What changed in this filing

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Item 1. Business

2024-02-27 compared with 2023-02-27 · 124 added, 127 removed, 526 unchanged (32% of the section changed)

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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.

Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body.

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 National OCS Program, or NOP, an innovative turnkey solution to provide outsourced organ retrieval and OCS organ management, 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 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.

Our 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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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.

Also, all three of our products, OCS Heart, OCS Lung and OCS Liver are approved 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 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.

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

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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.

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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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.

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.

This enables transplant centers 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.

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

For patients, we believe the OCS and the NOP provide additional access to life-saving transplants and allow for quicker

recovery following transplantation.

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.

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.

We have also acquired 13 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 believe the OCS and the NOP drive significant benefits to all stakeholders in the field of organ transplantation.

For patients, we believe the OCS and the NOP provide additional access to life-saving transplants and allow for quicker recovery following transplantation.

For hospitals, we believe the OCS and NOP provide a means to increase transplant volume, treat more patients, enhance provider status and improve transplant program economics.

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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 National OCS Program.

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

We have additional distribution and commercial operations in Europe.

As of December 31, 2022, we employed 212 people globally, most of whom were full-time employees.

As of December 31, 2023, we had 584 employees, most of whom were full-time and located in the United States.

We generated $241.6 million, $93.5 million and $30.3 million of total revenue during the years ended December 31, 2023, 2022 and 2021, respectively, representing year-over-year growth of 158.5% and 208.8% in 2023 and 2022, respectively.

Our business model is characterized by a high level of recurring revenue, which is derived primarily from sales of our single-use, organ-specific disposable sets that are required for each transplant using the OCS and services provided to transplant centers by our NOP.

Our business model is characterized by a high level of recurring revenue, which is derived primarily from sales of our single-use, organ-specific disposable sets that are required for each transplant using the OCS as well as services provided to transplant centers by our NOP.

Our Competitive Strengths

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• National OCS Program

Our National OCS Program was developed to provide a more efficient process to procure donor organs with the OCS.

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.

Our National OCS Program 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.

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.

• Transportation Logistics of the NOP

Transporting organs, clinical staff and medical technology in the field of organ transplant is very challenging.

Donor organs may become available at almost any hospital at any time.

The donor organ must be retrieved and transported to allocated recipients in a timely manner while protecting the organ from ischemic injury.

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.

• 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.

We have also initiated 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.

• Strong relationship with the clinical transplant community

The transplant community is highly concentrated in the leading academic medical centers around the world.

We have developed strong clinical relationships with many of these centers through their participation in our clinical trials.

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.

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

OCS products for additional organs are under development.

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.

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

• OCS Console:

The OCS Console is a highly portable electromechanical medical device that houses and controls the function of the OCS and is designed to fit in the current workflow for organ transplantation.

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• OCS Solutions:

The OCS Solutions are a set of nutrient-enriched solutions used with blood to replenish depleted nutrients and hormones needed to optimize the organ’s condition outside of the human body.

The OCS technology platform is equipped with the following core technologies that we designed to comprehensively address the limitations of cold storage and improve transplant outcomes:

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• Allows for organ viability assessment

Enables diagnostic evaluation of the donor organ using currently acceptable clinical standards to evaluate the organ’s suitability for transplantation and to maximize the post-transplant outcomes.

We believe that by comprehensively addressing the three limitations of cold static storage, the use of the OCS will allow for increased utilization of donor organs and improve post-transplant outcomes.

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Value to Patients

We believe the OCS increases patients’

access to what we believe is the best treatment option for end-stage organ failure, which results in improved quality of life and longer life expectancy.

We believe the OCS increases patients’ access to what we believe is the best treatment option for end-stage organ failure, which results in improved quality of life and longer life expectancy.

In addition, we believe improved clinical outcomes from use of the OCS will allow patients to recover more quickly following a transplant.

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Improvements in clinical outcomes could enable providers to meet the CMS post-transplant survival metrics required for reimbursement coverage and improve the overall financial profile of their transplant programs.

In addition, we believe the increase in transplant volumes enabled by the OCS will help providers achieve “Center of Excellence”

designations with payors and thus drive significant revenue growth for their transplant programs.

In addition, we believe the increase in transplant volumes enabled by the OCS will help providers achieve “Center of Excellence” designations with payors and thus drive significant revenue growth for their transplant programs.

Value to Payors

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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 National OCS Program, a turnkey solution to provide outsourced organ retrieval and organ management, to provide transplant programs with a more efficient process to procure donor organs with the OCS.

We have initiated a service program that leverages our clinical and logistical capabilities to provide access to and use of the OCS for transplant centers in certain regions of the United States.

We believe we could become a national clinical service provider of organ retrieval and perfusion service to transplant centers throughout the United States.

• 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.

