What changed in this filing

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Item 1A. Risk Factors

2026-02-24 compared with 2025-02-27 · 170 added, 128 removed, 938 unchanged (24% of the section changed)

9 unchanged sentences

Our financial results may fluctuate from quarter to quarter, which makes our results difficult to predict and may cause our results to fall short of expectations.

Our financial results may fluctuate from quarter to quarter due to a number of factors, including the availability of donor organs for transplantation, which is unpredictable and could impact the volume of transplant procedures performed at transplant centers using the OCS and demand for our NOP.

Our financial results may fluctuate from quarter to quarter due to a number of factors, including the availability of donor organs for transplantation and transplant center surgeons, which is unpredictable and could impact the volume of transplant procedures performed at transplant centers using the OCS and demand for our NOP.

Our revenue from sales may fluctuate significantly from quarter to quarter, and our future quarterly and annual expenses as a percentage of our revenue may be significantly different from those we have recorded in the past.

In addition, the timing of acquiring additional aircraft for our aviation transportation services is uncertain and the amount we incur for such acquisitions is likely to differ from quarter to quarter.

In addition, we intend to opportunistically evaluate acquisitions of additional aircraft for our aviation transportation services, for which the timing is uncertain and the amount we incur for such acquisitions is likely to differ from quarter to quarter.

Our financial results in some quarters may fall below expectations.

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If market rates increase substantially, we will have to pay additional interest on this indebtedness, which would further reduce cash available for our other business needs.

We may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under or refinance our indebtedness under the CIBC Credit Agreement, which is repayable in equal monthly installments starting in July 2026 until its maturity in July 2027.

Our obligations under the CIBC Credit Agreement are secured by substantially all of our assets and the assets of our wholly-owned material subsidiaries, subject to certain exceptions.

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We may not be able to sustain profitability.

In recent years, we have incurred significant operating losses and we have only recently achieved profitability.

Prior to 2024, we had incurred significant operating losses and we have only recently achieved profitability.

Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued customer utilization of our NOP.

We generated net income of $35.5 million for the year ended December 31, 2024.

We generated net income of $190.3 million and $35.5 million for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $278.0 million.

Our efforts to grow our business have been and may continue to be costlier than we expect.

Our efforts to grow our business may be costlier than we expect.

If our operating and capital expenditures are greater than we expect and if our revenue growth is not sufficient to support these expenditures, we will not be able to sustain profitability.

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and select non-U.S.

markets, including growing our NOP;

acquiring and maintaining additional aircraft to support aviation transportation;

growing our commercial team, which will pursue increasing commercial sales of our OCS products;

scaling our manufacturing operations;

continuing research and development for our next generation OCS products, including conducting clinical trials for our next generation OCS products;

and seeking regulatory clearance for new products and product enhancements, including new indications, in both the U.S.

and select non-U.S.

markets, including expanding our commercial team, growing our NOP, scaling our manufacturing and sterilization operations, continuing research, development and clinical trial efforts, including expanding our research and development and manufacturing capabilities in Italy, seeking regulatory approval for the next generation OCS, new products and product enhancements, including new indications, both in the United States and in select non-U.S.

markets, establishing and relocating to a new long-term global headquarters, and seeking greater control of air and ground transport for our NOP.

The timing and amount of our operating and capital expenditures will depend on many factors, including:

• revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions;

• revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions and other products that may be approved in the United States and select non-U.S.

• the costs and expenses of expanding our U.S.

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• the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products;

• the costs incurred in our efforts to operate and grow our NOP, including the costs and timing of growing our logistics capabilities, inclusive of acquiring and maintaining current and additional aircraft for our aviation transportation services;

• the costs associated with maintaining and growing our transplant logistics capabilities, including by means of attracting, training and retaining pilots, and the acquisition, maintenance, or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments;

• the costs and timing of research and development of the next generation of OCS products;

• the degree of success we experience in commercializing our OCS products for additional indications;

• the costs, timing and outcomes of any future clinical studies and regulatory reviews, including to seek and obtain approvals for the next generation of OCS products or for new indications for our OCS products;

• the costs, timing and outcomes of pre- and post-approval studies and any future clinical studies and regulatory reviews, including to seek and obtain approvals for the next generation of OCS products or for new indications for our OCS products;

• the emergence of competing or complementary technologies;

• the number and types of future products we develop and commercialize;

• the cost of constructing research and development and manufacturing facilities in Italy;

• the costs related to establishing and relocating to a new long-term global headquarters to accommodate the growing scale and complexity of our business;

• the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;

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Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or if we will be able to maintain profitability.

Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to limitations.

As of December 31, 2024, we had federal net operating loss, or NOL, carryforwards of $404.1 million, which may be available to offset future taxable income, of which $204.6 million of the total NOL carryforwards expire at various dates through 2037, while the remaining $199.5 million do not expire but are limited in their usage to an annual deduction equal to 80% of annual taxable income.

Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to future limitations.

As of December 31, 2025, we had federal net operating loss, or NOL, carryforwards of $370.9 million, which may be available to offset future taxable income, of which $74.0 million expire at various dates beginning in 2030, while the remaining $296.9 million do not expire but are limited in their usage to an annual deduction equal to 80% of taxable income.

As of December 31, 2025, we had state NOL carryforwards of $261.6 million, which may be available to offset future taxable income and expire at various dates beginning in 2030.

As of December 31, 2025, we also had U.S.

federal and state research and development tax credit carryforwards of $13.2 million and $8.3 million, respectively, which may be available to offset future tax liabilities.

federal research and development tax credit carry forwards expire at various dates through 2044.

A material portion of these NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.

In addition, in general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs, its research and development credit carryforwards and its disallowed interest expense carryovers to offset future taxable income.

Our existing NOLs and research and development credit carryforwards may be subject to limitations arising from previous ownership changes.

In addition, future changes in our stock ownership, some of which might be beyond our control, could result in an ownership change under Section 382 of the Code.

Our NOLs and credits may also be impaired under state law.

For these reasons, if we determine that an ownership change has occurred or in the event we experience a change of control, we may not be able to utilize a material portion of the NOLs, research and development credit carryforwards or disallowed interest expense carryovers incurred prior to 2019.

