What changed in this filing

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Item 1. Business

2025-02-27 compared with 2024-02-27 · 102 added, 112 removed, 538 unchanged (28% of the section changed)

We are a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states.

We are a medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states.

We developed the OCS to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide.

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As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment.

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

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.

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To date, we have developed three OCS products, one for each of heart, lung and liver transplantations, making the OCS the only FDA approved, portable, multi-organ, warm perfusion technology platform.

All three of our products, OCS Heart, OCS Lung and OCS Liver, have received Pre-Market Approval, or PMA, from the Food and Drug Administration, or FDA, for both organs donated after brain death, or DBD organs, and organs donated after circulatory death, or DCD organs.

All three of our products, OCS Heart, OCS Lung and OCS Liver, have received Pre-Market Approval, or PMA, from the FDA, for both organs donated after brain death, or DBD organs, and organs donated after circulatory death, or DCD organs.

Incidence of end-stage organ failure has been rapidly rising worldwide due to demographic trends that contribute to chronic diseases.

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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.

Our NOP provides trained organ procurement surgeons, clinical specialists and transplant coordinators that provide an end-to-end clinical solution using our OCS technology.

In 2023, we enhanced our NOP offering to include logistics services with the addition of a logistics team to expand our transportation logistics capabilities.

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

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.

On August 16, 2023, we acquired Summit Aviation, Inc.

Our NOP provides an end-to-end service offering delivering organs from anywhere in the United States on-demand directly to transplant centers leveraging our proprietary OCS technology, trained organ procurement surgeons and clinical specialists, and specially designed and dedicated air and ground transport logistics network.

Our end-to-end service offering is necessary to ensure:

(i) the successful execution of procuring and delivering healthy organs;

(ii) the availability of the necessary surgical and clinical resources;

(iii) that the highest transportation safety standards are met;

(iv) the sharing of cost efficiencies and reducing cost burden of DCD donors that do not progress to become donors;

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.

In August 2023, we acquired Summit Aviation, Inc.

and Northside Property Group, LLC, or together Summit.

Summit was a charter flight operator based in Bozeman, Montana.

The acquisition enabled us to add aircraft transportation services to our NOP and become a comprehensive national provider of donor organ retrieval and delivery in the United States.

The acquisition enabled us to add aircraft transportation services to our NOP and become a comprehensive national provider of donor organ procurement and delivery in the United States.

We have also acquired 21 fixed-wing aircraft to transport donor organs as part of the services offered under our NOP.

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

We also have a geographically distributed team in the United States supporting our NOP.

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.

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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 retrieval distance to extend, we believe the field will need alternatives to the current model in which the recipient transplant center sends its team to the donor site for retrieval.

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.

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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The donor site may not be easily accessible and the distance to travel from donor to recipient may be very long.

The expansion of our NOP to provide our own transportation logistics services, including 100% owned and operated private aircraft dedicated to organ retrieval, further improves the efficiency of utilizing the NOP as a complete solution for organ procurement.

The expansion of our NOP to provide our own transportation logistics services, including 100% owned and operated private aircraft dedicated to organ procurement, further improves the efficiency of utilizing the NOP as a complete solution for organ procurement.

• Significant body of strong clinical evidence

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

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

• Strong relationship with the clinical transplant community

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We have developed strong clinical relationships with many of these centers through their participation in our clinical trials and their commercial utilization of our products and services.

In addition, many transplant surgeons at our clinical trial locations may have moved to new centers, bringing their OCS experience with them and allowing our relationships to grow to these new centers.

In addition, many transplant surgeons at our clinical trial or commercial customer locations may have moved to new centers, bringing their OCS experience with them and allowing our relationships to grow to these new centers.

