What changed in this filing

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Item 1. Business

2026-09-25 compared with 2025-09-26 · 119 added, 100 removed, 477 unchanged (31% of the section changed)

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Our mission encompasses the advancement of both mass spectrometry and gas chromatography, two powerful analytical techniques that together enable precise detection and identification of chemical compounds across a wide range of high-demand environments.

We aim to expand access to mass spectrometry by simplifying the complexity of operating these devices within real-time testing environments such as airports, border checkpoints, cargo hubs, infrastructure security, correctional facilities, military bases, law enforcement centers, and industrial locations.

We are introducing our new line of products that are ultra-portable, on-site, rugged environmental testing instruments, featuring our proprietary ATi Mass Spectrometer Technology ("MS") and ATi Gas Chromatography Column ("GC") to achieve our mission through simplifying the user interface, ruggedizing the critical components to endure MS/GC field work, and enabling multiple configurations for sample intake options.

The Astrotech Mass Spectrometer Technology™ and ATi Gas Chromatograph Column (GC) platforms achieve our mission through simplifying the user interface, automating the complicated calibration process, ruggedizing the critical components to endure MS/GC field work, and enabling multiple configurations for sample intake options.

Since the TRACER 1000 was certified by the European Civil Aviation Conference (“ECAC”) in 2019, our customers have deployed our devices in approximately 34 locations 16 countries throughout United States of America, Europe, and Asia.

We aim to expand access to mass spectrometry and its use through the deployment of devices designed specifically for the appropriate levels of precision required in high-volume, real-time testing environments such as airports, border checkpoints, cargo hubs, infrastructure security, correctional facilities, military bases, law enforcement centers, and industrial locations.

We are introducing our new line of products that are ultra-portable, on-site, rugged environmental testing instruments, featuring our proprietary ATi Gas Chromatography Column (“GC”) and ATi Mass Spectrometer Technology (“MS”) to achieve our mission through simplifying the user interface, automating the complicated calibration process, ruggedizing the critical components to endure MS/GC field work, and enabling multiple configurations for sample intake options.

Our Board of Directors (the “Board”) recently approved strategic initiatives focused on future lunar resource development, autonomous lunar industrial infrastructure, Moon-based advanced computing, semiconductor manufacturing, lunar power generation and power infrastructure, mining, chemical manufacturing, product transportation and equipment leasing opportunities on the Moon (our “Lunar Initiatives”).

As part of the initiative, Astrotech intends to evaluate and potentially develop infrastructure technologies that could support future semiconductor processing, advanced computing systems, and quantum computing manufacturing operations on the lunar surface.

Astrotech believes the convergence of abundant solar energy, extreme lunar thermal conditions, reduced gravity, autonomous robotics, and access to strategic lunar materials such as Si-28 and 3 He may ultimately make the Moon an attractive long-term platform for advanced computational infrastructure and next-generation quantum manufacturing systems.

Our Business Units

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1 st Detect Corporation (“1 st Detect”) is a manufacturer of explosive trace detectors (“ETDs”) and narcotic trace detectors (“NTDs”) developed for use in security and detection at airports, border checkpoints, cargo hubs, infrastructure security, correctional facilities, military bases, and law enforcement centers.

1 st Detect holds an exclusive AMS Technology license from ATI for air passenger and cargo security applications.

1 st Detect holds an exclusive AMS Technology license from ATI for air passenger and cargo security applications as well as narcotics detection.

(“AgLAB”) is developing a series of mass spectrometers for use in the hemp and cannabis market with initial focus on optimizing yields in the distillation processes.

AgLAB holds an exclusive AMS Technology license from ATI for applications in the agriculture industry which require analyzing complex chemical compounds found in organic plant material and extracts.

BreathTech Corporation (“BreathTech”) is developing a breath analysis tool to screen for volatile organic compound (“VOC”) metabolites found in a person’s breath that could indicate a compromised condition including but not limited to a bacterial or viral infection.

BreathTech Corporation (“BreathTech”) is a breath analysis tool designed to screen for volatile organic compound (“VOC”) metabolites found in a person’s breath that could indicate a compromised condition including but not limited to a bacterial or viral infection.

