8 unchanged sentences
Risks Related to Our Financial Position and Need for Additional Capital
−Removed: We have incurred substantial losses since our inception and have never generated net income on an annual basis.
−Removed: Since our inception, we have incurred significant operating losses.
−Removed: Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued growth in customer utilization of our OCS products and services.
−Removed: We generated revenue of $241.6 million, $93.5 million and $30.3 million for the years ended December 31, 2023, 2022 and 2021, respectively, and incurred net losses of $25.0 million, $36.2 million and $44.2 million for these same years.
−Removed: As of December 31, 2023, we had an accumulated deficit of $503.7 million.
−Removed: To date, we have funded our operations primarily with proceeds from sales of equity, borrowings under loan agreements, issuance of our 1.50% convertible senior notes due 2028, or our Notes, and revenue from clinical trials and commercial sales of our OCS products and services.
−Removed: Our losses have resulted principally from costs incurred in connection with our research and development, clinical trials, manufacturing and commercialization activities, including the development of our NOP.
−Removed: We expect our operating and capital expenditures will continue to increase for the foreseeable future as we focus on growing commercial sales of our products in both the U.S.
−Removed: and select non-U.S.
−Removed: markets, including growing our NOP and expanding our NOP offerings to include transportation logistics services, including the acquisition of additional aircraft to support aviation transportation;
−Removed: growing our commercial team, which will pursue increasing commercial sales of our OCS products;
−Removed: scaling our manufacturing operations;
−Removed: continuing research and development for our next generation OCS products;
−Removed: and seeking regulatory clearance for new products and product enhancements, including new indications, in both the U.S.
−Removed: and select non-U.S.
−Removed: The timing and amount of our operating and capital expenditures will depend on many factors, including:
−Removed: • the amount of product revenue generated by 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.
−Removed: markets, revenue generated by our services, and growth of the NOP;
−Removed: • the costs and expenses of expanding our U.S.
−Removed: commercial infrastructure and our manufacturing operations;
−Removed: • the extent to which our OCS products are adopted by the transplant community;
−Removed: • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products;
−Removed: • 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 additional aircraft for our aviation transportation services;
−Removed: • the costs and timing of research and development of the next generation of OCS products;
−Removed: • the degree of success we experience in commercializing our OCS products for additional indications;
−Removed: • 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;
−Removed: • the emergence of competing or complementary technologies;
−Removed: • the number and types of future products we develop and commercialize;
−Removed: • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
−Removed: • the level of our selling, general and administrative expenses.
−Removed: 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 when, or if, we will be able to achieve or maintain profitability.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Our financial results in some quarters may fall below expectations.
+Added: Comparing our financial results on a period-to-period basis may not be meaningful, and past results may not be an indication of our future performance.
Our existing and any future indebtedness could adversely affect our ability to operate our business.
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This activity may have an impact on the value of our common stock.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Our financial results in some quarters may fall below expectations.
−Removed: Comparing our financial results on a period-to-period basis may not be meaningful, and past results may not be an indication of our future performance.
−Removed: Because the timing of organ transplant procedures is generally unpredictable, we have not experienced seasonality in our business from quarter to quarter.
+Added: We may not be able to sustain profitability.
+Added: In recent years, we have incurred significant operating losses and we have only recently achieved profitability.
+Added: Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued customer utilization of our NOP.
+Added: We generated net income of $35.5 million for the year ended December 31, 2024.
+Added: As of December 31, 2024, we had an accumulated deficit of $468.2 million.
+Added: Our efforts to grow our business have been and may continue to be costlier than we expect.
+Added: 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.
+Added: We expect our operating and capital expenditures will continue to increase for the foreseeable future as we focus on growing commercial sales of our products in both the U.S.
+Added: and select non-U.S.
+Added: markets, including growing our NOP;
+Added: acquiring and maintaining additional aircraft to support aviation transportation;
+Added: growing our commercial team, which will pursue increasing commercial sales of our OCS products;
+Added: scaling our manufacturing operations;
+Added: continuing research and development for our next generation OCS products, including conducting clinical trials for our next generation OCS products;
+Added: and seeking regulatory clearance for new products and product enhancements, including new indications, in both the U.S.
+Added: and select non-U.S.
+Added: The timing and amount of our operating and capital expenditures will depend on many factors, including:
+Added: • revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions;
+Added: • the costs and expenses of expanding our U.S.
+Added: commercial infrastructure and our manufacturing operations;
+Added: • the extent to which our OCS products are adopted by the transplant community;
+Added: • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products;
+Added: • 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;
+Added: • the costs and timing of research and development of the next generation of OCS products;
+Added: • the degree of success we experience in commercializing our OCS products for additional indications;
+Added: • 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;
+Added: • the emergence of competing or complementary technologies;
+Added: • the number and types of future products we develop and commercialize;
+Added: • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
+Added: • the level of our selling, general and administrative expenses.
+Added: 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.
−Removed: As of December 31, 2023, we had federal net operating loss, or NOL, carryforwards of $376.4 million, which may be available to offset future taxable income, of which $207.4 million of the total net operating loss carryforwards expire at various dates beginning in 2024, while the remaining $169.0 million do not expire but are limited in their usage to an annual deduction equal to 80% of annual taxable income.
−Removed: As of December 31, 2023, we had state net operating loss carryforwards of $328.8 million, which may be available to offset future taxable income and expire at various dates beginning in 2030.
+Added: 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.
+Added: As of December 31, 2024, we had state NOL carryforwards of $349.6 million, which may be available to offset future taxable income and expire at various dates beginning in 2030.
As of December 31, 2024, 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.
−Removed: federal research and development tax credit carry forwards expire beginning in 2024.
+Added: 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.
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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.