• Expertise in transplant reimbursement and billing

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• customized hemodynamics sensors to monitor and assess organ function outside of the human body;

• proprietary software-controlled, miniaturized, electromechanical system with universal power supply and hot-swappable batteries to maximize portability and travel distance for organ retrieval;

• proprietary software-controlled, miniaturized, electromechanical system with universal power supply and hot-swappable batteries to maximize portability and travel distance for organ procurement;

• proprietary wireless monitor and control software to provide an intuitive user interface for monitoring critical organ function;

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• Significant reduction in ischemia

Decreases current time and distance limitations on organ transport while also increasing the currently limited time period for retrieval during which high quality transplant outcomes can reliably be obtained.

Decreases current time and distance limitations on organ transport while also increasing the previously limited time period for procurement during which high quality transplant outcomes can reliably be obtained.

This maximizes organ utilization and enables increased access to organ transplantation, while also meaningfully improving post-transplant outcomes.

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We are focused on driving adoption of the OCS and NOP at leading, high volume transplant programs as well as expanding utilization to medium and smaller centers that can utilize OCS and NOP to provide transplants to more patients.

• Grow our NOP, a turnkey solution to provide outsourced organ retrieval, OCS organ management and logistics services, to provide transplant programs with a more efficient process to procure donor organs with the OCS.

• Grow our NOP, a turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs with a more efficient process to procure donor organs with the OCS.

Our NOP leverages our clinical, logistical and transportation capabilities to provide access to and use of the OCS for transplant centers throughout the United States.

We believe this program has the potential to accelerate adoption of the OCS, maximize utilization of donor organs for transplantation and, by standardizing the quality of use of the OCS, deliver better clinical outcomes.

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 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.

In addition, in August 2023, we acquired certain assets related to lung and heart perfusion technology from Bridge to Life, and we intend to further develop these technologies to expand our product offerings and indications for organ transplantation.

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 the development of required comprehensive material for various national healthcare systems throughout Europe.

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.

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our NOP and a direct acquisition model.

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

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 retrievals.

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.

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

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

Customer users are certified on the use of OCS at our training facility.

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Some states establish a global payment for the transplant and organ acquisition costs, and some states have separate payments for the inpatient stay based on the MS-DRG system and for organ acquisition costs.

Private insurers typically have agreements as to how they reimburse for the transplant costs and the organ acquisition costs,

which may be through a global payment for both, or a payment for the transplant and a separate mechanism for paying for organ acquisition costs.

Private insurers typically have agreements as to how they reimburse for the transplant costs and the organ acquisition costs, which may be through a global payment for both, or a payment for the transplant and a separate mechanism for paying for organ acquisition costs.

Nearly half of U.S.

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pivotal trials and have provided reimbursement for the OCS Lung, OCS Heart and OCS Liver following their FDA approvals.

This has established multiple years of billing precedent.

This has established a history of billing precedent.

We believe these established methods will continue to facilitate commercial reimbursement for the OCS Lung, OCS Heart and OCS Liver.

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however, reimbursement decisions are required in each individual country and may require national health systems to review and approve OCS reimbursement for each organ-specific product.

Currently, national healthcare systems do not reimburse transplant centers for the use of the OCS and reimbursement in international markets may require us to undertake additional clinical studies.

However, international hospitals using the OCS currently pay for the OCS from their hospital budget or charitable funds.

Currently, there are a few areas of national reimbursement for use of OCS for transplant.

Most notably, reimbursement is in place in the UK and the Netherlands for DCD heart transplant.

However, most national healthcare systems do not reimburse transplant centers for the use of the OCS and additional reimbursement in international markets may require us to undertake additional clinical studies.

Some international hospitals using the OCS currently pay for the OCS from their hospital budget or charitable funds.

We are in the process of seeking long-term reimbursement for our OCS products in several jurisdictions.

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As of December 31, 2024, our patent portfolio relating to the OCS Lung or lung transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a lung ex vivo using both perfusion and ventilation.

Such patents are issued in the United States, Australia, Belgium, Canada, China, Denmark, Europe, France, Germany, Ireland, Israel, Italy, Japan, Hong Kong, Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and patent applications are pending in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, Japan and New Zealand.

