What changed in this filing

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Item 1. Business

2026-02-24 compared with 2025-02-27 · 90 added, 75 removed, 565 unchanged (23% of the section changed)

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We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS.

Our logistics services include aviation transportation, ground transportation, and other coordination activity.

Our transplant logistics services include aviation transportation, ground transportation, and other coordination activity.

We believe the use of the OCS combined with the NOP has the potential to significantly increase the number of organ transplants and improve post-transplant outcomes.

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Cold storage is a rudimentary approach to organ preservation in which a donor organ is flushed with cold pharmaceutical solutions, placed in a plastic bag on top of ice and transported in a cooler.

Cold storage subjects organs to significant injury due to a lack of oxygenated blood supply, or ischemia, does not allow physicians to assess organ viability and lacks the ability to optimize an organ’s condition once it has been retrieved from the donor.

Cold storage subjects organs to significant injury due to a lack of oxygenated blood supply, or ischemia.

Further, cold storage does not allow physicians to assess organ viability and lacks the ability to optimize an organ’s condition once it has been retrieved from the donor.

Time-dependent ischemic injury has been shown to result in short- and long-term post-transplant clinical complications and, together with the inability to assess or optimize organs, contributes to the severe underutilization of donor organs.

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the lung is breathing, the heart is beating and the liver is producing bile.

Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and offers the potential to significantly improve donor organ utilization.

Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and reported high donor organ utilization rates for transplants.

We developed the NOP to provide additional capabilities to transplant centers for the complicated organ procurement process that often requires resources and logistics beyond a transplant center’s existing capabilities and capacity, thereby limiting the number of organs the transplant center may be able to retrieve.

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and (v) the increased access to donor organs that are historically unutilized, all of which combine to make certain that TransMedics is able to provide the highest quality of service to transplant recipients, increasing the likelihood of success in the transplant process for each individual, and ultimately increasing the number of organs transplanted each year in the United States.

Since 2023, we have offered logistics services through our NOP, including aviation transportation, ground transportation, and other coordination activity that is capable of arranging procurement missions on limited notice and at various hours of the day.

Our NOP provides transplant centers with the

ability to utilize the OCS to procure and transplant more organs for their patients than they would otherwise be able to do without increasing their own staff.

Our transplant logistics services include aviation transportation, ground transportation, and other coordination activity that is capable of arranging procurement missions on limited notice and at various hours of the day.

Our NOP provides transplant centers with the ability to utilize the OCS to procure and transplant more organs for their patients than they would otherwise be able to do without increasing their own staff.

In August 2023, we acquired Summit Aviation, Inc.

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We have also acquired 22 fixed-wing aircraft to transport donor organs as part of the services offered under our NOP.

We intend to acquire additional fixed-wing aircraft as we scale our fleet of aircraft to reduce our dependence on third party transportation providers.

We intend to opportunistically evaluate acquisitions of additional fixed-wing aircraft to enhance our logistics capabilities and support international expansion.

We believe the OCS and the NOP drive significant benefits to all stakeholders in the field of organ transplantation.

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We are in the process of seeking long-term reimbursement for our products outside of the United States.

Our corporate headquarters, manufacturing and clinical training facilities are located in Andover, Massachusetts.

Our current corporate headquarters, manufacturing and clinical training facilities are located in Andover, Massachusetts.

In January 2026, we entered into an operating lease for premises in Somerville, Massachusetts to serve as our new corporate headquarters.

The lease term began in January 2026, and we expect to transition certain of our operations to the Somerville premises on or before January 1, 2028, with the goal of ultimately replacing our existing headquarters in Andover, Massachusetts.

We also have a geographically distributed team in the United States supporting our NOP and a designated maintenance hub for our aircraft in Dallas, Texas.

We have additional distribution and commercial operations in Europe.

As of December 31, 2024, we had 728 employees, most of whom were full-time and located in the United States.

We have additional distribution, commercial and research and development operations in Europe.

As of December 31, 2025, we had a total of 898 employees worldwide, most of whom were full-time and located in the United States.

We generated $605.5 million, $441.5 million and $241.6 million of total revenue during the years ended December 31, 2025, 2024 and 2023, respectively, representing year-over-year growth of 37.1% and 82.7% in 2025 and 2024, respectively.

