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MDxHealth SA

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Market Data: Yahoo Finance, Bloomberg

Report Link: Research Note Released (Dated 10/29/2018)

Symbol: MXDHF
Analyst: Howard Halpern
Taglich Rating: Speculative Buy
Price Target: $3.90
Time Horizon: 12 Months
Rating Established: May 5, 2016
Price When Established: $4.03
Most Recent Report: October 29, 2018
Price When Issued: $2.41

What's New

MDxHealth Provides Business Update

On January 14, 2019, MDxHealth announced preliminary full year revenue for the twelve-month period ended December 31, 2018 of approximately $28.3 million, on more than 38,000 tests preformed. The company expects to report cash of $26.2 million at December 31, 2018.

Management announced it intends to rationalize and restructure certain operations that should result in annualized cost savings of approximately $10 million.

Taglich Brothers' full year 2018 forecast calls for total revenue of $30 million.

MDxHealth Announces SelectMDx Approved by New York State

On November 21, 2018, MDxHealth announced that the New York State Department of Health approved its SelectMDx test for prostate cancer. This approval completes MDxHealth`s state licensing requirements for the SelectMDx prostate cancer test.

The company’s SelectMDx test for prostate cancer will be available to be prescribed in every state in the United States.

MDxHealth Announces SelectMDx Study improves prostate Biopsy Decision-Making

On November 7, 2018, MDxHealth announced publication in The Journal Urology Practice of a study demonstrating the clinical utility of its SelectMDx non-invasive 'liquid biopsy' test to identify patients at increased risk of aggressive prostate cancer.

The company believes this study should allow urologists to have confidence in the accuracy of SelectMDx results when making clinical decisions, as well as decreasing potentially unnecessary diagnostic procedures and treatments. Utilization of SelectMDx could lead to substantial cost savings within the healthcare system.

Company Description

MDxHealth, headquartered in Herstal, Belgium, was established in 2003. The company maintains a US headquarters in Irvine, CA, and operates a CLIA (Clinical Laboratory Improvement Act) diagnostic laboratory in Irvine, California, and a laboratory in Nijmegen, the Netherlands.

The company has developed noninvasive diagnostics based on epigenetics, which uses selected biomarkers to detect the presence of cancer and gauge the extent of its progress by analyzing a patients’ tissue, blood or urine samples. Biomarkers are measurable structures or processes in the body that indicate the presence of a disease and, potentially, the effects of treatments for that disease.

MDx’s lead product, ConfirmMDx, was launched in 2012. ConfirmMDx, analyzes a biopsy tissue sample from suspected prostate cancer cases who have tested negative. As initial biopsies (as well as follow-up ones) can be inconclusive, repeat biopsies are frequently performed to verify or rule out a diagnosis of prostate cancer. Confirm MDx can confirm a true negative biopsy, sparing the patient the ordeal and risks of unnecessary repeat biopsies. It can also identify cases of undetected cancer.

SelectMDx was launched in Europe in 2015 and in the US in March 2016. Select MDx, an initial diagnostic tool, analyzes a patient’s urine and identifies patients at low risk for prostate cancer, as well as patients at high risk for undetected aggressive prostate cancer that should be treated with greater urgency.

MDx is also developing AssureMDx, a bladder cancer test, and is exploring diagnostics for kidney cancer. The company has developed markers for non-urologic – colon, brain and cervical – cancers that have been licensed to other diagnostic companies, adding royalties and milestone payments to its potential revenue stream.

At current incidence rates, the number of US men diagnosed with prostate cancer could rise to 255,000 by 2050, up from an estimated 181,000 in 2016. Almost three million men in the US who have been diagnosed with prostate cancer at some point in their lives are alive today. Roughly 26,000 US patients will succumb to the disease in 2016 We believe that the statistics for Western Europe are comparable.

As non-invasive and inexpensive diagnostics, ConfirmMDx and SelectMDx could significantly reduce the cost of prostate cancer diagnosis by enabling patients to avoid biopsies − they cost the US healthcare system around $4 billion annually − and improve outcomes by identifying cases of potentially lethal fast growing disease more quickly.

Company Reports

Updated Research Note (Dated 10/29/2018)

Updated Research Report (Dated 09/11/2018)

Updated Research Report (Dated 05/16/2018)

Updated Research Report (Dated 03/05/2018)

Updated Research Note (Dated 01/11/2018)

Updated Research Note (Dated 11/07/2017)

Updated Research Report (Dated 09/12/2017)

Updated Research Report (Dated 05/23/2017)

Updated Research Report (Dated 08/24/2016)

Initial Research Report (Dated 05/05/2016)


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