Such patents are issued in the United States, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Europe, France, Germany, Ireland, Israel, Italy, Japan, Hong Kong, Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and patent applications are pending in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, Japan and under the Patent Cooperation Treaty.

These patents, and any patents issued from pending patent applications, are expected to expire in 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

As of December 31, 2024, our patent portfolio relating to the OCS Heart or heart transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a heart ex vivo.

Such patents are issued in the United States, Australia, Belgium, Canada, China, Denmark, Europe, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and patent applications are pending in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, Japan, and New Zealand.

Such patents are issued in the United States, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Europe, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and patent applications are pending in the United States, Australia, Brazil, Canada, China, Europe, Israel, Japan, and New Zealand.

These patents, and any patents issued from pending patent applications, are expected to expire in 2038, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

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As of December 31, 2024, 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.

Such patents are issued in the United States and Australia, and applications are pending in the United States, Australia, Canada, China, Hong Kong, Israel, Japan and New Zealand.

Such patents are issued in the United States, Austria, Australia, Belgium, Canada, China, Czech Republic, Denmark, Europe, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and applications are pending in the United States, Australia, Canada, Israel and Japan.

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.

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As of December 31, 2024, 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.

Such patents are issued in the United States, Australia, China, Israel, Japan, New Zealand and patent applications are pending in the United States, Canada, China, Europe, Hong Kong, and New Zealand.

Such patents are issued in the United States, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Europe, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Spain, Sweden and United Kingdom, and patent applications are pending in the United States, Canada, China, Europe and Hong Kong.

These patents, 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.

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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 believe that our principal competitive factors include:

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• regulatory approvals for broad clinical indications of use;

• ease of integration into current organ retrieval workflow, including system portability across all modes of transportation;

• ease of integration into current organ procurement workflow, including system portability across all modes of transportation;

• platform capabilities designed to support multiple organ transplant programs;

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

We have recently increased the size of our manufacturing facility at the Andover site to increase our manufacturing capacity to meet current and future demand.

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

We have added a second shift to our existing cleanroom and we have the ability to add additional shifts to the new, expanded, cleanroom to further increase production capacity.

We manufacture our sterilized disposable OCS Perfusion Sets in a class 10,000 cleanroom.

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 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.

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Fresenius is our single-source supplier of OCS Solutions for the OCS Lung and OCS Heart.

Our agreement with Fresenius for the supply of OCS Lung Solution was previously through April 2024 and was automatically extended for 24 months through April 2026.

Upon expiration the agreement will continue to extend for subsequent periods of 24 months each, unless terminated by either party at least 12 months prior to the end of the initial term or the then-current extension term.

Our agreement with Fresenius for the supply of OCS Lung Solution had an original term through April 2024 and was automatically extended for an extension term through April 2026.

Upon expiration of the extension term, the agreement will continue to extend for subsequent periods of 24 months each, unless terminated by either party at least 12 months prior to the end of the then-current extension term.

We may also terminate this agreement with 12 months’ notice if we request that Fresenius qualifies a second manufacturing plant or qualifies a reputable third party to manufacture the OCS Lung Solution and Fresenius fails to respond to this request.

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Product Regulation

Our OCS products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in the European Union and other countries.

Our OCS products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable international authorities including, but not limited to, those in the European Union.

Our products are subject to regulation as medical devices under the Federal Food, Drug and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.

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Regardless of whether we have or are required to obtain FDA clearance or approval for a product, we will be required to obtain the relevant authorizations/approvals before commencing clinical trials/investigations and to obtain the necessary authorizations, approvals or certifications of our products under the comparable regulatory authorities of countries outside of the United States before we can commence clinical trials/investigations or commercialize our products in those countries.