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We developed our NOP to provide transplant programs with a more efficient process to procure donor organs with the OCS.

As we expect the number of transplants to increase and the procurement distance to extend, we believe the field will need alternatives to the previous model in which the recipient transplant center sends its team to the donor site for procurement.

The NOP is designed to support increasing numbers of transplants and extended procurement distances, and provides an alternative to the previous model in which the recipient transplant center sends its team to the donor site for procurement.

Our NOP provides a turnkey solution that leverages the technical advantage of the OCS and provides transplant centers with a more efficient way to increase their volume of transplants without significantly increasing resources.

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In order to receive FDA approval for our PMA products, we have conducted clinical trials with large numbers of patient participants, with the results of these trials published in leading medical journals.

We also continue to collect clinical data through post-market registries for all of our products and plan to continue to provide the scientific results of these registries to the clinical user community.

We also continue to collect clinical data

through post-market registries for all of our products and plan to continue to provide the scientific results of these registries to the clinical user community.

We expect to continue to build new clinical evidence through new programs to demonstrate the clinical value of product enhancements.

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thus, there are no means for evaluating the suitability of these organs for transplantation.

This further limits utilization of available organs as donor populations worldwide are growing older and have concomitant risk factors that benefit from sophisticated diagnostic evaluation capabilities to predict whether the donor organ is suitable and safe to transplant.

This further limits utilization of available organs as donor populations

worldwide are growing older and have concomitant risk factors that benefit from sophisticated diagnostic evaluation capabilities to predict whether the donor organ is suitable and safe to transplant.

Our Technology and Solution

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To date, we have developed three OCS products, one for each of lung, heart and liver transplantation.

We have initiated the development of the next generation multi-organ platform to improve the usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.

We have initiated the development of OCS Kidney, which is intended to be a smaller platform and include features such as automation and remote monitoring to enable longer preservation time and organ functional assessment.

OCS Kidney will leverage our third generation, or Gen-3, multi-organ platform, which is being developed to improve the OCS usability, incorporate new technology, and further facilitate the use of OCS in our NOP.

Each OCS product consists of three primary components customized for each organ:

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Since its inception in 2021, the NOP has accelerated adoption of the OCS, and we believe this program has the potential to maximize utilization of donor organs for transplantation and, by standardizing the quality of use of the OCS, deliver better clinical outcomes.

• Develop the next generation OCS technology platform to improve user experience and facilitate our NOP.

We are developing the next generation multi-organ platform to improve the usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.

In 2025, we expect the initial next generation OCS improvements in the OCS Lung and OCS Heart products to be introduced to the clinical setting through the enrollment of several new clinical trials.

• Expand internationally by accessing national reimbursement for OCS in key European countries.

We have begun to add resources in Europe focused on commercial expansion and market access.

We believe international expansion will be an additional growth driver for us in the long-term.

• Develop the next generation and Gen-3 OCS technology platforms, including expansion into additional organs, to improve user experience and facilitate our NOP.

In 2025, we introduced next generation OCS improvements in the clinical setting for OCS Lung and OCS Heart through the enrollment of two new clinical trials.

The clinical programs are intending to generate new clinical evidence aimed at demonstrating superiority of OCS to static cold storage methods while additionally showing improved donor organ function beyond preservation and enabling safe, reproducible scheduled heart and lung transplants.

In addition, we are developing the Gen-3 multi-organ platform to improve the OCS usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.

The OCS Kidney will leverage Gen-3 technology and is intended to be a smaller platform, and include features such as automation and remote monitoring, with the objective of enabling longer preservation time and facilitating functional assessment of donor kidney.

• Expand internationally in key European countries.

We believe international expansion could represent an additional growth driver for us in the long-term.

We have begun to add resources in Europe focused on commercial expansion and market access, including the introduction of NOP in certain regions.

In the second half of 2025, we initiated activities related to the expansion of our logistics network in certain European regions to support the offering of our NOP, including infrastructure required for organ transplantation ground transportation services in Italy.

We currently conduct research and development activities in Mirandola, Italy and we plan to construct research and development and manufacturing facilities in Italy to further expand our capabilities in Europe.