BreathTech holds an exclusive AMS Technology license from ATI for breath analysis applications.

Pro-Control, Inc.

Pro-Co ntrol, Inc.

(“Pro-Control”) is focused on applying the AMS Technology in industrial process control applications.

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EN-SCAN, Inc.

(“EN-SCAN”) is developing advanced environmental testing and monitoring solutions, integrating gas chromatography and mass spectrometry technology in rugged, portable designs.

EN-SCAN’s products are expected to support industrial, environmental, and regulatory applications, helping organizations meet compliance requirements and environmental safety.

EN-SCAN will use proprietary ATi Gas Chromatograph Column ("GC") and ATi Mass Spectrometer Technology ("MS") for instant feedback to accurately detect soil, water, and air contamination source location and migration.

(“EN-SCAN”) is developing advanced environmental testing and monitoring solutions built around rugged, portable gas chromatography-based systems.

EN-SCAN’s current platform integrates a proprietary micro-electro-mechanical preconcentrator (“MEMS”), MEMS micro gas chromatographic column, and a photoionization detector to provide rapid, on-site detection of volatile organic compounds for industrial, environmental, and regulatory applications.

These systems are designed to support compliance monitoring, industrial hygiene, and environmental safety by enabling fast identification of contamination sources and migration pathways.

EN-SCAN utilizes the proprietary ATi Gas Chromatograph and AMS Technology license from ATI to deliver gold standard analytical feedback for soil, water, and air assessments.

EN-SCAN plans to expand its analytical capabilities by incorporating mass spectrometry into future product generations, further enhancing compound identification and broadening application scope.

Lunar Power and Light Corporation (“LP&L”) is a recently approved strategic initiative focused on future lunar resource development, autonomous lunar industrial infrastructure, Moon-based advanced computing, semiconductor, manufacturing, lunar power generation and power infrastructure, mining, chemical manufacturing, product transportation and equipment leasing opportunities on the Moon.

As part of the initiative, Astrotech intends to evaluate and potentially develop infrastructure technologies that could support semiconductor processing, advanced computing systems, and quantum computing manufacturing operations on the lunar surface.

Astrotech Technologies, Inc.

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With a number of diverse market opportunities for the core technology, ATI is structured to license the intellectual property for different fields of use.

ATI currently licenses the AMS Technology to four wholly-owned subsidiaries of Astrotech on an exclusive basis, including to 1st Detect for use in security and detection applications, to AgLAB for use in the agriculture application, to BreathTech for use in breath analysis applications, Pro-Control for use in production applications, and EN-SCAN for use in industrial and environmental applications.

ATI currently licenses the AMS Technology to five wholly-owned subsidiaries of Astrotech on an exclusive basis, including to 1st Detect for use in security and detection applications, to AgLAB for use in the agriculture application, to BreathTech for use in breath analysis applications, Pro-Control for use in production applications, and EN-SCAN for use in industrial and environmental applications.

1 st Detect Corporation

1st Detect, a licensee of ATI for security and detection applications, has developed the TRACER 1000™, the world’s first MS based ETD certified by the ECAC and approved by the U.S.

1st Detect, a licensee of ATI for security and detection applications, has developed the TRACER 1000™, the world’s first MS based ETD approved by the European Civil Aviation Conference ( “ ECAC”) and the U.S.

Transportation Security Administration ( “ TSA”) for air cargo.

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In contrast, adding additional compounds to the TRACER 1000’s detection library does not degrade its detection capabilities, as it has a virtually unlimited and easily expandable threat library.

We obtained ECAC certification in 2019 which allows us to sell the TRACER 1000 to airport and cargo security customers in the European Union and certain other countries.

We currently sell the TRACER 1000 to customers who accept ECAC certification.

We obtained ECAC certification in 2019 which allows us to sell the TRACER 1000 to airport and cargo security customers in the European Union (“EU”) and certain other countries.

We are currently selling the TRACER 1000 to customers who accept ECAC certification.

