IRVINE, CA, and HERSTAL, BELGIUM – November 3, 2015 – MDxHealth SA (Euronext: MDXH.BR) today announced its third quarter 2015 Business Update for the period ended September 30, 2015.

Dr. Jan Groen, Chief Executive Officer of MDxHealth, commented: “The strategic investments made in our managed care team during the first half of 2015, coupled with the expansion of our sales force shortly after our June capital raise have bolstered both revenue growth and adoption of ConfirmMDx for Prostate Cancer in the U.S. Carrying our strong Q3 performance into Q4, we maintain our guidance for the full year.

“With the acquisition of NovioGendix and continued development of our existing pipeline this past quarter, we have established a solid foundation for our expanded uro-oncology product offering and the progression of our global commercial strategy. On November 1st, we launched SelectMDx(TM) for Prostate Cancer service testing in the Benelux region and look forward to launching our CE marked SelectMDx kits across Europe and in the U.S. in the beginning of 2016.  Additionally, with promising data to date, and ongoing validation studies for our urine-based bladder cancer test, we continue to expand our novel liquid biopsy product pipeline, which we expect to be a key focus of our future commercial portfolio.”

Q3 2015 Highlights



Post-Period Events

Key non-audited financials as of September 30, 2015
Amounts at and for the three months ended:

Dollars thousands Sept 30, 2015 Sept 30, 2014
Total Revenues 4,088 3,496
EBITDA (Loss) (4,708) (3,465)
EBIT Operating Income (Loss) (4,827) (3,552)
Net Profit (Loss) (4,840) (4,193)
Cash and cash equivalents 35,111 7,611

Amounts at and for the nine months ended:

Dollars thousands Sept. 30, 2015 Sept 30, 2014
Total Revenues 11,948 8,299
EBITDA Income (Loss) (9,985) (11,398)
EBIT Operating Income (Loss) (10,302) (11,637)
Net Profit (Loss) (10,324) (12,237)
Cash and cash equivalents 35,111 7,611

Commercial revenues up 44% for the first 9 months

Total Revenues for the first nine months amounted to $11.9 million, representing 44% growth over the prior year nine-month period, primarily due to an increase in ConfirmMDx test sales, which rose by 48% over the corresponding period in 2014.

Operating Expenses were $22.3 million in the first nine months of 2015, versus $20.0 million in the same period in 2014. Approximately $1 million of this increase was related to the acquisition of NovioGendix, with the balance attributable to our continued investment in product development, sales, marketing and managed care.

Net Loss of $10.3 million for the first nine months of 2015 decreased by $1.9 million compared to the same period in 2014. Continued investment in U.S. commercial operations and a higher cost of sales due to increasing volumes for the ConfirmMDx for Prostate Cancer test were offset by higher recognized sales revenues.

Cash Position as of September 30, 2015 was $35.1 million in cash and equivalents, compared to $7.6 million on September 30, 2014. In June 2015, the company completed a $30.1 million equity raise. Average net cash burn in the first nine months of 2015 was approximately $1.5 million per month.

Q4 and FY2015 Outlook

The Company maintains its guidance for 2015 projected revenues of $16-20 million and case volumes of 15,000 to 17,000 based upon the continued focus on broad-based adoption of ConfirmMDx in the U.S. and the Company’s strengthened managed care team and sales force. The Company also expects that DSOs will improve as the payor mix evolves to a higher percentage of contracted payors.

Based on recent U.S. demographic data, approximately 31% or 96.8 million people in the US are between the ages of 50 and 84. This population is at the greatest risk for harboring urologic cancers. The Medicare population currently represents 54% of the total 96.8 million men and women within this “at risk” population. MDxHealth, with its current Medicare coverage, along with our expanding Medicare Advantage and Commercial Carrier contracts, is well-positioned to address the specific needs of those patients aged 50 to 84 at the highest risk of harboring a urologic cancer. 

The Company’s strategic focus will continue to be on pursuing broad-based adoption of ConfirmMDx for Prostate Cancer in the U.S., developing and commercializing liquid biopsy products for both prostate and bladder cancer, and expanding our service offering through partnerships outside the U.S. With the recent acquisition of NovioGendix, and the license agreement with Erasmus, we look forward to further expanding our commercial product offering, specifically in liquid biopsies, in both the U.S. and Europe.

About MDxHealth

MDxHealth is a multinational healthcare company that provides actionable (epi)genetic and molecular information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary gene methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit and follow us on Twitter at:

For more information:


Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70


Consilium Strategic Communications
Amber Fennell, Chris Welsh & Hendrik Thys
UK: +44 20 3709 5701


Rx Communications
Melody Carey, Steve Silver

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, SelectMDx, AssureMDx, and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.