Commercialization

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our NOP and a direct acquisition model.

Our NOP enables transplant centers to outsource the organ procurement, OCS perfusion management and transplant logistics process to our trained organ procurement surgeons, clinical specialists and transplant and logistics coordinators using our OCS products.

Our offering allows the transplant center to focus their internal resources on the transplant surgery and patient care.

Utilizing our NOP saves the transplant center from investing in additional resources to support higher volumes and longer distance procurements.

Since the launch of the NOP, our sales of the OCS have primarily been through the NOP.

Since the launch of the NOP in the U.S., our sales of the OCS have primarily been through the NOP.

Our direct acquisition model is provided to transplant centers to train their own teams for organ procurement and OCS perfusion management on the OCS.

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Customers in the direct acquisition channel keep inventory of OCS disposables available and order replenishment as they are used.

All of our international customers and a small number of our U.S.

customers purchase our OCS products through the direct acquisition model.

Through 2025, all of our international customers and a small number of our U.S.

customers purchased our OCS products through the direct acquisition model.

Reimbursement

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OCS Clinical Trial Overview Table

Next-Generation OCS Trials

In August 2025 and January 2026, we received FDA approval under Investigational Device Exemptions, or IDEs, to initiate multi-part, prospective clinical trials for next-generation versions of our OCS Heart and OCS Lung systems, respectively.

The OCS Heart trial, referred to as the ENHANCE Heart trial, was initiated in the fourth quarter of 2025 and is designed to evaluate the performance of a next-generation OCS Heart platform under extended perfusion conditions and to further assess clinical outcomes relative to static cold storage in certain donor populations.

The ENHANCE Heart trial is structured as a multi-center, two-part clinical study and is expected to enroll more than 650 heart transplant recipients across participating centers.

Enrollment in the ENHANCE Heart trial is expected to occur over multiple years, with data available following the completion of each respective part of the trial.

The OCS Lung DENOVO trial is intended to evaluate the performance of the modified OCS Lung system and may allow for claims of superiority on the label compared to static cold storage.

The DENOVO Lung trial is expected to enroll transplant recipients who meet protocol-defined eligibility criteria.

Enrollment is expected to commence following site activation and regulatory readiness, with clinical data anticipated to become available on a staged basis during the enrollment and follow-up period.

These trials are intended to support potential future regulatory submissions for our next generation OCS Heart and Lung Systems, including PMA supplements, and may enable expanded indications for use of our OCS Heart system.

Intellectual Property

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These patents, and any patents issued from pending patent applications, are expected to expire in 2039, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

We have requested patent term extension for one patent relating to the OCS Heart, U.S.

7,651,835, which, if granted, would expire in 2032.

Patent term extension for one patent relating to the OCS Heart, U.S.

7,651,835, was granted on July 2, 2025, extending the patent term to expire on March 13, 2032.

As of December 31, 2025, our patent portfolio relating to the OCS Liver or liver transplantation technology includes a family of issued and pending patent applications with claims that are generally directed to certain systems, including perfusion circuits for perfusing a liver ex vivo.

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This patent and any patents issued from pending patent applications are expected to expire in 2035, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

We have requested patent term extension for one patent relating to the OCS Liver, U.S.

10,076,112, which, if granted, would expire in 2035.

Patent term extension for one patent relating to the OCS Liver, U.S.

10,076,112, was granted on June 24, 2025, extending the patent term to expire on September 28, 2035.

As of December 31, 2025, our patent portfolio relating to the OCS Solutions or other solutions for transplantation systems includes families comprised of patents and patent applications with claims that are generally directed to compositions of certain perfusion fluids.

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In most countries, including the United States, the patent term is generally 20 years from the earliest filing date of a non-provisional patent application in the applicable country.

We cannot assure that patents will be issued from any of our pending applications or that, if patents are issued, they will be of sufficient scope or strength to provide meaningful protection for our technology.

Patents may not be issued from any of our pending applications and, if patents are issued, they may not be of sufficient scope or strength to provide meaningful protection for our technology.

Notwithstanding the scope of the patent protection available to us, a competitor could develop methods or devices that are not covered by our patents.

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In warm perfusion, the organs are functioning and metabolically active.