−Removed: Furthermore, our ability to utilize our NOLs or credits is conditioned upon our attaining profitability and generating U.S.
+Added: Furthermore, our ability to utilize our NOLs or credits is conditioned upon our maintaining profitability and generating U.S.
federal and state taxable income.
−Removed: As described above, we have incurred significant net losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future;
−Removed: and therefore, we do not know whether or when we will generate the U.S.
+Added: As described above, prior to 2024, we incurred significant net losses since inception;
+Added: 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.
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Our long-term growth depends on our ability to expand access to the OCS through our NOP.
−Removed: We have developed the NOP, an innovative turnkey solution to provide outsourced organ retrieval and OCS organ management, to provide transplant programs with a more efficient process to procure donor organs with the OCS.
+Added: We have developed the NOP, an innovative turnkey solution to provide outsourced organ procurement and OCS perfusion management, to provide transplant programs with a more efficient process to procure donor organs with the OCS.
We believe the NOP will continue to expand access and use of the OCS.
−Removed: However, we may not be successful in the continued development of our NOP, which will depend on recruiting, training and retaining qualified surgeons and pilots and establishing and maintaining effective coordination with transplant centers and regional Organ Procurement Organizations to locate donor organs and recipients.
−Removed: We may not be able to recruit, train and retain surgeons, pilots and other qualified personnel, including due to demand for their capabilities and competitive compensation offered by other employers.
+Added: However, continued operations of our NOP depend on recruiting, training and retaining qualified surgeons, clinical specialists, pilots, and other personnel and establishing and maintaining effective coordination with transplant centers and regional Organ Procurement Organizations to locate donor organs and recipients.
+Added: We may not be able to continue to recruit, train and retain qualified personnel, including due to demand for their capabilities and competitive compensation offered by other employers.
In order to recruit, train and retain such highly qualified employees, we also may need to increase the level, or change the form or composition, of the compensation that we pay to them, which would increase our expenses.
−Removed: In addition to our own surgical and clinical personnel, we utilize a network with a limited number of partners for organ retrieval, organ preservation and transportation services offered through our NOP.
+Added: In addition to our own surgical and clinical personnel, we utilize a network with a limited number of partners for organ procurement, organ preservation and transportation services offered through our NOP.
If any of these relationships are interrupted or terminated, or if one or more partners are unable or unwilling to fulfill their obligations for any reason, NOP services to our customers may be interrupted.
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Additional expenses incurred by our NOP could adversely affect our business, gross margin, financial condition, operating results, cash flows and prospects.
+Added: Our long-term growth depends on our ability to improve the OCS platform, including by developing the next generation of our products or expanding into new indications.
+Added: Our business plan contemplates that we will continue to improve the OCS platform, including by developing the next generation of our products or expanding into additional organs.
+Added: Developing such new or modified products is expensive and time-consuming and diverts management’s attention away from current operations.
+Added: The success of any new product offering or product enhancements to our OCS platform will depend on several factors, including our ability to:
+Added: • properly identify and anticipate surgeon and patient needs;
+Added: • develop and introduce new products and product modifications in a timely manner;
+Added: • avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties;
+Added: • demonstrate the safety and efficacy of new products and product modifications;
+Added: • obtain necessary regulatory clearances or approvals;
+Added: • comply with regulations regarding the marketing of new products or product modifications;
+Added: • provide adequate training to potential users of our products;
+Added: • receive adequate coverage and reimbursement for procedures performed with our products;
+Added: • develop an effective commercialization effort.
+Added: If we are not successful in expanding our indications and developing the next generation of our products, our ability to increase our revenue may be impaired, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
We will need to increase our manufacturing and sterilization capacity in the future and may encounter problems at our manufacturing facility or otherwise.
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We aim to maintain strategic reserves of our OCS Perfusion Sets, but if we are not able to manufacture and assemble OCS Perfusion Sets at a rate that will allow us to maintain these reserves, then we will be required to rely on alternative strategies to deliver OCS Perfusion Sets in a timely manner, which may impact our expenses and results of operations.
−Removed: We depend heavily on the success of the OCS and it gaining additional market acceptance.
−Removed: If we are unable to continue to successfully commercialize the OCS, our business may fail.
−Removed: We have invested substantial efforts and financial resources in the development of the OCS, educating surgeons, transplant centers, Organ Procurement Organizations and private and public payors of the benefits of the OCS, providing services related to the OCS and launching our NOP.
−Removed: Although we have received PMAs from the FDA for each of our three OCS products, we might not be able to continue to successfully commercialize the OCS for these approved indications or obtain approvals for additional indications or in additional jurisdictions on our planned timing or at all.
−Removed: Our ability to generate product revenue and become profitable depends primarily on sales of OCS Perfusion Sets and OCS Solutions, which we refer to collectively as disposable sets.
+Added: We depend heavily on the success of the OCS and it gaining additional market acceptance as well as the success of the next generation OCS.
+Added: If we are unable to continue to successfully commercialize the OCS or the next generation OCS, our business may fail.
+Added: We have invested substantial efforts and financial resources in the development of the OCS, educating surgeons, transplant centers, Organ Procurement Organizations and private and public payors of the benefits of the OCS, providing services related to the OCS and developing and operating our NOP.
+Added: Although we have received PMA approvals from the FDA for each of our three OCS products, we might not be able to continue to successfully commercialize the OCS for these approved indications or obtain approvals for additional indications or in additional jurisdictions on our planned timing or at all.
+Added: Our ability to generate product revenue and remain profitable depends primarily on sales of OCS Perfusion Sets and OCS Solutions, which we refer to collectively as disposable sets.
Our assumptions regarding demographic trends, donor organ availability and the use of transplantation as a treatment for end-stage organ failure may prove to be incorrect.
