Strata Critical Medical, Inc.

Current report

We have incurred significant losses since inception and may continue to incur net losses from continuing operations in the future, and we may not be able to achieve or maintain profitability.

Current report

•the costs associated with finalizing the divestment of the Passenger business and the integration of acquisitions;

Current report

Any inability to realize the anticipated benefits of the sale of the Passenger business or acquisition of Keystone could negatively impact our stock price and our business and financial results.

Current report

On August 29, 2025, the Company completed the sale of its Passenger business to Joby Aero, Inc. (“Joby Buyer”) on September 16, 2025, the Company completed the acquisition of Keystone. We completed these transactions with the expectation that they could result in various benefits to us, but such anticipated benefits are subject to a number of uncertainties, including our ability to timely realize cost efficiencies and accretive benefits and our ability to successfully integrate Keystone and retain its key employees and clients following the acquisition. Failure to achieve these anticipated benefits could result in decreases in the amount of expected revenues and diversion of management’s time and energy, which could in turn materially adversely affect our stock price, business and financial results. In addition, while the Company will be entitled to up to $35.0 million in contingent consideration from the Joby Buyer upon the satisfaction of certain employee retention and financial performance targets, there can be no assurance that we will receive such contingent consideration. Any contingent consideration that we receive may be paid in cash or shares of Joby Aviation at the election of the Joby Buyer and, as a result, the value of any contingent consideration we receive may be subject to risks associated with Joby Aviation’s business and common stock over which we have no control.

Current report

Furthermore, the sale of the Passenger business has resulted in our business becoming less diversified. As a result, we are more vulnerable to changing market conditions that impact our Medical Customers, including changes in hospital budgets, transplant volumes, or regulatory requirements. In addition, the diversification of our revenues, costs and cash flows has diminished as a standalone company, such that our results of operations, cash flows, working capital and financing requirements may be subject to increased volatility and our ability to fund capital expenditures may be diminished.

Current report

•any of the foregoing events affecting our competitors or the broader transplant logistics, aviation or healthcare services industries, to the extent such resulting negative perception affects the public’s perception of us or our industry as a whole.

Current report

We provide clinical services to our customers and perfusion staffing services to hospitals and health systems. We may be subject to negative publicity and reputational damage related to the provision of such services, as well as litigation, claims, investigations, and other proceedings, which could result in actions including substantial judgments, settlement costs, uninsured or underinsured liabilities, and other adverse consequences.

Current report

We rely significantly on our ability to attract, develop, and retain professionals who possess the skills, experience and, as required, licensure, necessary to perform organ recovery services and perfusion staffing services. Our professionals are involved in clinical services such as surgical recovery, which involves the retrieval of organs from donors, and normothermic regional perfusion services, which operate in heavily regulated environments. The requirements and protocols for such services are complex and may vary amongst our customers. If there is a negative outcome in a particular case, or if a particular case raises ethical questions or concerns, even if our staff were not directly involved in the case, we may be subject to negative publicity, reputational harm, investigations, litigation, claims, and governmental actions that could have an adverse effect on our operations, financial results, and reputation.

Current report

Public or professional debate regarding organ recovery techniques, perfusion practices, or evolving clinical protocols may subject our services to heightened scrutiny by regulators, medical societies, or the media. Changes in accepted clinical standards or adverse publicity relating to the broader transplant ecosystem, even if not directly related to our services, could reduce customer confidence or lead to increased regulatory oversight.

Current report

The market for qualified perfusionists, surgical recovery personnel, and other specialized clinical professionals remains highly competitive, and shortages of experienced clinicians, increased turnover, credentialing delays, or workforce fatigue could adversely affect our ability to provide services at scale. In addition, evolving hospital privileging requirements, state licensure rules, or customer-specific credentialing standards may limit our ability to deploy personnel efficiently across different jurisdictions or customers, which could increase costs, reduce operational flexibility, or result in service disruptions.

Current report

We rely significantly on contractual relationships with certain transplant centers, hospitals, OPOs and other strategic partners and alliances for a substantial portion of our medical logistics and clinical services business. These relationships are important to our ability to expand into new markets and deepen our presence in existing markets. Our growth depends in part on our ability to successfully compete for and maintain these relationships, including through requests for proposals and other procurement processes, and many of our contracts may be subject to termination, non-renewal, pricing pressure or changes in scope.

