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Strata Critical Medical, Inc. (SRTA) Business

Verbatim Item 1 Business section from Strata Critical Medical, Inc.'s latest 10-K. Filing date: 2026-03-03. Accession: 0001628280-26-013628.

This page reproduces the company's own Item 1 Business text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.

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Item 1. Business

Business Overview

Strata Critical Medical, Inc.(f/k/a Blade Air Mobility, Inc.) (“Strata” or the “Company”) is a time-critical logistics and medical services provider to the United States healthcare industry. The Company operates one of the nation’s largest air transport and surgical services networks for transplant hospitals and organ procurement organizations, offering an integrated “one call” solution for donor organ recovery. Strata’s core services include air and ground logistics, organ placement, surgical organ recovery, normothermic regional perfusion and preservation for the transplant industry, as well as perfusion staffing and equipment solutions for cardiovascular surgery centers, offered under the Trinity Medical Solutions (“Trinity”) and Keystone Perfusion Services LLC (“Keystone”) brands.

Strata’s mission is to increase the number of organs that are successfully transplanted while leveraging the Company’s expertise and resources to provide other medical and logistics services to a broader customer base. Strata’s goals are closely aligned with those of all participants in the transplant ecosystem, including transplant centers, regulators, Organ Procurement Organizations (“OPOs”) and other service providers. We believe that, by working with Strata, industry participants can save money, save more lives and operate more efficiently by working with Strata.

Strata operates across two operating segments: Logistics and Clinical (see Note 11 to the consolidated financial statements included in this Annual Report on Form 10-K for further information on reportable segments), offering a variety of logistics and clinical services related to organ transplant and the broader healthcare industry. All of Strata’s services are provided to transplant centers, organ procurement organizations, hospitals or other businesses that pay the Company directly. Strata provides:

Logistics Segment

Our Logistics segment is marketed under the Trinity brand name and includes the following:

•Air Logistics – Air transportation of human organs for transplant as well as related staff, equipment, blood samples, and tissue samples. Service is typically provided on fixed wing aircraft operating specifically for each individual organ. Strata also offers on-board couriers for commercial flights and “next flight out” shipping coordination.

•Ground Logistics – Ground transportation of human organs for transplant as well as related staff, equipment, blood samples and tissue samples.

•Organ Placement – Administrative services related to the acceptance of potential donor organs for recipients and support coordinating the transplant process.

Clinical Segment

Our Clinical segment is marketed under the Keystone brand name and includes the following:

Transplant Clinical

•Organ Recovery – Surgical procurement of donor organs.

•Normothermic Regional Perfusion (“NRP”) – In situ perfusion of donor organs with oxygenated blood to improve clinical outcomes and enable functional assessment prior to recovery.

•Preservation – Operation of devices utilized to preserve organs prior to being transplanted into a recipient.

Other Clinical

•Cardiac Care – Cardiac perfusion, blood management & autotransfusion and disposables. Services are typically provided under contract with hospitals to support open-heart surgery procedures.

•Other – Extracorporeal Membrane Oxygenation (ECMO) services, perfusion temporary staffing and equipment rental offered to healthcare providers.

Our Business Model

Logistics Segment

We typically provide logistics services to transplant centers, organ procurement organizations and other businesses on a contractual basis including provisions stipulating that Strata will be the “first call” for any transportation needs.

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Pricing is based on a fixed price per flight hour flown with a fuel cost surcharge above a set benchmark. Ancillary costs such as landing fees and de-icing are passed through to the end customer.

Strata leverages an asset-light air logistics business model. We primarily utilize aircraft that are owned and/or operated by third parties on Strata’s behalf. In these arrangements, pilots, maintenance, hangar, insurance, and fuel are all costs borne by our network of operators, which provide aircraft flight time to Strata at fixed hourly rates. This enables our operator partners to focus on training pilots, maintaining aircraft and flying, while we maintain the relationship with our customer from booking through flight arrival.

When utilizing third-party aircraft and/or aircraft operators, we typically pre-negotiate fixed hourly rates and flight times, paying only for flights actually flown, creating a predictable and flexible cost structure. Strata provides guaranteed flight commitments to some of our third-party operators through capacity purchase agreements (“CPAs”), which enable Strata to ensure dedicated access to such aircraft with enhanced crew availability, lower costs and, in many cases, the ability to unlock more favorable rates when flying more than the minimum number of hours we guarantee to the operator. Additionally, a significant portion of trips are flown by safety-vetted operators to whom we make no commitments, providing us with additional flexible capacity for high demand periods.