4 unchanged sentences
In addition, our international customers and some U.S.
−Removed: customers use a direct acquisition model pursuant to which transplant centers train their own teams for retrieval and organ management using the OCS rather than utilizing our NOP.
+Added: customers use a direct acquisition model pursuant to which transplant centers train their own teams for organ procurement and OCS perfusion management using the OCS rather than utilizing our NOP.
Surgeons may not be willing to undergo training to use the OCS, may decide the OCS is too complex to adopt without appropriate training and may choose not to use the OCS, which may limit the adoption of the OCS under the direct acquisition model.
−Removed: Based on these and other factors, transplant center program directors, Organ Procurement Organizations and private and public payors may decide that the benefits of the OCS do not outweigh its costs.
+Added: Further, the OCS replaces a decades-old standard of care and the NOP has significantly expanded service offerings available to transplant centers for the complicated organ procurement process that often requires resources and logistics beyond a transplant center’s existing clinical capabilities and capacity.
+Added: As a result, we may face opposition from industry participants reluctant to change.
+Added: An activist short seller published a disparaging report about our business, which may impact our reputation in the market and deter surgeons and transplant centers from adopting the OCS or utilizing our NOP.
+Added: In addition, this activist short seller has submitted a petition to the FDA, requesting that the FDA suspend the PMA approval for the OCS and take other adverse actions related to the OCS, and in particular the OCS Liver, due to alleged off-label use of the device.
+Added: We have responded to this petition, stating both legal and factual bases for rejection.
+Added: Even if the FDA rejects the petition, the petition may nonetheless impact how surgeons, patients and transplant centers perceive the safety and efficacy of our OCS products, which would have a material adverse effect on our business, financial condition, results of operations and prospects, as well as harm our reputation.
+Added: Based on these or other factors, transplant center program directors, Organ Procurement Organizations and private and public payors may decide not to use OCS.
In addition, adoption of the OCS may be constrained by the capacity of individual transplant centers to perform transplants due to factors such as the number of its surgeons trained on the use of the OCS.
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We are responsible for the clinical data regarding the organ that is provided to transplant surgeons who participate in the NOP.
−Removed: Our long-term growth depends on our ability to improve the OCS platform, including by developing the next generation of our products or expanding into new indications.
−Removed: Our business plan contemplates that we will continue to improve the OCS platform, including by developing the next generation of our products or expanding into additional organs.
−Removed: Developing such new or modified products is expensive and time-consuming and diverts management’s attention away from current operations.
−Removed: The success of any new product offering or product enhancements to our OCS platform will depend on several factors, including our ability to:
−Removed: • properly identify and anticipate surgeon and patient needs;
−Removed: • develop and introduce new products and product modifications in a timely manner;
−Removed: • avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties;
−Removed: • demonstrate the safety and efficacy of new products and product modifications;
−Removed: • obtain necessary regulatory clearances or approvals;
−Removed: • comply with regulations regarding the marketing of new products or product modifications;
−Removed: • provide adequate training to potential users of our products;
−Removed: • receive adequate coverage and reimbursement for procedures performed with our products;
−Removed: • develop an effective commercialization effort.
−Removed: If we are not successful in expanding our indications and developing the next generation of our products, our ability to increase our revenue may be impaired, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
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.
−Removed: On August 2, 2023, we acquired certain assets related to lung and heart perfusion technology from Bridge to Life Ltd.
+Added: 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.
+Added: In addition, in August 2023, we acquired certain assets related to lung and heart perfusion technology from Bridge to Life Ltd.
and its subsidiary Tevosol, Inc., or together Bridge to Life.
−Removed: In addition, on August 16, 2023, we acquired Summit, an aviation business.
−Removed: We have separately acquired 13 fixed-wing aircraft, and intend to acquire additional fixed-wing aircraft, that will be operated as part of our NOP.
−Removed: Utilization of these acquired assets and integration of Summit, may be complex, costly and time consuming and we may face unanticipated issues, expenses and liabilities.
+Added: Utilization of these acquired assets may be complex, costly and time consuming and we may face unanticipated issues, expenses and liabilities.
We may not successfully or profitably utilize newly acquired assets or integrate, operate, maintain and manage any newly acquired operations or employees.
−Removed: Further development of the assets we acquired from Bridge to Life, or the Bridge to Life Assets, will require extensive clinical development, management of nonclinical, clinical and manufacturing activities.
+Added: 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.
−Removed: We also may face challenges integrating Summit into our organization.
−Removed: We have never provided aviation transportation services prior to the acquisition and will depend on the management team of Summit for the successful operation and integration into our NOP services offering.
−Removed: Even if we are able to utilize the Bridge to Life Assets and integrate Summit or any other acquired assets or businesses successfully, we may not realize the expected benefits of the transactions.
−Removed: These are the Company’s first acquisitions, and we may need to invest in additional business processes and systems to support the Summit integration or to utilize the Bridge to Life Assets.
−Removed: Such additional costs may offset the financial benefits that may be realized from the acquisitions.
−Removed: We also may suffer the loss of key employees and strategic partners of Summit and it may be difficult to implement our corporate culture.
−Removed: There also may be increased risk due to integrating financial reporting and internal control systems of Summit.
+Added: 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.
+Added: 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
+Added: 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.
−Removed: There can be no assurance that we will be able to identify suitable candidates or consummate future transactions on favorable terms.
+Added: We may not be able to identify suitable candidates or consummate future transactions on favorable terms.
If required, the financing for future transactions could result in an increase in our indebtedness, dilute the interests of our shareholders or both.
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We generate a significant amount of our revenue from a limited number of customers.