We are aware of only two other companies providing warm perfusion systems, OrganOx Limited and XVIVO Perfusion AB, both of which offer single-organ warm perfusion systems for the liver and lung, respectively.

We also compete with other cold preservation devices in this industry, such as those from Paragonix Tecchnologies, Inc.

Paragonix Technologies was acquired by Getinge in September 2024.

We are aware of only two other companies providing warm perfusion systems, OrganOx Limited, which was acquired by Terumo Corporation in October 2025, and XVIVO Perfusion AB, both of which offer single-organ warm perfusion systems for the liver and lung, respectively.

We also compete with other cold preservation devices in this industry, such as those from Paragonix Technologies, Inc., which was acquired by Getinge in September 2024.

We believe that our principal competitive factors include:

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• superior technology;

• our NOP, including clinical service and logistics services;

• our NOP, including clinical service and transplant logistics services;

• regulatory approvals for broad clinical indications of use;

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Research, Development and Clinical Trial Operations

Our research, development and clinical trial operations function consists of a dedicated clinical trial team that has trial management, data collection and biostatistics expertise.

Our product engineering function consists of multi-disciplinary engineering teams that have electrical, mechanical, systems and software engineering expertise.

Our regulatory function includes a team with both U.S.

and international medical device regulatory expertise and is supported by senior FDA regulatory advisors and outside legal counsel.

For the years ended December 31, 2024, 2023 and 2022 our research, development and clinical trials expenses were $56.0 million, $36.1 million and $26.8 million, respectively.

This team is focused on the following research, development and clinical trial activities:

• developing the next generation OCS;

• developing applications to expand the access and use of the data generated from the OCS;

• expanding the body of clinical evidence supporting the use of the OCS platform through pre-market clinical trials, post-market registries and scientific publications;

Our research, development and clinical trial operations function is focused on developing the next generation and Gen-3 OCS, including development of OCS products for additional organs;

improving incrementally the technology and manufacturing efficiency of our current platform;

• conducting research to investigate new clinical applications and uses for the OCS platform.

expanding the body of clinical evidence supporting the use of the OCS platform through pre-market clinical trials, post-market registries and scientific publications;

developing applications to expand the access and use of the data generated from the OCS;

and conducting research to investigate new clinical applications and uses for the OCS platform.

The function includes a dedicated clinical trial team that has trial management, data collection and biostatistics expertise.

Additionally, our product engineering function consists of multi-disciplinary engineering teams that have electrical, mechanical, systems and software engineering expertise.

Finally, our regulatory function includes a team with both U.S.

and international medical device regulatory expertise and is supported by senior ex-FDA regulatory advisors and outside legal counsel.

For the years ended December 31, 2025, 2024 and 2023 our research, development and clinical trials expenses were $69.1 million, $56.0 million and $36.1 million, respectively.

Manufacturing and Supply Chain Operations

We design and assemble our OCS Consoles and disposable OCS Perfusion Sets at our facility in Andover, Massachusetts.

We believe this facility’s capacity is sufficient to cover the next several years of forecasted demand.

We utilize two assembly shifts and we have the ability to add additional shifts to the cleanroom to further increase production capacity.

We manufacture our sterilized disposable OCS Perfusion Sets in an ISO class 7 cleanroom.

We plan to move into our new corporate headquarters on or before January 1, 2028, and the new facility is expected to provide additional manufacturing and assembly space and infrastructure to support our operations over time.

We may continue to utilize certain functions of our existing facility in connection with our operations.

We believe the capacity of these facilities is sufficient to cover the next several years of forecasted demand.

We rely on third parties to sterilize our products prior to sale.

We source many of the components for the OCS Console and OCS Perfusion Sets from third-party suppliers that are required to manufacture and test them according to our specifications.

We purchase some of the components of the OCS Console and OCS Perfusion Set from single-source suppliers and, in a few cases, sole-source suppliers.

We rely on third parties to sterilize our products prior to sale.

We source the OCS Solutions using our proprietary formulas from third-party suppliers.

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Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent and regulatory controls needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and/or the user and are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events and device malfunctions, and truthful and non-misleading labeling, advertising, and promotional materials.

