Merit Medical Systems Profile
Merit Medical Systems, Inc. (Merit) operates as a manufacturer and marketer of proprietary medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.
Business Strategy
The company's business strategy focuses on five target areas as follows: enhancing global growth and profitability through research and development, sales model optimization, and operational focus; optimizing the company's operational capability through lean processes, environments and asset utilization; targeting high-growth, high-return opportunities by understanding, innovating and delivering in the company's core divisions; maintaining a highly disciplined, customer-focused enterprise guided by strong core values to globally address unmet or underserved healthcare needs; and creating a sustainable business for the company's shareholders and community.
Products
The company designs, develops, markets and manufactures, through its own operations and contract manufacturers, medical products that offer a high level of quality, value and safety to the company's customers, as well as the patients they serve. The company's products are used in the following clinical areas: radiology; diagnostic and interventional cardiology; interventional radiology; neurointerventional radiology; vascular, general and thoracic surgery; electrophysiology; cardiac rhythm management; interventional pulmonology; interventional nephrology; orthopedic spine surgery; interventional oncology; pain management; breast cancer surgery, outpatient access centers; intensive care; computed tomography; ultrasound; and interventional gastroenterology.
The success of the company's products is enhanced by the extensive experience of its management team in the healthcare industry, the company's experienced direct sales force and distributors, the company's ability to provide custom procedural solutions, such as kits, trays and procedural packs at the request of the company's customers, and its dedication to offering facility-unique solutions in the markets the company serves worldwide.
Segments
The company conducts its business through two operating segments: Cardiovascular and Endoscopy.
The following sections describe the company's principal product offerings by reporting segment and product category.
Cardiovascular segment
The company offers a broad line of medical devices used to gain and maintain vascular access. These products include the company's micropuncture kits, angiographic needles, the company's family of Prelude Introducer Sheaths and a wide range of guide wires and safety products. The company's cardiovascular segment includes the following product categories: peripheral intervention, cardiac intervention, custom procedural solutions, and original equipment manufacturer ('OEM').
Peripheral Intervention
The company's peripheral intervention products support the minimally invasive diagnosis and treatment of diseases in peripheral vessels and organs throughout the body, excluding the heart. Products in the company's peripheral intervention product category are organized into the following product groups: peripheral intervention, spine, and oncology.
Merit Vascular - Peripheral
The company's peripheral intervention products include product offerings in the following product portfolios: access (peripheral), angiography, drainage, delivery systems, embolotherapy, and intervention (peripheral). The company recently expanded the renal therapies portion of the company's access (peripheral) portfolio, which now includes the following key products:
HeRO (Hemodialysis Reliable Outflow) Graft, a fully subcutaneous vascular access system, which is intended for use in maintaining long-term vascular access for chronic hemodialysis patients;
CentrosFLO Long-Term Hemodialysis Catheter and ProGuide Chronic Dialysis Catheter;
Broad offering of peritoneal dialysis catheters, accessories and implantation kits for home dialysis therapy;
Merit Wrapsody Endoprosthesis, a cell-impermeable endoprosthesis which is designed to maintain long-term vessel patency in patients with obstructions in the dialysis outflow circuit (this device is not available for use in the United States); and
Surfacer Inside-Out Access Catheter System that restores and preserves access in chronically occluded veins.
The products in the company's angiography portfolio are used to identify blockages and other disease states in the blood vessel. The principal product offerings in the company's angiography portfolio include the company's:
Newest offering of Merit SplashWire hydrophilic Steerable Guide Wires, combining optimum lubricity, exceptional torque response and enhanced visibility;
Performa and Impress Diagnostic Catheters, a catheter offering designed for traversing difficult to access peripheral blood vessels; and
Performa Vessel Sizing Catheters for vessel measurement.
The company offers a broad line of drainage products. The principal product offerings in the company's drainage portfolio include the company's:
Aspira Pleural Effusion Drainage and Aspira Peritoneal Drainage Systems, a compassionate treatment option for end-stage cancer, allowing patients to spend more time at home by reducing the need for frequent hospital visits to treat their drainage needs;
Family of ReSolve Drainage Catheters, including the company's ReSolve ConvertX Stent System and ReSolve Mini Locking Drainage Catheter, and the company's related tubing sets and drainage bag;
One-Step and Valved One-Step Drainage Catheters, sold individually and in kits, for quickly removing unwanted fluid accumulation; and
Revolution Catheter Securement Device and StayFIX Fixation Device, used to stop migration, movement and accidental removal of percutaneous catheters.
