44 unchanged sentences
We offer a broad line of medical devices used to gain and maintain vascular access.
−Removed: These products include our micropuncture kits, angiographic needles, our family of Prelude® Introducer Sheaths and a wide range of guide wires and safety products.
+Added: These products include our micropuncture kits, angiographic needles, family of Prelude® Introducer Sheaths and wide range of guide wires and safety products.
Our cardiovascular segment includes the following product categories:
3 unchanged sentences
Products in our peripheral intervention product category are organized into the following product groups:
−Removed: peripheral intervention, spine, and oncology.
+Added: peripheral intervention, and oncology.
Merit Vascular – Peripheral
1 unchanged sentence
access (peripheral), angiography, drainage, delivery systems, embolotherapy, and intervention (peripheral).
−Removed: We recently expanded the renal therapies portion of our access (peripheral) portfolio, which now includes the following key products:
+Added: The renal therapies portion of our access (peripheral) portfolio includes the following key products:
● Merit Wrapsody® Cell-Impermeable Endoprosthesis (the “Wrapsody Device”), a cell-impermeable endoprosthesis which is designed to maintain long-term vessel patency in patients with obstructions in the dialysis outflow circuit;
● 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;
−Removed: ● CentrosFLO® Long-Term Hemodialysis Catheter and ProGuide® Chronic Dialysis Catheter;
+Added: ● CentrosFLO® Long-Term Hemodialysis Catheter and ProGuide® Chronic Dialysis Catheter, which are designed to maintain optimal blood flow;
● BioFlo DuraMax® Catheter, which provides optimal ease of insertion and high flow rates at modest arterial pressure;
20 unchanged sentences
● HepaSphere® Microspheres, soft embolics with a consistent cross-sectional diameter for predictable, flow-directed targeting;
−Removed: ● Recently-launched Siege™ Vascular Plug, a self-expanding vascular implant designed for peripheral arterial embolization in vessels measuring 1.5mm to 6.0mm in diameter.
+Added: ● Siege® Vascular Plug, a self-expanding vascular implant designed for peripheral arterial embolization in vessels measuring 1.5mm to 6.0mm in diameter.
The products in our 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.
5 unchanged sentences
● EN Snare® and One Snare® Endovascular Snare Systems, a complete line of snares designed to manipulate, capture and retrieve foreign material in the body.
−Removed: Our spine products are used in the treatment of vertebral compression fractures and metastatic spinal tumors and in musculoskeletal biopsy procedures.
−Removed: Our spine product line includes the following product portfolios:
−Removed: vertebral augmentation, radiofrequency ablation, and bone biopsy systems.
−Removed: Our primary product offerings in the vertebral augmentation and radiofrequency ablation portfolios include our:
−Removed: ● STAR™ Tumor Ablation System, designed to provide palliative treatment of painful metastatic spinal tumors in cancer patients by targeted radiofrequency ablation;
−Removed: ● Arcadia® Steerable and straight balloons, designed to achieve controlled, precise, targeted cavity creation in vertebral augmentation procedures;
−Removed: ● StabiliT® MX Vertebral Augmentation System, which uses our inflation devices to deliver bone cement.
−Removed: The bone biopsy systems portfolio comprises a full offering of manual bone biopsy products, including our Madison™, Huntington™, Kensington™, Preston™ and Westbrook™ biopsy products.
Merit Oncology
4 unchanged sentences
● CorVocet® Biopsy System, one of our innovative soft tissue core needle biopsy and accessory products, designed to cut a full core of tissue and provide large specimens for pathological examination;
−Removed: ● Achieve®, Temno® and Tru-Cut® Soft Tissue Biopsy Devices;
−Removed: ● BioSentry® biopsy tract sealant system;
+Added: ● Achieve®, Temno® and Tru-Cut® Soft Tissue Biopsy Devices which are designed to produce superior soft tisuue biopsy samples;
+Added: ● BioSentry® biopsy tract sealant system designed to address the issues of biopsy-related pneumothorax;
● SAVI® Brachytherapy, a precise, targeted approach to accelerated partial breast irradiation with lower toxicities and reduced treatment duration.
4 unchanged sentences
Merit Vascular – Cardiac
−Removed: The principal product offerings in our access portfolio (cardiac) include our family of Prelude Introducer Sheaths, for both radial and femoral access, featuring our 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.