In 2024, we acquired ten fixed wing aircraft. We made the decision to invest in a limited number of owned aircraft based in high-volume geographies as we believe direct asset ownership will enable (i) improved economies of scale; (ii) increased uptime, enabling more reliable service and higher asset utilization; and (iii) the ability to compete for certain contracts where asset ownership is preferred or required. All of these aircraft are operated and maintained by third-party service providers under Strata’s oversight. We prioritize the use of owned aircraft and dedicated aircraft under CPAs, which provide better economies of scale. We size our owned fleet and our commitments under CPAs significantly below our expected demand, enabling us to maximize utilization on those aircraft while fulfilling incremental demand through our network of non-dedicated operators.

We provide ground logistics using a combination of owned vehicles, which are allocated to hub positioned near our customers across the United States, and third-party providers.

We utilize a combination of company employees and contractors as couriers to facilitate the transportation of organs, typically kidneys, aboard scheduled commercial flights. For next flight out services, where kidneys are placed in the cargo hold of a commercial flight, we coordinate with third-party providers on behalf of our customer.

Organ placement services, branded as “TOPS,” are provided on a contractual basis with a fixed monthly fee based on the size of the customer’s program.

Clinical Segment

We employ perfusionists and transplant surgeons that are primarily dedicated to a specific customer in a particular geography. We own perfusion equipment which is often provided as part of our services or offered through a traditional leasing arrangement.

Our clinical work for OPOs typically consists of surgical recovery, operation of preservation devices, NRP services and related equipment provided on a contractual basis with a combination of retainer and per case fees.

For transplant centers, surgical recovery, preservation and NRP services are typically provided on an ad hoc basis with pricing on a per case basis. We leverage surgeons, perfusionists and equipment in place to support our OPO customers to provide more efficient options to transplant centers, utilizing locally available resources wherever possible to avoid incremental logistics costs.

For cardiac care hospitals, we typically provide perfusion staffing, often combined with perfusion equipment, on a contractual basis with a combination of retainer and per case fees.

Technology

We also utilize proprietary technology to manage staffing, training and chain of custody, as well as help customers streamline organ evaluation (through our Trinity Organ Placement Services - TOPS), procurement and logistics. Our

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technology enhances the efficiency and cost-effectiveness of our service offerings, further strengthening our position in the organ transportation industry.

Competition

In Air and Ground Logistics, we compete primarily with Part 135 jet operators and a limited number of asset-light logistics businesses. We compete primarily based on our technology-enabled service and access to a wide variety of aircraft types, including jets, turboprops and helicopters, in many locations across the United States. This can lower costs for our customers based on our ability to select the most appropriate aircraft located in the most efficient area for the requested distance and payload.

In Organ Placement within the Logistics segment, we primarily compete with transplant centers’ own internal resources or a limited number of specialty firms focused on organ evaluation and coordination of the donation process. We compete primarily on our ability to (i) enable customers to efficiently evaluate a larger number of organ offers for potential transplant; (ii) coordinate the complex logistics and scheduling demands of the organ donation process; and (iii) provide our services at a competitive price point.

In our Clinical segment, we compete primarily with a hospital or OPOs own internal resources to provide surgical recovery, NRP or perfusion and a number of businesses with clinical offerings similar to ours. We compete primarily on our ability to consistently provide skilled clinical practitioners to our customers with a lower cost structure and more reliability than they could achieve with internal resources.

Many of our transplant customers utilize services in both our Logistics and Clinical segments together given the ease of use inherent in our integrated offering, but this is not required. Some of our competitors offer many of the same services we provide in an integrated “one call” offering, but we believe that our offering is more comprehensive in terms of both the variety of services we provide and the breadth of third-party devices that we support.

The organ transportation industry is rapidly evolving as new technology for organ preservation is introduced. We believe new technology will benefit our business by increasing the overall supply of organs to be transplanted and enabling such transplants at lower cost. However, some companies that manufacture proprietary organ preservation devices, which we do not possess, now also provide bundled logistics and clinical services that compete with us.

We believe our ability to compete successfully will depend on a number of factors, which may change in the future due to increased competition, including the price of our offerings, customer confidence in the safety and reliability of our offerings, customer satisfaction for the service we offer, and, for our clinical services, the successful outcomes of cases in which we are involved. If we are unable to compete successfully, our business, financial condition and results of operations could be adversely affected.