Current report

Our medical logistics and clinical services business is highly dependent on the volume of human organs procured for transplant by our Medical Customers. If our Medical Customers cannot procure human organs for transplant or if the transplant industry experiences a shortage of human organs, whether due to changes in public health trends, donor eligibility criteria, regulatory or policy changes, or other factors, we may experience reduced demand for our services, revenue volatility and challenges in achieving or maintaining profitability. The transplant ecosystem in the United States is relatively concentrated among a limited number of transplant centers and OPOs, and our relationships within this ecosystem may expose us to heightened customer concentration and ecosystem risk. The loss of one or more significant Medical Customers, changes in procurement or allocation practices, or shifts in relationships among transplant centers, hospitals or OPOs could have a disproportionate impact on our operations, revenue and growth prospects. Reduced transplant challenges could also impair our ability to effectively utilize third-party aircraft and ground operators and could negatively affect our operating margins.

Current report

Additionally, advances in new organ preservation technology, changes in clinical practice, or the development of alternative treatments, including the emergence of animal-derived, synthetic, or lab-grown organs, could reduce the need for rapid, dedicated air transportation of human organs or alter the mix of services required by our Medical Customers. Any such developments could reduce demand for our services, require changes to our business model or place downward pressure on pricing, any of which could materially adversely affect our business, results of operations and financial condition.

Current report

Our growth may depend on the adoption and effective utilization of integrated clinical and logistics workflows by our Medical Customers, and failure to achieve such adoption could adversely affect our business, financial condition, and results of operations.

Current report

Our strategy includes expanding offerings that integrate clinical services, logistics coordination, and technology-enabled workflows designed to support transplant centers, OPOs, and hospitals. The successful adoption and utilization of these integrated solutions by our Medical Customers may depend on factors outside of our control, including customers’ willingness to modify existing clinical practices, adopt new technologies, integrate our systems into their workflows, and allocate resources toward training and implementation.

Current report

Medical Customers may be slow to adopt new solutions due to regulatory considerations, internal governance processes, budgetary constraints, competing technologies, or concerns regarding clinical outcomes, data security, or operational disruption. Even where customers initially adopt our solutions, they may not use them as extensively as anticipated, may fail to achieve expected efficiencies, or may discontinue use if competing offerings, preservation technologies, or alternative workflows become available.

Current report

In addition, the clinical environment in which transplant services are delivered is highly complex and involves multiple stakeholders, including surgeons, perfusionists, coordinators, and regulatory bodies. If our integrated offerings are perceived as difficult to implement, do not integrate effectively with customer systems, or fail to demonstrate measurable clinical or operational value, our ability to grow adoption among existing and prospective Medical Customers could be adversely affected.

Current report

Any failure to achieve widespread adoption or effective utilization of our integrated clinical and logistics offerings, including technology-enabled placement or coordination services, could reduce demand for our services, limit our ability to realize anticipated efficiencies or revenue growth, and materially adversely affect our business, financial condition, and results of operations.

Current report

The organ transportation and clinical services markets in which we operate are highly competitive, and increased competition could adversely affect our business, financial condition and results of operations.

Current report

The markets in which we operate are highly competitive and continue to evolve rapidly. We compete with a range of providers, including organ transportation and logistics companies, aviation operators, healthcare service providers, transplant logistics coordinators, and manufacturers of organ preservation technologies. Some competitors may have greater financial resources, longer operating histories, broader geographic reach, proprietary technologies, or more established relationships with transplant centers, OPOs, hospitals, or healthcare systems than we do.

Current report

Increasingly, we compete with companies that offer integrated logistics and clinical service models, proprietary preservation technologies, or differentiated device ecosystems. While we now offer a broader suite of clinical services, including surgical organ recovery, Normothermic Regional Perfusion (“NRP”), and perfusion staffing following the Keystone acquisition, competitors may benefit from proprietary preservation platforms, vertically integrated device offerings, or alternative business models that may be perceived by customers as providing clinical or operational advantages. In addition, some competitors may bundle preservation devices, logistics coordination, and clinical services into a single offering, which may create pricing, contracting or technological advantages that could place pressure on our margins or customer relationships.

Current report

Competition may result in reduced pricing, lower margins, loss of customers, increased marketing and operating costs, or reduced demand for our services. In addition, consolidation among competitors, strategic partnerships, or the entrance of new market participants, including healthcare providers, aviation operators, technology companies, or device manufacturers, could intensify competitive pressures. If we are unable to compete effectively on the basis of safety, reliability, clinical capabilities, pricing, or customer relationships, our business, financial condition, and results of operations could be materially adversely affected.

Current report

Additionally, broader public health and societal factors, such as pandemics or other public health crises, changes in accident or mortality rates, or modifications to donor eligibility criteria, may impact the availability of donor organs or the timing and logistics associated with organ recovery and transplant. Changes in oversight, performance standards or allocation policies applicable to OPOs or transplant centers could also impact transplant volumes or operational workflows.