+Added: The principal product offerings in our access portfolio (cardiac) include our family of Prelude Introducer Sheaths, for both radial and femoral access, featuring our recently-launched Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ technology and our 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 our angiography portfolio include our InQwire® Guide Wires and Performa Diagnostic and Ultimate™ catheters for femoral and radial procedures.
2 unchanged sentences
The principal product offerings in our electrophysiology and CRM portfolio include our:
−Removed: ● Recently-acquired Evolution® system for lead removal procedures relating to pacemakers and implantable cardioverter defibrillators;
+Added: ● Evolution® system for lead removal procedures relating to pacemakers and implantable cardioverter defibrillators;
● Worley™ Advanced LV Delivery System, used to aid in the insertion and implantation of left ventricular pacing leads;
1 unchanged sentence
● 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;
−Removed: ● SafeGuard Focus TM and Focus Cool TM compression devices, used to protect closed surgical sites in the immediate postoperative period.
+Added: ● SafeGuard Focus® and Focus Cool TM compression devices, used to protect closed surgical sites in the immediate postoperative period.
The product offerings in our fluid management portfolio include manifolds, control syringes and tubing.
−Removed: The principal products we offer in our hemodynamic monitoring portfolio include the Meritrans DTXPLUS® disposable transducer, SAFEDRAW® closed arterial sampling system and related accessories.
+Added: The principal products we offer in our hemodynamic monitoring portfolio include the Meritrans DTXPLUS® disposable transducer, SAFEDRAW® closed arterial blood sampling system and related accessories.
The principal product offerings in our hemostasis portfolio include our Prelude SYNC EVO®, PreludeSYNC Distal™, PreludeSYNC EZ TM 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.
−Removed: The principal product offerings in our intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the BasixSKY™, BasixCompak™, basixTOUCH™, Blue Diamond™ and DiamondTouch™ inflation devices and the PhD™ Hemostasis Valve, the latest addition to our hemostasis valve portfolio.
+Added: The principal product offerings in our intervention (cardiac) portfolio include a full line of inflation devices and hemostasis valves, including the BasixSKY®, BasixCompak®, basixTOUCH®, Blue Diamond® and DiamondTouch™ inflation devices, the PhD™ Hemostasis Valve, and the 10Fore™ Hemostasis Valve, the latest addition to our hemostasis valve portfolio.
Custom Procedural Solutions
3 unchanged sentences
● Critical care products;
−Removed: ● Dual Cap® Disinfection Protection System and Medallion ® syringes;
+Added: ● Medallion® syringes;
● Manifold kits;
5 unchanged sentences
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.
+Added: In 2025, we reorganized our sales teams and product categories to include our spine products under our OEM product category.
+Added: Our spine products are used in the treatment of vertebral compression fractures and metastatic spinal tumors and in musculoskeletal biopsy procedures.
+Added: Our spine product line includes the following product portfolios:
+Added: vertebral augmentation, radiofrequency ablation, and bone biopsy systems.
+Added: Our primary product offerings in the vertebral augmentation and radiofrequency ablation portfolios include our:
+Added: ● STAR™ Tumor Ablation System, designed to provide palliative treatment of painful metastatic spinal tumors in cancer patients by targeted radiofrequency ablation;
+Added: ● Arcadia® Steerable and straight balloons, designed to achieve controlled, precise, targeted cavity creation in vertebral augmentation procedures;
+Added: ● StabiliT® MX Vertebral Augmentation System, which uses our inflation devices to deliver bone cement.
+Added: The bone biopsy systems portfolio comprises a full offering of manual bone biopsy products, including our Madison™, Huntington™, Kensington™, Preston™ and Westbrook™ biopsy products.
The products in our endoscopy operating segment, Merit Medical Endotek ® , are organized in two product portfolios:
2 unchanged sentences
Our primary product offerings in our gastroenterology portfolio include our:
−Removed: ● Recently-acquired EsophyX® Z+ system for minimally invasive non-pharmacological treatment of gastroesophageal reflux disease;
+Added: ● Recently-launched Resilience Through-the-Scope Esophageal Stent which provides luminal patency in the esophagus;
+Added: ● Recently-acquired C2 CryoBalloon® device and related technology intended to treat patients suffering from Barretts esophagus and other gastrointestinal disorders;
+Added: ● EsophyX® Z+ system for minimally invasive non-pharmacological treatment of gastroesophageal reflux disease;
● Alimaxx-ES™ and EndoMAXX® Fully Covered Esophageal Stents for maintaining esophageal luminal patency in certain esophageal strictures;
25 unchanged sentences
and interventional gastroenterology.