Furthermore, our ability to utilize our NOLs or credits is conditioned upon our maintaining profitability and generating U.S.

federal and state taxable income.

As described above, prior to 2024, we incurred significant net losses since inception;

and therefore, we do not know whether we will generate the U.S.

federal or state taxable income necessary to utilize our NOL or credit carryforwards.

Under the Tax Cuts and Jobs Act, or TCJA, NOLs arising in taxable years beginning after December 31, 2017 will not be subject to expiration.

In addition, the deduction for NOLs in any taxable year is limited to 80% of annual taxable income in respect of NOLs generated during or after 2018.

The TCJA also reduced the corporate income tax rate to 21%, from a prior rate of 35%.

This may cause a reduction in the potential economic benefit of our NOLs and other available deferred tax assets.

federal and state research and development tax credit carryforwards of $7.3 million and $4.0 million, respectively, available to offset future tax liabilities.

federal research and development tax credit carry forwards expire at various dates beginning in 2026.

A portion of our NOL and tax credit carryforwards could expire unused if we do not generate sufficient federal and state taxable income prior to their expiration.

In addition, a corporation that undergoes an “ownership change,” generally defined in Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs and its research and development credit carryforwards to offset future taxable income.

Our existing NOLs and research and development credit carryforwards may be subject to limitations arising from future ownership changes.

Our NOLs and credits may also become impaired under state law.

For these reasons, if an ownership change occurs, or in the event we experience a change of control, we may not be able to utilize a portion of the NOLs and research and development credit carryforwards.

We may need to raise additional funding, which might not be available on favorable terms or at all.

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In order to manufacture the OCS in quantities sufficient to meet our anticipated commercial opportunity, we will need to continue to increase our manufacturing capabilities and retain third parties to sterilize our products.

We may encounter technical challenges to increasing the scale at which we manufacture the OCS, including with respect to material procurement and quality control and assurance.

We anticipate that our new

headquarters, which we expect to move into on or before January 1, 2028, will meet these increased requirements but we may encounter technical challenges to increasing the scale at which we manufacture the OCS, including with respect to material procurement and quality control and assurance.

An increase in production could make it more difficult for us to comply with quality system regulations or other applicable requirements that are currently enforced by the FDA and other regulatory authorities, or that may be introduced in the future, in both the United States and in other countries.

Further, we may experience disruptions to our manufacturing as a result of the move to the new headquarters that could potentially limit our production capacity.

Commercial scale production of the OCS on a continuing basis also will require us to continue to hire and retain additional management and technical personnel who have the necessary manufacturing experience and skills.

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Our inability to increase the scale of our manufacturing of the OCS could impair our ability to generate revenue and adversely affect market acceptance of our product.

In addition, all of our manufacturing operations are conducted at a single facility in Andover, Massachusetts.

In addition, all of our manufacturing operations are currently conducted at a single facility in Andover, Massachusetts and we may continue to conduct certain manufacturing activities at this facility while utilizing additional facilities over time.

Any interruption in operations at this location could result in our inability to satisfy product demand.

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Inventory levels in excess of customer demand may result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs or write-offs.

Conversely, if we underestimate customer demand for our products or our own requirements for components, subassemblies and materials, our manufacturing partners and suppliers may not be able to deliver components, sub-assemblies and materials to meet our requirements and our manufacturing may be affected by the impact of inflation and labor shortages on our suppliers, which could result in inadequate inventory levels or interruptions, delays or cancellations of deliveries to our customers, any of which would damage our reputation, customer relationships and business.

Conversely, if we underestimate customer demand for our products or our own requirements

for components, subassemblies and materials, our manufacturing partners and suppliers may not be able to deliver components, sub-assemblies and materials to meet our requirements and our manufacturing may be affected by the impact of inflation and labor shortages on our suppliers, which could result in inadequate inventory levels or interruptions, delays or cancellations of deliveries to our customers, any of which would damage our reputation, customer relationships and business.

In addition, several components, sub-assemblies and materials incorporated into our products require lengthy order lead times, and additional supplies or materials may not be available when required on terms that are acceptable to us or our manufacturing partners, or at all, and our manufacturing partners and suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, any of which could have an adverse effect on our ability to meet customer demand for our products and our results of operations.

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An important part of our commercialization efforts is to educate transplant center program directors and other surgeons on the relative merits of the OCS.

Our success depends, in large part, on effectively marketing and educating program directors and other surgeons about the benefits of the OCS and our NOP.

Our success depends, in large part, on effectively marketing and educating program

directors and other surgeons about the benefits of the OCS and our NOP.

Acceptance of the OCS also depends on educating program directors, other surgeons and private and public payors as to the distinctive characteristics, perceived medical and economic benefits, safety, ease of use and cost-effectiveness of the OCS and our NOP.

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We may not fully realize the anticipated benefits of our completed or future acquisitions, joint ventures, and strategic investments, such transactions may expose us to additional risks.

Since our acquisition of Summit, an aviation business, in 2023, we have separately acquired 21 fixed-wing aircraft, and intend to acquire additional fixed-wing aircraft, that will be operated as part of our NOP.

Since our acquisition of Summit, an aviation business, in 2023, we have separately acquired 22 fixed-wing aircraft, and intend to opportunistically evaluate acquisitions of additional fixed-wing aircraft that will be operated as part of our NOP.

In addition, in August 2023, we acquired certain assets related to lung and heart perfusion technology from Bridge to Life Ltd.

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We may not successfully or profitably utilize newly acquired assets or integrate, operate, maintain and manage any newly acquired operations or employees.

Further development of the assets we acquired from Bridge to Life, or the Bridge to Life Assets, have and will continue to require extensive clinical development, management of nonclinical, clinical and manufacturing activities.

In addition, we may decide that only certain of the acquired technology is useful for the next generation of the OCS, or that integration of the acquired technology is not feasible or is too costly.

We may decide that only certain of the acquired technology is useful for the next generation of the OCS, or that integration of the acquired technology is not feasible or is too costly.

We have a limited history of providing aviation transportation services and we continue to depend on certain members of the former management team of Summit for the successful operation and integration into our NOP services offering.

