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Here are 1-2 brief analogies for MDxHealth:

• Exact Sciences for prostate cancer diagnostics. (MDxHealth develops and commercializes specialized molecular diagnostic tests, similar to Exact Sciences' Cologuard, but focused on prostate cancer for risk assessment and biopsy guidance.)
• Guardant Health for prostate cancer risk assessment. (MDxHealth utilizes advanced molecular diagnostics, including liquid biopsies for prostate cancer risk assessment, mirroring Guardant Health's focus on liquid biopsies for cancer detection and management.)

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• ConfirmMDx®: A DNA methylation test that helps rule out prostate cancer in men with a prior negative biopsy, reducing the need for repeat biopsies.
• SelectMDx®: A liquid biopsy (urine test) that assesses the risk of aggressive prostate cancer, guiding the decision for prostate biopsy.
• AssureMDx®: A urine test for the molecular surveillance and recurrence monitoring of non-muscle invasive bladder cancer.

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MDxHealth (symbol: MDXH) sells primarily to other companies, specifically healthcare providers.

Major Customers:

MDxHealth's primary customers are healthcare providers, including a wide range of urology practices and hospitals/healthcare systems, predominantly in the United States. They operate their own CLIA-certified laboratory where their diagnostic tests are processed after being ordered by medical professionals.

• Urology Practices: These include individual urology clinics and larger group practices. These are typically private entities and not publicly traded companies.
• Hospitals and Healthcare Systems: Urologists and other medical professionals within hospital environments and larger integrated delivery networks (IDNs) also order MDxHealth's tests. These can be individual hospitals, or part of larger regional or national health systems, which may be public or private.

Due to the highly fragmented nature of the healthcare provider market in the United States, and the confidential nature of individual commercial agreements, MDxHealth does not typically disclose specific names of individual urology practices, hospitals, or healthcare systems that account for a major portion of its revenue. The company's revenue is derived from a large volume of orders from a multitude of these entities rather than concentration in a few large customers. Therefore, it is not possible to list specific public or private customer companies by name or provide their stock symbols.

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• Qiagen N.V. (Symbol: QGEN)
• Thermo Fisher Scientific Inc. (Symbol: TMO)
• F. Hoffmann-La Roche AG (Symbol: ROG)
• Abnova Corporation

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Michael K. McGarrity, Chief Executive Officer, Director

Michael K. McGarrity was appointed CEO of MDxHealth in February 2019. He brings over 25 years of experience in the healthcare industry, encompassing devices, diagnostics, and biotechnology. Prior to joining MDxHealth, he served as CEO of Sterilis Medical. Before that, he was the CEO of Nanosphere (NASDAQ: NSPH), a nanotechnology-based molecular diagnostics company, where he orchestrated a strategic turnaround that culminated in its successful sale to Luminex (NASDAQ: LMNX) in 2016. Mr. McGarrity also spent 13 years at Stryker Corporation (NYSE: SYK), holding leadership positions in sales and marketing.

Scott McMahan, Interim Chief Financial Officer

Scott McMahan assumed the role of interim Chief Financial Officer for MDxHealth effective July 30, 2025, following the resignation of Ron Kalfus. Previously, he served as the Vice President of Finance and Accounting at MDxHealth. Mr. McMahan is a seasoned finance professional with over 15 years of experience in the healthcare industry. His background includes key financial leadership positions as Chief Financial Officer and Controller in various healthcare organizations. He is recognized for strategically implementing best-practice business processes to drive sustainable profitability and possesses expertise in financial operations, budgeting, and cash flow management.

John Bellano, Chief Commercial Officer

John Bellano is the Chief Commercial Officer at MDxHealth. He has more than 25 years of experience in the healthcare industry, having started his career in pharmaceuticals before transitioning to molecular diagnostics, where he has spent the past two decades. Mr. Bellano has held significant roles at companies such as Sterilis and Roche Diagnostics, and is known for driving revenue growth, operational efficiencies, and successful product launches.

Joseph Sollee, Executive Vice President of Corporate Development and General Counsel

Joseph Sollee serves as the Executive Vice President of Corporate Development and General Counsel at MDxHealth. He has been a key figure at MDxHealth since its inception in 2003, providing legal counsel as its chief legal officer. Mr. Sollee brings over 20 years of experience in the healthcare industry, including senior management roles in private and publicly listed pharmaceuticals, health information technology, and molecular diagnostics companies. His diverse background includes practicing as a corporate attorney at Swidler & Berlin in Washington D.C. and as an investment banker at Smith Barney in New York.

Miriam Reyes, Executive Vice President of US Operations

Miriam Reyes is the Executive Vice President of US Operations at MDxHealth. She is a highly accomplished senior executive with over 25 years of experience in the diagnostics and medical device industry. Ms. Reyes specializes in clinical laboratory operations and quality management, with a proven track record of implementing compliant laboratory operations and developing innovative molecular diagnostics that drive revenue growth. Her leadership responsibilities include overseeing IT activities and ensuring regulatory compliance across international operations.

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The key risks to MDxHealth's business include challenges in securing and maintaining adequate reimbursement for its diagnostic products, the need to comply with extensive regulatory requirements, and intense competition within the precision diagnostics market.