Current report

If the availability or utilization of viable organs declines or if legislative, regulatory or policy changes limit the efficiency or scope of organ procurement or transportation, demand for our services could decrease, volumes could become more volatile, and our ability to efficiently deploy transportation and clinical resources could be adversely affected. Any of the foregoing could negatively impact our business, results of operations, financial condition and growth prospects.

Current report

Although we employ rigorous operational protocols designed to mitigate these risks, including route redundancies, temperature-controlled storage solutions, monitoring systems, and close coordination with medical teams and third-party transportation providers, organ transport remains inherently complex and unpredictable. Failures in organ delivery may damage our relationships with hospitals, OPOs, and transplant centers, erode trust in our services, and reduce demand for our offerings, any of which could materially adversely affect our business, financial condition, results of operations, and reputation.

Current report

Because our services involve the coordination of clinical activities with aviation and ground transportation operations, incidents may implicate multiple regulatory and liability frameworks, including healthcare standards of care, aviation safety regulations, and contractual obligations to customers. The interaction between these regimes could increase the complexity, duration, and cost of investigations, insurance claims, or litigation arising from a single event and may expose us to risks that are greater than those faced by companies operating solely within either the healthcare or aviation industries.

Current report

Risks associated with our ground transportation operations could adversely affect our business and financial results.

Current report

In addition to aviation logistics, we provide and coordinate ground transportation services using a combination of owned vehicles and third-party providers. Ground transportation operations involve inherent risks, including vehicle accidents, driver error, adverse weather conditions, equipment failure, regulatory compliance challenges, and operational delays. Because many organ transport missions are time-sensitive, disruptions to ground transportation may negatively impact transplant outcomes, customer relationships and our reputation.

Current report

Our ground operations may also expose us to additional regulatory requirements at the federal, state and local level, including licensing requirements, emergency transport regulations, vehicle safety standards and labor-related obligations.

Current report

Compliance with these requirements may increase operational complexity and costs, and failure to comply could result in fines, penalties, loss of licenses or reputational harm.

Current report

As we expand our ground transportation footprint, including through owned vehicles or acquisitions, we may incur increased insurance costs, maintenance expenses, staffing requirements or liability exposure. Any significant incident, accident or operational disruption involving ground transportation could result in litigation, regulatory scrutiny, reputational damage or increased operating costs, which could materially adversely affect our business, financial condition and results of operations.

Current report

Safety and reliability are key considerations for our Medical Customers when selecting air transportation providers. Any failure by us or our third-party operators to maintain safety and reliability standards acceptable to our customers may adversely impact our ability to retain current customers or attract new customers. We may also face adverse publicity stemming from any public incident involving our company, our people, our brand, or aircraft utilized in our operations, including aircraft owned or operated by third-party operators. Such an incident could involve actual or alleged misconduct, operational failures, or regulatory enforcement actions, and could lead to reputational harm, reduced demand for our services, and increased scrutiny from regulators or customers.

Current report

In addition, accidents or safety-related investigations involving aircraft used in our operations, including aircraft owned by third parties, aircraft bearing our branding, or aircraft types commonly utilized by our third-party operators, could expose us to litigation, liability claims, and financial losses. Although we maintain insurance coverage, such insurance may be unavailable, inadequate, or subject to exclusions or disputes, and may not fully cover potential liabilities. If one or more of our third-party aircraft operators were to experience an accident, regulatory grounding, or other safety-related interruption, we may be required to cancel or delay flights until alternative aircraft or personnel can be secured, which could adversely affect our operations, reputation, financial condition, and results of operations.

Current report

We are subject to risks associated with climate change, including regulatory developments and the potential increased impacts of severe weather events on our operations and infrastructure.

Current report

Climate change-related regulatory developments may adversely affect our business and financial results by requiring us, or the third parties on which we rely, to reduce emissions, incur additional operating costs, make capital investments to modernize aircraft or other aspects of our operations, or comply with enhanced disclosure and reporting obligations. Such developments could increase the cost of aviation fuel, aircraft ownership or operation, or transportation services provided by third-party operators. As we evaluate future fleet or infrastructure investments, evolving emissions standards or sustainability regulations may increase costs, require operational changes, or impose additional compliance burdens.

Current report

Terrorist attacks, geopolitical conflict, security incidents, or perception of such events could adversely affect our business, reputation, brand, and operations. The aviation and transportation industries remain high-profile targets for security threats, and disruptions arising from such events, whether or not directly involving our operations, may reduce customer confidence, increase regulatory scrutiny, or limit the availability or efficiency of air transportation services on which we rely.