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During Stage II testing, we are conducting field trials with the TSA.

If field trials are successful, the TRACER 1000 will be added to the "qualified" list.

We have also commenced the process to pass TSA checkpoint testing.

If field trials are successful, the TRACER 1000 will be added to the "qualified" list which provides long-term designation for permitted air-cargo screening use.

We have also started the process to pass TSA checkpoint testing.

This process involves Developmental Test and Evaluation in which the Transportation Security Laboratory ( “ TSL”) will test the TRACER 1000 and work with 1st Detect to ensure its readiness to enter certification testing.

The certification test is then completed by the Independent Test & Evaluation department of TSL.

For the fiscal year 2023, the United States federal government had a budget of over 6,000 ETD units at checkpoint and baggage screening points for which we believe that the TSA would benefit from utilizing our AMS Technology.

We are currently accepting orders for the TRACER 1000 ETD and NTD which are listed in the United States General Services Administration ( “ GSA”) IT Schedule 70 under Contract No.

GS-35F-250GA with SRI Group LLC, Special Item Number 334290 in April 2024.

The TRACER 1000 ETD and NTD are high-performance laboratory instruments capable of rapid detection of trace levels of explosive and narcotic compounds in seconds.

The TRACER 1000 ETD and NTD are high-performance laboratory-grade instruments designed for the field capable of rapid detection of trace levels of explosive and narcotic compounds in seconds.

The TRACER 1000 ETD and NTD both provide a ruggedized platform that can be applied across various markets including airports, border security, checkpoint, cargo and infrastructure security, correctional facilities, military, and law enforcement.

IT Schedule 70 is a long-term contract issued by the GSA to commercial technology vendors that allows sales to the United States federal government, one of the largest buyers of goods and services in the world.

On January 14, 2025, our wholly owned subsidiary, 1st Detect Corporation, announced that it has been awarded research and development contract 70RSAT24CB0000015 with the United States Department of Homeland Security ("DHS") to research, develop and mature the TRACER 1000 for DHS next generation explosives trace detection.

On March 10, 2025, we announced the launch of the enhanced TRACER 1000 Narcotic Trace Detector ("TRACER 1000 NTD").

This innovative mobilized mass spectrometer is specifically configured to screen for the full range of synthetic opiates and novel psychoactive substances ("NPS") delivering accuracy and speed to counter the global drug crisis.

In April 2025, Astrotech received a $429,000 purchase order for TRACER 1000™ explosive trace detectors ("ETDs") from Intuitive Research and Technology, a TSA approved contractor.

In April 2025, we fulfilled the purchase order and sold six TRACER 1000 explosive detectors to Intuitive Research and Technology Corporation.

This is the first TSA-approved sale of our TRACER 1000 ETD, which utilizes mass spectrometry technology, known for its accuracy and low false alarm rate.

On June 12, 2025, we sold the first sale and deployment of the TRACER 1000 Narcotic Trace Detector in Vietnam, by way of its subsidiary 1st Detect.

This milestone marked a significant step in expanding the 1st Detect footprint across Southeast Asia and reinforces its commitment to enhancing narcotics trace detection inspection capabilities.

We continue to showcase the TRACER 1000 NTD and ETD at the trade events in the U.S.

AgLAB, an exclusive licensee of ATI for the use in the agriculture industry to analyze complex chemical compounds found in organic plant material and extracts, has developed the AgLAB 1000™ series of mass spectrometers for use in the hemp and cannabis markets with the initial focus on optimizing yields in the distillation process.

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Sales efforts for the AgLAB 1000-D2 are currently underway.

AgLAB announced the presentation of the AgLAB Maximum Value Processing at MJBizCon.

The AgLAB MVP is an innovative process control system proven to increase the potency of ending-weight yields and increase revenue.

The AgLAB MVP is an innovative process control system proven to increase the potency of ending-weight yields and increase revenue for distillation customers.

The AgLAB MVP process provides real-time data, allowing distillers to adjust parameters to optimize the quality and quantity of each batch of oil.