Class I includes devices with the lowest risk to the patient and/or the user and are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation, or QMSR (that recently replaced the Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events and device malfunctions, and truthful and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting a substantial equivalence determination that provides permission to commercially distribute the device.

of the FDCA requesting a substantial equivalence determination that provides permission to commercially distribute the device.

The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

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The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ manufacturing facility or facilities to ensure compliance with the QSR and, in some cases, will audit the applicant and clinical sites as part of its Bioresearch Monitoring program.

In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ manufacturing facility or facilities to ensure compliance with the QMSR and, in some cases, will audit the applicant and clinical sites as part of its Bioresearch Monitoring program.

During the PMA review, the FDA assesses whether the data and information in the PMA constitute valid scientific evidence to support a determination that there is a reasonable assurance that the device is safe and effective for its intended use(s) based on the proposed labeling.

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Clinical trials are almost always required to support a PMA application and may be necessary to support PMA supplements for additional indications or modified versions of a marketed device product.

All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of study review and approval, informed consent, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of study review and approval, informed consent, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

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• establishment registration and device listing with the FDA;

• QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

• QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

• labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

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• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Our manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master record, device history file, and complaint files.

By February 2, 2026, we are required to transition to the Quality Management System Regulation, or QMSR, that FDA issued in 2024 and that incorporates by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization ISO 13485:2016.

Our manufacturing processes are required to comply with the applicable portions of the QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.

The QMSR also requires, among other things, maintenance of records and documentation to meet the requirements of the QMSR.

The QMSR recently replaced the QSR to harmonize and modernize the regulatory requirements for devices in the U.S.

with those used by regulatory authorities in other jurisdictions, primarily through incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization ISO 13485:2016.

As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with the QSR or other applicable regulatory requirements could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

Our failure to maintain compliance with the QMSR or other applicable regulatory requirements could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

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Compliance with a harmonized standard developed to implement a GSPR also creates a rebuttable presumption that the device satisfies that essential requirement.

To date, the European Commission has harmonized a limited number of standards, including, for example, standards of sterilization, biological evaluation, the quality management system, etc.

To date, the European Commission has harmonized certain standards, including, for example, standards of sterilization, biological evaluation, the quality management system, etc.

but will continue to harmonize more standards going forward.

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These include obligations to have in place quality management, post-market surveillance and vigilance systems.

These requirements include that the manufacturer must report to the relevant national competent authorities any serious incident involving devices made available on the market and any field safety corrective action in respect of devices made available on the market or undertaken in a third country in relation to a device made available on the market.

These requirements include that the manufacturer must report to the relevant national competent authorities (a) any serious incident involving devices made available on the EU market and (b) any field safety corrective action (i) in respect of devices made available on the EU market or (ii) undertaken in a third country in relation to a device made available on the EU market if the reason for such action is not limited to the device made available in the third country.

Additionally, the manufacturer of high risk devices must submit periodic safety update reports to its notified body and manufacturers of lower risk devices must maintain periodic safety update reports as part of the technical documentation for their products.

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The MHRA is also responsible for the designation and monitoring of UK approved bodies (the equivalent of EU notified bodies).

Since May 26, 2021, the MDR has applied throughout EU and Northern Ireland.

As the MDR took effect after the UK left the European Union, it was not retained and therefore does not apply in Great Britain (England, Wales and Scotland).

Since May 26, 2021, the MDR has applied throughout the EU and Northern Ireland.

As the MDR took effect after the UK left the European Union, it was not retained in UK law and therefore does not apply in Great Britain (England, Wales and Scotland).

It applies in Northern Ireland under the terms of the Northern Ireland Protocol.

In the United Kingdom medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), or the UK MDR, which give effect to the MDD and associated EU legislation which has since been repealed and replaced in the European Union by the MDR.

This means that the route to market of medical devices in Great Britain is based on the requirements derived from pre-existing directly applicable EU legislation prior to the UK’s exit from the EU.

Despite the MDR not applying in Great Britain, the UK MDR provides a transitional period that allows manufacturers to place devices CE marked under the MDR (including their relevant transition periods), on the market in Great Britain potentially up until June 30, 2030, depending on the class of device.

Since January 1, 2021 (when the Brexit transition period ended), there have been a number of changes, introduced through secondary legislation, on how medical devices are placed on the market in Great Britain (England, Wales and Scotland).

Despite the MDR not applying in Great Britain, the UK MDR provides a transitional period that allows manufacturers to place devices CE marked under the MDR on the market in Great Britain potentially up until June 30, 2030.

Since January 1, 2021 (when the Brexit transition period ended), there have been a number of changes, introduced to the UK MDRs, which regulate how medical devices are placed on the market in Great Britain.

These include:

• a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market;

• all medical devices, including in vitro diagnostic medical devices, or IVDs, custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market;

• medical device manufacturers based outside the UK who wish to place a device on the Great Britain market need to appoint a single UK Responsible Person for all devices who will act on their behalf to carry out specified tasks, such as registration.

• a Great Britain-specific pathway to market which involves product marking with the UKCA mark, potentially involving a UK Approved Body, depending on the class of device;

• an obligation to register all medical devices, including in vitro diagnostic medical devices, or IVDs, custom-made devices and systems or procedure packs, with the MHRA before they are placed on the Great Britain market;

• an obligation on medical device manufacturers based outside the UK who wish to place a device on the Great Britain market to appoint a single UK Responsible Person for all devices who will act on their behalf to carry out specified tasks, such as registration.

We have appointed a UK Responsible Person for our devices in the UK.

• the EU no longer recognizes UK Notified Bodies and UK Notified Bodies are not able to issue CE certificates.

(Following Brexit, certificates issued by our UK notified body (BSI UK) were no longer recognized for CE marking purposes.

BSI Netherlands thus reissued the certificates that allow CE marking of the OCS products);

• UK Notified Bodies can apply to be designated as UK Approved Bodies.

UK Approved Bodies can issue UKCA marking certificates.

The UK Government recently proposed new post-market surveillance legislation and is currently consulting on proposed changes to pre-market medical device regulation under the UK MDR 2002.

The UK Government recently adopted new post-market surveillance legislation (through amendments to the UK MDR) and plans to adopt further changes to pre-market medical device regulation in 2026.

The UK Government also plans to consult on the indefinite recognition of the CE mark for medical devices placed on the market in Great Britain.

Clinical Investigations

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The manufacturer must also ensure their device meets appropriate standards of safety and performance for as long as it is in use.

The advertising and marketing of medical devices is governed in the UK by both legislation and self-regulatory codes of practice.

The advertising and marketing of medical devices is governed in the UK primarily by self-regulatory codes of practice.

The MHRA Enforcement of Medical Device Regulations in the UK

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Many countries in which we operate have laws with extra-territorial effect—those laws apply to our operations outside the relevant country, to the extent they are breached.

Examples of such laws include the Foreign Corrupt Practices Act, or the FCPA, the UK Bribery Act 2010 and the General Data Protection Regulation, or the GDPR.

Examples of such laws include the Foreign Corrupt Practices Act, or the FCPA, the UK Bribery Act of 2010, or the Bribery Act, and the General Data Protection Regulation, or the GDPR.

The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state.

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Our human capital strategy is comprehensive and leverages our work practices and collaborative culture.

As of December 31, 2024, we employed 728 people globally, most of whom were full-time employees.

As of December 31, 2025, we employed 898 people globally, most of whom were full-time and located in the United States.

We strive to foster a global, engaging, and safe work environment where employees want to grow their careers.

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We provide employee benefits to eligible employees to promote personal health and well-being and to provide certain financial security and protection upon retirement or in the event of death, disability or illness.

These benefits to eligible employees include a 401(k) retirement plan with an employer matching contribution, health insurance (including medical, dental, and vision), life insurance, short- and long-term disability insurance, and paid time off policies.

We offer an employee stock purchase plan to facilitate broad-based stock ownership by our employees.

Career Development:

We are proud to have a work environment that promotes continued development for our employees.

Each employee is provided formal written feedback, at least annually, and together with his/her manager, develops individual goals that are derived from our overall corporate and financial goals.

Employees are provided with formal written feedback, at least annually, and together with their manager, develop individual goals that are derived from our overall corporate and financial goals.

Moreover, we collaborate with our employees to provide customized career development plans as well as general and targeted training curricula based on their roles.

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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.

What changed 10-K

Item 1. Business