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.

Develop the next generation OCS technology platform to improve user experience and facilitate our National OCS Program.

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 National OCS Program.

• 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.

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

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our NOP and a direct acquisition model.

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

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

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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 who are interested in training 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 retrieval and organ management on the OCS.

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

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Reimbursement

Medicare’s reimbursement for organ transplant procedures is well-established and involves two payment mechanisms.

The first is the inpatient hospital prospective payment system, which reimburses the transplant hospital for operating costs incurred during the inpatient stay in which the transplant procedure is performed.

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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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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.

However, 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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and foreign patent applications in our portfolio are expected to expire between 2025 and 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

As of December 31, 2022, our patent portfolio relating to the OCS Lung includes a family 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.

As of December 31, 2023, 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.

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, 2022, our patent portfolio relating to the OCS Heart includes a family comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a heart ex vivo.

As of December 31, 2023, 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.

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

As of December 31, 2022, our patent portfolio relating to the OCS Liver 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, Europe, Hong Kong, Israel, Japan and New Zealand.

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.

As of December 31, 2023, 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.

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.

As of December 31, 2022, our patent portfolio relating to the OCS Solutions includes a family comprised of patents and patent applications with claims that are generally directed to compositions of certain perfusion fluids.

As of December 31, 2023, 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.

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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 you 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.

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.

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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Adverse determinations in litigation could subject us to significant liabilities to third parties, could require us to seek licenses from third parties and could prevent us from manufacturing, selling or using the OCS, any of which could severely harm our business.

For more information, see “Item 1A.

Risk Factors—Risks Related to Our Intellectual Property”

in this Annual Report on Form 10-K.

For more information, see “Item 1A.

Risk Factors—Risks Related to Our Intellectual Property” in this Annual Report on Form 10-K.

Competition in organ preservation for transplantation can be classified into two main segments:

(1) cold storage and cold perfusion technologies and (2) warm perfusion technologies.

In both cold storage and cold perfusion, the organs are not functioning or metabolically inactive.

In both cold storage and cold perfusion, the organs are not functioning and are metabolically inactive.

The characteristics of cold storage and cold perfusion described above significantly limit donor organ utilization and are a primary driver of post-transplant complications.

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• superior technology;

• our NOP, including clinical service and logistics services;

• regulatory approvals for broad clinical indications of use;

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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 a multi-disciplinary engineering team that has electrical, mechanical, systems and software engineering 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.

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• 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;

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

Manufacturing, Supply and Operations

Manufacturing and Supply Chain Operations

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 and expect this to be certified by the FDA in the near future.

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

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.

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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 originally through April 2022 and was automatically extended for 24 months through April 2024.

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.

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.

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.

Our agreement with Fresenius includes an obligation to meet certain annual minimum purchase commitments based upon rolling order forecasts that we provided to Fresenius in accordance with this agreement.

Our agreement with Fresenius for the supply of OCS Heart Solution has one-year evergreen terms, terminable by either party at least 12 months prior to the end of the then-current term.

Our operations team includes production and test employees, manufacturing engineers and field service technicians.

Our supply chain and operations team includes supply chain procurement and planning, production and test employees, sustaining engineers, manufacturing engineers and field service technicians.

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.

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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.

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.

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Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a PMA or issuance of a de novo classification order.

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 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.

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

Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent”

to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or a device that was reclassified from Class III to Class II or I, or another commercially available device that was cleared through the 510(k) process or that was granted marketing authorization through the de novo classification process under section 513(f)(2) of the FDCA.

We received 510(k) clearance for the OCS Lung Solution for cold flush, storage and transportation of donor lungs in July 2021, and for the OCS Lung Donor Flush Set in November 2022.

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

Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or a device that was reclassified from Class III to Class II or I, or another commercially available device that was cleared through the 510(k) process or that was granted marketing authorization through the de novo classification process under section 513(f)(2) of the FDCA, or a 510(k) exempt device.

We received 510(k) clearance for the OCS Lung Solution for cold flush, storage and transportation of donor lungs in July 2021, for the OCS Lung Donor Flush Set in November 2022, and for the OCS Heart Leukocyte Reducing Filter in October 2023.

Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting and many implantable devices, or devices that have been found not substantially equivalent to a legally marketed Class I or Class II predicate device, are placed in Class III, requiring approval of a PMA.

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The PMA must also contain a full description of the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review generally takes one year, or even longer, from the time the PMA application is submitted to the FDA until an approval is obtained.

An advisory committee of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

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.

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.

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.

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.

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.

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.

To be approved, an IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

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• 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;

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;

• 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;

• approval of a PMA supplement for certain modifications to PMA-approved devices that affect the safety or effectiveness of the device, or clearance of a new 510(k) premarket notification for modifications to 510(k) cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of the device;

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• correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

complying with the federal law and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;

the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death;

• complying with the federal law and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;

• the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death;

• 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.