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We believe these ongoing field trials demonstrate the solution can be a valuable tool for cannabis and hemp oil processors worldwide.

On June 13, 2024, AgLAB and SC Laboratories ("SC Labs") entered into a master lease agreement providing for the joint marketing of the AgLAB 1000-D2™ mass spectrometer and the AgLAB Maximum Value Process™ testing method to SC Labs' clients.

BreathTech Corporation

BreathTech, an exclusive licensee of ATI for use in breath analysis applications, has developed the BreathTest-1000™, a breath analysis tool to screen for VOC metabolites found in a person’s breath that could indicate they may have compromised condition.

We believe that new tools to quickly identify the presence of a VOC metabolite could play an important role in detecting and containing airborne diseases.

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Pro-Control, Inc.

On December 12, 2023, we announced the formation of our new wholly-owned subsidiary, Pro-Control, and ATI’s entry into an exclusive license with Pro-Control to utilize our AMS Technology for industrial process control applications involving chemical distillation outside of the agriculture industry.

Pro-Control has an exclusive license with ATI to utilize our AMS Technology for industrial process control applications involving chemical distillation outside of the agriculture industry.

Pro-Control uses advanced mass spectrometer instrumentation to monitor and control the production and operations of manufacturing processes using real-time, in-process samples.

Pro-Control provides the vital spectral qualitative and quantitative data needed to control the production parameters (temperatures, flow, speed, and pressure) while significantly improving efficiency.

Pro-Control provides the vital qualitative and quantitative spectral data needed to control the production parameters (temperatures, flow, speed, and pressure) to improve efficiency.

Pro-Control has introduced its proprietary Pro-Control Maximum Value Processing and the Pro-Control 1000-D2™ mass spectrometer, which in combination are designed to test, measure and increase reaction intermediates, purity and percent yields in industrial processes.

EN-SCAN, Inc.

On February 28, 2025, we announced the formation of our new wholly owned subsidiary, EN-SCAN, to manufacture and sell a new line of instruments built for environmental testing using its proprietary ATi GC and AMS Technology for outdoor field work for on-site, real-time air, water, and soil analysis providing instant feedback for accurate contamination source location and migration.

EN-SCAN manufactures and sells a line of instruments built for environmental testing using its proprietary ATi GC and AMS Technology for outdoor field work for on-site, real-time air, water, and soil analysis providing instant feedback for accurate contamination source location and migration.

With a focus on real-time monitoring, EN-SCAN is expected to enable organizations to make data-driven decisions while reducing testing costs and time delays.

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Each of these three testing solutions are designed for specific applications.

The EN-SCAN product line includes ultra-portable rugged environment testing instruments, featuring our proprietary ATi Gas Chromatograph Column and ATi Mass Spectrometer Technology through our wholly owned subsidiary, EN-SCAN, Inc.

Our customers gain access to real-time results and on-demand reporting, enabling continuous monitoring and immediate response in critical applications.

Lunar Power and Light Corporation

Our Board recently approved our Lunar Initiatives.

As part of our Lunar Initiatives, we intend to evaluate and potentially develop infrastructure technologies that could support future semiconductor processing, advanced computing systems, and quantum computing manufacturing operations on the lunar surface.

We believe the convergence of abundant solar energy, extreme lunar thermal conditions, reduced gravity, autonomous robotics, and access to strategic lunar materials such as Si-28 and 3 He may ultimately make the Moon an attractive long-term platform for advanced computational infrastructure and next-generation quantum manufacturing systems.

Each of our Lunar Initiatives is in a very early stage and subject to all of the risks inherent in the establishment of a new business venture.

Currently, there are no commercial operations of any kind on the lunar surface.

Our Lunar Initiatives are in the explorative planning and design stages and have not yet been proven to be technically, financially, or commercially viable, and may ultimately be unsuccessful.

To date, no formal business plan or capital budget has been approved relating to any of our Lunar Initiatives and no final products, sites, capacities, routes, launch schedules, service dates or project costs have been determined.

We do not have any binding power-purchase agreement, customer or vendor commitments, strategic-partner agreement, financing commitment or launch contract.