Even if we are able to utilize the Bridge to Life Assets and fully realize the benefits of our acquisition of Summit, we may not realize the expected

benefits of other future transactions.

Even if we are able to utilize the Bridge to Life Assets and fully realize the benefits of our acquisition of Summit, we may not realize the expected benefits of other future transactions.

We may review additional acquisition, joint ventures and strategic investment opportunities to expand our current product offerings, increase the size and geographic scope of our operations or otherwise offer growth and operating efficiency opportunities.

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If we are unable to deliver OCS products to customers through their participation in the NOP, our revenue would be materially reduced, which would materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS.

We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS, and any supply interruption could harm our business.

We rely on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS.

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Our suppliers may not be able to meet our demand for their products, either because of acts of nature, the nature of our agreements with those manufacturers or our relative importance to them as a customer, and our manufacturers may decide in the future to discontinue or reduce the level of business they conduct with us.

In addition, if these suppliers are unable to deliver components to us, whether due to a labor shortage, slow down or stoppage, or for any other reason, we would be required to seek alternative suppliers.

If our single or sole-source suppliers are unable or unwilling to deliver components to us, whether due to a labor shortage, slow down or stoppage, or for any other reason, we may not be able to manufacture or have available one or more products during such period of unavailability and our business could suffer, possibly materially.

In such a case, we would be required to seek alternative suppliers.

We might not be able to identify and qualify additional or replacement suppliers for any of these components quickly or at all or without incurring significant additional costs.

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We could be adversely affected if we experience any delay or deficiency in the quality of products obtained from suppliers and/or if we have to replace our suppliers.

Establishing additional or replacement suppliers for any of these materials or components, if required, or any supply interruption from our suppliers, could limit our ability to manufacture our products, result in production delays and increased costs and adversely affect our ability to deliver products to our customers on a timely basis.

Our inability to obtain sufficient quantities of components for the OCS also could adversely affect development of the next generation of the OCS.

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As a condition to our PMA approvals, we are required to conduct post-market studies.

For example, we have post-approval registries ongoing for all three of our organ products, including the OCS Lung Thoracic Organ Perfusion Registry, or TOP Registry, the OCS Heart Perfusion Registry, or OHP, and the OCS Liver Perfusion Registry, or OLP.

For example, we have post-approval registries ongoing or completed for all three of our organ products, including the OCS Lung Thoracic Organ Perfusion Registry, or TOP Registry, the OCS Heart Perfusion Registry, or OHP, and the OCS Liver Perfusion Registry, or OLP.

Adverse outcomes in post-approval studies can result in withdrawal of approval of a PMA or restrictions on the approval.

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Failure can occur at any stage of clinical testing.

For example, our clinical studies may produce negative or inconclusive results, and, in the future, we may decide, or regulators may require us, to conduct clinical and non-clinical testing in addition to those we have planned.

For example, our clinical studies may produce negative or inconclusive results, and, in the case of our ENHANCE and DENOVO clinical trials, we may not be successful in demonstrating superiority when compared to static cold storage methods.

Additionally, in the future, we may decide, or regulators may require us, to conduct clinical and non-clinical testing in addition to those we have planned.

After submission of our PMA applications for OCS Lung and OCS Heart, the FDA requested certain additional clinical analyses, technical information and clarifications as part of the agency’s normal review process.

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Any of these occurrences could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

Risks Related to Our Logistics Operations

Risks Related to Our Transplant Logistics Operations

We have limited experience operating aircraft, and we may not be able to achieve the anticipated benefits of our aircraft operations.

We have limited experience operating aircraft, and we continue to depend on certain members of the former management team of Summit and additional employees we may hire for the successful operation of aviation transportation services and the integration into our NOP services offering.

We must comply with applicable laws and regulations to manage our growing NOP logistics network.

We must comply with applicable laws and regulations to manage our growing NOP transplant logistics network.

The operation of aircraft is a highly regulated activity and one that involves unique risks, including those described above, which we have not needed to manage previously.

We may not successfully manage these risks or profitably utilize, integrate, operate, maintain and manage our newly acquired aircraft, employees and other aircraft operations.

If we fail to retain certain members of the existing management of Summit, or if we fail to successfully manage our aircraft operations or growing logistics network, our ability to realize the anticipated benefits of the acquisition of Summit or expansion of our NOP may be adversely affected.

If we fail to retain certain members of the existing management of Summit, or if we fail to successfully manage our aircraft operations or growing transplant logistics network, our ability to realize the anticipated benefits of the acquisition of Summit or expansion of our NOP may be adversely affected.

The operation of aircraft is subject to various risks, and failure to maintain an acceptable safety record may have an adverse impact on our ability to obtain and retain customers.

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As part of our services offered under our NOP, we have acquired a fleet of fixed-wing aircraft.

All of the aircraft we currently operate are variants of a single model produced by a single manufacturer.

Parts and services from this manufacturer are subject to their product and workmanship warranties and capacity to service aircraft.

All of the aircraft we currently operate are standardized variants of a certificated model produced by a single manufacturer.

Parts and services from this manufacturer

are subject to their product and workmanship warranties and capacity to service aircraft.

If this manufacturer fails to adequately fulfill its obligations towards us or experiences interruptions or disruptions in production or provision of services due to, for example, bankruptcy, natural disasters, labor strikes or disruption of its supply chain we may experience a significant delay in the delivery of or fail to receive previously ordered parts, which would adversely affect our revenue and results of operations and could jeopardize our ability to meet the demands of our customers.

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Failure to perform timely maintenance and repairs results in aircraft being underutilized which could have an adverse impact on our business, financial condition and results of operations.

On occasion, airframe manufacturers and/or regulatory authorities require mandatory or recommended modifications across a particular fleet which may ground a particular type of aircraft.

On occasion, airframe manufacturers and/or regulatory authorities require mandatory or

recommended modifications across a particular fleet which may ground a particular type of aircraft.

This may cause operational disruption to, and impose significant costs on us.

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For example, in November 2024, the FAA announced that a shortage of air traffic controllers had significantly impacted flight traffic.

Additionally, U.S.

federal government shutdowns have negatively affected the FAA, including causing significant impacts on flight traffic, and any future shutdown could negatively impact our aviation transportation operations.