Current report

Security incidents may arise from external threats, geopolitical instability, or other acts of violence, including events occurring in public areas outside our control. Such incidents could result in increased security costs, airspace restrictions, changes to approved flight routes, delays or cancellations of flights, or disruption to transportation infrastructure. Because our services often involve time-sensitive organ transport, any such disruptions could adversely affect our operations, customer relationships, and financial performance.

Current report

In addition, geopolitical tensions or security-related developments may lead to changes in aviation regulations, heightened compliance requirements, or limitations on aircraft operations. Any of these events, whether actual or perceived, could result in reputational harm, increased operating costs, operational delays, or reduced demand for our services, any of which could materially adversely affect our business, financial condition and results of operations.

Current report

Our ability to provide air transportation services depends in part on the availability and cost of aircraft fuel to the third-party aircraft operators and, where applicable, aircraft we utilize. Although aircraft operators currently have access to adequate fuel supplies, we cannot predict future fuel availability or pricing. Disruptions in fuel supply or significant increases in fuel costs may increase operating expenses for our third-party operators, reduce aircraft availability, or limit the ability to perform scheduled flights, which could adversely affect our business.

Current report

Aircraft fuel supply and pricing are influenced by numerous factors outside of our control, including natural disasters affecting refining or distribution infrastructure, geopolitical conflicts, economic sanctions, changes in governmental policies or tariffs, environmental regulations, transportation or storage constraints, and broader volatility in global energy markets. Any of these factors could result in fuel shortages, distribution disruptions, or increased costs for aircraft operations.

Previous report

We have incurred significant losses since inception. While we currently generate revenue primarily from the sale of air transportation, it is difficult for us to predict our future operating results. As a result, our losses may be larger than anticipated, and we may not achieve profitability when expected, or at all. Even if we do, we may not be able to maintain or increase profitability. Further, some of our future growth plans are dependent upon the availability of EVA. There can be no assurance that regulatory approval and availability of EVA, or consumer acceptance of EVA, will occur in a timely manner, if at all. In addition, there may be additional costs associated with the initial build out of EVA infrastructure needed to service our routes and we cannot be sure that EVA will result in expected cost savings or efficiencies, which could in turn affect our profitability.

Previous report

•the extent to which our urban air mobility services are utilized by fliers in the regions we operate;

Previous report

•a failure to enforce our flight operations policies in a manner that users perceive as effective, fair, and transparent;

Previous report

•a failure to provide routes and flight schedules sought by fliers;

Previous report

•inadequate or unsatisfactory flier support service experiences;

Previous report

All climate change-related regulatory activity and developments may adversely affect our business and financial results by requiring us to reduce our emissions, make capital investments to modernize certain aspects of our operations, or otherwise pay for our emissions. Such activity may also impact us indirectly by increasing our operating costs. In addition, passenger demand may be negatively impacted by climate change concerns. As we consider purchasing additional aircraft, there could be additional costs and disclosure requirements if we were to own and/or operate.

Previous report

Terrorist attacks, geopolitical conflict or security events, or the fear or threat of any of these events, could have a significant adverse effect on our business, reputation and brand. Despite significant security measures at airports and heliports, the aviation industry remains a high-profile target for terrorist groups. Security events, primarily from external sources but also from potential insider threats, also pose a significant risk to our passenger and organ transport operations. These events could include random acts of violence and could occur in public areas that we cannot control. Terrorist attacks, geopolitical conflict or security events, or the fear or threat of any of these events, even if not made directly on or involving the aviation industry, could have a significant negative impact on us by discouraging passengers from flying, leading to decreased revenue. In addition, potential costs from these types of events include increased security costs, impacts from avoiding flight paths over areas in which conflict is occurring or could occur, such as flight redirections or cancellations, reputational harm and other costs. If any or all of these types of events occur, they could have a material adverse effect on our business, financial condition and results of operations.

Previous report

In the future, we could be required to raise capital through public or private financing or other arrangements. Such financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could harm our business. For example, unfavorable economic conditions, whether related to inflation, interest rates, economic instability or otherwise have, resulted in, and may continue to result in, significant disruption and volatility of global financial markets that could adversely impact our ability to access capital. We may sell equity securities or debt securities in one or more transactions at prices and in a manner we may determine from time to time. If we sell any such securities in subsequent transactions, our current investors may be materially diluted. Any debt financing, if available, may involve restrictive covenants and could reduce our operational flexibility or profitability. If we cannot raise funds on acceptable terms, we may not be able to grow our business or respond to competitive pressures.