We do not currently have any lunar or space operations and do not currently have employees with the technical expertise necessary to fully develop the Lunar Initiatives.

Implementation will depend on technical validation, ability to attract and retain employees with technical expertise, customer demand, partnerships, lunar transportation, sufficient financing and other factors.

These efforts require substantial and ongoing investments of financial, technical and human resources over extended time horizons, including, but not limited to, research and development, testing, infrastructure, and mission execution.

The technologies, systems and operational capabilities required for each of these Lunar Initiatives involve significant technical complexity and are subject to design, engineering, and performance risks, many of which may only become apparent as development and testing progress.

We currently do not have the technical expertise or operational capabilities to execute on any of our Lunar Initiatives.

Many of these technologies, systems and operational capabilities are novel and untested, and we expect to incur significant capital expenditures over a period of years before our Lunar Initiatives, including related products and services, and other strategic initiatives, including in-orbit, lunar, and interplanetary industrialization efforts, may become commercially scalable or profitable, which may never occur.

The markets we intend to enter are expected to attract significant competition from commercial entities and government-sponsored programs, many of which have substantially greater financial, technical, manufacturing, marketing and personnel resources than we do.

Because our Lunar Initiatives remain in the explorative planning and design stage, we have not yet demonstrated the technical feasibility of our planned offerings, potential customer base or generated any revenue from the Lunar Initiatives, and we may be unable to compete effectively against entities that are further advanced in their lunar programs.

Our failure to compete effectively could have a material adverse effect on our business, financial condition and results of operations.

The capital expenditures we expect to incur to evaluate, pursue and develop our Lunar Initiatives will be significant, and we currently do not have the cash or resources to do so.

Our Lunar Initiatives will require substantial capital expenditures to design, develop, expand, and maintain our technologies and infrastructure to support development of such potential operations.

These expenditures include, but are not limited to, costs associated with research and development, construction and expansion of production capabilities, acquisition of property and equipment, and ongoing maintenance and upgrades to ensure reliability and competitiveness.

The Company’s ability to obtain financing that will be needed to fund our Lunar Initiatives will depend, in part, upon factors beyond the Company’s control, and there can be no assurance that appropriate financing will be available to the Company in amounts necessary to fund any of our Lunar Initiatives or on commercially viable terms or at all.

Accordingly, our Lunar Initiatives, and the related intended business and operations, may not prove to be successful in the future, if at all.

For additional information regarding the risks of our Lunar Initiatives, see Part I, Item 1A.

“Risk Factors.”

1 st Detect Corporation

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Critical Infrastructure Security Checkpoints

On May 11, 2026, we announced the TRACER 1000 system has achieved ECAC/EU G1 approval, meeting the highest European standards for aviation security.

This approval reflects compliance with the ECAC and European Commission requirements for trace detection systems, supporting enhanced security for airline passengers.

On June 8, 2026, we announced that the 1 st Detect TRACER 1000 system has received the ECAC certification for wand swabbing, approved for use in screening both passengers and cargo in aviation security operations.

The system satisfies the ECAC Explosives Detection Standard and Standard G1 under Concept of Operations Revision 38 which opens the customer base to include airports that require wand swabbing.

On June 16, 2026, we announced that the Board authorized our management to pursue a potential sale process of 1 st Detect, developer of the TRACER 1000 mass spectrometry-based explosives and narcotics trace detection platform.

We are evaluating a potential sale of 1 st Detect to provide additional capital for the announced strategic initiatives we are committed to building.

We continue to showcase the TRACER 1000 NTD and ETD at the trade events in the U.S.

Initial interest for the AgLAB-1000 series has come from the hemp and cannabis industry.

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Chemical plants

On May 21, 2026, we announced the commercial launch of the Labrador HH-GC, a rugged, field-portable gas chromatograph engineered to bring laboratory-grade VOC analysis directly to the point of investigation.

The Labrador HH-GC places actionable analytical intelligence directly into the hands of field operators, enabling faster decisions and accelerated remediation timelines.

LP&L Corporation

As part of our lunar power and resource development initiatives, Astrotech intends to evaluate and potentially develop infrastructure technologies that could support future semiconductor processing, advanced computing systems, and quantum computing manufacturing operations on the lunar surface.

Our Initiatives intend to explore five potential strategic categories:

Lunar power generation focused on installing solar power, long-generation energy storage, recharge stations and associated transmission lines;

Rover rental and equipment leasing to potential government and commercial customers;

Mining and material handling, potentially involving AI-directed excavation and transport of lunar regolith;

AI-directed chemical manufacturing, integrating our GC-MS data with autonomous process control.

Product transportation, including moving raw and finished materials on the lunar surface;

Products and Services

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MS can analyze a wide range of molecules, from small organic compounds to large biomolecules like proteins and nucleic acids.

Other separation techniques can be coupled with MS, such as gas chromatography (“GC-MS”) or liquid chromatography (“LC-MS”), to enhance the analysis of complex mixtures and provide additional separation before detection.

Other separation techniques can be coupled with MS, such as gas chromatography (“GC-MS”) or liquid chromatography, to enhance the analysis of complex mixtures and provide additional separation before detection.

The innate capabilities of MS and its ability to incorporate multiple sample intake methods allows us to continually expand and adapt the libraries used by our business units for the identification of compounds of interest in new applications of our AMS Technology.

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We now have units deployed in 37 locations in 16 countries.

While we have had some degree of success securing and fulfilling orders, the sales cycles in the regulated and government markets are normally long and much of the pipeline opportunities were delayed by the COVID-19 pandemic.

AgLAB uses direct and channel sales.

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Confirmatory technology

The currently available technology that we believe to be the only direct competition to our MS-based system is high performance liquid chromatography (“HPLC”).

The currently available technology that we believe to be the only direct competition to our MS-based system is high-performance liquid chromatography.

We believe the AgLAB-1000 series of products offers a more customer-friendly interface, quicker results, and, once the AgLAB-1000-D1 is launched, the ability to provide closed loop process control, ensuring maximum yield and product quality.

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The BreathTest-1000 product is designed to screen for VOC metabolites in a person’s breath and which could indicate the person may have a compromised condition.

Given that breath samples are quick, inexpensive, and painless, we anticipate that the BreathTest-1000 will help screen for signs of disease.

Given that breath samples are quick, inexpensive, and painless, we anticipate that the BreathTest-1000 could help screen for signs of disease.

We do not see this as competing with traditional tests but supplementing and improving medical care.

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Its emphasis on real-time, on-site analysis and cost efficiency positions in the environmental testing market.

LP&L Corporation

The commercial lunar and space industries are characterized by rapid and disruptive technological change, evolving industry standards, the emergence of new and well-funded competitors, and frequent new product and service introductions.

Such markets are rapidly evolving and intensely competitive, and we face competition from a range of established and emerging companies, including large, well-capitalized technology companies and aerospace firms, including foreign competitors.

Many of our current and potential competitors have significantly greater resources and more advanced operational capabilities than we do.

For example, Space Exploration Technologies Corp.

(“SpaceX”) is substantially better capitalized than us and possesses substantial vertical integration across launch, spacecraft manufacturing and mission operations, which provides it with significant cost and schedule advantages that could enable it to offer competing lunar infrastructure services at lower prices or on faster timelines than we are able to achieve.

Other competitors, including Blue Origin, Intuitive Machines and international space agencies, are also pursuing lunar surface operations and may establish infrastructure or secure customer commitments before we are able to deploy our planned systems.

Because our Lunar Initiatives remain in the explorative planning and design stage, we have not yet demonstrated the technical feasibility of our planned offerings, potential customer base or generated any revenue from our Lunar Initiatives, and we may be unable to compete effectively against entities that are further advanced in their lunar programs.

In addition, the award processes for government programs such as Appendix A:

Lunar Enabling Infrastructure Accelerator (“Appendix A Program”) and NASA’s Commercial Lunar Payload Services 2 program (“CLPS2 Program”) are highly competitive, subject to extensive evaluation criteria, and influenced by factors beyond our control, including government budgetary constraints, shifting policy priorities, the number and quality of competing proposals, and the discretion of the awarding agency.