−Removed: According to statistics published by the National Center for Health Statistics, cardiovascular disease continues to be a leading cause of death and a significant health problem in the U.S.
+Added: According to statistics published by the World Health Organization, cardiovascular disease continues to be a leading cause of death and a significant global health problem.
Treatment options range from dietary changes to surgery, depending on the nature of the specific disease or disorder.
Endovascular techniques, including angioplasty, stenting and endoluminal stent grafts, continue to represent important therapeutic options for the treatment of vascular disease.
−Removed: Breast cancer is the most commonly diagnosed cancer in women and is the second leading cause of cancer death among women.
We derive a large percentage of our revenues from sales of products used during percutaneous diagnostic and interventional procedures such as angiography, angioplasty and stent placement, and we intend to pursue additional sales growth by building on our existing market position in both core technology and accessory products.
8 unchanged sentences
Suggestions for new products and product improvements may also come from engineers, marketing and sales personnel, and physicians and technicians who perform clinical procedures.
−Removed: When we believe that a product suggestion demonstrates a sustainable competitive advantage, meets customer needs, fits strategically and technologically with our business and has a good potential financial return, we generally assemble a “project team” comprised of individuals from our sales, marketing, engineering, manufacturing, legal and quality assurance departments.
+Added: When we believe that a product suggestion demonstrates a sustainable competitive advantage, meets customer needs, fits strategically and technologically with our business and has a good potential financial return, we generally assemble a “project team” comprised of individuals from our sales, marketing, engineering, manufacturing, legal, regulatory and quality assurance departments.
This team works to identify the customer requirements, develop the design, compile necessary documentation and testing, and prepare the product for market introduction.
4 unchanged sentences
In the U.S., we have 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.
−Removed: Internationally, we employ sales representatives and contract with independent dealer organizations and custom procedure tray manufacturers to distribute our products worldwide, including territories in Europe, the Middle East, Africa, Asia, Oceania, Central and South America, Mexico and Canada.
+Added: Internationally, we employ sales representatives and contract with independent distributor organizations and custom procedure tray manufacturers to distribute our products worldwide, including territories in Europe, the Middle East, Africa, Asia, Oceania, Central and South America, Mexico and Canada.
In 2025, our international sales grew 9.1% over our 2024 international sales and accounted for 40% of our net sales.
Our largest non-U.S.
−Removed: market is China, which represented 11% of our net sales in 2024 and reported net sales of $149.8 million, $147.3 million, and $149.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: We maintain a distribution center and administrative office in Beijing and sales offices in a few major cities in China.
+Added: market is China where we maintain a distribution center and administrative office in Beijing and sales offices in other major cities.
We sell our products through more than 500 distributors in mainland China, who are responsible for reselling our products, primarily to hospitals.
1 unchanged sentence
In 2019, China announced a volume-based procurement (“VBP”) policy applicable to medical device manufacturers that is designed to reduce the price of medical devices sold in China.
−Removed: We began experiencing the impact of the VBP policy in
−Removed: 2022 and 2023 in the form of decreased sales prices and revenue.
−Removed: The negative impacts of the VBP policy persisted in 2024 and we expect to continue to experience these negative impacts in 2025.
+Added: We began experiencing the impact of the VBP policy in 2022 in the form of decreased sales prices and revenue.
+Added: The negative impacts of the VBP policy have persisted since 2022 and we expect to continue to experience these negative impacts in 2026.
For further discussion of the risks and uncertainties associated with the VBP policy, please refer to disclosure under the heading “ Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies.” set forth in Item 1A “Risk Factors.”
−Removed: In Europe, the Middle East and Africa (“EMEA), we have both direct and modified direct sales operations.
+Added: In Europe, the Middle East and Africa (“EMEA”), we have direct, modified direct and distributor 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.
2 unchanged sentences
We are currently conducting education programs specific to radial access, spinal intervention, surgical grafts, wire-free tumor localization, electrophysiology, endoscopy, dialysis and embolism.
−Removed: We require our international dealers to store products and sell directly to customers within defined sales territories.
+Added: We require our international distributors to store products and sell directly to customers within defined sales territories.