In the European Union, the manufacturer of a device must affix a Conformité Européene mark, or CE Mark, which allows the device to be placed on the market anywhere in the EU and additional Member States of the European Economic Area, or EEA, (i.e ., Norway, Lichtenstein and Iceland).

The EU CE mark is also recognized in Turkey and, for a transitional period following the UK’s withdrawal from the European Union, referred to as Brexit, in the United Kingdom.

The authorization/approval processes for devices outside the European Union will vary from country to country and the time may be longer or shorter than that required for FDA clearance or approval or EU CE marking.

In the European Union, the manufacturer of a medical device must affix a Conformité Européene mark, or CE mark, after the device in question has successfully passed a conformity assessment to establish its safety and device characteristics.

The CE mark allows the device to be placed on the market anywhere in the EU and additional Member States of the European Economic Area, or EEA, (i.e ., Norway, Lichtenstein and Iceland).

The CE mark is also recognized in Turkey and, for a limited transitional period following the UK’s withdrawal from the European Union, referred to as Brexit, in the United Kingdom.

FDA Premarket Clearance and Approval Requirements

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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.

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

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In the European Union, our products are regulated as medical devices.

Regulation of our medical devices in the European Union is harmonized through Regulation (EU) 2017/745, or the MDR, which repealed and replaced the Medical Devices Directive (93/42/EEC) with effect from May 26, 2021.

However, the competent authorities in each member state enforce the standards set out in the MDR against relevant economic operators (including the manufacturer, importer, authorized representative and distributors) making medical devices available in the member state (although, under the MDR there are provisions for national competent authorities to inform other competent authorities, the European Commission and Notified Bodies, as applicable, of certain non-compliances).

Regulation of medical devices in the European Union is harmonized through Regulation (EU) 2017/745, or the MDR, which repealed and replaced Directive 93/42/EEC on medical devices, or the MDD, with effect from May 26, 2021.

The national competent authorities in each member state oversee and enforce compliance with the standards set out in the MDR against relevant economic operators (including device manufacturers, importers, authorized representatives and distributors).

Under the MDR, national competent authorities can inform other national competent authorities, the European Commission and Notified Bodies, as applicable, of certain non-compliances.

Under the MDR, a medical device placed on the market in the European Union must meet the applicable General Safety and Performance Requirements, or GSPRs, laid down in Annex I of the MDR.

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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.

Currently the European Commission has only harmonized a relatively limited number of standards (these include, for example, standards of sterilization, biological evaluation, the quality management system, etc.

) but the Commission will continue to harmonize more standards.

To demonstrate compliance with the GSPRs, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

Conformity assessment procedures require an assessment of available clinical evidence, literature data for the product and post-market experience in respect of similar products already marketed.

For all devices other than low risk devices ( i.e.

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.

but will continue to harmonize more standards going forward.

To demonstrate compliance with the GSPRs, medical device manufacturers must undergo a conformity assessment procedure, the specifics of which vary according to the type of medical device and its classification.

Conformity assessment procedures involve an assessment of available clinical evidence, literature data for the product and post-market experience in respect of similar products already marketed.

For all medical devices other than low risk devices ( i.e.

, Class I non-sterile, non-measuring devices), a conformity assessment procedure requires the intervention of a notified body.

The notified body must audit and examine a product’s technical dossier and the manufacturer's quality system.

If satisfied that the relevant product conforms to the relevant GSPRs, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

Notified bodies are independent organizations which audit and examine a product’s technical dossier and the manufacturer's quality system.

If satisfied that the relevant medical device conforms to the relevant GSPRs, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer may then affix the CE mark to the device, which allows the device to be placed on the market throughout the European Union (and by extension the European Economic Area).

Once the product has been placed on the market in the European Union, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with the medical device.

Once the device has been placed on the market in the European Union, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with its use.

The notified body has ongoing audit rights and must be notified of all significant changes to the device.

Although the MDR now applies so all new devices placed on the market must be CE marked under it, under the transition period granted by the MDR, certificates issued by notified bodies for medical devices under the Medical Devices Directive before May 26, 2021 may remain valid and the devices may continue to be placed on the EU market potentially until the end of December 2027 or 2028 (depending on the class of device) and provided the manufacturer satisfies certain requirements, including that there are no significant changes in the design and intended purpose of these devices.

The requirements of the MDR are significantly more onerous than under the EU Medical Devices Directive.

The increased regulation includes the following:

• strengthening of the rules on placing devices on the market, by requiring more evidence substantiating safety and efficacy of the device and more detailed content in the technical documentation for each device;

• requiring a structured post-market clinical follow-up program for every medical device;

• necessitating more thorough post-market surveillance program, with an emphasis on active gathering and analyzing the data;

• establishing explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market and new responsibilities for distributors and importers;

• improving the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

• setting up a central database into which manufacturers and other economic operators are required to input data with the goal of providing EU competent authorities as well as provide patients, healthcare professionals and the public with comprehensive information on products available in the European Union;

• strengthening rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

All of our products that were previously certified under the EU Medical Devices Directive, including OCS Heart, OCS Lung, and OCS Liver systems, which includes the OCS Console, the OCS disposables, and the OCS solution additives, have now been recertified under the MDR.

We received the CE Mark for the OCS Liver combined with our solution additives under the MDR in May 2023, with an effective date of April 2023.

All of our medical devices that were previously certified under the MDD, including OCS Heart, OCS Lung, and OCS Liver systems, which includes the OCS Console, the OCS disposables, and the OCS solution additives, have been recertified under the MDR.

Clinical Investigations

Clinical evidence is required for most medium and high risk devices.

In some cases, a clinical study may be required to support the CE marking of a device.

A manufacturer that wishes to conduct a clinical study involving the device is subject to the clinical investigation requirements of the MDR, EU member state requirements, and current good clinical practices defined in harmonized standards and guidance documents.

Clinical investigations for medical devices cannot proceed without a positive opinion of an ethics committee and approval by or notification to the relevant national regulatory authorities.

Both regulators and ethics committees also require the submission of serious adverse event reports during a study and may request a copy of the final study report.

Clinical evidence is required for the conformity assessment of most medium and high risk devices.

In some cases, a clinical investigation may be required to support the CE marking of a device.

All clinical investigations involving medical devices must comply with the relevant requirements of the MDR, EU member state requirements, and current good clinical practices defined in harmonized standards and guidance documents.

Clinical investigations for medical devices cannot proceed without a positive opinion of an ethics committee and notification to the relevant national competent authorities.

Both national competent authorities and ethics committees also require the submission of serious adverse event reports during a study and may request a copy of the final study report.

Post-marketing Requirements

In the European Union, we are currently required to comply with strict post-marketing obligations that apply after a device is placed on the market.

These include the obligation to have in place a post-market surveillance system and vigilance system.

In the European Union, we are currently required to comply with strict post-marketing obligations.

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.

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.

Authorities in the European Union also closely monitor the marketing programs implemented by device companies.

National competent authorities in the European Union also closely monitor the marketing programs implemented by device companies.

The MDR prohibits making misleading claims, including promoting the product for or suggesting a use that is not part of its intended purpose.

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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 EU Medical Devices Regulation (Regulation 2017/745), or the EU MDR, has applied in EU Member States and Northern Ireland.

Further, the In Vitro Diagnostic Medical Devices Regulation (Regulation 2017/746), or the EU IVDR, has applied in EU Member States and Northern Ireland since May 26, 2022.

As these EU regulations took effect after the UK left the European Union, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not and will not apply in Great Britain (England, Wales and Scotland).

In the United Kingdom medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which give effect in UK law to the directives listed below (which have now been repealed and replaced in the European Union by the EU MDR and EU IVDR):

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)

• Directive 93/42/EEC on medical devices (EU MDD)

• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

This means that the Great Britain route to market is based on the requirements derived from the above EU legislation and is thus different to the route to market for the European Union.

However, although neither the EU MDR nor EU IVDR apply in Great Britain, the UK MDR 2002 provide a transitional period that allows manufacturers to place devices CE marked under the EU MDR or EU IVDR (including their relevant transition periods), on the market in Great Britain potentially up until June,30 2030.

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).

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).

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• 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.

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.

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

• UK Notified Bodies have become UK Approved Bodies.

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

UK Approved Bodies can issue UKCA marking certificates.

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

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.

Clinical Investigations

In order to demonstrate compliance with the essential requirements of the UK MDR 2002 and the general safety and performance requirements of the EU MDR, and in order to justify the application of UKCA/CE/CE UKNI marking, it will sometimes be necessary for the manufacturer of the device to provide clinical data with which to back up claims made for that device.

In order to demonstrate compliance with the essential requirements of the UK MDR and the GSPRs of the MDR, and in order to justify the application of UKCA/CE/CE UKNI marking, it will sometimes be necessary for the manufacturer of the device to provide clinical data with which to substantiate claims made for that device.

This may involve the need for a specifically designed clinical investigation to:

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• determine any undesirable side-effects and to assess whether these are acceptable risks when weighed against the intended performance of the device.

If such an investigation is necessary, and will be conducted in the UK, the manufacturer must make an application to the MHRA before the investigation is due to begin, and such a clinical investigation may only proceed provided no grounds for objection are raised by the MHRA within the statutory review time constraint.

The MHRA will reach a decision aided by a number of expert assessors.

It is the responsibility of the manufacturer both to notify the MHRA and to submit the documentation required by the UK MDR 2002 to the MHRA.

The clinical investigator will normally have no direct contact with the MHRA.

If such an investigation is necessary, and will be conducted in the UK, the manufacturer must submit a notification to the MHRA before the investigation is due to begin, and such a clinical investigation may only proceed provided no grounds for objection are raised by the MHRA within the statutory review time constraint.

The manufacturer must also obtain ethics committee approval for the investigation.

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The MHRA Enforcement of Medical Device Regulations in the UK

To ensure that medical devices placed on the market and put into service in the UK meet applicable regulatory requirements the MHRA perform the following activities:

• assess all allegations of non-compliance brought to them, using a risk-based system;

To ensure that medical devices placed on the market and put into service in the UK meet applicable regulatory requirements the MHRA will:

• conduct risk-based assessments of all allegations of non-compliance brought to their attention;

• monitor the activity of UK Approved Bodies designated by MHRA to assess the compliance of manufacturers;

• investigate medical devices as a result of adverse incident reports or intelligence indicating a potential problem.

If MHRA considers that a person or company has committed a serious offense by failing to comply with applicable regulations or the conditions of a notice issued then a person/company may be subject to prosecution.

If the MHRA considers that a person or company has committed a serious offense by failing to comply with applicable regulations or the conditions of a notice issued then a person/company may be subject to prosecution.

UK Regulations Applicable to Organs Intended for Transplantation

The standards for the quality and safety of organs for transplantation has been enacted into UK law through The Quality and Safety of Organs Intended for Transplantation Regulations 2012, as amended.

This Regulation allows for the establishment of a Competent Authority for the regulation of organ transplantation.

In the UK the Competent Authority is the Human Tissue Authority, which has published the “The Quality and Safety of Organs Intended for Transplantation:

This Regulation provided for the establishment of a competent authority for the regulation of organ transplantation, the Human Tissue Authority, or the HTA.

The HTA has published the “The Quality and Safety of Organs Intended for Transplantation:

a documentary framework” which details mandatory requirements as well as guidance on how those requirements may be met.

While we are not directly affected by this Regulation and guidelines, our UK customers are, and our products may either help or impede their compliance with this Regulation.