Previous report

We have and intend to continue to explore potential strategic acquisitions of assets and businesses, including partnerships, aircraft, route acquisitions or joint ventures with third parties. Our management has limited experience with acquiring and integrating acquired strategic assets and companies into our business, and there is no assurance that any future acquisitions will be successful. We may not be successful in identifying appropriate targets for such transactions. In addition, we may not be able to continue the operational success of such businesses or successfully finance or integrate any assets or businesses that we acquire or with which we form a partnership or joint venture. We have and may continue to have impairment of intangible assets or goodwill related to our acquisitions. For example, during the year ended December 31, 2024, the Company recognized an impairment charge for the exclusive rights to air transportation services associated with Blade Canada in the amount of $5.8 million, which was included in intangible impairment expense within general and administrative expenses in the consolidated statements of operations and is part of the Passenger segment. The impairment resulted from a modification to the November 30, 2021 agreement with Helijet, effective June 1, 2024, which included an earlier termination date of August 31, 2025 (previously an initial term of five years with automatic renewals for successive two-year periods). During the year ended December 31, 2024, the termination date was subsequently advanced to August 31, 2024.

Previous report

If our operations continue to grow as planned, of which there can be no assurance, we will need to expand our sales, marketing, operations, and the number of aircraft operators with whom we do business. Our continued growth could increase the strain on our resources, and we could experience operating difficulties, including difficulties in hiring, training, and managing an increasing number of employees. These difficulties may result in the erosion of our brand image, divert the attention of management and key employees, and impact financial and operational results. In addition, in order to continue to increase our presence, we expect to incur substantial expenses as we continue to attempt to increase our route offerings, flight frequency, passenger terminal footprint, and employee base. The continued expansion of our business may also require additional space for administrative support. If we are unable to drive commensurate growth, these costs, which include lease commitments, marketing costs and headcount, could result in decreased margins and reduced profitability, which could have a material adverse effect on our business, financial condition, and results of operations.

Previous report

We believe that safety and reliability are two of the primary attributes fliers consider when selecting air transportation services. Our failure, or that of our third-party operators, to maintain standards of safety and reliability that are satisfactory to our customers may adversely impact our ability to retain current customers and attract new customers. We are at risk of adverse publicity stemming from any public incident involving our company, our people, or our brand. Such an incident could involve the actual or alleged behavior of any of our employees or third-party aircraft operators. Further, if our personnel, one of our third-party operators’ aircraft, one of our third-party operators’ Blade-branded aircraft, a Blade-owned aircraft, or a type of aircraft in our third-party operators’ fleet that is used by us is involved in a public incident, accident, catastrophe, or regulatory enforcement action, which could be attributed, in part, to a lack of sufficient safety auditing, we could be exposed to significant reputational harm and potential legal liability. Blade-branded aircraft have in the past been involved in accidents and despite our best efforts, there can be no guarantee that such events will not occur in the future. The insurance we carry may be inapplicable or inadequate to cover any such incident, accident, catastrophe, or action. In the event that our insurance is inapplicable or inadequate, we may be forced to bear substantial losses from an incident or accident. In addition, any such incident, accident, catastrophe, or action involving our employees, a Blade-owned aircraft, one of the Blade-branded aircraft used by us belonging to our third-party operators’ fleet (or personnel and aircraft of our third-party operators), or the same type of aircraft as used by our third-party operators could create an adverse public perception, which could harm our reputation, resulting in current or prospective customers being reluctant to use our services and adversely impacting our business, results of operations, and financial condition. If one or more of our third-party aircraft operators were to suffer an accident or lose the ability to fly certain aircraft due to safety concerns or investigations, we may be required to cancel or delay certain flights until replacement aircraft and personnel are obtained.

Previous report

Our management has limited experience with operating aircraft. We may not be successful in identifying all potential costs and regulatory requirements related to the operation and maintenance of aircraft, and we may incur considerable costs.

Previous report

The operation of aircraft is subject to various risks, including catastrophic disasters, crashes, mechanical failures and collisions, which may result in loss of life, personal injury and/or damage to property and equipment. We may experience accidents in the future if we choose to operate some aircraft directly (either on our own or via the acquisition of a third-party). These risks could endanger the safety of our customers, our employees, third parties, equipment, organs and other medical cargo, and the environment. 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 and damage to our reputation and customer relationships. 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, our Medical customers and property owners.