Each of our products must be approved for sale under the laws of the country in which it is sold.
−Removed: International dealers are responsible for compliance with applicable anti-corruption laws, such as the U.S.
+Added: International distributors 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.
11 unchanged sentences
Our research and development operations have been central to our historical growth, and we believe they will be critical to our continued growth.
−Removed: In recent years, our commitment to innovation has led to the introduction of several new products, improvements to our existing products and expansion of our product lines, as well as enhancements and new equipment in our research and development facilities.
+Added: In recent years, our commitment to innovation has led to the introduction of several new products,
+Added: improvements to our existing products and expansion of our product lines, as well as enhancements in our research and development facilities.
We continue to develop new products and make improvements to our existing products utilizing many different sources.
−Removed: In 2024, our Chief Executive Officer and our Executive Vice President of Global Research & Development worked closely with our sales and marketing teams to incorporate feedback from physicians and clinicians in the field, which contributed to innovative new products and improvements to our existing products.
+Added: In 2025, we endeavored to facilitiate cross-functional collaboration by aligning our research and development and marketing teams with our sales organization to enhance the integration of physician feedback into new product development and project prioritization.
+Added: This alignment strengthens our ability to execute on product development strategies and accelerate new product introductions.
+Added: By more effectively incorporating customer feedback into our innovation process, we are better positioned to deliver solutions that meet clinical needs and improve patient outcomes.
+Added: This approach supports disciplined resource allocation, fosters operational efficiency, and reinforces our commitment to delivering differentiated products that drive long-term growth.
In 2025, we completed projects that resulted in the newest additions to our product lineup:
−Removed: the Wrapsody Device, basixSky™ Inflation Device, MIGHTYwire® Guide Wire, Siege™ Vascular Plug, Bearing nsPVA Express™ Syringe, and 10FoRe™ hemostasis valve.
+Added: the 10FoRe™ hemostasis valve, Ventrax® Delivery System, MAK™ Gold Mini Access Kits, and Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ technology.
Other products added to our new product portfolio include simplified connections to our Centesis and Aspira® drainage systems to facilitate compatibility with a broader range of drainage tools.
−Removed: Currently, we have research and development facilities in California, Texas, Utah, Ireland and France.
+Added: Currently, we have research and development facilities in California, Minnesota, Texas, Utah, Ireland and France.
Manufacturing
−Removed: We manufacture many of our products using our proprietary technology and our expertise in plastic injection molding, insert molding and extrusion, along with many other technologically advanced manufacturing processes.
+Added: We manufacture many of our products using our proprietary technology and our expertise in plastic injection molding, insert molding and extrusion and in embolotherapy products production, along with many other technologically advanced manufacturing processes.
We generally contract with third parties for the tooling of our molds, but we design and own most of our molds.
−Removed: We have also received various International Standards Organization (“ISO”) certifications for many of our facilities;
+Added: We have also received various International Organization of Standardization (“ISO”) certifications for many of our facilities;
for further details, please refer to Item 1.
2 unchanged sentences
(“Merit Sensors”) develops and markets silicon pressure sensors to a range of enterprises and presently supplies the sensors we use in our digital inflation devices and blood pressure sensors.
−Removed: We have specialized manufacturing personnel at most of our ten global manufacturing facilities.
+Added: We have specialized manufacturing personnel at most of our eleven global manufacturing facilities.
Consequently, we possess the capability to flexibly locate or shift the manufacture of products to the facilities providing the most strategic advantages.
The determination of manufacturing location is based upon multiple factors, including facility technological capabilities, market demand, acquisition and integration activities and economic and competitive conditions.
−Removed: We currently produce and package all of our embolotherapy products.
−Removed: Manufacturing of our embolotherapy products includes the synthesis and processing of raw materials and third-party manufactured compounds.
−Removed: We have packaging and manufacturing facilities located in Texas, Virginia, Utah, Minnesota, Mexico, Brazil, Ireland, France, The Netherlands, and Singapore.
+Added: We have packaging and manufacturing facilities located in Texas, Florida, Virginia, Utah, Minnesota, Mexico, Brazil, Ireland, France, The Netherlands, and Singapore.
“Properties.”
16 unchanged sentences
Our primary competitors in our spine market are Medtronic, Stryker Corporation, and Johnson & Johnson.