−Removed: However, our customers may not continue to utilize our products or services at current levels, pricing, or at all, and our revenue could fluctuate significantly due to changes in economic conditions, the use of other methods for organ preservation, such as cold storage, or the loss of, reduction of business with, or less favorable terms with any of our largest customers.
+Added: However, our customers may not continue to utilize our products or services at current levels, pricing, or at all, and our revenue could fluctuate significantly due to changes in economic conditions, the use of other methods for organ preservation, such as cold storage or normothermic regional perfusion, or the loss of, reduction of business with, or less favorable terms with any of our largest customers.
Our future success will depend upon the timing and volume of business from our largest customers and the financial and operational success of these customers.
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customers now participate in our NOP and our success will depend on our ability to maintain the function and efficiency, while increasing capacity and capability, of the NOP.
−Removed: 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 effect our business, financial condition, operating results, cash flows and prospects.
+Added: 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.
9 unchanged sentences
We also may choose to establish our own manufacturing process of certain components and we may not be successful in doing so.
−Removed: For example, we will need to seek FDA approval for any component design we choose to manufacture, which may not be granted in a reasonable time, or at all.
In addition, the components we design may not be successful or may not provide a functional or economic benefit compared to similar components manufactured by third parties.
+Added: We would also need to seek FDA approval for any change in the design of our device, including different components, which may not be granted in a reasonable time, if at all.
If we choose to establish our own manufacturing process of components of the OCS, we may be required to procure additional raw materials for such processes, which may not be available.
−Removed: We may also face regulatory delays or be required to seek additional regulatory clearances or approvals if we experience any delay or deficiency in the quality of products obtained from suppliers or if we have to replace our suppliers.
In addition, many of the components used in the OCS are specifically designed for use in the OCS, which means that off-the-shelf components may not be available as substitutes.
+Added: 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.
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We also may be required to seek alternative and, potentially more costly, flight services.
−Removed: Although the cost of flights is paid by our customers, a substantial increase in the cost of flight services, due to prolonged increases in fuel prices, lack of availability of aircraft or otherwise, may require us to incur additional costs to identify and obtain alternative flights or rebalance our inventory by shipping products to locations for which flight costs are less expensive or from which flights are more readily available, and customers may be unwilling or unable to incur higher costs of flights and therefore forgo use of our services and products for the retrieval of donor organs despite availability.
+Added: Although the cost of flights is paid by our customers, a substantial increase in the cost of flight services, due to prolonged increases in fuel prices, lack of availability of aircraft or otherwise, may require us to incur additional costs to identify and obtain alternative flights or rebalance our inventory by shipping products to locations for which flight costs are less expensive or from which flights are more readily available, and customers may be unwilling or unable to incur higher costs of flights and therefore forgo use of our services and products for the procurement of donor organs despite availability.
Further, the capacity of our NOP is limited by the number of aircraft and pilots available for our use and as we continue to grow our NOP, we will be required to obtain access to a greater number of available aircraft and pilots.
We may not be able to achieve or maintain satisfactory pricing and margins for our products or services.
−Removed: Manufacturers of medical devices have a history of price competition, and we can give no assurance that we will be able to achieve satisfactory prices for our products or maintain prices at the levels we have historically achieved.
+Added: Manufacturers of medical devices have a history of price competition, and we may not be able to achieve satisfactory prices for our products or maintain prices at the levels we have historically achieved.
Any decline in the amount that payors reimburse our customers for OCS products or services could make it difficult for customers to continue using, or to adopt, our products and could create additional pricing pressure for us.
6 unchanged sentences
Significant price increases could adversely affect our results of operations and operating margins.
−Removed: In particular, inflation, changes in trade policies, the imposition of duties and tariffs and public health crises (such as the COVID-19 pandemic) could adversely impact the price or availability of raw materials and the components of our products.
+Added: In particular, inflation, changes in trade policies, the imposition of duties and tariffs and public health crises could adversely impact the price or availability of raw materials and the components of our products.
+Added: continues to implement certain trade actions, including imposing tariffs on certain goods imported from China and other countries.
+Added: Significant tariffs have been proposed by the new administration, although it is not possible to predict the extent or focus of any such tariffs at this time.
+Added: Additional tariffs, trade restrictions and export controls imposed by the U.S.
+Added: on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, may impact our suppliers and the price of our components for our OCS products or our aircraft.
We may not be able to pass along increased component part prices to customers in the form of price increases or our ability to do so could be delayed.
58 unchanged sentences
Risks Related to Our Logistics Operations
−Removed: Prior to our acquisitions to facilitate our aircraft operations, we had no experience operating aircraft ourselves, and we may not be able to achieve the anticipated benefits of our acquisitions or further expansion of our aircraft operations.
−Removed: Prior to our acquisitions to facilitate our aircraft operations, we had no experience operating aircraft ourselves, and we depend on the 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.
−Removed: The management teams must work together to comply with applicable laws and regulations and to manage our growing NOP logistics network.
+Added: We have limited experience operating aircraft, and we may not be able to achieve the anticipated benefits of our aircraft operations.
+Added: 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.
+Added: We must comply with applicable laws and regulations to manage our growing NOP 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.
−Removed: If we fail to retain 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.
+Added: 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.
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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If any of these events were to occur, we could experience loss of revenue, termination of customer contracts, higher insurance rates, litigation, regulatory investigations and enforcement actions (including potential grounding of our fleet and suspension or revocation of our operating authorities) and damage to our reputation and customer relationships.
−Removed: In addition, to the extent an accident occurs with an aircraft we operate or charter, we could be held liable for resulting damages, which may involve claims from injured passengers, and survivors of deceased passengers and property owners.
+Added: In addition, to the extent an accident occurs with an aircraft we own or through the use of a third-party network of private aircraft, we could be held liable for resulting damages, which may involve claims from injured passengers, and survivors of deceased passengers and property owners.
