxhealth, commented: “We believe these preliminary results for mdxhealth reflect our stated and firm commitment to deliver consistent and sustainable growth in our business, driven by our broad menu, sales execution and operating discipline. We are quite confident that this execution is now fundamentally built in across our operating teams and provide a unique profile of top line growth trajectory and operating leverage to meet our expected turn to adjusted EBITDA profitability in the first half of 2025.

Based on our visibility to sustainable growth, we are taking our 2024 revenue guidance up from $83-85 million to $85-87 million, representing 23% year-over-year revenue growth at the midpoint of our guidance. We look forward to providing our full financial results and update on August 21st.”

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.

Financial information and auditor review

The preliminary unaudited financial data for the second quarter and six-month period ended June 30, 2024, and the updated 2024 revenue guidance set forth above were derived from preliminary internal financial reports. The Company has not yet finalized its complete results of operations for the period ended June 30, 2024. 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 and guidance set forth above.

For more information:

info@mdxhealth.com

LifeSci Advisors (IR & PR)

US: +1 949 271 9223

ir@mdxhealth.com

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “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 expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and 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 materially different. 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. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the Oncotype DX^® GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors 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 its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

Non-IFRS Measures. The Company’s reference to adjusted EBITDA is a forward-looking statement about the Company’s future financial performance, and is a non-IFRS measure that excludes a number of expense items that are included in net loss, including adjustments for items like stock-based compensation, acquisition and integration costs, impairment of long-lived assets, fair-value adjustment, loan extinguishment costs, as well as other non-operating, non-recurring expenses that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. Non-IFRS financial information has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with IFRS, and such information is referenced for supplemental information purposes only. Management does not forecast many of the excluded items for internal use, as these are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Information reconciling forward-looking non-IFRS measures to IFRS measures is therefore not available without unreasonable effort, and is not provided. The occurrence, timing, and amount of any of the items excluded from IFRS to calculate non-IFRS measures could significantly impact the Company's IFRS results.