Previous report

There can be no assurance that the amount of our insurance coverage available in the event of such losses would be adequate to cover such losses, or that we would not be forced to bear substantial losses from such events, regardless of our insurance coverage. Moreover, any aircraft accident or incident, even if fully insured, and whether involving us or other private aircraft operators, could create a public perception that we are less safe or reliable than other private aircraft operators, which could cause our customers to lose confidence in us and switch to other private aircraft operators or other means of transportation. In addition, any aircraft accident or incident, whether involving us or other private aircraft operators, could also affect the public’s view of industry safety, which may reduce the amount of trust by our customers.

Previous report

In our Passenger segment, our success also depends on our ability to generate more revenue per flight by maintaining high flier utilization rates (i.e., the number of seats purchased on each flight). Flier utilization rates may be reduced by a variety of factors, including the introduction of new routes or schedules. In some cases, we may choose to offer flights with low flier utilization rates to increase or maintain flier satisfaction and brand recognition and for marketing or other purposes. We have utilized certain commuter passes and bulk purchasing options to increase our flier utilization rates in the past; however, these products may be less appealing due to changes in consumer preferences, discretionary spending, and other economic factors.

Previous report

While historically we have maintained daily aircraft and flier utilization rates sufficient to offset the costs we pay to operators, we may be unable to maintain and increase utilization rates as our business grows and expands. The risk of delays, cancellations, and flight rescheduling, which could negatively impact our utilization rates, may increase as we expand our business to include new markets and destinations, more frequent flights on current routes, and expanded facilities.

Previous report

Our Short Distance business concentrated in a small number of metropolitan areas and airports which makes us particularly susceptible to natural disasters, outbreaks and pandemics, economic, social, political, weather, growth constraints, and regulatory conditions or other circumstances affecting these metropolitan areas.

Previous report

We derive a significant portion of our Short Distance revenue from flights that either originate from or fly into heliports and airports located in or near New York, New York, the South of France and Monaco. As a result of our geographic concentration, our business and financial results are particularly susceptible to natural disasters, outbreaks and pandemics, economic, social, political, weather, growth constraints, and regulatory conditions or other circumstances in each of these metropolitan areas. A significant interruption or disruption in service at one of the locations where we have a significant volume of flights could result in the cancellation, reduction or delay of a significant portion of our flights and, as a result, could have a severe impact on our business, results of operations, and financial condition. In addition, any changes to local laws or regulations within these key metropolitan areas that affect our ability to operate or increase our operating expenses in these markets would have an adverse effect on our business, financial condition, and operating results.

Previous report

Disruption of operations at the airports or heliports where we operate, whether caused by labor relations, utility or communications issues or fuel shortages, could harm our business. Certain governing bodies, airports or heliports may regulate flight operations, such as limiting or restricting the number of landings, which could reduce our operations. Bans or restrictions on our operations or the introduction of any new permitting requirements could similarly impact our business. In addition, demand for our urban air mobility services could be impacted if drop-offs or pick-ups of fliers become inconvenient because of airport rules or regulations, or more expensive for fliers because of airport-imposed fees, which would adversely affect our business, financial condition, and operating results.

Previous report

Our concentration in large metropolitan areas and heavily trafficked airports also makes our business susceptible to an outbreak of a contagious disease, such as the Ebola virus, Middle East Respiratory Syndrome, Severe Acute Respiratory Syndrome, H1N1 influenza virus, avian flu, Zika virus, COVID-19, or any other similar illness, both due to the risk of a contagious disease being introduced into the metropolitan area through the high volume of travelers flying into and out of such airports and the ease at which contagious diseases can spread through densely populated areas, as seen with the spread of COVID-19.

Previous report

Natural disasters, including tornados, hurricanes, floods and earthquakes, wildfires and severe weather conditions, such as heavy rains, strong winds, dense fog, blizzards, or snowstorms, may damage or impact our facilities, those of third-party aircraft operators, or otherwise disrupt flights into or out of the airports from which our flights arrive or depart. For example, our Northeast United States operations are subject to severe winter weather conditions. Less severe weather conditions, such as rainfall, snowfall, fog, mist, freezing conditions, or extreme temperatures, may also impact the ability for flights to occur as planned, which could reduce our sales and profitability and may result in additional expenses related to rescheduling of flights.

Previous report

The occurrence of one or more natural disasters, severe weather events, epidemic or pandemic outbreaks, terrorist attacks, or disruptive political events in regions where we operate and where our facilities are located, or where our third-party aircraft operators’ facilities are located, could adversely affect our business.