While we are not directly affected by this regulation and guideline, our UK customers are, and our products may either help or impede their compliance with this regulation.

Regulation in Other Countries

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• content and language of instructions for use;

• clinical trials;

• clinical trials/investigations;

• record keeping procedures;

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• necessity of testing performed in country by distributors for licensees.

The time required to obtain clearance by foreign countries may be longer or shorter than that for FDA clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

The time required to obtain marketing authorization in foreign countries may be longer or shorter than that for FDA approval or clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

We received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung.

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For example, if, as a result of manufacturing error, the efficacy of our products does not meet the standards claimed in the accompanying instructions for use, regulatory authorities could prevent our products from being placed on the market.

Internationally, the approaches to product defects will vary.

A product may be recalled in one country but not in others.

Internationally, the regulatory requirements relating to product defects may vary.

A regulatory authority in a specific country may request or require a product recall while others may not.

Federal, State and Foreign Fraud and Abuse and Physician Payment Transparency Laws

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generally and may increase our costs of compliance with data privacy legislation due to the requirement to enter into EU Standard Contractual Clauses (or, in case of the UK personal data, the UK Addendum to EU Standard Contractual Clauses or the IDTA) and further extra steps set out above.

In December 2022, the European Commission published its draft adequacy decision on the EU-US transfers of personal data - the new Data Privacy Framework, or EU-US DPF.

Under the EU-US DPF, it will be possible to transfer EEA personal data freely to the US recipient that has self-certified under the EU-US DPF regime, although this may be challenged in the European Union Court of Justice by EU based privacy advocates.

In July 2023, the European Commission announced that it had adopted its adequacy decision on the EU-US transfers of personal data - the new Data Privacy Framework, or EU-US DPF, which became effective in July 2023.

Under the EU-US DPF, it is possible to transfer EEA personal data freely to the US recipient that has self-certified under the EU-US DPF regime, although this may be challenged in the European Union Court of Justice by EU based privacy advocates.

We are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject to applicable law.

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

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

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

Our workforce consists of individuals from countries all over the world, representing many different faiths, languages, backgrounds, and cultures.

We want our employees to feel welcome and comfortable in our organization and feel that they are supported in growing their career.

We promote understanding of our mission, vision, and values and create strong relationships with our employees through various engagement and career development initiatives.

For example, we hold quarterly Town Hall meetings with all employees to provide them with an open forum to ask questions, voice any concerns, and provide input on our corporate goals and vision for the future.

Diversity, Equity, and Inclusion:

The keystone of our diversity strategy is mutual respect and fostering a sense of belonging – we want everyone to feel welcome and comfortable in our organization and feel that they are supported in growing their career.

Our workforce consists of individuals from countries all over the world, representing many different faiths, languages, backgrounds, and cultures.

We believe that our diversity is one of our greatest strengths.

We are committed to creating and maintaining an inclusive workplace in which all employees have an opportunity contribute to the success of the business.

This commitment is embedded in our company policies and human capital management practices.

We have adopted policies to promote compliance with laws and regulations as well as to foster a respectful workplace for all employees.

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Talent Attraction, Retention, and Development

We continually seek exceptionally talented and dedicated people to join our team to help shape both our future and the future of transplant medicine.

In recent years, the focus of our recruitment efforts has been centered on finding talent for the NOP and our engineering, manufacturing, and supply chain operations.

Since the launch of our aircraft operations in 2023, we are also seeking additional resources in the field of logistics and aviation, including logistics coordinators, pilots and aviation mechanics.

We seek exceptionally talented and dedicated people to join our team to help shape both our future and the future of transplant medicine.

The focus of our recruitment efforts has been centered on finding talent for the NOP, our engineering, manufacturing, and supply chain operations, and in the field of logistics and aviation, including logistics coordinators, pilots and aviation mechanics.

We aim to hire people with the right skill sets, growth mindset, and work ethic to drive business results and help us achieve our goals.

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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