The principal product offerings in the company's delivery systems portfolio include the company's:
SwiftNINJA Steerable Microcatheter, an advanced microcatheter with a 180-degree articulating tip;
Merit Maestro and Merit Pursue Microcatheters, small microcatheters designed for pushability and trackability through small and tortuous vessels; and
True Form Reshapable Guide Wire, designed to be reshaped multiple times, reducing the need for multiple guide wires.
The company's embolotherapy products treat disease by blocking or slowing the flow of blood into the arteries or delivering chemotherapy drugs in the treatment of primary and metastatic liver cancer. The principal product offerings in the company's embolotherapy portfolio include the company's:
Embosphere Microspheres, a highly-studied, round embolic for consistent and predictable results; and
HepaSphere Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-directed targeting.
The products in the company's intervention (peripheral) portfolio are chiefly used to remove blood clots, retrieve foreign bodies in blood vessels and assist with placing balloons and stents to treat arterial disease. The principal product offerings in the company's intervention (peripheral) portfolio include the company's:
ClariVein Specialty Infusion Catheter which is designed for controlled 360-degree dispersion of physician specified agents to the peripheral vasculature;
Dynamis AV PTA Dilatation Catheter, a line of balloon catheters that facilitates the opening of blockages located in the arteriovenous system of dialysis patients;
Q50X and Q50 Stent Graft Balloon Catheters, a line of catheters that treat abdominal and thoracic endovascular aortic repair procedures and reinterventions;
Fountain Infusion System and Mistique Infusion Catheters, a line of catheters that treat arterial and hemodialysis graft occlusions and deep vein thrombosis; and
EN Snare and One Snare Endovascular Snare Systems, a complete line of snares designed to manipulate, capture and retrieve foreign material in the body.
Merit Spine
The company's spine products are used in the treatment of vertebral compression fractures and metastatic spinal tumors and in musculoskeletal biopsy procedures. The company's spine product line includes the following product portfolios: vertebral augmentation, radiofrequency ablation, and bone biopsy systems. The company's primary product offerings in the vertebral augmentation and radiofrequency ablation portfolios include the company's:
STAR Tumor Ablation System, designed to provide palliative treatment of painful metastatic spinal tumors in cancer patients by targeted radiofrequency ablation;
Arcadia Steerable and straight balloons, designed to achieve controlled, precise, targeted cavity creation in vertebral augmentation procedures; and
StabiliT MX Vertebral Augmentation System, which uses the company's inflation devices to deliver bone cement.
The bone biopsy systems portfolio comprises a full offering of manual bone biopsy products, including the company's Madison, Huntington, Kensington, Preston and Westbrook biopsy products.
Merit Oncology
The company's oncology products are dedicated to the accurate diagnosis and localization of breast and soft tissue tumors and the innovative treatment of early-stage breast cancer. The company also offers an extensive line of soft tissue biopsy products and accessories. The company's primary product offerings in the company's oncology portfolio include the company's:
SCOUT Radar Localization System, a nonradioactive, wire-free tumor localization system that facilitates successful surgical removal of marked lesions and lymph nodes, improving workflow and the patient experience;
CorVocet Biopsy System, one of the company's innovative soft tissue core needle biopsy and accessory products, designed to cut a full core of tissue and provide large specimens for pathological examination;
Achieve, Temno and Tru-Cut Soft Tissue Biopsy Devices;
BioSentry biopsy tract sealant system; and
SAVI Brachytherapy, a precise, targeted approach to accelerated partial breast irradiation with lower toxicities and reduced treatment duration.
Cardiac Intervention
The company manufactures and sells a variety of products designed to treat various heart conditions. Products in the company's cardiac intervention product category are organized into the following product portfolios: access (cardiac), angiography, electrophysiology and CRM, fluid management, hemodynamic monitoring, hemostasis, and intervention (cardiac).