The amount of our insurance coverage may not be adequate to cover such losses, or we may be forced to bear substantial losses from such events, regardless of our insurance coverage.
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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.
+Added: If there is a shortage of replacement parts that are compatible with the model of aircraft we operate, our entire fleet may be impacted and we would not be able to rely on other model aircraft during replacement part shortages or outages.
+Added: Our operation of a single model of aircraft may therefore limit flexible use of our fleet.
Although we could choose to operate aircraft of other manufacturers or increase our reliance on third-party operators, such a change would involve substantial expense to us and could disrupt our business activities.
We rely on Pratt & Whitney aircraft engines to power our owned aircraft, and we may enter into program agreements covering certain of our aircraft related to engine maintenance and overhauls for certain aircraft in our fleet.
−Removed: If Pratt & Whitney fails to adequately fulfill its obligations towards us or experiences interruptions or disruptions in production or provision of parts or 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 aircraft engines and parts, which could result in grounded aircraft.
+Added: If Pratt & Whitney fails to adequately fulfill its obligations towards us or experiences interruptions or disruptions in production or provision of parts or services due to, for example, bankruptcy, natural disasters, labor strikes, increased FAA, oversight of the production process, or disruption of its supply chain, we may experience a significant delay in the delivery of or fail to receive previously ordered aircraft engines and parts, which could result in grounded aircraft.
These disruptions would adversely affect our revenue and profitability and could jeopardize our ability to meet the demands of our customers.
In addition, if we fail to meet our obligations or are otherwise in default under the program agreements, our access to aircraft engines and parts may become limited, which could adversely impact our business, operations, cash flow, financial condition and liquidity.
−Removed: The Federal Aviation Administration, or FAA, could suspend or restrict the use of our aircraft in the event of actual or perceived mechanical problems or safety issues while it conducts its own investigation, whether involving our aircraft or another operator’s aircraft.
+Added: The FAA could suspend or restrict the use of our aircraft in the event of actual or perceived mechanical problems or safety issues while it conducts its own investigation, whether involving our aircraft or another operator’s aircraft.
+Added: For example, in 2023, the FAA required the removal of certain Pratt & Whitney engines for inspection.
+Added: If the FAA requires inspections of the types of Pratt & Whitney aircraft engines that we utilize, our ability to operate our NOP may be limited, which could adversely impact our business, operations, cash flow, financial condition and liquidity.
The availability of pilots to the private aviation industries is limited and may negatively affect our operations and financial condition.
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If our attrition rates are higher than our ability to hire and retain replacement pilots, our operations and financial results would be adversely affected.
+Added: We may not be able to balance the number of pilots we employ with the number of aircraft in our fleet and demand for our NOP, as well as accurately forecast pilot attrition and hiring needs.
+Added: If our forecasts are inaccurate and we do not effectively balance the number of pilots we employ, or if the supply of pilots becomes constricted, such events could disrupt our business activities.
In addition, our operations and financial condition may be negatively impacted if we are unable to train pilots in a timely manner.
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Moreover, as our aircraft base increases and our fleet ages, our maintenance costs could potentially increase and we may be unable to manage the composition of our fleet in a manner that reduces costs due to the availability and prices for replacement aircraft and parts.
+Added: When our aircraft are grounded for maintenance, we are required to rely on third-party logistics service providers to transport organs for our NOP, which increases the cost of operating our NOP.
We rely on third-party service providers to perform functions integral to our operations, including ground handling, landing fees, fueling, maintenance, and other services.
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Our aircraft operations are affected by factors beyond our control, including air traffic congestion at airports, air traffic control inefficiencies and staffing shortages, increased and changing security measures, changing regulatory and governmental requirements, and new or changing travel-related taxes.
+Added: For example, in November 2024, the FAA announced that a shortage of air traffic controllers had significantly impacted flight traffic.
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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The air traffic control system, which is operated by the FAA, in the U.S., faces challenges in managing the growing demand for U.S.
+Added: air travel and attracting air traffic controllers.
air-traffic controllers often rely on outdated technologies that routinely overwhelm the system and compel aviation operators to fly inefficient, indirect routes resulting in delays and increased operational cost.
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Further, implementation of the Next Generation Air Transport System by the FAA could result in changes to aircraft routings and flight paths that could lead to increased noise complaints and lawsuits, resulting in increased costs.
+Added: Future changes to air traffic control systems or protocols could lead to increased costs, legal issues or operational inefficiencies, in each case which adversely impact our business and results of operations.
Our aircraft operations are subject to significant governmental regulation and changes in government regulations imposing additional requirements and restrictions on our aircraft operations could increase our operating costs and result in service delays and disruptions.
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Any unexpected increase in maintenance costs may negatively impact our financial position and results of operations.
−Removed: Our inability to acquire additional aircraft may adversely affect operations.
−Removed: Additional aircraft may be needed to service our customers and grow our business.
−Removed: The inability to acquire sufficient aircraft in the secondary market at acceptable prices could adversely affect our business and could jeopardize our ability to meet the demands of our customers or result in continued reliance on third-party charter operations that could result in additional costs or lower reliability.
−Removed: Typically, aircraft manufacturers have a significant backlog of orders resulting in new orders being scheduled more than a year after execution of purchase agreements.
−Removed: Furthermore, manufacturers can face production delays due to many factors, including natural disasters, pandemics, supply chain disruptions, labor strikes or availability of skilled labor.
+Added: We are subject to risks associated with climate change, including the potential increased impacts of severe weather events on our operations and infrastructure.
+Added: The potential physical effects of climate change, such as increased frequency and severity of storms, floods, fires, and other climate-related events, could affect our operations, infrastructure, and financial results.