Factors that cause flight delays could prevent us from effectively transporting organs in a timely manner, which could have a material adverse effect on our business, results of operations and financial condition.

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We strive to create a culture in which our employees act with integrity, treat each other with respect and consider themselves empowered to report suspected misconduct.

Our ability to attract and retain a high-quality workforce depends upon our commitment to a diverse and inclusive environment, along with our perceived trustworthiness and ethics.

Issues can arise in any number of circumstances, including employment-related offenses such as workplace harassment and discrimination, regulatory noncompliance, failure to properly use and protect data and systems, and violations of our employee policies, as well as from actions taken by regulators or others in response to such conduct.

Our ability to attract and retain a high-quality workforce depends upon our commitment to an inclusive environment, along with our perceived trustworthiness and ethics.

others in response to such conduct.

Addressing allegations of misconduct detracts focus from business operations and is expensive.

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• political, social, and economic instability abroad, terrorist attacks, and security concerns in general;

• the burdens of complying with a wide variety of foreign laws and different legal standards, such as anti-bribery laws, including the FCPA, and UK Bribery Act of 2010, or the Bribery Act, data privacy requirements, labor laws and anti-competition regulations;

• the burdens of complying with a wide variety of foreign laws and different legal standards, such as anti-bribery laws, including the FCPA, and the Bribery Act, data privacy requirements, labor laws and anti-competition regulations;

• differing protection of intellectual property;

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In addition, our expected growth will require us to hire a significant number of qualified personnel, including clinical development, regulatory, sales, marketing, engineering, scientific, clinical, logistics and aviation support and administrative personnel.

There is intense competition from other companies and research and academic institutions for qualified personnel in the areas of our activities.

There is intense competition from other companies and research and academic institutions for qualified personnel in the

areas of our activities.

If we cannot continue to attract and retain, on acceptable terms, the qualified personnel necessary for the continued development of our business, we might not be able to sustain our operations or become profitable.

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If we are unable to effectively manage our growth, our expenses may increase more than expected, our revenue could grow more slowly than expected and we might not be able to achieve our research and development and commercialization goals, which in turn could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

We may experience disruptions to our business as a result of the relocation of our headquarters and general expansion of our operations.

We may experience disruptions as we continue to expand our operations and facilities and execute on our growth strategy.

In January 2026, we entered into a lease agreement with the intent to move our headquarters to a larger space in Somerville, Massachusetts.

We intend to renovate the facility before moving our operations, including manufacturing, to this facility.

The process of moving our business, opening new facilities and bringing operations online at this new site is inherently complex and is not part of our day-to-day operations.

The relocation and expansion of our headquarters and the opening of any additional new facilities, including our planned expansion in Italy, may cause significant disruption to our operations, divert management attention and resources and involve significant costs, all of which could have a material adverse effect on our business, financial condition and results of operations.

The relocation of our headquarters and any additional facilities that we seek to open may take longer than anticipated or may not proceed as planned, and the expected benefits may be less than anticipated.

Our international expansion may expose us to operational, compliance and financial risks that could adversely affect our business and results of operations.

We are expanding our operations outside the United States, which increases operational complexity and may require significant management attention and resources.

Our international operations involve increased logistics and supply chain complexity, foreign customs and trade requirements, and reliance on third-party service providers, which may result in delays or increased costs.

Operating internationally also exposes us to legal and compliance risks, as well as differing healthcare systems and reimbursement frameworks that may limit adoption of our OCS technologies, NOP services or related offerings or reduce expected revenues and margins, If we are unable to effectively manage these risks, our business, financial conditions and results of operations could be materially and adversely affected.

Our use of artificial intelligence, or AI, and other emerging technologies could adversely impact our business and financial results.

We currently make limited use of AI technologies in our operations, and we may continue to explore further use cases.

The rapid advancement of these technologies presents opportunities for us in research, manufacturing, commercialization, and other business endeavors, but also entails risks, including that AI-generated content, analyses, or recommendations we utilize could be deficient, that our competitors may more quickly or effectively adopt AI capabilities, or that our use of AI or other emerging technologies increases regulatory, privacy, cybersecurity and other significant risks.

In addition, any disruption or failure in the AI functionality we incorporate into our business activities, products or services could adversely impact our business or result in delays or errors in our product offerings.

The legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain, including in the areas of intellectual property, cybersecurity and privacy and data protection.

Compliance with new or changing laws, regulations or industry standards relating to AI may impose significant costs on us and limit our ability to effectively develop, deploy or use AI technologies.

Furthermore, if we are unable to effectively manage the use of AI technologies by our employees and service providers, our confidential information, intellectual property and reputation could be put at risk.

Failure to appropriately respond to this evolving landscape may result in reputational, competitive and business harm as well as litigation and regulatory action and fines, penalties and expenses related thereto.

Risks Related to Our Intellectual Property

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The large number of patents, the rapid rate of new patent applications and issuances, the complexities of the technology involved, and the uncertainty of litigation may increase the risk of business resources and management’s attention being diverted to patent litigation.

If any third-party patents were asserted against us, even if we believe such claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability, or priority.

If any third-party patents were asserted against us, even if we believe such claims are without merit, a court may not find in our favor on questions of infringement, validity, enforceability, or priority.

A court of competent jurisdiction could hold that the asserted third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize our products.

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As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S.

patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S.

patent claim, a court of competent jurisdiction may not invalidate the claims of any such U.S.

We may choose or, if we are found to infringe a third party’s patent rights and we are unsuccessful in demonstrating that such patents are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing, and marketing any of our products.

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The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater

financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete.

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With respect to the patents and patent applications that we own, any patents that have or may issue from our currently issued or pending patent applications would be expected to expire between 2026 and 2043, assuming all required fees are paid.

However, we cannot provide any assurances that any of our patents have, or that any of our pending patent applications that mature into issued patents will include, claims with a scope sufficient to protect our OCS technology, any additional features we develop for our OCS technology or any new products.

However, our patents or pending patent applications that mature into issued patents may not include claims with a scope sufficient to protect our OCS technology, any additional features we develop for our OCS technology or any new products.