1. Reimbursement and Payer Acceptance: A primary risk for MDxHealth is its ability to achieve and maintain sufficient coverage and reimbursement for its products and services from healthcare providers and payers. Delays or difficulties in obtaining favorable reimbursement decisions, such as those experienced with Medicare coverage for certain tests, can directly impact the company's revenue and financial performance.
2. Regulatory Approvals and Compliance: Operating in a highly regulated industry, MDxHealth must continually obtain and maintain regulatory approvals for its diagnostic tests and comply with a complex web of applicable regulations. Failure to adhere to these laws and regulations can lead to severe civil and criminal penalties, adverse publicity, withdrawal of products from the market, or partial suspension of testing, which could significantly harm the business.
3. Competition: MDxHealth faces substantial competition in the precision diagnostics market. The amount and nature of this competition for its products and services are significant factors that could cause actual results to differ materially from expectations.

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The increasing adoption and refinement of multiparametric MRI (mpMRI) for prostate cancer diagnostics poses a clear emerging threat. As mpMRI technology and its interpretation continue to advance, it offers increasingly accurate risk stratification and precise biopsy guidance for men with elevated PSA or prior negative biopsies. This can reduce the diagnostic ambiguity that MDxHealth's molecular tests, such as SelectMDx and ConfirmMDx, aim to address, potentially diminishing the market demand for these supplemental tests by providing a primary, often preferred, method for deciding the necessity and targeting of prostate biopsies.

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MDxHealth's main products address the prostate cancer diagnostics market.

• SelectMDx: The addressable market in the United States for the SelectMDx test is estimated to be approximately $1.5 billion. This estimation is based on an annual projection of 3 million men demonstrating an elevated PSA level, with an assumed average revenue of $500 per test.
• ConfirmMDx: The addressable market in the United States for the ConfirmMDx test is estimated at approximately $500 million. This figure is derived from an estimated 300,000 men annually receiving a negative biopsy result, assuming an average revenue of $1,600 per test.

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• Growth in Diagnostic Test Volumes: The company anticipates continued substantial growth in both tissue-based and liquid-based diagnostic test units billed. MDxHealth reported a 50% increase in tissue-based units and a 10% increase in liquid-based units for Q4 2024, contributing to overall revenue growth. For the full year 2024, tissue-based units grew 31% and liquid-based units grew 28%, demonstrating robust market penetration and adoption of its diagnostic solutions.
• Strategic Acquisition of ExoDx: The acquisition of the ExoDx business from Bio-Techne is a significant growth driver. This acquisition is expected to accelerate top-line revenue growth, contributing over $20 million in revenue in 2026 and projecting an accelerated growth rate to approximately 30%. The integration of ExoDx is also anticipated to be immediately accretive to adjusted EBITDA.
• Expansion of the Test Menu and Comprehensive Solutions: MDxHealth has expanded its test menu from one to four revenue-generating precision diagnostics. The ExoDx acquisition further solidifies its position as a comprehensive provider of prostate cancer diagnostic solutions, enhancing cross-selling opportunities and broader payer coverage.
• Enhanced Market Penetration and Commercial Execution: The company attributes its consistent growth to strong commercial execution and effective market positioning within the urological diagnostics space. This has led to increasing clinical adoption of its precision diagnostics platform, without requiring an expansion of its sales organization, indicating leverage from its existing sales channel.

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Share Issuance

• In September 2024, MDxHealth raised $40 million in gross proceeds through a public offering of 20,000,000 shares at $2.00 per share, with an additional $4.4 million from an overallotment option exercised in October 2024.
• In February 2023, the company raised $40 million in gross proceeds via a public offering of 10,000,000 shares at $4.00 per share, with an additional $3.0 million from an overallotment option in March 2023.
• MDxHealth implemented a $50 million At-The-Market ("ATM") program in 2024 to facilitate long-term shareholder development.

Inbound Investments

• In May 2024, MDxHealth closed a $100 million loan and security agreement with OrbiMed Advisors LLC, from which $55 million was drawn at closing to replace existing debt and for working capital.
• The OrbiMed facility provides the option to draw an additional $45 million in delayed term loans in 2025 and 2026.
• In September 2024, AWM Investment Company, Inc. acquired 4,250,000 shares of MDxHealth at $2.08 per share, representing a new holding in their portfolio.

Outbound Investments

• In August 2025, MDxHealth signed a definitive agreement to acquire the Exosome Diagnostics, Inc. business from Bio-Techne for a total consideration of $15 million, paid with $5 million in stock at closing and $2.5 million annually over the next four years in cash or stock.
• In August 2022, MDxHealth acquired the Oncotype DX Genomic Prostate Score (GPS) test from Exact Sciences for up to $100 million.
• The GPS acquisition included an upfront payment of $25 million in cash and $5 million in American Depositary Shares (ADS), with up to $70 million in additional milestone payments due through fiscal year 2025.

Capital Expenditures

• Capital expenditures for 2024, 2023, and 2022 amounted to $1.2 million, $2.7 million, and $2.8 million, respectively.
• These expenditures primarily focused on laboratory equipment, information technology equipment, and leasehold improvements.
• The company expects investments to remain mainly in the United States, where its molecular laboratory facility is located.