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• withdrawing a PMA approval that has already been granted;

refusal to grant export or import approvals for our products;

• refusal to grant export permits or certificates for our products;

• criminal prosecution.

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In addition, the GSPRs include (but are not limited to) that the device must achieve the performances intended by the manufacturer, be designed, manufactured and packaged in a suitable manner and the manufacturer must establish, implement, document and maintain a risk management plan.

The European Commission has adopted various standards applicable to medical devices, referred to as harmonized

The European Commission has adopted various standards applicable to medical devices, referred to as harmonized standards.

While not mandatory, compliance with these harmonized standards is often viewed as the easiest way to satisfy the GSPRs as a practical matter.

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, 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.

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

Therefore, so long as there are no significant changes in the design and intended purpose of these devices, the devices can continue to be placed on the market until the date the Medical Devices Directive certificate becomes void.

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.

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• 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;

• 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;

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• 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 and OCS Lung systems, both of which includes the OCS Console, the OCS disposables, and the OCS solution additives, and the OCS Liver Console and disposables, have now been recertified under the MDR.

We have also applied for and expect to receive the CE Mark for the OCS Liver combined with our solution additives under the MDR within the next 12 months.

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.

Clinical Investigations

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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):

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)

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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 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;

CE marking will continue to be recognized in Great Britain until June 30, 2024;

certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until June 30, 2024;

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

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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, 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.

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.

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

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

Post-marketing Requirements

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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:

a documentary framework”

which details mandatory requirements as well as guidance on how those requirements may be met.

In the UK the Competent Authority is the Human Tissue Authority, which 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.

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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.

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.

Adverse events and potential adverse events are monitored closely by regulatory authorities.

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federal government;

and/or require disclosure to the government and/or public of financial interactions, so-called “sunshine laws”.

The healthcare laws and regulations applicable to us, including those described above, contain ambiguous requirements and are subject to evolving interpretations and enforcement discretion.

Manufacturers must adopt reasonable interpretations of

requirements if there is ambiguity and those interpretations could be challenged.

Manufacturers must adopt reasonable interpretations of requirements if there is ambiguity and those interpretations could be challenged.

If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal and civil financial penalties, including, for example, exclusion from participation as a supplier of product to beneficiaries covered by Medicare or Medicaid.

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For example, the advertising and promotion of our products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EU member state legislation governing the advertising and promotion of medical devices.

Sometimes the relevant rules are found in industry guidance rather than legislation—for example, relationships with healthcare professionals in the UK are governed by the code of Association of British Healthcare Industries, or ABHI, and rules may limit or restrict the advertising and promotion of our products to the general public and impose limitations on our promotional activities with healthcare professionals.

Sometimes the relevant rules are found in industry guidance rather than legislation—for example, relationships with healthcare professionals in the UK are governed by the code of Association of British HealthTech Industries, or ABHI, and rules may limit or restrict the advertising and promotion of our products to the general public and impose limitations on our promotional activities with healthcare professionals.

In the European Union the consequences for failing to comply with advertising and promotional laws might lead to reputational damage, fines, exclusions from public tenders and actions for damages from competitors for unfair competition.

Laws with Extra-territorial Effect

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.

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The Health Insurance Portability and Accountability Act of 1996, or HIPAA, governs the conduct of certain electronic healthcare transactions and requires certain entities, called covered entities, to handle and protect, among other things, the privacy and security of protected health information, or PHI, in certain ways.

HIPAA also requires business associates to enter into business associate agreements with covered entities and to safeguard a covered entity’s PHI against improper use and disclosure.

HIPAA privacy regulations cover the use and disclosure of PHI by covered entities as well as business associates, which are defined to include subcontractors that create, receive, maintain, or transmit PHI on behalf of a business associate.

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Under these laws, the covered entity must notify any individual whose PHI is breached as required under the breach notification rule.

Although we believe that we currently are neither a “covered entity”

nor a “business associate”

directly under HIPAA, a business associate relationship may be imputed from facts and circumstances even in the absence of an actual business associate agreement.

Although we believe that we currently are neither a “covered entity” nor a “business associate” directly under HIPAA, a business associate relationship may be imputed from facts and circumstances even in the absence of an actual business associate agreement.

In addition, HIPAA may affect our interactions with customers who are covered entities or their business associates.

The HIPAA privacy and security regulations establish a uniform federal “floor”

and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their health and other personal information.

The HIPAA privacy and security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their health and other personal information.

States are increasingly regulating the privacy and security of individually identifiable information, including financial information and health information.