+Added: Operational impacts, such as the delay or cancellation of flights or physical damage to our aircraft, could result in loss of revenue from our NOP and reputational harm if we are unable to fulfil customer demand for our NOP.
+Added: In particular, severe weather events in the Dallas area may have an adverse impact on our ability to utilize our Dallas facility for maintenance of our aircraft and we would be required to rely on third parties to complete required aircraft maintenance.
+Added: In addition, certain airports that we frequently utilize and certain of our facilities are in locations susceptible to the impacts of storm-related flooding, fires and other climate-related events, which could result in increased costs and loss of revenue from NOP customers those regions.
Risks Related to Our Business
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The efficient operation of our business depends on our information technology systems.
−Removed: We rely on our information technology systems to effectively manage sales and marketing data, accounting and financial functions, inventory management, product development tasks, clinical data, donor and patient data, customer service and technical support functions.
+Added: We rely on our information technology systems to effectively manage sales and marketing data, accounting and financial functions, inventory production and management, product development tasks, clinical and other data required to support NOP missions, customer service and logistics activities, and technical support functions.
However, our information technology systems are vulnerable to damage or interruption, including from earthquakes, fires, floods and other natural disasters;
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For example, during the second quarter of 2023, we became aware of an infiltration of portions of our information technology network.
−Removed: As part of our investigation into this incident, we engaged outside security experts and identified unauthorized theft of data although no sensitive data were involved and we do not store patient related data on our network or anywhere within the company premises.
−Removed: We have implemented additional security safeguards that we believe have secured the system, however, these additional security safeguards may not be successful.
+Added: As part of our investigation into this incident, we engaged outside security experts and identified unauthorized theft of data although no sensitive data were involved.
While the impact from this incident was not material to the operations of the Company, future impacts from such threats may be material.
−Removed: While we maintain insurance coverage for these types of incidents, such policies, may not provide coverage for, or offset the costs of responding to and remediating this infiltration or any other such incidents or any other liability that may arise from this infiltration or any other such incident.
+Added: While we maintain insurance coverage for these types of incidents, such policies, may not provide coverage for, or offset the costs of responding to and remediating such incidents or any other liability that may arise from such incident.
We have access to sensitive, confidential or personal data or information that is subject to privacy and security laws, regulations or customer-imposed controls.
−Removed: Despite our implementation of controls designed to protect our systems and sensitive, confidential or personal data or information, we have suffered the infiltration described above (and may have suffered other intrusions in the past) and may in the future be vulnerable to material security breaches, theft, misplaced, lost or corrupted data, employee errors and/or malfeasance (including misappropriation by departing employees) that could potentially lead to the compromising of sensitive, confidential or personal data or information.
+Added: Despite our implementation of controls designed to protect our systems and sensitive, confidential or personal data or information, the infiltration of our information technology systems, including security breaches, theft, misplaced, lost or corrupted data, employee errors and/or malfeasance (including misappropriation by departing employees) could lead to the compromise of sensitive, confidential or personal data or information.
While we attempt to mitigate these risks by employing a number of measures, including employee training and maintenance of protective systems, such measures did not prevent the infiltration described above and may not prove adequate to prevent cyberattacks, and we remain potentially vulnerable to additional known or unknown threats.
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Our growth will require significant capital expenditures and may divert financial resources from other projects, such as the development of the OCS for transplants involving additional indications or other organs.
−Removed: Our NOP, an innovative turnkey solution to provide outsourced organ retrieval, OCS organ management and logistics services, will also require additional capital expenditures.
+Added: Operating our NOP requires significant capital expenditures, including the acquisition and maintenance of our fleet of aircraft.
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.
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In addition, certain changes and other events with respect to regulatory approvals may cause an event of default under our CIBC Credit Agreement.
−Removed: Management’s Discussion and Analysis - Long-Term Debt,” in this Annual Report on Form 10-K.
+Added: Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Long-term Debt” in this Annual Report on Form 10-K.
Our products have been and may in the future be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
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We may initiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA.
−Removed: If the FDA disagrees with our determinations, we could be required to report those actions as recalls.
+Added: If the FDA disagrees with our determinations, we could be required to report those recalls.
A recall announcement could harm our reputation with customers and negatively affect our sales.
Additionally, any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.
−Removed: In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, seizure of our products or delay in clearance or approval of future products.
+Added: In addition, the FDA could take enforcement action for failing to initiate a recall or to report recalls when they were conducted, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, seizure of our products or delay in clearance or approval of future products.
We have voluntarily recalled certain OCS products from clinical sites in the past and may need to take similar actions in the future, which may result in notices to regulatory agencies in other jurisdictions.
As we continue to expand commercialization of our products and sell OCS products to new customers, the impact of any future product recall increases, and any future product recalls would require greater administrative and response efforts than historical product recalls.
−Removed: Internationally, the approaches to product defects will vary.
−Removed: A product may be recalled in one country but not in others.
−Removed: However, within the European Union, competent authorities are required without delay to take corrective action against a device (including withdrawal/recall of a device) and notify other national competent authorities, the European Commission and notified bodies (as applicable) of any devices that present an unacceptable risk to the health or safety of patients, users or other persons, or other aspects of the protection of public health.
+Added: Internationally, the regulatory requirements relating to product defects may vary.
+Added: A regulatory authority in a specific country may request or require a product recall while others may not.
+Added: Within the European Union, competent authorities are required without delay to take corrective action against a device (including withdrawal/recall of a device) and notify other national competent authorities, the European Commission and notified bodies (as applicable) of any devices that present an unacceptable risk to the health or safety of patients, users or other persons, or other aspects of the protection of public health.