Previous report

Although aircraft operators are currently able to obtain adequate supplies of aircraft fuel, we cannot predict the future availability. Natural disasters (including hurricanes or similar events in the U.S. Southeast and on the Gulf Coast where a significant portion of domestic refining capacity is located), political disruptions or wars involving oil-producing countries, economic sanctions imposed against oil-producing countries (for example, the wars in Ukraine and the Middle East) or specific industry participants, changes in fuel-related governmental policy, tariffs implemented by the U.S. on countries where aircraft fuel is sourced from, the strength of the U.S. dollar against foreign currencies, changes in the cost to transport or store petroleum products, changes in access to petroleum product pipelines and terminals, speculation in the energy futures markets, changes in aircraft fuel production capacity, environmental concerns and other unpredictable events may result in fuel supply shortages or distribution challenges in the future. Any of these factors or events could cause a disruption in or increased demands on oil production, refinery operations, pipeline capacity, or terminal access and possibly result in diminished availability of aircraft fuel supply for our third-party aircraft operators or our potentially owned aircraft. The impact of such events may limit our ability to expand internationally, attract and retain fliers and commercial customers, and our third-party aircraft operators’ ability to perform our by-the-seat flights, which could result in loss of revenue and adversely affect our ability to provide our services.

Previous report

Risks Related to our Medical Segment

Previous report

We rely significantly on contractual relationships with certain transplant centers, hospitals and Organ Procurement Organizations and other strategic partners and alliances for portions of our Medical product line business, to expand into new markets and deepen our presence in existing markets. In recent years, we have entered into strategic business relationships with, and responded to requests for proposals from, among others, Organ Procurement Organizations, hospitals and transplant centers to increase opportunities for growth in our Medical product line. Our Medical product line growth is highly dependent on the procurement of human organs for transplant by our Medical Customers.

Previous report

If our Medical Customers cannot procure human organs for transplant or the industry experiences a shortage of human organs, potentially due to the reduction of opioid deaths, motor vehicle deaths, or stricter donor eligibility criteria, we may face challenges in fulfilling our contractual obligations with third-party aircraft and ground operators. This could negatively impact our reputation, ability to generate increased revenue and achieve profitability.

Previous report

Additionally, if new organ preservation technology or the emergence of animal-derived, synthetic, or lab-grown organs makes rapid, dedicated air transportation of human organs unnecessary, our Medical Customers may no longer require our services to successfully complete organ transplants for their patients, which could have a material adverse effect on our business, results of operations, and financial condition.

Previous report

Our Medical product line relies on a concentrated number of key Medical Customers, including transplant centers, hospitals, and Organ Procurement Organizations.

Previous report

A loss of one or more of our key Medical customers, a reduction in their organ procurement activity, or a shift in their transportation preferences could materially impact our revenue and profitability. Additionally, consolidation within the healthcare industry or changes in procurement practices could further increase our dependency on a limited number of customers, heightening the risks associated with customer concentration.

Previous report

The organ transportation market is highly competitive and some providers benefit from proprietary organ preservation technology or additional capabilities that could put us at a disadvantage.

Previous report

We compete for organ transportation business primarily on our ability to provide reliable, end-to-end air and ground transportation at competitive pricing. Increasingly, we compete directly with manufacturers of organ preservation equipment that also offer transportation or with providers that offer additional services, such as surgical organ recovery or Normothermic Regional Perfusion, that our customers find valuable. We may face increased competition as our Medical Customers may prefer a streamlined logistics offering, including services or technology that we cannot provide, which could have a material adverse effect on our business, results of operations, and financial condition. Additionally, low-cost transportation alternatives, such as drones or other emerging logistics technologies, could further intensify competition and impact our market position.

Previous report

Furthermore, the organ transportation market is highly regulated and continually evolving. In order to continue to offer competitive organ transport solutions, we have pursued, and may continue to pursue, acquisitions related to our Medical segment. All future acquisitions are subject to various conditions, including regulatory approvals. Acquisitions may encounter intense scrutiny under federal and state antitrust laws. Any delays, injunctions, conditions or modifications by any government agencies could have a negative effect on us and result in the abandonment of all or part of attractive acquisition opportunities. Additionally, as we expand our Medical offerings, we have been in the past, and could be in the future, the subject of anticompetitive litigation by the Federal Trade Commission (“FTC”), the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”).

Previous report

While we employ rigorous operational protocols, including redundancies in transport routes, temperature-controlled storage solutions, and close coordination with medical teams, the inherent unpredictability of medical transport presents ongoing risks.

Previous report

Healthcare policy changes, including recently enacted or potential future legislation reforming the U.S. healthcare system, could harm our business, financial condition, and results of operations. The U.S. federal and state governments continue to propose and implement healthcare legislation and regulatory changes that may impact the availability, cost, and reimbursement of medical transportation services, including organ procurement logistics. Ongoing healthcare reform efforts, particularly those related to organ procurement and transplantation, could materially affect our business, financial condition, and results of operations. For example, the Centers for Medicare & Medicaid Services (CMS) issued regulations in 2020 and 2021 revising Medicare conditions of participation for organ procurement organizations and adjusting organ acquisition payment policies for transplant centers, donor hospitals, and organ procurement organizations. Additionally, the 2023 Securing the U.S. Organ Procurement and Transplantation Network Act granted the Health Resources and Services Administration (HRSA) increased oversight over the Organ Procurement and Transplantation Network (OPTN), including establishing an independent board, allowing both for-profit and non-profit entities to participate in contracts, and removing funding caps.

Previous report

Future federal or state healthcare legislation, regulations, and policies may further impact coverage and reimbursement for organ procurement and medical transport services. Any reduction in reimbursement rates, limitations on coverage, or other regulatory changes could decrease demand for our services and exert downward pressure on pricing. Such changes could materially and adversely impact our operations, financial condition, and overall business performance. Current proposals and directives to change or modify the implementation of such laws and regulations, whether legislative, regulatory, or in the form of executive orders or other executive actions, create areas of uncertainty and, if such proposals are enacted or actions are implemented, may create the potential for material adverse impacts on our business.

Previous report

Changes in Medicare reimbursement policies, increased enforcement of healthcare regulations, or modifications to applicable laws could impact our customers' ability to receive reimbursement, which may, in turn, affect demand for our services. Additionally, evolving regulatory interpretations or heightened scrutiny of business arrangements in the healthcare sector could require us to modify our operations, increase compliance costs, or expose us to potential liability. Any failure to comply with applicable laws and regulations, even inadvertently, could result in significant penalties, reputational harm, or other adverse effects on our business. Our business is governed by comprehensive federal, state, and local laws and regulations relating to the healthcare industry. Though we are not directly reimbursed by Medicare for any of our services, our customers—including healthcare providers and organ procurement organizations—are often reimbursed by Medicare for a portion of the services we provide to them. As a result, we may be subject to various healthcare regulations, including the federal Anti-Kickback Statute, the Stark Law, the False Claims Act, and other fraud, waste, and abuse laws. The federal Anti-Kickback Statute prohibits the offer, payment, solicitation, or receipt of any form of remuneration to induce, or in return for, the referral of individuals for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under Medicare or other governmental health programs or in return for the purchase, lease, or order of items or services, or arranging for or recommending the purchase, lease or order of any good, facility, item or service that is covered by Medicare or other federal governmental health programs. The federal Anti-Kickback Statute has been interpreted to apply to, among others, financial arrangements between entities that have the ability to refer and generate business that is subject to healthcare reimbursement. Sanctions for violating federal and state anti-kickback laws may include criminal and civil fines and exclusion from federal and state healthcare programs. While there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly and practices that involve remuneration may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person or entity does not need to have specific intent or knowledge to violate in order to have committed a violation, and a claim including an item or a service resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA described below.

Previous report

The federal false claims laws, including the civil FCA, among other things, impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent, for knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or for knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. We may be subject to audits, reviews and investigation of our practices and arrangements and the federal government might conclude that they violate the FCA, the Anti-Kickback Statute and/or other federal and state laws governing fraud and abuse. Further, the FCA can be enforced by private citizens through civil qui tam actions.

Previous report

Risks Related to our Passenger Segment

Previous report

The markets for our Passenger offerings are still in relatively early stages of growth, and if such markets do not continue to grow, grow more slowly than we expect, or fail to grow as large as we expect, our business, financial condition, and results of operations could be adversely affected.

Previous report

Blade’s Passenger urban air mobility services have grown rapidly since we launched our business in 2014, however, our service offerings are still relatively new, and it is uncertain to what extent market acceptance will continue to grow, if at all.

Current report — wording carried from elsewhere

If OCR determines that we have failed to comply with applicable HIPAA privacy or security standards, we could face civil or criminal penalties. OCR has increased enforcement activity in recent years and has authority to impose monetary penalties or require resolution agreements and corrective action plans that impose ongoing compliance obligations. Enforcement activity can result in financial liability, reputational harm, and significant diversion of internal resources. In addition to federal enforcement, state attorneys general may bring civil actions under HIPAA or similar state laws seeking injunctions or damages in response to violations that threaten the privacy of state residents.

Previous report — wording carried elsewhere

•operating in jurisdictions that do not protect intellectual property rights to the same extent as the United States; and