Other parties may have developed technologies that may be related to or competitive with our system, may have filed or may file patent applications and may have received or may receive patents that overlap or conflict with our patent applications, either by claiming the same methods or devices or by claiming subject matter that could dominate our patent position.

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For example, the Leahy-Smith Act provides that an administrative tribunal known as the Patent Trial and Appeals Board, or PTAB, provides a venue for challenging the validity of patents at a cost that is much lower than district court litigation and on timelines that are much faster.

Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.

Proceedings challenging our patents could result in either loss of the patent or

denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.

Furthermore, an adverse decision in an interference proceeding can result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our products.

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Depending upon the timing, duration and specifics of FDA marketing approval of our products, one or more of the U.S.

patents we own or license may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.

The Hatch-Waxman Act permits a patent restoration term of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.

However, even if, at the relevant time, we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to exercise due diligence during the testing phase or regulatory review process, to fail to apply within applicable deadlines or prior to expiration of relevant patents or otherwise to fail to satisfy applicable requirements.

Moreover, the time period of the extension or the scope of patent protection afforded could be less than we request.

Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims covering the approved product, a method for using it or a method for manufacturing it may be extended.

If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable product will be shortened and our competitors may obtain approval of competing products following our patent expiration.

patents we own or license may be eligible for patent term restoration (also referred to as patent term extension) under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.

The Hatch-Waxman Act permits a patent restoration term of up to five years for a patent covering an approved product as compensation for effective patent term lost as a result of product development and the FDA regulatory review process.

However, even if, at the relevant time, we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to apply within applicable deadlines or prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.

Moreover, the time period of the extension could be less than we request, for example, if we are found to have failed to exercise due diligence during the testing phase or regulatory review process.

Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years after approval and only patents claiming the approved product, a method for using it or a method for manufacturing it may be extended.

If we are unable to obtain patent term extension, the term of any such extension is less than we request, or the scope of patent protection is less than we would expect it to be during extension period, the period during which we could enforce our patent rights for the applicable product may be shortened and our competitors may obtain approval of competing products sooner.

As a result, our ability to generate revenue could be materially adversely affected.

Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

Further, our competitors may launch their product earlier than might otherwise be the case.

If we do not have adequate patent protection or other exclusivity for our products, our business, financial condition or results of operations could be materially adversely affected.

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Litigation may be necessary to defend against claims, and it may be necessary or we may desire to enter into a license to settle any such claim;

however, there can be no assurance that we would be able to obtain a license on commercially reasonable terms, if at all.

however, we may not be able to obtain a license on commercially reasonable terms, if at all.

If our defense to those claims fails, in addition to paying monetary damages or a settlement payment, a court could prohibit us from using technologies, features or other intellectual property that are essential to our products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.

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• operating restrictions or partial suspension or total shutdown of production;

• refusing or delaying our requests for premarket approval of new products or for modifications to existing products, and refusing or delaying our requests for PMAs for new intended uses of the OCS;

• refusing or delaying our requests for PMA of new products or for modifications to existing products, and refusing or delaying our requests for PMAs for new intended uses of the OCS;

• withdrawing or suspending PMA approvals that have already been granted, resulting in prohibitions on sales of our products;

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Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol but does not apply in Great Britain (England, Wales and Scotland).

The UK Medical Devices Regulations 2002 (UK MDR 2002) provided a transitional period under which the UK will recognize EU CE marks and the MHRA has confirmed that this will apply potentially until June 30, 2030 (subject to certain conditions and depending on the type of device).

The UK Medical Devices Regulations 2002 (UK MDR 2002) provided a transitional period under which the UK will recognize EU CE marks and the MHRA has confirmed that this will apply potentially until June 30, 2030 (although a consultation is expected that may further extend this period).

To be placed on the market in Great Britain after this date, medical devices must have undergone a conformity assessment in accordance with the UK MDR 2002 (as amended or replaced) and have the UKCA mark affixed.

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for example, there are broader registration requirements with the Medicines and Healthcare products Regulatory Agency, or the MHRA, and if the manufacturer is located outside the UK, a UK Responsible Person must be appointed.

The MHRA is currently consulting on an International Reliance Scheme for UK recognition of international regulatory approvals of certain medical devices, including CE marks.

To continue to place products on the market in the European Union and United Kingdom, we will need to meet the conditions set out in the EU MDR or UK MDR 2002, as applicable.

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Because prospective payments are based on predetermined rates and may be less than a hospital’s actual costs in furnishing care, hospitals have incentives to lower their inpatient operating costs by utilizing products, devices and supplies that will reduce the length of patients’ hospital stays, decrease labor or otherwise lower their costs.

In addition to these MS-DRG-based payments, Medicare reimburses transplant centers for “reasonable and necessary” organ acquisition costs, which are considered “pass-through” costs from the prospective payment system, and are not based on the payments for the applicable MS-DRG.

Pass-through organ acquisition costs include services required for the acquisition of an organ, such as tissue typing, organ preservation, transport of organs, donor evaluation and other acquisition costs.

In addition to these MS-DRG-based payments, Medicare reimburses transplant centers for “reasonable and necessary” organ acquisition costs, which are considered “pass-through” costs distinct from the prospective payment system, and are not based on the payments for the applicable MS-DRG.

Pass-through organ acquisition costs include services required for the acquisition of an organ,

such as tissue typing, organ preservation, transport of organs, donor evaluation and other acquisition costs.

The separate payments for these costs are determined on a reasonable cost basis established through the transplant center’s Medicare cost report.

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Either CMS or a Medicare contractor might determine that Medicare will not cover and reimburse for the cost of the OCS in the absence of reliable clinical data evidencing the benefits to patients of the use of the OCS.

The data we collect from our prior, ongoing and planned clinical studies and patient registry may not be sufficient for this purpose in a coverage determination by CMS or a Medicare contractor.

The data we collect from our prior, ongoing and planned clinical studies and patient registry may not be deemed sufficient to support a finding by CMS or a Medicare contractor that use of the OCS is reasonable and necessary such that coverage is warranted.

Accordingly, Medicare might not reimburse transplant centers for all or a portion of the cost of the OCS.

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We may not obtain international reimbursement approvals in a timely manner, if at all.