Merit Vascular - Cardiac
The principal product offerings in the company's access portfolio (cardiac) include the company's family of Prelude Introducer Sheaths, for both radial and femoral access, featuring the company's Prelude IDeal Hydrophilic Sheath Introducer, an ultra-thin wall introducer sheath that provides more room for the insertion of catheters and other devices in the radial artery.
The principal product offerings in the company's angiography portfolio include the company's InQwire Guide Wires and Performa Diagnostic and Ultimate catheters for femoral and radial procedures.
Electrophysiology is the study of diagnosing and treating abnormal electrical activities of the heart. Cardiac rhythm management ('CRM') is the field of cardiac disease therapy that relates to the diagnosis and treatment of cardiac arrhythmias or the improper beating of the heart. The principal product offerings in the company's electrophysiology and CRM portfolio include the company's:
Worley Advanced LV Delivery System, used to aid in the insertion and implantation of left ventricular pacing leads;
HeartSpan Transseptal Needle, for left-heart access procedures;
HeartSpan Steerable and Fixed Curve Sheath Introducer, featuring a neutral position indicator and tactile click to help physicians identify curve orientation with an expanded product line that includes fixed curve shapes; and
SafeGuard Focus and Focus Cool compression devices, used to protect closed surgical sites in the immediate postoperative period.
The product offerings in the company's fluid management portfolio include manifolds, control syringes and tubing.
The principal products the company offers in its hemodynamic monitoring portfolio include the Meritrans DTXPLUS disposable transducer, SAFEDRAW closed arterial sampling system and related accessories.
The principal product offerings in the company's hemostasis portfolio include its Prelude SYNC EVO, PreludeSYNC Distal, PreludeSYNC EZ Radial Compression devices (designed to reduce and stop blood flow after radial access procedures), and the SafeGuard Pressure Assisted Device which provides hemostasis after femoral procedures.
The principal product offerings in the company's intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the BasixCompak, basixTOUCH, Blue Diamond and DiamondTouch inflation devices and the PhD Hemostasis Valve, the latest addition to the company's hemostasis valve portfolio.
Custom Procedural Solutions
The company's custom procedural solutions product category is consisted of standard and custom kit and pack solutions that include items needed for peripheral procedures, safety and waste management products, and hemostasis accessories. The company's kit and pack solutions can optimize efficiency and reduce waste. The principal product offerings in this product category include critical care products; dual cap disinfection protection system and medallion syringes; manifold kits; and trays and packs.
OEM
The company provides coating services for medical tubes and wires under OEM brands in addition to many of the products identified above. The company offers coated tubes and wires to customers on a spool or as further manufactured components, including guide wire components, coated mandrels/stylets and coated needles.
The company also manufactures and sells sensor components for microelectromechanical systems. These components consist of piezoresistive pressure sensors in various forms, including bare silicon die, die mounted on ceramic substrates, and fully calibrated components for numerous applications both inside and outside the healthcare industry.
Endoscopy segment
The products in the company's endoscopy operating segment, Merit Medical Endotek, are organized in two product portfolios: gastroenterology and pulmonary.
The company's gastroenterology products include a complete range of innovative, gastrointestinal solutions. The company's primary product offerings in its gastroenterology portfolio include the company's:
Alimaxx-ES and EndoMAXX Fully Covered Esophageal Stents, for maintaining esophageal luminal patency in certain esophageal strictures;
BIG60 Inflation Device, a 60-mL syringe and gauge designed to inflate and deflate non-vascular balloon dilators while monitoring and displaying inflation pressures up to 12 atmospheres; and
Elation Fixed Wire, Wire Guided and new 5-stage Balloon Dilators, intended for use in the alimentary tract.
The company's pulmonary products consist of laser-cut tracheobronchial stents, advanced over-the-wire and direct visualization delivery systems and dilation balloons to endoscopically dilate strictures. The company's primary product offerings in its pulmonary portfolio include the company's:
AERO, AEROmini and AERO DV Fully Covered Tracheobronchial Stents, for the treatment of tracheobronchial strictures produced by malignant neoplasms; and
Elation Pulmonary Balloon Dilator, for the dilation of strictures of the trachea and bronchi.
The company also offers a variety of kits and accessories for endoscopy and bronchoscopy procedures.
Marketing and Sales
Target Market/Industry. The company's principal target markets are peripheral intervention, cardiac intervention, interventional oncology, critical care and endoscopy. Within these markets the company's products are used in the following clinical areas: diagnostic and interventional cardiology; interventional radiology; neurointerventional radiology; vascular, general and thoracic surgery; electrophysiology; cardiac rhythm management; interventional pulmonology; interventional nephrology; orthopedic spine surgery; interventional oncology; pain management; breast cancer surgery; outpatient access centers; intensive care; computed tomography; ultrasound; and interventional gastroenterology.
The company derives a large percentage of its revenues from sales of products used during percutaneous diagnostic and interventional procedures, such as angiography, angioplasty and stent placement. The company intends to pursue additional sales growth by building on its existing market position in both core technology and accessory products.
The U.S. and International Sales: In the U.S., the company has dedicated, direct sales organizations primarily focused on selling to end-user physicians, hospitals and alternate site facilities (e.g., office-based labs), major buying groups and integrated healthcare networks.
Internationally, the company employs sales representatives and contract with independent dealer organizations and custom procedure tray manufacturers to distribute the company's products worldwide, including territories in Europe, the Middle East, Africa, Asia, Oceania, Central and South America, Mexico and Canada. The company maintains a distribution center and administrative office in Beijing and sales offices in a few major cities in China. The company sells its products through more than 500 distributors in mainland China, who are responsible for reselling the company's products, primarily to hospitals. The company uses the 'modified direct' sales approach in China, employing sales personnel throughout China who work with the company's distributors to promote the clinical advantages of the company's products to clinicians and other decision makers at hospitals.
In Europe, the Middle East and Africa ('EMEA), the company has both direct and modified direct sales operations. Such sales operations are active throughout the region, including the largest markets in Western, Southern, Central and Eastern Europe and the emerging markets within EMEA.
The company's direct sales personnel are principally engaged in each of its divisions. The company is conducting education programs specific to radial access, spinal intervention, surgical grafts, wire-free tumor localization, electrophysiology, endoscopy, dialysis and embolism.
The company requires its international dealers to store products and sell directly to customers within defined sales territories. Each of the company's products must be approved for sale under the laws of the country in which it is sold. International dealers are responsible for compliance with applicable anti-corruption laws, such as the U.S. Foreign Corrupt Practices Act, as well as all applicable laws and regulations in their respective countries.
The company considers training to be a critical factor in the success of its sales force. Members of the company's sales force are trained by its clinical marketers, the company's staff professionals, consulting physicians, and senior field trainers in their respective territories.
OEM Sales. The company's global OEM Division sells components and finished devices, including molded components, sub-assembled goods, custom kits and bulk non-sterile goods, to medical device manufacturers. These products may be combined with other components and products from other companies and sold under a Merit or customer label. Products sold by the company's OEM Division can be customized and enhanced to customer specifications, including packaging, labeling and a variety of physical modifications. The company's OEM Division serves customers with a staff of regional sales representatives based in the U.S., Europe and Asia; and a dedicated OEM Engineering and Customer Service Group.
Customers
The company provides products to hospitals and alternate site-based physicians, technicians and nurses. Hospitals and acute care facilities in the U.S. purchase the company's products through its direct sales force, distributors, OEM partners, or custom procedure tray manufacturers who assemble and combine the company's products in custom kits and packs. Outside the U.S., hospitals and acute care facilities generally purchase the company's products through its direct sales force, or, in the absence of a sales force, through independent distributors or OEM partners.
Research and Development
In 2023, the company completed projects that resulted in the newest additions to the company's product lineup: BIG60 Alpha Inflation Device, Radial Length Merit Maestro Microcatheters, Prelude Roadster Guide Sheath Line Extensions, and the Micro ACE Advanced Micro-Access System, a novel addition to the company's Micro-Access lineup.
The company's research and development expenses included $82.7 million for the year ended December 31, 2023.
Competition
The company's primary competitors in its peripheral intervention market are Teleflex Incorporated ('Teleflex'), Cook Medical Incorporated ('Cook Medical'), Medtronic plc ('Medtronic'), Boston Scientific Corporation ('Boston Scientific'), and Becton, Dickinson and Company ('BD').
The company's primary competitors in its cardiac intervention market are BD, Teleflex, Medtronic, Abbott Laboratories, Terumo Corporation, Edwards Lifesciences Corporation, Cook Medical, and Boston Scientific.
The company's primary competitors in its spine market are Medtronic, Stryker Corporation, and Johnson & Johnson. The company's primary competitors in its oncology market are BD, Hologic, Inc., Endomagnetics Ltd., Argon Medical Devices, Inc., and Cook Medical.
The company's primary competitors in its endoscopy market are Getinge AB, Boston Scientific, Cook Medical, and Olympus Corporation.
Proprietary Rights
As of December 31, 2023, the company owned approximately 1,700 U.S. and international patents and patent applications.
The Merit name and logo are trademarks in the U.S. and other countries. In addition to the Merit name and logo, the company has used, registered or applied for registration of other specific trademarks and service marks to help distinguish the company's products, technologies and services from those of the company's competitors in the U.S. and foreign countries.
As of December 31, 2023, the company owned approximately 700 U.S. and foreign trademark registrations and trademark applications.
Regulation
The company's products and operations are global and are subject to regulations by the U.S. Food and Drug Administration (FDA) and various other federal and state agencies, as well as by foreign governmental agencies. These agencies enforce laws and regulations that control the design, development, testing, clinical trials, manufacturing, labeling, storage, advertising, marketing, distribution, and post-market surveillance of the company's medical products.
The company is conducting a large, multinational pivotal human clinical trial of the Wrapsody Endoprosthesis, which is required for the company to obtain approval from the FDA and some foreign regulatory agencies.
The Federal Food, Drug and Cosmetic Act ('FDCA') and its counterpart non-U.S. laws require the company to comply with quality system regulations ('QSR') pertaining to all aspects of the company's product design, purchasing and supplier controls, manufacturing, distribution, servicing, complaint handling, corrective and preventive action and internal quality system audits.
The company's labeling and promotional activities are also subject to scrutiny by the FDA and foreign regulators.
The company's product promotion is also subject to regulation by the Federal Trade Commission (the 'FTC'), which has primary oversight of the advertising of unrestricted devices, including FDA-cleared devices.
The company is also subject to regulations that require manufacturers to report to the FDA, or an equivalent foreign regulatory body, any incident in which their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur.
The company's international operations are subject to the Foreign Corrupt Practices Act (the 'FCPA'), the U.K. Bribery Act, and other foreign anti-corruption laws. The FCPA prohibits offering, paying, or promising to pay anything of value to foreign officials for the purpose of obtaining or maintaining an improper business advantage. The FCPA also requires that the company maintains fair and accurate books and records and devise and maintain an adequate system of internal accounting controls. In certain countries, the individuals and entities that the company regularly interact with may meet the definition of a foreign government official for purposes of the FCPA. As part of the company's compliance program, the company trains its U.S. and international employees, and the company also trains and monitors foreign third parties with whom the company contracts (e.g., distributors), to comply with the FCPA and other anti-corruption laws.
The company is also subject to corporate social responsibility ('CSR') laws and regulations, which require the company to monitor the labor standards in its supply chain, including the California Transparency in Supply Chains Act, the U.K. Modern Slavery Act, and the U.S. Federal Acquisition Regulations regarding Combating Trafficking in Persons.
Internationally, Merit is impacted by a number of stringent privacy regimes, such as the General Data Protection Regulation ('GDPR') in the E.U. and the Personal Information Protection Law ('PIPL') in China.
Seasonality
The company's worldwide sales have not historically reflected a significant degree of seasonality; however, customer purchases have historically been lower during the third quarter of the year, as compared to other quarters (year ended December 2023). This reflects, among other factors, lower demand during summer months in countries in the northern hemisphere.
History
Merit Medical Systems, Inc. was founded in 1987 as a Utah corporation. The company was incorporated in 1987.