Other non-compliance with the MDR may also lead to corrective action being taken and notifications being sent if the non-compliance is not rectified within a given time period (as determined by the competent authority).
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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).
−Removed: 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 be extended potentially until June 30, 2030 (subject to certain conditions).
−Removed: 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 and have the UKCA mark affixed.
+Added: 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).
+Added: 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.
However, even devices that benefit from the transition period must still comply with the other requirements of the UK MDR 2002;
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.
+Added: 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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For example, if, as a result of manufacturing error, the efficacy of our products does not meet the standards claimed in the accompanying instructions for use, regulatory authorities could prevent our products from being placed on the market in the European Union, Northern Ireland, Great Britain and elsewhere.
−Removed: If transplant centers and hospitals cannot obtain adequate reimbursement or funding from governments or third-party payors for purchases of the OCS and additional disposable sets and for costs associated with procedures that use the OCS and the NOP, our prospects for generating revenue and achieving profitability will suffer materially.
−Removed: Our prospects for generating revenue and achieving profitability depend heavily upon the availability of adequate reimbursement or funding in both the United States and other markets for purchases of the OCS and for organ transplant procedures that use the OCS and the NOP.
+Added: If transplant centers and hospitals cannot obtain adequate reimbursement or funding from governments or third-party payors for purchases of the OCS and additional disposable sets and for costs associated with procedures that use the OCS and the NOP, our prospects for generating revenue and maintaining profitability will suffer materially.
+Added: Our prospects for generating revenue and maintaining profitability depend heavily upon the availability of adequate reimbursement or funding in both the United States and other markets for purchases of the OCS and for organ transplant procedures that use the OCS and the NOP.
In the United States, Medicare generally reimburses the facilities in which transplant procedures are performed based upon prospectively determined amounts.
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Alternatively, we may be required to enter into risk sharing arrangements with payers.
−Removed: Adoption of our products in the European Union may be hindered if they impede our customer’s compliance with the requirements of Directive 2010/53/EU (formerly Directive 2010/45/EU), and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (Statutory Instrument (SI) 2012 No.
+Added: Adoption of our products in the European Union may be hindered if the adoption impedes or otherwise compromises our customer’s compliance with the requirements of Directive 2010/53/EU (formerly Directive 2010/45/EU), and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (Statutory Instrument (SI) 2012 No.
1501) (the Regulations) in the United Kingdom which imposes certain standards on procurement, preservation and transport of organs intended for transplantation.
−Removed: Even where reimbursement or funding is available, in some foreign countries, particularly in the European Union, the pricing of medical devices is subject to governmental control.
+Added: Even where reimbursement or funding is available, in some foreign countries, particularly in the European Union, the pricing of medical devices is subject to governmental control and a determination of affordability for medical devices to be accessed.
In these countries, reimbursement and pricing negotiations with governmental authorities can take considerable time after the CE marking of a product.
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If hospitals in the United States or the European Union are not able to obtain reimbursement or funding for the cost of the OCS and additional disposable sets or for transplant procedures generally, they may not have sufficient economic incentives to purchase the OCS.
−Removed: If hospitals or surgeons determine that the benefits of the OCS do not or will not outweigh the initial cost and ongoing expense of the OCS, we might fail to achieve significant sales and may never become profitable.
+Added: If hospitals or surgeons determine that the benefits of the OCS do not or will not outweigh the initial cost and ongoing expense of the OCS, we might fail to achieve significant sales and may fail to maintain profitability on a sustained basis.
Reimbursement in international markets is likely to require us to undertake country-specific reimbursement activities, including additional clinical studies, which could be time-consuming and expensive and may not yield acceptable reimbursement rates.
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In February 2024 FDA issued the QSMR Final Rule to amend the QSR, incorporating by reference ISO 13485:2016.
−Removed: Until the QSMR becomes effective on February 2, 2026, we are required to comply with the QSR.
+Added: Until the QSMR becomes effective on February 2, 2026, and we are required to transition to the QMSR by that date.
+Added: 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.
−Removed: Outside the United States, our products and operations are also often required to comply with standards set by industrial standards bodies, such as the International Organization for Standardization.
+Added: 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.
For example, in the European Union the MDR includes detailed requirements for clinical investigations, which are in line with the international standard ISO 14155:2020 on good clinical practical, or GCP.
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Furthermore, we would need to pay any product liability losses in excess of our insurance coverage or within the deductibles provided under our insurance policies applicable to the claim out of cash reserves, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
−Removed: The FDA has warned that the threat of cyberattacks on medical devices is no longer theoretical.
+Added: The FDA has recognized the threat of cyberattacks on medical devices, and imposes requirements on medical device manufacturers to ensure the cybersecurity of devices.
Hackers and other third parties may try to circumvent security controls on an OCS to gain access to information on the OCS, alter the way an OCS operates, to act as a trojan horse or other entry point to other systems that could lead to those systems suffering cybersecurity breaches or attacks, or to cause harms to transplanted organs or individuals.
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There may be increased risk of injury to patients if surgeons attempt to use the OCS off-label.
−Removed: Furthermore, the use of the OCS for indications other than those approved by the FDA/ by any foreign regulatory body or for which they are CE marked may not effectively treat such conditions, which could harm our reputation in the marketplace among surgeons and patients.
+Added: Furthermore, the use of the OCS for indications other than those approved by the FDA or by any foreign regulatory body or for which they are CE marked may not effectively treat such conditions, which could harm our reputation in the marketplace among surgeons and patients.
If the FDA or any foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, or that the materials or training are false or misleading, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of a warning letter, an untitled letter (which is used for violations that do not necessitate a warning letter), injunction, seizure, civil fine or criminal penalties.
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or additional record keeping.