In addition, even if we do obtain international reimbursement approvals, the level of reimbursement may not be enough to commercially justify expansion of our business into the approving jurisdiction.

In addition, even if we do obtain international reimbursement approvals, the level of reimbursement may not be enough to commercially justify expansion of our business into the

approving jurisdiction.

To the extent we or our customers are unable to obtain reimbursement for products in major international markets in which we seek to market and sell our products, our international revenue growth would be harmed, and our business and results of operations would be adversely affected.

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For example, we might need to conduct additional clinical trials and provide additional technical information to the appropriate notified body before the CE mark can be affixed to the changed product.

If we fail to comply with the FDA’s QSR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the relevant EU competent authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.

In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QSR.

The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices.

In February 2024 FDA issued the QSMR Final Rule to amend the QSR, incorporating by reference ISO 13485:2016.

Until the QSMR becomes effective on February 2, 2026, and we are required to transition to the QMSR by that date.

Prior to February 2, 2026 we are required to comply with the QSR.

The FDA enforces the QSR through periodic inspections and unannounced “for cause” inspections.

We are subject to periodic FDA inspections to determine compliance with QSR and pursuant to the Bioresearch Monitoring Program, which have in the past and may in the future result in the FDA issuing Form 483s, including during the conduct of clinical trials.

If we fail to comply with the FDA’s QSMR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the relevant EU competent authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.

In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QMSR.

The QMSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices.

The FDA enforces the QMSR through periodic inspections and unannounced “for cause” inspections.

The QMSR recently replaced the QSR and incorporates by reference ISO 13485:2016.

The QSMR became effective on February 2, 2026, at which time we transitioned to the QMSR.

Unlike the QSR, the QMSR gives FDA the authority to inspect management review, quality audits, and supplier audit reports.

We are subject to periodic FDA inspections to determine compliance with the QSMR and pursuant to the Bioresearch Monitoring Program, which have in the past and may in the future result in the FDA issuing Form 483s, including during the conduct of clinical trials.

Outside the United States, our products and operations are also often required to comply with standards set by international standards bodies, such as the International Organization for Standardization.

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The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies.

Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements, and the QSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing our products, refusal to permit the import or export of our product, prohibition on sales of our product, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer.

Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements, and the QMSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing our products, refusal to permit the import or export of our product, prohibition on sales of our product, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer.

We may not be able to obtain or maintain regulatory qualifications outside the United States, which could harm our business.

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Foreign regulatory authorities may not clear or approve our product for the same uses cleared or approved by the FDA.

In addition, we may not be able to affix the CE mark to new or modified products and we may fail to obtain any additional regulatory qualifications, clearances or approvals or to comply with additional legal obligations required by the individual member states of the European Union or other countries in which we seek to market the OCS.

we may not be able to affix the CE mark to new or modified products and we may fail to obtain any additional regulatory qualifications, clearances or approvals or to comply with additional legal obligations required by the individual member states of the European Union or other countries in which we seek to market the OCS.

The FDA also regulates the export of medical devices from the United States.

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Counterfeit medical devices are an increasing presence on the market.

Third parties may seek to develop, manufacture, distribute and sell systems that we believe infringe our proprietary rights, which would compete against the OCS and impair our ability to sell the OCS in jurisdictions in which our proprietary rights are not upheld.

Third parties may seek to develop, manufacture, distribute and sell systems that we believe infringe our proprietary rights, which would compete against the OCS and impair our

ability to sell the OCS in jurisdictions in which our proprietary rights are not upheld.

In addition, counterfeit products may be promoted in a way that misleads consumers into believing they are affiliated with us.

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Although the MDR now applies so all new devices placed on the market must be CE marked under it, the transition periods provided by the MDR may extend the validity of the certificates issued by notified bodies for medical devices under the Medical Devices Directive before May 26, 2021 provided that certain conditions are satisfied.

As such, devices may continue to be placed on the EU market 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.

Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol but does not apply in Great Britain (England, Wales and Scotland).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks potentially until June 30, 2030 depending on the class of device and subject to certain conditions and depending on the type of device.

To be placed on the market in Great Britain after this date, medical devices must have undergone a conformity assessment in accordance with UK legislation and have the UKCA mark affixed.

As such, devices CE marked under the Medical Devices Directive may continue to be placed on the EU market 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.

Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol

but does not apply in Great Britain (England, Wales and Scotland).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks under the EU MDR potentially until June 30, 2030 depending on the class of device and subject to certain conditions and depending on the type of device.

To be placed on the market in Great Britain after this date, medical devices must have undergone a conformity assessment in accordance with UK legislation and have the UKCA mark affixed (although the UK Government has announced its intent to consult on the indefinite recognition of the CE mark, which may change the time frame for UKCA mark requirements).

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

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However, although neither the EU MDR nor EU IVDR apply in Great Britain, the national UK medical devices rules currently allow 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, depending on the class of device and provided certain conditions are met.

The UK Government has recently proposed post-market surveillance legislation and is currently consulting on proposed changes to pre-market medical device regulation.

This might lead to substantial changes in the regulatory framework/requirements imposed on medical devices.

The UK Government has recently adopted post-market surveillance legislation and plans to adopt further changes to pre-market medical device regulation in 2026.

This might lead to substantial changes in the regulatory framework/requirements imposed on medical devices for the Great Britain market.

We will need to continue to monitor the developments in the UK to assess how they impact our devices sold in Great Britain.

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Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

• the federal Physician Sunshine Act under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred to as the Affordable Care Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and teaching hospitals.

• the federal Physician Payments Sunshine Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and other prescribers and teaching hospitals.

Applicable manufacturers are required to submit annual reports to CMS.

Failure to submit required information may result in substantial civil monetary penalties;

• 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.

• 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 FCPA, Bribery Act and the GDPR.

the FCPA, the Bribery Act and the GDPR.

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

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state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, including the GDPR, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers;

foreign and state laws, including the GDPR, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

and state laws related to insurance fraud in the case of claims involving private insurers.

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Responding to investigations can be time-and resource-consuming and can divert management’s attention from the business.

Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Additionally, as a result of these investigations, healthcare companies and healthcare providers may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

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Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws, including the FCPA, as well as export control laws, customs laws, sanctions laws and other laws governing our operations could result in civil or criminal penalties, other remedial measures and legal expenses.

As we grow our international presence, we are increasingly exposed to trade and economic sanctions and other restrictions imposed by the United States, the European Union and other governments and organizations.

Departments of Justice, Commerce, State and U.S.

Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the FCPA and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC.

In addition, the Bribery Act prohibits both domestic and international bribery, as well as bribery across both private and public sectors.

The substantive offences of offering or receiving a bribe will be committed by an individual where either the bribery takes place in the U.K, or the person paying or receiving the bribe has a close connection with the UK An organization which is either incorporated in or carries on part of its business in the U.K will be liable under the Bribery Act if a person associated with the organization (being persons performing services for it) pays a bribe anywhere in the world intending to obtain or retain business for the organization.

This is a strict liability offense with the only defenses available being that the organization implemented “adequate procedures” to prevent bribery or it was reasonable for it to not have such procedures in place.

Under these laws and regulations, as well as other anti-corruption laws, anti-money laundering laws, export control laws, customs laws, sanctions laws and other laws governing our operations, various government agencies may require export licenses, may seek to impose modifications to business practices, including cessation of business activities in sanctioned countries or with sanctioned persons or entities and modifications to compliance programs, which may increase compliance costs, and may subject us to fines, penalties and other sanctions.

A violation of these laws or regulations would negatively affect our business, financial condition and results of operations.

Due to sales of our products to government or government-affiliated entities, we may be exposed to heightened risk of potential violations of the FCPA, the Bribery Act, or other relevant law.

As we grow our international presence, we are increasingly subject to anti-corruption laws, anti-money laundering laws, export control laws, customs laws, sanctions laws and other laws and regulations imposed by the United States, the European Union and other governments and organizations in countries where we operate.

Departments of Justice, Commerce, and State, and the U.S.

Treasury and other federal agencies and authorities, may seek to impose a broad range of civil and criminal penalties against corporations and individuals for violations of sanctions laws, export control laws, the FCPA, and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC.

In addition, the Bribery

Act prohibits both domestic and international bribery across both private and public sectors.

We have implemented policies and procedures designed to ensure compliance by us and our directors, officers, employees, representatives, consultants, and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations.

We cannot be certain, however, that our policies and procedures are or will be sufficient or that directors, officers, employees, representatives, consultants and agents have not engaged and will not engage in conduct for which we may be held responsible, nor can we provide assurance that our business partners have not engaged and will not engage in conduct that could materially affect their ability to perform their contractual obligations to us or even result in our being held liable for such conduct.

Violations of the FCPA, OFAC restrictions, the Bribery Act or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could have a material adverse effect on our business, financial condition and results of operations.

However, given that we sell our products to government or government-affiliated entities, we may be exposed to heightened risk of potential violations of the FCPA, the Bribery Act, or other anti-bribery or anti-corruption laws.

In addition, various government agencies may require export licenses, or may seek to impose modifications to business practices, including cessation of business activities in sanctioned countries or with sanctioned persons or entities, and modifications to compliance programs, which may increase costs.

Violations of the FCPA, OFAC restrictions, the Bribery Act or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations may result in severe criminal or civil sanctions, and other potential liabilities, which could have a material adverse effect on our business, financial condition, and results of operations.

We are subject to, and may in the future become subject to additional, U.S., state and foreign laws and regulations imposing obligations on how we collect, store, process or share information concerning individuals.

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Even if we are not determined to have violated applicable data laws, government investigations into these issues can be expensive and lengthy and generate adverse publicity, which could harm our business, financial condition, results of operations or prospects.

The EEA and the UK, as well as other international jurisdictions, also have laws and regulations dealing with the collection, use and processing of personal data concerning individuals who are located there.

Those laws are often more restrictive than those in the United States.

For example, we are subject to the requirements of the GDPR, which imposes more stringent administrative requirements for controllers and processors of personal data, including, for example, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to health data and pseudonymized (i.e., key-coded) data, additional obligations when we contract with service providers, and more robust rights for individuals over their personal data.

The GDPR provides that EU member states may make their own further laws and regulations, including laws and regulations limiting the processing of genetic, biometric or health data, which could limit our ability to use and share personal data or cause our costs to increase, and harm our business and financial condition.

If we do not comply with our obligations under the GDPR, we could be exposed to enforcement activity from EU regulators, including substantial fines and litigation.

The EEA and the UK, as well as other international jurisdictions, also have laws and regulations dealing with the collection, use and processing of personal data concerning individuals.

Those laws are often more restrictive than analogous privacy laws in the United States.

For example, we are subject to the requirements of the GDPR, which imposes more stringent administrative requirements for controllers and processors of personal data, including, for example, demanding timelines for notifying personal data breaches, limitations on retention of personal information, stringent requirements pertaining to the processing of health data, rules regulating pseudonymized (i.e., key-coded) data, additional obligations when we contract with service provider processors, and robust rights for individuals with respect to their personal data.

The GDPR also provides that EU member states may impose further conditions on the processing of personal data, including genetic, biometric and health data, which could limit our ability to use and share personal data or cause our costs to increase, and harm our business and financial condition.

If we do not comply with our obligations under the GDPR, we could be exposed to enforcement activity from EU regulators, who may impose substantial fines, and civil litigation.

In addition, EU law restricts transfers of personal data to the United States unless certain requirements are met.

The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business.

For example, in July 2020, the Court of Justice of the European Union invalidated the U.S.-EU Privacy Shield Framework, which has led to increased scrutiny of data transfers from the EEA and the UK to the United States generally and may increase our costs of compliance with data privacy legislation.

For example, in July 2020, the Court of Justice of the European Union invalidated the U.S.-EU Privacy Shield Framework, which has since been replaced by the EU-U.S.

Data Privacy Framework.

There continues to be heightened scrutiny of data transfers from the EEA and the UK to the United States generally, as well as other jurisdictions, and this may increase our costs of compliance with data privacy legislation.

We rely on a mixture of mechanisms to transfer personal data from our European business to the United States.

We are also subject to the laws of each EU member state implementing any EU directive applicable to our processing activities, including Directing 2002/58/EC.