For example, the California Consumer Privacy Act, or

CCPA, gives California residents certain rights, including the right to ask covered companies to disclose the types of personal information collected and delete a consumer’s personal information, and imposes several obligations on covered companies to provide notice to California consumers regarding their data processing activities and limitations on covered companies’

ability to sell personal information.

These protections will be expanded by California Privacy Rights Act of 2020, or CPRA, which will be operational in most key respects in 2023, along with new privacy laws in Virginia, Colorado, Utah and Connecticut.

For example, the California Consumer Privacy Act, or CCPA, gives California residents certain rights, including the right to ask covered companies to disclose the types of personal information collected and delete a consumer’s personal information, and imposes several obligations on covered companies to provide notice to California consumers regarding their data processing activities and limitations on covered companies’ ability to sell personal information.

These protections have been expanded by California Privacy Rights Act of 2020, or CPRA, along with new privacy laws in Virginia, Colorado and several other states.

We expect additional federal and state legislative and regulatory efforts to regulate consumer privacy in the future.

In the European Economic Area, or EEA, as well as in the United Kingdom, or the UK, -post-Brexit, we may be subject to laws relating to our collection, control, processing and other use of personal data, such as data relating to an identified or identifiable living individual.

Some states have also passed further protections focused on data protection for health information, including the Washington My Health My Data Act.

In the EEA, as well as in the United Kingdom, or the UK, -post-Brexit, we may be subject to laws relating to our collection, control, processing and other use of personal data, such as data relating to an identified or identifiable living individual.

Following Brexit, the UK has substantively retained the same privacy rules as it had when a member of the European Union.

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The GDPR was retained post-Brexit in the UK as the UK GDPR.

In addition, many EEA member states have passed legislation addressing areas where the GDPR permits member states to derogate from the regulation’s requirements, thus leading to divergent requirements between member states in spite of the GDPR’s stated goal of creating a uniform privacy law for the entire EEA.

The UK has done the same.

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Personal data must not be kept for longer than necessary for the purposes of collection.

To the extent that we process, control or otherwise use sensitive data relating to living individuals (for example, patients’

health or medical information, or genetic data or biometric data used for identification purposes, and other types of "special category data" listed in GDPR), more stringent rules may apply, limiting the circumstances and the manner in which we are legally permitted to process that data and transfer that data outside of the EEA (UK).

To the extent that we process, control or otherwise use sensitive data relating to living individuals (for example, patients’ health or medical information, or genetic data or biometric data used for identification purposes, and other types of "special category data" listed in GDPR), more stringent rules may apply, limiting the circumstances and the manner in which we are legally permitted to process that data and transfer that data outside of the EEA (UK).

In particular, in order to process such data, explicit consent to the processing (including any cross-border transfer) may be required from the data subject (being the person to whom the personal data relates), though in certain cases, and depending on the jurisdiction in which the data originate or are processed, such data may be processed absent explicit consent for purposes of medical diagnosis, public interest in the area of public health (including the safety and efficacy of medical devices) or scientific research.

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

As of December 31, 2022, we had 212 full-time employees, all of which are located in the United States other than five employees located in Europe.

Except for certain European employees, none of our employees are represented by a labor union or are the subject of collective bargaining agreements, and we believe we have a strong relationship with our employees.

As of December 31, 2023, we employed 584 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 promote understanding of our mission, vision, and values and create strong relationships with our employees through various engagement and career development initiatives.

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.

We also host in-person events at our headquarters in Andover, Massachusetts, and invite employees from around the world to participate.

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 –

we want everyone to feel welcome and comfortable at our organization.

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.

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.

For example, we offer three personal days to provide each employee time away from work to use for any purpose, such as observing holidays that are meaningful to them.

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

These policies include a code of business conduct and ethics, an insider trading policy, a Regulation FD policy, a sexual harassment policy, a regulated fraternization policy, and a whistleblower policy.

Along with an overview of the company, our culture and expectations, training on these policies is a key component of our employee onboarding process.

Health and Safety:

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

We provide relocation benefits to eligible employees whom we request to move in connection with their employment with the objective of attracting and deploying top talent.

Compensation and Benefits:

We offer competitive compensation and benefits in an exciting, demanding, and fast-paced work environment.

Our employee benefits 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, reimbursement for fitness memberships and 15 vacation days per year.

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.

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

Each employee is assigned individual goals that are derived from our overall corporate and financial goals.

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.

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

We also provide skill development courses, manager training, and opportunities for managers and non-managers to develop their leadership skills.

Corporate Information and Organizational Transactions

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Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report on Form 10-K.

Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including exhibits, proxy and information statements and amendments to those reports filed or furnished pursuant to Sections 13(a), 14, and 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available through the “Investors”

portion of our website free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

In addition, our filings with the SEC may be accessed through the SEC’s Electronic Data Gathering, Analysis and Retrieval system at http://www.sec.gov .

All statements made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law.

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