Company Description
Merit Medical Systems, Inc. (NASDAQ: MMSI) is a healthcare technology and medical device company engaged in the development, manufacture, and distribution of proprietary medical devices. These devices are used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. According to the company’s public disclosures, Merit serves customers worldwide through a domestic and international sales force and clinical support team and employs thousands of people globally.
Founded in 1987, Merit Medical has grown into a global manufacturer and marketer of healthcare technology. The company reports two primary operating segments: Cardiovascular and Endoscopy. Within the Cardiovascular segment, Merit discloses product categories such as peripheral intervention, cardiac intervention, custom procedural solutions, and OEM. The Endoscopy segment focuses on endoscopy devices. These segments reflect Merit’s focus on devices used in minimally invasive procedures and other interventional settings.
Business segments and focus areas
Merit’s Cardiovascular segment includes cardiology and radiology medical device products that assist in diagnosing and treating coronary artery disease, peripheral vascular disease, and other non-vascular diseases. As described in its company profile, this segment includes embolotherapeutic, cardiac rhythm management, electrophysiology, critical care, and interventional oncology and spine devices. Merit’s reported revenue tables further break this segment into peripheral intervention, cardiac intervention, custom procedural solutions, and OEM product categories.
The Endoscopy segment consists of endoscopy devices. Public announcements describe Merit as expanding its endoscopy portfolio and participating in gastroenterology markets through devices intended to treat gastrointestinal disorders. The company has also disclosed that it intends to integrate acquired technologies, such as the C2 CryoBalloon device and related technology, into its Endoscopy portfolio.
Interventional and therapeutic device portfolio
Merit states that its proprietary medical devices are used across a range of interventional, diagnostic, and therapeutic procedures. These procedures span cardiology, radiology, oncology, critical care, and endoscopy. In oncology and related areas, Merit has highlighted products such as the SCOUT Radar Localization system, which is used as a wire-free, non-radioactive localization technology in breast cancer care. According to company communications, SCOUT Radar Localization is used to help physicians surgically remove abnormal breast tissue while reducing trauma to surrounding healthy tissue, and has been used in many facilities and countries worldwide.
In the area of vascular access for hemodialysis patients, Merit has emphasized the WRAPSODY Cell-Impermeable Endoprosthesis (CIE). Company news releases describe WRAPSODY CIE as intended to help physicians restore vascular access in patients on hemodialysis who experience venous outflow obstructions, including stenosis or occlusion. Merit has reported clinical data from its WAVE trial and real-world registries, indicating that WRAPSODY CIE is designed to extend functional vascular access in this patient population.
Geographic footprint and customer base
Merit reports that it serves customers worldwide and that it has a domestic and international sales force and clinical support team totaling more than 800 individuals. The company’s disclosures note that it employs several thousand people worldwide. These statements underscore Merit’s presence in multiple geographic regions and its focus on supporting physicians and healthcare providers through both sales and clinical support personnel.
Corporate structure and leadership
Merit Medical Systems, Inc. is incorporated in Utah and lists its principal offices in South Jordan, Utah in SEC filings. The company’s common stock trades on the NASDAQ under the ticker symbol MMSI. Public filings describe Merit as a registrant subject to the reporting requirements of the Securities Exchange Act of 1934. The company has also disclosed board and leadership changes, including the appointment of a new President and Chief Executive Officer and changes in board chair responsibilities, through Form 8-K filings and press releases.
Growth, acquisitions, and product development
Merit’s public communications describe a strategy that includes organic growth and acquisitions. For example, the company has reported acquisitions of businesses and assets such as Biolife Delaware, L.L.C., assets acquired from Cook Medical Holdings LLC, EndoGastric Solutions, Inc., and the C2 CryoBalloon device and related technology from Pentax of America, Inc. Merit has stated that these acquisitions are intended to expand its product offerings in areas such as endoscopy and gastroenterology and to support its broader healthcare technology portfolio.
Merit also emphasizes clinical evidence and registries to support its products. For WRAPSODY CIE, the company has described the WAVE trial, the WRAP North America Registry, and the WRAP Global Registry as key sources of clinical data. For SCOUT Radar Localization, Merit has noted that the technology has been mentioned in numerous clinical publications and used in many facilities and countries. These disclosures highlight the company’s focus on generating and sharing clinical data to inform physician decision-making.
Financial reporting and non-GAAP measures
In its earnings releases and Form 8-K filings, Merit reports net sales, operating income, and other financial metrics for its Cardiovascular and Endoscopy segments. The company frequently presents both GAAP and non-GAAP financial measures, including constant currency revenue, non-GAAP gross profit and margin, non-GAAP operating income and margin, non-GAAP net income, non-GAAP earnings per share, and free cash flow. Merit explains that its management uses these non-GAAP measures to evaluate profitability, efficiency, and period-over-period performance, while also providing reconciliations to the most directly comparable GAAP measures.
Merit’s disclosures also include forward-looking statements and financial guidance for net sales and non-GAAP earnings per share, along with detailed risk factor summaries that reference its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The company notes that it does not provide guidance for certain GAAP measures beyond revenue because it cannot predict with reasonable certainty the impact of various items such as acquisition-related expenses, non-cash amortization, and litigation-related costs.
Regulatory and reimbursement environment
As a medical device manufacturer, Merit is subject to U.S. and global regulatory requirements. Company releases reference premarket approval from the U.S. Food and Drug Administration (FDA) and approvals from Health Canada and the Conformité Européenne (CE) Mark for WRAPSODY CIE. Merit has also discussed interactions with the U.S. Centers for Medicare & Medicaid Services (CMS) regarding Transitional Pass-Through incremental payment for WRAPSODY CIE procedures and has described how reimbursement decisions can affect commercialization strategies.
In risk factor summaries and cautionary statements, Merit identifies potential impacts from governmental and private insurance reimbursement policies, government scrutiny and regulation of the medical device industry, and changes in tax and regulatory regimes. These disclosures illustrate the regulatory and reimbursement considerations that can influence the company’s operations and financial performance.
Research, clinical trials, and evidence generation
Merit highlights its investment in research and development and its involvement in clinical trials and registries. The WAVE trial and WRAP registries for WRAPSODY CIE are designed to evaluate outcomes such as target lesion primary patency and access circuit primary patency in hemodialysis patients with venous outflow obstructions. Merit has also emphasized the importance of long-term clinical data in supporting physician adoption and payer discussions.
For SCOUT Radar Localization, Merit notes that the technology has been referenced in numerous clinical publications and used in many cases worldwide. The company describes SCOUT as supporting multiple treatment needs, including placement in breast tissue and lymph nodes and use in various stages of breast cancer treatment. These statements underscore Merit’s focus on generating and disseminating clinical evidence for its technologies.
Stock information and investor communications
Merit Medical Systems, Inc. trades on the NASDAQ under the ticker symbol MMSI. The company regularly communicates with investors through earnings releases, conference calls, investor presentations, and participation in healthcare conferences. Public announcements describe Merit’s participation in events such as the J.P. Morgan Healthcare Conference, where management presents company overviews and updates.
Through its SEC filings, including Forms 10-K, 10-Q, and 8-K, Merit provides detailed information on its financial condition, results of operations, risk factors, and material events such as acquisitions, leadership changes, and product updates. These filings, along with press releases and other public communications, form the primary source of information for investors researching MMSI stock and Merit’s business.