We are subject to the requirements of the UK Data Protection Law as amended and superseded from time to time.

As a result of the UK’s decision to leave the EU (i.e., Brexit), we are subject to the requirements of the UK Data Protection Law as amended and superseded from time to time.

UK Data Protection Law means:

(i) the GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal) Act 2018;

(ii) the Data Protection Act 2018;

(iii) the Privacy and Electronic Communications (EC Directive) Regulations 2003 as they continue to have effect by virtue of section 2 of the European Union (Withdrawal) Act 2018;

and (iv) any other laws in the field of data protection in force in the UK from time to time applicable (in whole or in part) to us.

(ii) the UK Data Protection Act 2018;

(iii) the UK Privacy and Electronic Communications (EC Directive) Regulations 2003 as they continue to have effect by virtue of section 2 of the European Union (Withdrawal) Act 2018;

and (iv) any other laws pertaining to data protection in force in the UK from time to time applicable (in whole or in part) to us.

Any actual or perceived failure by us or the third parties with whom we work to comply with data privacy or security laws, policies, legal obligations or industry standards, or any security incident that results in the unauthorized release or transfer of information concerning individuals, may result in governmental enforcement actions and investigations, including by European data protection authorities and U.S.

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It is difficult to predict how executive actions that may be taken under the current administration may affect the FDA’s ability to exercise its regulatory authority.

Inadequate funding for the FDA, SEC or other government agencies could impact the timeliness of responses or action and may slow the time necessary for agency reviews, which in turn would have a material adverse effect on our business, financial condition and results of operations

Inadequate funding for the FDA or other government agencies could impact the timeliness of responses or action and may slow the time necessary for agency reviews, which in turn would have a material adverse effect on our business, financial condition and results of operations

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs and improve access to transplantation.

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In addition, in 2023, the Securing the U.S.

Organ Procurement and Transplantation Network act was signed into law, which allows HRSA to make changes to the Organ Procurement and Transplantation Network, or OPTN, including requiring an independent board, awarding contracts to both non-profit and for-profit entities, and eliminating the cap on funding.

Organ Procurement and Transplantation Network Act was signed into law, which allows HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTN.

It also specifies that the awards to operate the OPTN shall be distinct from awards to support the networks’ board of directors.

In September 2024, HRSA began awarding contracts aimed at supporting the multi-vendor model.

HRSA continues to implement efforts to improve and modernize the OPTN, including enhancements to patient data on organ procurement, expanded transparency through a publicly accessible data dashboard for allocation out of sequence (AOOS) events, expanded outreach and financial support for living organ donors, and a new OPTN fee collection process whereby HRSA directly collects and distributes patient registration fees under authorities originally granted by the 2025 Full-Year Continuing Appropriations and Extensions Act and extended by the 2026 Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act.

The impact that HRSA's initiatives and the Securing the U.S.

Organ Procurement and Transplantation Network Act may have on our business, including on our NOP, is uncertain at this time.

We expect additional state and federal healthcare policies and reform measures to be adopted in the future, any of which could limit coverage or reimbursement for healthcare products and services or otherwise result in reduced demand for the OCS or additional pricing pressure and have a material adverse effect on our industry generally and on our customers.

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Furthermore, an accident could damage or force us to shut down our operations.

federal government shutdowns could adversely affect our business, financial condition, operating results, cash flows and prospects.

Congressional disagreement over the federal budget and the maximum amount of debt the federal government is permitted to have outstanding (commonly referred to as the “debt ceiling”) caused the U.S.

federal government to recently shut down.

Prolonged government shutdowns impact us and our customers, vendors and others we do business with.

During a U.S.

government shutdown, certain regulatory agencies, such as the FDA, FAA and the SEC, have had to furlough critical FDA, FAA, SEC, and other government employees and stop critical activities.

In addition, the current administration has stated that it could eliminate jobs at federal agencies.

Furthermore, although air traffic controllers are deemed to be essential employees who are required to continue to work during a government shutdown, in past shutdowns, including the most recent shutdown, air traffic controllers have more frequently called out of work, creating staffing shortages that affect flights and which could impact our aviation services.

Product development and regulatory activities depend on the continuity and capacity of the FDA and other health authorities.

Disruptions at the FDA and other agencies may slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which could adversely affect our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated in the past as a result.

In addition, government funding of the FDA and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

If there are future shutdowns, our business, financial condition, operating results, cash flows or prospects could be adversely affected.

Risks Related to Our Common Stock and General Risks

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This provision will not apply to actions arising under the Exchange Act, or the Securities Act of 1933, as amended, or the Securities Act.

Additionally, this exclusive forum provision may limit the ability of our shareholders to bring a claim in a judicial forum that such shareholders find favorable for disputes with us or our directors or officers, which may discourage such lawsuits against us and our directors and officers.

Alternatively, if the Business

Litigation Session of the Superior Court of Suffolk County, Massachusetts or a court outside of Massachusetts were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other venues or jurisdictions, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

Additionally, this exclusive forum provision may limit the ability of our shareholders to bring a claim in a judicial forum that such shareholders find favorable for disputes with us or

our directors or officers, which may discourage such lawsuits against us and our directors and officers.

Alternatively, if the Business Litigation Session of the Superior Court of Suffolk County, Massachusetts or a court outside of Massachusetts were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other venues or jurisdictions, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

We have identified a material weakness in our internal control over financial reporting, and we may identify additional material weaknesses in the future.

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As described in Item 9A – Controls and Procedures elsewhere in this Annual Report on Form 10-K, in connection with the audit of our financial statements for the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting with regard to a deficiency in our control over inventory movement within our manufacturing network.

Management, with the oversight of the audit committee of our board of directors, is in the process of assessing and finalizing its plan for remediation for the material weakness described above.

Management, with the oversight of the audit committee of our board of directors, is actively implementing a remediation plan to address the material weakness in internal control over financial reporting.

The remediation plan includes the design and implementation of new control activities, including system-based controls, to ensure that inventory movements are recorded in a timely and accurate manner throughout the reporting period, as well as strengthening review and approval procedures.

However, our remediation efforts with respect to our identified material weakness may be inadequate.

8 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors