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 March 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 March 12, 2024, MDxHealth SA (the “Company”) issued
a press release, a copy of which is attached hereto as Exhibit 99.1.
The information in the attached
Exhibit 99.1 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.
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.
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MDXHEALTH SA |
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Date: March 12, 2024 |
By: |
/s/ Michael McGarrity |
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Name: |
Michael McGarrity |
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Title: |
Chief Executive Officer |
2
Exhibit 99.1
Mdxhealth
Adds Hereditary Prostate Cancer Genetic Test to Prostate Cancer Offering
IRVINE,
CA, and HERSTAL, BELGIUM – March 12, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or
“mdxhealth”), a commercial-stage precision diagnostic company, announces the introduction of a non-invasive genetic prostate
cancer test through its urology sales channel.
With
a simple saliva sample, the new comprehensive hereditary prostate cancer test offering provides insights into a patient’s risk
of developing cancer, disease progression, and response to prostate cancer therapies. Germline testing of prostate cancer patients is
recommended in the National Comprehensive Cancer Network (NCCN) guidelines and is covered by Medicare and many commercial insurance plans,
for eligible patients.
Michael
K. McGarrity, CEO of mdxhealth, commented: “The addition of this test to our menu reflects our commitment to delivering clinically
actionable precision diagnostics to our urology customer base, providing both clinicians and patients with insights into the diagnosis
and treatment of prostate cancer, particularly where genetic factors play a critical role. Given the established clinical guidelines
and reimbursement, we believe this portfolio addition will contribute to revenue and growth in the second half of this year.”
Prostate
cancer remains a leading cause of cancer-related death among men, with an estimated 288,300 new diagnoses and 34,700 deaths annually.
Decades of research indicate that prostate cancer has a strong genetic component with implications to ancestry.
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. For more information, visit mdxhealth.com
and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/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; expectations for development of new or improved products and services and their impact on patients;
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.
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.
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