−Removed: In the EU, Regulation (EU) 2017/745, or the MDR, repealed and replaced the Medical Devices Directive (93/42/EEC) with effect from May, 26 2021.
−Removed: 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 potentially remain valid (subject to certain Conditions) 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.
+Added: In the EU, the MDR repealed and replaced the Medical Devices Directive (93/42/EEC) with effect from May, 26 2021.
+Added: 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.
+Added: 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).
−Removed: The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks until June 30, 2030 (subject to certain conditions).
+Added: 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.
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We also recognize that our products may need to be certified and have a UKCA mark affixed to be placed on the market in Great Britain in the future.
−Removed: 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, provided certain conditions are met.
−Removed: The UK Government is expected to publish updated UK medical devices legislation in 2025.
+Added: 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.
+Added: 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.
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Healthcare reform initiatives could harm our business, financial condition and results of operations.
+Added: There is substantial uncertainty as to how, if at all, the current administration will seek to revise the policies of the FDA and other government agencies.
+Added: While many of the current administration’s proposed policies appear to be focused on deregulation, the administration and federal government could adopt legislation, regulation, or policy that adversely affects our business or creates a more challenging and costly environment to pursue future clinical trials for, or expand commercialization of, our OCS products.
+Added: Additionally, because one objective of the current administration appears to be to decrease spending in the federal government, the FDA could face staff reductions, which could impact the FDA’s ability to engage in routine regulatory and oversight activities and result in delays or limitations on our ability to proceed with clinical development programs and obtain regulatory approvals.
+Added: 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.
+Added: 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
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.
−Removed: Organ Procurement and Transplantation Network act was signed into law, which allows HRSA to make changes to the Organ Procurement and Transplantation Network (OPTN), including requiring an independent board, awarding contracts to both non-profit and for-profit entities, and eliminating the cap on funding.
+Added: 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.
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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In addition, other broader legislative changes have been adopted that could have an adverse effect upon, and could prevent, our products’ commercial success.
−Removed: The Budget Control Act of 2011, as amended, or the Budget Control Act, includes provisions intended to reduce the federal deficit, including reductions in Medicare payments to providers through 2030 (except May 1, 2020 to March 31, 2022).
+Added: The Budget Control Act of 2011, as amended, or the Budget Control Act, includes provisions intended to reduce the federal deficit, including reductions in Medicare payments to providers through fiscal year 2032 (except May 1, 2020 to March 31, 2022).
Any significant spending reductions affecting Medicare, Medicaid, or other publicly funded or subsidized health programs, or any significant taxes or fees imposed as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, or otherwise, could have an adverse impact on our anticipated product revenue.
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If securities or industry analysts issue an adverse or misleading opinion regarding our business or do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.
−Removed: The trading market for our common stock is influenced by the research and reports that industry or securities analysts publish about us or our business.
+Added: The trading market for our common stock is influenced by the research and reports that industry or securities analysts or activist investors or other third parties publish about us or our business.
If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
−Removed: Moreover, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model or our stock performance, or if our operating results fail to meet the expectations of the investor community, one or more of the analysts who cover our company may change their recommendations regarding our company, and our stock price could decline.
+Added: Moreover, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, or if activist investors continue to, our business model or our stock performance, or if our operating results fail to meet the expectations of the investor community, one or more of the analysts who cover our company may change their recommendations regarding our company, and our stock price could decline.
We have adopted anti-takeover provisions in our restated articles of organization and amended and restated bylaws and are subject to provisions of Massachusetts law that may frustrate any attempt to remove or replace our current board of directors or to effect a change of control or other business combination involving our company.
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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.
−Removed: 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.
−Removed: If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company.
+Added: Alternatively, if the Business
+Added: 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.
+Added: We have identified a material weakness in our internal control over financial reporting, and we may identify additional material weaknesses in the future.
+Added: If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, and current and potential shareholders may lose confidence in our financial and other public reporting, which would harm our business and have a negative effect on the trading price of our common stock.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended, our management is required to report on, and our independent registered public accounting firm is required to attest to, the effectiveness of our internal control over financial reporting.
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In addition, we are required to comply with the SEC’s rules implementing Section 302 of the Sarbanes-Oxley Act, which requires management to certify financial and other information in our quarterly and annual reports, and we are required to disclose significant changes made in our internal controls and procedures on a quarterly basis.
−Removed: If we identify a material weakness in our internal control over financial reporting, we may not be able to remediate the material weakness identified in a timely manner or maintain all of the controls necessary to remain in compliance with our reporting obligations.
−Removed: If we identify any material weaknesses in our internal controls over financial reporting or we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal controls over financial reporting are effective, or if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting in future periods, investors may lose confidence in the accuracy and completeness of our financial reports.
−Removed: As a result, the market price of our common stock could be materially adversely affected.
+Added: 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.
+Added: 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.
+Added: However, our remediation efforts with respect to our identified material weakness may be inadequate.
+Added: The elements of our remediation plan can only be accomplished over time and our remediation plan may not ultimately have its intended effects.
+Added: In addition, if we identify any additional material weaknesses or significant deficiencies in our internal control over financial reporting, we may not be able to remediate such material weaknesses or significant deficiencies identified in a timely manner or maintain all of the controls necessary to remain in compliance with our reporting obligations or to prevent fraud.
+Added: If we identify any additional material weaknesses in our internal controls over financial reporting or if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal controls over financial reporting are effective, or if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting in future periods, investors may not have a complete understanding of our operations or may lose confidence in our financial and other public reporting.
+Added: Our future access to capital markets could be restricted and we may face other consequences imposed by the SEC or Nasdaq.
+Added: Such events would harm our business and have a negative effect on the trading price of our common stock.
Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our financial condition and results of operations.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.