−Removed: Our primary competitors in our oncology market are BD, Hologic, Inc., Endomagnetics Ltd., Argon Medical Devices, Inc.
+Added: Our primary competitors in our oncology market are BD, Hologic, Inc., Argon Medical Devices, Inc.
and Cook Medical.
5 unchanged sentences
for control syringes, radar localization, waste-disposal systems, embolic beads, tubing and manifolds.
−Removed: Although we believe our recent and planned additions to these product
−Removed: lines will help us compete even more effectively in both the U.S.
+Added: Although we believe our recent and planned additions to these product lines will help us compete even more effectively in both the U.S.
and international markets, we cannot give any assurance that we will be able to maintain our existing competitive advantages or compete successfully in the future.
29 unchanged sentences
In October 2020, we entered into a Corporate Integrity Agreement (“CIA”) with the Office of Inspector General (“OIG”), a five-year agreement that was a condition of our settlement with the United States Department of Justice (“DOJ”).
−Removed: The CIA subjects us to certain compliance, monitoring, reporting, certification, oversight and training obligations.
−Removed: The CIA requires, among other matters, that we (i) maintain a compliance officer, a compliance committee, board review and oversight of certain federal healthcare compliance matters and compliance and disclosure programs;
−Removed: (ii) establish compliance policies and procedures to meet the requirements of all federal health care programs and the U.S.
−Removed: Food and Drug Administration (“FDA”) ;
−Removed: (iii) provide management certifications and compliance training and education;
−Removed: (iv) engage an independent review organization to conduct a thorough review of our systems, policies, processes and procedures related to promotional materials, product evaluations, consulting agreements, trainings provided to healthcare professionals, sponsorships, grants and charitable contributions;
−Removed: (v) implement a risk assessment and internal review process;
−Removed: (vi) establish a disclosure program for whistleblowers;
−Removed: (vii) increase oversight of the interactions between our sales personnel and healthcare providers;
−Removed: and (viii) report or disclose certain events and physician payments.
−Removed: We recently completed our fourth reporting period under the CIA and continue to implement compliance program enhancements.
−Removed: Our failure to comply with our obligations under the CIA could result in monetary penalties and our exclusion from participation in federal health care programs.
−Removed: The foregoing description of the CIA is qualified in its entirety by the full terms of the CIA, which is attached as Exhibit 10.39 hereto and incorporated herein by reference.
+Added: The CIA, which expired in October 2025, subjected us to certain compliance, monitoring, reporting, certification, oversight and training obligations.
+Added: On January 23, 2026, we received a letter from OIG that signaled formal completion of the CIA.
+Added: We intend to continue our compliance program with continual improvements tailored to the nature of our medical device business.
Regulatory Approvals .
19 unchanged sentences
Finally, even after regulatory approval or clearance, Merit is subject to several laws, rules and regulations, and the failure to comply with any applicable laws, rules or regulations at any time during the lifecycle of a product, including without limitation, after approval or clearance, may subject us to a variety of administrative or judicial proceedings, penalties or sanctions, including refusal by the applicable regulatory authority to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.
−Removed: With respect to regulatory approvals for the Wrapsody Device, in May 2020, we received the CE mark and in December 2024, we received premarket approval from the FDA.
−Removed: We continue to seek regulatory approvals for the Wrapsody Device in other jurisdictions.
−Removed: We are conducting a large, multinational pivotal human clinical trial of the Wrapsody Device, which was required for us to obtain approval from the FDA and is required by some foreign regulatory agencies.
−Removed: Human clinical trials of a medical device are often required for regulatory clearance or approval for devices and are expensive, time-consuming and uncertain.
Quality System Requirements.
1 unchanged sentence
laws require us to comply with quality system regulations (“QSR”) pertaining to all aspects of our product design, purchasing and supplier controls, manufacturing, distribution, servicing, complaint handling, corrective and preventive action and internal quality system audits.
−Removed: The FDA, Notified Bodies, and foreign regulators enforce these requirements through periodic inspections of medical device manufacturers.
+Added: The FDA, Notified Bodies, and foreign regulators enforce these requirements through
+Added: periodic inspections of medical device manufacturers.
These requirements are complex, technical and require substantial resources to remain compliant.
28 unchanged sentences
The FDA also regularly inspects companies to determine compliance with the QSRs and other post-market requirements.
−Removed: Please refer to our discussion of
−Removed: the risks and uncertainties associated with these post-market requirements under the heading “ The FDA regulatory clearance process is extensive and dynamic, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.” set forth in Item 1A “Risk Factors.”
+Added: Please refer to our discussion of the risks and uncertainties associated with these post-market requirements under the heading “ The FDA regulatory clearance process is extensive and dynamic, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.” set forth in Item 1A “Risk Factors.”
Reimbursement.
71 unchanged sentences
The state laws also compel companies to post clear privacy policies that detail the types of personal information they collect about consumers, with whom they share this data, and how consumers can control their personal data.
−Removed: We post on our websites our privacy
−Removed: notices, policies and practices regarding the collection, use and disclosure of user data, as well as providing our privacy policies to our employees (including job applicants) by linking to the Merit privacy policy (posted on the Merit website) from our Employee Handbook and our job application board.
−Removed: Any failure, or perceived failure, by us to comply with our posted privacy notices or policies or with any applicable regulatory requirements or orders, or privacy, data protection, information security or consumer protection-related privacy laws and regulations in one or more jurisdictions could result in proceedings or actions against us by governmental entities or others, including class action privacy litigation in certain jurisdictions, subject us to significant fines, penalties, judgments and negative publicity, require us to change our business practices, increase the costs and complexity of compliance, and adversely affect our business.
+Added: We post on our websites our privacy notices, policies and practices regarding the collection, use and disclosure of user data, as well as providing our privacy policies to our employees (including job applicants) by linking to the Merit privacy policy (posted on the Merit website) from our Employee Handbook and our job application board.
+Added: Any failure, or perceived failure, by us to comply with our posted privacy notices or policies or with any applicable regulatory requirements or orders, or privacy, data protection, information security or consumer protection-related privacy laws and regulations in one or more jurisdictions could result in proceedings or actions against us by governmental entities or, in some jurisdictions, individuals, including class action privacy litigation, subject us to significant fines, penalties, judgments and negative publicity, require us to change our business practices, increase the costs and complexity of compliance, and adversely affect our business.
Because privacy and data security laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.
11 unchanged sentences
Additionally, repeated sterilization to address such risks is not possible because it may adversely affect the quality of the materials used in many of our products and result in the failure of our product to function properly if used in multiple medical procedures.
−Removed: Consequently, many of our used products will likely end up in a medical waste disposal facility at the end of their usefulness.
+Added: Consequently, many of our used products will likely end up in regulated medical waste disposal facilities at the end of their usefulness.
We continually look for opportunities to deliver sustainable, long-term growth of our business.
3 unchanged sentences
Our sustainability values in action include:
−Removed: ● achievement of the International Organization for Standardization (“ISO”) 14001 certification at nine facilities including eight manufacturing facilities (eight in scope) and one large distribution facility (one in scope).
+Added: ● achievement of the ISO 14001 certification (international standard that specifies requirements for an effective environmental management system) at nine facilities including eight manufacturing facilities (eight in scope) and one large distribution facility (one in scope).
A key part of our ISO 14001 program is energy management which includes yearly energy reviews and procurement controls for energy efficient purchasing;
−Removed: (ISO 14001 is the international standard that specifies requirements for an effective environmental management system);
● establishment and support of employee gardens that promote pollination and provide farm-to-table nutrition for our employees at our headquarters in South Jordan, Utah;
6 unchanged sentences
This project saves millions of pieces of paper and thousands of plastic sleeves annually.
−Removed: Currently, our eWorq program is in place at three of our largest manufacturing sites and in 2024 we estimate that we eliminated 4,223,770 pages of paper.
+Added: Currently, our eWorq program is in place at five of our largest manufacturing sites.
+Added: We estimate that we eliminated 4,931,000 pages of paper during 2025.
We plan to continue implementing this program at our manufacturing facilities globally to eliminate as much paper as we can within our operations;
● recycling programs where we recycle materials, including food waste, paper, plastic, cardboard, beverage containers, scrap metal, and pallets;
+Added: ● Waste to energy (WtE) programs where we divert hard-to-recycle items from the landfill to certified WtE plants that utilize advanced pollution controls to burn the waste and create steam to drive turbines, resulting in the production of electricity and heat for homes and businesses;
● placement of free car charging stations for employees who have transitioned to electric vehicles;
3 unchanged sentences
To learn more about our sustainability programs and accomplishments, you may visit www.merit.com/about/corporate-sustainability/.