Human Capital Resources

As of December 31, 2025, the Company employed 601 employees, all of whom were located across the United States. Among these employees, we had 327 full-time employees and 274 part-time employees. The Company’s workforce consists of 223 employees in our Logistics segment, 359 employees in our Clinical segment, and 19 employees in our headquarters functions. None of our employees are represented by a labor union. We believe we have good relationships with our employees and have not experienced any interruptions of operations due to labor disagreements.

The Company’s human capital practices are designed to support its operational needs while maintaining compliance with applicable employment, labor, and workplace laws and regulations. The Company maintains employment-related policies applicable to employees, including a code of business conduct and ethics, an insider trading policy, and other employment-related policies intended to promote a professional and respectful workplace.

The Company seeks to attract and retain employees with the skills and experience necessary to support its operations. Employee compensation and benefits are structured to be competitive within relevant labor markets.

Health and safety considerations are integrated into the Company’s operations where relevant, including compliance with applicable workplace safety requirements and role-appropriate training.

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Government Regulation

Transportation and Aviation

As an arranger of air travel and an indirect air carrier, we are subject to United States Department of Transportation (“DOT”) regulations governing, among other things, advertising, contracting practices, and unfair deceptive practices. Certain of our logistics activities, including the transportation of organs for transplant, may also be subject to DOT rules and guidance applicable to the handling and transport of sensitive medical cargo. Although we do not currently operate aircraft, the third-party aircraft operators that conduct flights arranged by us are subject to the laws and regulations relating to the operation and maintenance of aircraft promulgated by the Federal Aviation Administration (“FAA”). Because we do not currently operate aircraft, our business operations are not directly regulated by the FAA. Our ground transportation offerings are governed by applicable local, state and federal regulations and include (i) owned vehicles, both with and without lights and sirens; and (ii) third-party owned and operated vehicles. Depending on the jurisdiction, these operations may be subject to vehicle safety requirements, emergency transport regulations, licensing requirements or other local transportation rules.

Healthcare

The procurement and transportation of organs in the United States occurs within a highly regulated framework. The organ transplantation system is governed by the National Organ Transplant Act and administered through the Organ Procurement and Transplantation Network (“OPTN”) under federal oversight by the Health Resources and Services Administration (“HRSA”). OPOs, which are nonprofit entities responsible for coordinating organ recovery and allocation, must meet statutory criteria and performance standards to maintain certification and participation in Medicare and Medicaid programs. Hospitals that receive Medicare or Medicaid funding must also meet certain conditions of participation related to organ, tissue and eye procurement.

Changes to OPTN governance, OPO performance metrics, organ allocation policies, or federal oversight initiatives could affect the manner in which transplant logistics are coordinated and may influence demand for our services. In addition, transplant centers, OPOs and hospitals that are our customers are subject to evolving regulatory and reimbursement requirements, which may indirectly impact our operations.

A number of federal and state healthcare laws, generally referred to as fraud and abuse laws, apply to healthcare providers and others that make, offer, seek or receive referrals or payments for products or services that may be paid for through federal or state healthcare programs and, in some instances, private health insurance programs. Given the breadth of these laws and regulations, they may affect our business either directly or indirectly through their application to our customers and business partners.

For example, the federal Anti-Kickback Statute (the “AKS”) broadly prohibits knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in return for or to induce referrals or business reimbursable under federal healthcare programs. Regulators and courts have interpreted the AKS broadly, and a violation may be found even if only one purpose of an arrangement is to induce referrals. Violations of the AKS can result in criminal penalties, civil monetary penalties, exclusion from participation in federal healthcare programs and potential liability under the federal civil False Claims Act (“FCA”).

The FCA imposes civil and criminal liability on individuals and entities that knowingly present or cause to be presented false or fraudulent claims for payment to the federal government. Actions under the FCA may be brought by the U.S. Department of Justice or by private individuals under qui tam provisions. Companies found liable under the FCA may be subject to significant monetary penalties, treble damages and extensive compliance obligations.

The Health Insurance Portability and Accountability Act, as amended, and implementing privacy, security, and breach notification regulations (“HIPAA”) also includes healthcare fraud and false statement provisions that prohibit schemes to defraud healthcare benefit programs and knowingly making materially false statements in connection with healthcare services or payment. Violations may result in fines, imprisonment or exclusion from government programs.

Additionally, the federal Civil Monetary Penalties Law authorizes the imposition of civil monetary penalties, assessments and exclusion for a variety of prohibited conduct, including submitting false claims, violating the AKS or failing to report and return identified overpayments. Many states maintain similar fraud and abuse laws that may apply regardless of whether services are reimbursed by Medicare or Medicaid. A determination of liability under these laws could result in fines, penalties, administrative sanctions, refund obligations, exclusion from healthcare programs and reputational harm.

