IRVINE, CA, and HERSTAL, BELGIUM – November 11, 2019 – MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today provided a business update for the three and nine months ended September 30, 2019. 

Michael McGarrity, CEO of MDxHealth, said: “During this transitional period for MDxHealth we have set a foundation that will enable us to drive growth into our best in class menu which provides a pathway for both clinicians and patients screened for prostate cancer. We are confident that our refocused commercial organization, strengthened leadership team, financial operating discipline and clear strategic focus will serve as drivers of revenue growth.

This confidence is based in the actions we have taken to strengthen and focus our commercial organization and our ability to leverage the following key areas, which will be the catalyst for our growth projections. First, we are driving utilization into our current ConfirmMDx customer base, with a clear targeted approach to segmenting our focus through analytics related to payer mix and experience with adoption of a clinical pathway. We expect to see a return of this focus evidenced by growth in our unit volume for ConfirmMDx going forward.

Secondly, we have clear visibility to Medicare coverage for our SelectMDx test, evidenced by the Draft LCD achieved during the third quarter. It should be noted that final issuance of coverage will drive immediate revenue growth for that segment of our customer base. We look forward to providing visibility and guidance to both these growth drivers at the time of our full year results.”

Operational highlights for the three and nine months ended September 30, 2019


      ·For the three months ended September 30, 2019, billable test volume was up 5% to 4,305 versus 4,111 for the same period last year


Summary of billable test volume by product

Territory Products Nine Months Ended September 30,
2019 2018 % Change
U.S. ConfirmMDx 13,037 14,975 (13)%
SelectMDx 13,418 7,250 85%
E.U. SelectMDx 3,383 1,903 78%

Territory Products Three Months Ended September 30,
2019 2018 % Change
U.S. ConfirmMDx 4,305 4,111 5%
SelectMDx 3,200 2,315 38%
E.U. SelectMDx 1,073 525 104%

Financial Highlights for the nine months ended September 30, 2019

Financial review for the nine months ended September 30, 2019

USD in thousands (except per share data) Nine Months Ended September 30,
2019 2018 $ Change % Change
Product revenue 15,270 22,117 (6,847) (31)%
Royalties and patent income 342 1,865 (1,523) (82)%
Total Revenue 15,612 23,982 (8,370) (35)%
Gross Profit 6,819 15,116 (8,297) (55)%
Operating expenses (27,452) (37,660) 10,208 27%
Operating loss (20,633) (22,544) 1,911 8%
Net loss (20,915) (22,842) 1,927 8%
Basic and diluted loss per share (0.35) (0.40) 0.05 13%

Post Period Developments

Commenting on the changes to the MDxHealth Board, Mr. Koen Hoffman, Chairman of the Board, said “We welcome Tim Still to the board and offer our thanks and deep appreciation for the many years of valuable service by Walter Narajowski.”

About MDxHealth

MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit and follow us on social media at:, and

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Consilium Strategic Communications (IR & PR)
Amber Fennell, Chris Welsh, Marieke Vermeersch, Nicholas Brown
UK: +44 20 3709 5701


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. 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. 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, ConfirmMDx, and SelectMDx are trademarks or registered trademarks of MDxHealth SA.