−Removed: As of December 31, 2024, we had approximately 7,400 employees located in approximately 40 different countries in a variety of different roles.
+Added: As of December 31, 2025, we had approximately 7,500 employees located in approximately 43 countries performing a variety of roles.
In the highly competitive medical device industry, we consider attracting, developing, and retaining talented people in technical, operational, marketing, sales, research, management, and other positions to be critical to our overall long-term growth strategy.
7 unchanged sentences
To further promote a culture of inclusion, during 2021 we started the Women’s Leadership Initiative (“WLI”), our first ever affinity group led by women and open to all Merit employees.
−Removed: The WLI contributes to our long-term strategies by promoting a culture of diversity, equity and inclusion through (i) sponsoring professional development activities focused on overcoming barriers and restraints to the advancement of women’s careers, (ii) facilitating external interactions with organizations and thought leaders, and (iii) providing resources focused on improving diversity, equity, and inclusion.
+Added: The WLI contributes to our long-term strategies by promoting a culture of inclusion through (i) sponsoring professional development activities focused on overcoming barriers and restraints to the advancement of women’s careers, (ii) facilitating external interactions with organizations and thought leaders, and (iii) providing resources focused on improving inclusion.
+Added: Through the WLI, the first global Strategic Leadership Program was launched in 2025 in partnership with the University of Utah and an external leadership development partner.
Employee Engagement.
The engagement of our workforce is critical to delivering on our competitive strategy, and we place high importance on informed and engaged employees.
−Removed: We communicate frequently with our employees through a variety of communication methods, including video and written communications, town hall meetings, and our company intranet, and we acknowledge individual contributions to Merit by celebrating milestones of service in five-year increments.
+Added: We communicate frequently with our employees through a variety of communication methods, including video and written communications, town hall meetings, and our company intranet, and we acknowledge individual contributions to Merit by celebrating milestones of service in five-year
Since 2021, we have substantially strengthened our employee communication capabilities through the addition of dedicated internal resources and programs aimed at doing even more to communicate with and engage our workforce.
−Removed: In partnership with the Gallup organization, in 2022 we launched our first ever global employee engagement survey.
−Removed: We repeated this employee engagement survey in 2024.
−Removed: This survey provided us with many insights into the engagement of
−Removed: our employees from which we have been able to develop action plans at the team and company level in order to further strengthen employee engagement.
−Removed: Additionally, for four consecutive years, our subsidiary in China has been recognized as a “China Top Employer” by the Top Employers Institute.
+Added: In partnership with the Gallup organization, in 2022 we launched our first ever global employee engagement survey and have continued this survey in each subsequent year, with increasing participation and engagement results.
+Added: This survey provides us with many insights into the engagement of our employees from which we have been able to develop action plans at the team and company level in order to further strengthen employee engagement.
+Added: The employee participation rate in the engagement survey reached a high of 93% in 2025.
+Added: Additionally, for five consecutive years, our subsidiary in China has been recognized as a “China Top Employer” by the Top Employers Institute.
This award reflects our unwavering commitment to excellence in human resources practices.
1 unchanged sentence
The Merit Way—Our Core Values.
−Removed: In 2024, Merit launched a new core values program known as “The Merit Way,” which is an employee culture initiative to preserve the workplace attributes that have contributed to Merit’s success while preparing the organization for the future.
−Removed: The Merit Way is further described with the acronym H.E.A.R.T.
+Added: In July 2025, Merit celebrated the one-year anniversary of the launch of our values program known as “The Merit Way,” which is an employee initiative designed to create a single global culture united by common values that honors Merit’s past and future.
+Added: The Merit Way values are described with the acronym H.E.A.R.T.
● H ealth – Committed to employee and patient well-being
3 unchanged sentences
● T eamwork – Collaborate and communicate to achieve a common goal.
−Removed: The Merit Way program aims to reinforce our purpose and create a consistent global culture with common terminology and expectations for all employees.
−Removed: The development of the Merit Way program was a cross-organizational effort which included interviews with employees and leaders, workshops across departments and survey feedback from over 5,000 employees.
+Added: In 2025, the Merit Way values were embedded in performance management recognition programs in addition to global and local communications.
Compensation and Benefits.
Because our mission is to create innovative medical devices that improve lives, we aim to hire and develop employees who want to build something special through hard work, team effort, and commitment.