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Privacy and Data Protection

In connection with our clinical logistics and coordination activities, we receive and process personal information, including protected health information (“PHI”), that is subject to extensive federal and state privacy and security laws. The PHI that we receive is subject to HIPAA. HIPAA limits the use and disclosure of PHI, and requires the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of individually identifiable health information in both paper and electronic form. In many instances, we act as a Business Associate under HIPAA, and may be subject to penalties for, or required to enter into monitoring or resolution agreements for, among other activities, failing to enter into written agreements where required by law and violations of HIPAA, including breaches. Under the breach notification rule, the Covered Entities, such as the hospitals with which we enter into agreements, must notify affected individuals without unreasonable delay in the case of a breach of unsecured PHI, which compromises the privacy or security of the PHI: these Covered Entity customers may also delegate the breach notification responsibility to us in their agreements. In addition, notification must be provided to the U.S. Department of Health and Human Services (“HHS”) and the local media in cases where a breach affects 500 or more individuals. Breaches affecting fewer than 500 individuals must be reported to the HHS on an annual basis. There can be no assurance that we will not be the subject of an investigation (arising out of a reportable breach incident, audit, or otherwise) alleging non-compliance with HIPAA in our maintenance of PHI. In some cases, HIPAA violations have resulted in lawsuits, settlement payments, and actions by state attorneys general to prosecute HIPAA violations committed against residents of their states. While HIPAA does not create a private right of action that would allow individuals to sue in civil court for a HIPAA violation, its standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.

In addition to HIPAA, we must adhere to U.S. state patient privacy laws that are not pre-empted by HIPAA, including those that are more stringent than HIPAA requirements. Numerous other U.S. state, federal, and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality, and security of patient health information. In addition, Congress and some U.S. states are considering new laws and regulations that further protect the privacy and security of medical records or medical information. The Federal Trade Commission (the “FTC”) also regulates health-related privacy and security. The FTC has taken enforcement actions against companies for statements or promises made about the privacy or security of health information through Section 5 of the Federal Trade Commission Act, which prohibits unfair or deceptive acts or practices, as well as through the Health Breach Notification Rule, which applies to certain “personal health record-related entities” or “third party service providers.” We may also be subject to scrutiny by federal and state regulators, partners, and consumers of our collection, use and disclosure of consumer personal information, including consumer health data. Additionally, federal and state consumer protection laws are increasingly being applied by FTC and states’ Attorneys General to regulate the collection, use, storage, and disclosure of personal information.

Environmental

Our third-party aircraft operators are subject to various federal, state and local environmental laws relating to, among other things, emissions, aircraft noise, fuel usage and the discharge or disposal of materials and chemicals. These laws are administered by numerous federal, state and local agencies. We seek representations of compliance with applicable environmental laws from our operators. Increased environmental regulation affecting aviation emissions, fuel standards or noise requirements could indirectly increase the costs of transportation arranged by us and impact our operations.

Corporate Background

Our predecessor was a special purpose acquisition company incorporated in Delaware in 2019 under the name of Experience Investment Corp. (“EIC”). In 2021, EIC acquired Blade Urban Air Mobility, Inc. (“Old Blade”) and changed its name to Blade Air Mobility, Inc.

In August 2025, the Company completed the divestiture of its legacy Passenger mobility business. Following that transaction, the Company rebranded as Strata Critical Medical, Inc. and now operates as a focused provider of integrated medical logistics and clinical services.

Available Information

Our Annual Report on Form 10-K (this “Annual Report”), Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements and amendments to those reports filed or furnished pursuant to Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), are available on the Investor Relations section of our website

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(https://ir.stratacritical.com/) as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. We also make available through our website other reports filed with or furnished to the SEC under the Exchange Act, including reports filed by our officers and directors under Section 16(a) of the Exchange Act. All of the information on our Investor Relations website is available to be viewed free of charge. The SEC maintains a website (https://www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

We routinely use the Investor Relations section of our website (https://ir.stratacritical.com/), our corporate website (www.stratacritical.com) and our X feed (@StrataCritical) as channels of distribution to publish important information about us, including financial or other information that may be deemed material to investors. Information contained on our websites or social media channels is not part of this Annual Report or our other filings with the SEC. Except as specifically incorporated by reference into this document, information on these websites or social media channels is not part of this document.