−Removed: That is why we provide all our employees with competitive total rewards packages and strive to provide the most cost-effective medical benefits and wellness programs.
+Added: That is why we provide our employees with competitive total rewards packages and strive to provide the most cost-effective medical benefits and wellness programs.
As a result of our focus on competitive health and wellness benefits, we have achieved our tenth consecutive year of zero health care plan cost increases for our U.S.
employees who participate in our group healthcare plans.
−Removed: Our total rewards package include competitive pay, annual incentive awards and bonus opportunities, healthcare and retirement benefits, an Employee Stock Purchase Plan, paid time off and sick leave, paid parental leave, flexible work schedules, remote working opportunities, and a wellness program.
+Added: Our total rewards package includes competitive pay, annual incentive awards and bonus opportunities, healthcare and retirement benefits, an Employee Stock Purchase Plan, paid time off and sick leave, paid parental leave, flexible work schedules, remote working opportunities, and a wellness program.
Talent Development.
−Removed: In 2021, we hired our first ever Director of Global Talent Management who continues to be focused on building and strengthening global programs around strategic talent management, employee performance, development, succession planning and engagement.
−Removed: To improve employee performance, we have begun developing a global performance management program which we expect to officially implement in 2025 using our recently-launched human resources information system.
−Removed: Employee development programs are also being executed at different regional and local levels with a focus on management and leadership development.
+Added: Since 2021, we have been building and strengthening global programs around strategic talent management, employee performance, development, succession planning and engagement.
+Added: In 2025, we launched an automated global performance management program with a focus on The Merit Way values using our global HR information system.
+Added: Employee development programs are also being executed at different global and local levels with a focus on management and leadership development.
+Added: For example, we deployed Gallup’s “Conversations That Matter” training to more than 500 managers worldwide in our operations, quality assurance and research and development departments.
Our employees are actively involved in their communities and supporting causes.
2 unchanged sentences
Areas that our employees have supported in recent years include Breast Cancer Awareness Month, Heart Health Month, children’s charities and supporting those in need.
−Removed: In 2024, we continued our support of humanitarian missions through Merit product donations in Belize, Cape Verde, Ethiopia, Haiti, Honduras, Kenya, Mauritius, Nicaragua, Peru and Tanzania.
+Added: In 2025, we continued our support of humanitarian missions through Merit product donations in Belize, Honduras, Ethiopia, Peru, Tanzania, Haiti, Mauritius, Nicaragua, and Syria.
Merit also conducts and/or participates in medical education conferences around the globe.
−Removed: Wellness is at the foundation of creating a positive employee experience.
−Removed: At our company headquarters in Utah, we have an onsite medical clinic available for our employees and their families where we provide preventative and general medical care.
−Removed: We have a monthly wellness committee meeting and create a “Get Healthy” wellness program available to all sites across the globe.
+Added: Wellness is at the foundation of creating a positive employee experience and is the reason for “Health” being the first of the Merit Way values.
+Added: At both our company headquarters in Utah and at our largest manufacturing location in Tijuana, Mexico, we have an onsite medical clinic available for our employees and their families where we provide preventative and general medical care.
+Added: We have a monthly wellness committee meeting and create a “Get Healthy”
+Added: wellness program available to all sites across the globe.
Programs include providing health information from medical and nutrition experts, newsletters with wellness and dietary tips, and activities promoting health and wellbeing such as walking groups and fitness challenges.
11 unchanged sentences
Occupational Safety and Health Administration requirements.
−Removed: We have obtained ISO 45001 certification at six manufacturing facilities (eight in scope) and one distribution facility (one in scope).
−Removed: This is a globally recognized standard for employee occupational health and safety, established by the International Standards Organization, which provides a voluntary framework to identify key occupational health and safety aspects associated with our business helping to deliver continuous improvement.
−Removed: We plan to achieve this certification at our seventh and eighth in scope facilities by the end of 2025.
+Added: We have obtained ISO 45001 certification at eight manufacturing facilities (eight in scope) and one distribution facility (one in scope).
+Added: This is a globally recognized standard for employee occupational health and safety, established by the International Organization for Standardization, which provides a voluntary framework to identify key occupational health and safety aspects associated with our business helping to deliver continuous improvement.
We also have formal plans in place to protect our employee’s safety in the event of an emergency and maintain emergency action plans that employees receive training on annually.
17 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.