Research and Development

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Pro-Control is in the early stages of using the core AMS Technology.

It is refining its product line to include other valuable products and it is developing its library for chemical manufacturers.

It is refining its product line to include other valuable products and developing its library for chemical manufacturers.

En-Scan, Inc.

EN-SCAN is set to manufacture and sell a new line of instruments built for environmental testing using its proprietary ATi GC and AMS Technology for outdoor field work for on-site, real-time air, water, and soil analysis providing instant feedback for accurate contamination source location and migration.

EN-SCAN is selling a new line of instruments built for environmental testing using its proprietary ATi GC and AMS Technology for outdoor field work for on-site, real-time air, water, and soil analysis providing instant feedback for accurate contamination source location and migration.

EN-SCAN’s commitment to innovation is reflected in its active R&D efforts.

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Under the Federal Food Drug and Cosmetic Act (“FDCA”), administered by the FDA, medical devices are classified into one of three classes, Class I, Class II, or Class III, depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory controls needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation (“QMSR”), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Some Class I devices may require premarket notification to the FDA.

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The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR.

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA application constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

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state licensure requirements for the manufacturing and distribution of medical devices;

FDA’s QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process;

FDA’s QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process;

FDA labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced, provide adequate directions for use, and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

FDA regulations and guidance pertaining to clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA devices;

FDA’s medical device reporting (“MDR”) regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

FDA’s medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

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

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With respect to any medical devices that we may commercialize in the U.S.

in the future, our manufacturing processes, or those of any contract manufacturer that we engage, will be required to comply with the applicable portions of the QSR, which cover the methods and the facilities, controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

in the future, our manufacturing processes, or those of any contract manufacturer that we engage, will be required to comply with the applicable portions of the QMSR, which cover the methods and the facilities, controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The QMSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

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recalls, withdrawals, or administrative detention or seizure of our products;

operating restrictions or partial suspension or total shutdown of production (due to violations of the QSR or other applicable regulations) refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;

operating restrictions or partial suspension or total shutdown of production (due to violations of the QMSR or other applicable regulations) refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;

withdrawing 510(k) clearances or PMA approvals that have already been granted;

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Once the product has been placed on the market in the EEA, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with the medical device.

In order to demonstrate safety and efficacy for their medical devices, manufacturers must conduct clinical investigations in accordance with the requirements of Annex X to the Medical Devices Directive ("MDD"), Annex 7 of the Active Implantable Medical Devices Directive ("AIMDD"), and applicable European and International Organization for Standardization standards, as implemented or adopted in the EEA member states.

In order to demonstrate safety and efficacy for their medical devices, manufacturers must conduct clinical investigations in accordance with the requirements of Annex X to the Medical Devices Directive, Annex 7 of the Active Implantable Medical Devices Directive, and applicable European and International Organization for Standardization standards, as implemented or adopted in the EEA member states.

Clinical trials for medical devices usually require the approval of an ethics review board and approval by or notification to the national regulatory authorities.

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strengthened rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

In the European Union, member states are responsible for enforcing the EU’s medical device rules and for ensuring that only compliant medical devices are placed on the market or put into service in their jurisdictions.

In the EU, member states are responsible for enforcing the EU’s medical device rules and for ensuring that only compliant medical devices are placed on the market or put into service in their jurisdictions.

They have powers to suspend the marketing and use, or demand the recall, of unsafe or non-compliant devices.

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Federal, State, and Foreign Fraud and Abuse and Physician Payment Transparency Laws.

In addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws may restrict our business practices if our products will be reimbursable under federal or state healthcare programs.

These laws include, without limitation, foreign, federal, and state anti-kickback and false claims laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.

The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs.

Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved.

Civil penalties for such conduct can further be assessed under the federal False Claims Act.

Violations can also result in criminal penalties, including criminal fines of up to $100,000 and/or imprisonment of up to 10 years.

Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid.

Liability under the federal Anti-Kickback Statute may also arise because of the intentions or actions of the parties with whom we do business.

The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

A claim includes “any request or demand” for money or property presented to the U.S.

The federal civil False Claims Act also applies to false submissions that cause the government to be paid less than the amount to which it is entitled, such as a rebate.

Intent to deceive is not required to establish liability under the federal civil False Claims Act.

In addition, private parties may initiate “qui tam” whistleblower lawsuits against any person or entity under the federal civil False Claims Act in the name of the government and share in the proceeds of the lawsuit.

Penalties for federal civil False Claim Act violations include fines for each false claim, plus up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion from the federally funded healthcare program The criminal False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious or fraudulent and, unlike the federal civil False Claims Act, requires proof of intent to submit a false claim.

When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties ranging from $11,803 to $23,607 for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid, and other federal healthcare programs.

The Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, or offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier.

The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and including implementing regulations (collectively, “HIPAA”) also created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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

In addition to the applicable FDA regulations governing the research, development, manufacture, marketing and sale of our products, if approved and commercialized, we may become subject to various federal and state healthcare laws and regulations.

These laws and regulations are intended to, among other things, prevent fraud and abuse in the healthcare industry, promote transparency in interactions among healthcare industry participants, and protect government healthcare programs from improper expenditures.

Applicable healthcare laws and regulations may include, but are not limited to, the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or reward referrals of items or services reimbursable by a federal healthcare program;

the federal False Claims Act, which imposes liability for knowingly presenting, or causing to be presented, false or fraudulent claims for payment to the federal government;

the Civil Monetary Penalties Law, which authorizes the imposition of penalties for a variety of prohibited conduct involving federal healthcare programs;

the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), which establishes certain requirements relating to healthcare fraud and abuse as well as the privacy and security of protected health information;

the federal Physician Payments Sunshine Act, which requires manufacturers of certain healthcare products to report payments and other transfers of value provided to physicians, teaching hospitals, and certain other healthcare providers;

and analogous state and foreign laws and regulations relating to anti-kickback and fraud and abuse practices, false claims, transparency and reporting obligations, and other healthcare compliance matters.

These laws and regulations may affect a wide range of business activities, including research and development activities, clinical research activities, product commercialization efforts, sales and marketing programs, interactions with healthcare professionals and healthcare organizations, and arrangements with distributors and other third parties.

Many foreign countries have similar laws relating to healthcare fraud and abuse.

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These laws may limit or restrict the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

Also, many U.S.

states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Data Privacy and Security Laws .

In the future, we may also be subject to various federal, state, and foreign laws that protect personal information including certain patient health information, such as the E.U.

General Data Protection Regulation (“GDPR”) and the California Consumer Privacy Act (“CCPA”), and restrict the use and disclosure of patient health information, such as HIPAA, and analogous state laws, many of which apply more broadly than HIPAA, in the U.S.

HIPAA established uniform standards governing the conduct of certain electronic healthcare transactions and requires certain entities, called covered entities (as defined under HIPAA), to comply with standards that include the privacy and security of Protected Health Information (“PHI”).

HIPAA also requires business associates (as defined under HIPAA), that may include independent contractors or agents of covered entities that access, use or disclose PHI in connection with providing a service to or on behalf of a covered entity to enter into business associate agreements with the covered entity and to safeguard the covered entity’s PHI against improper use and disclosure.

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

They also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or disclosure of PHI.

The security regulations establish requirements for safeguarding the confidentiality, integrity, and availability of PHI that is electronically transmitted or electronically stored.

HITECH, among other things, established certain health information security breach notification requirements.

A covered entity must notify any individual whose PHI is breached according to the specifications set forth in the breach notification rule.

The HIPAA privacy and security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their records containing PHI or insofar as such state laws apply to personal information that is broader in scope than PHI as defined under HIPAA.

HIPAA requires the notification of patients, and other compliance actions, in the event of a breach of unsecured PHI.

If notification to patients of a breach is required, such notification must be provided without unreasonable delay and in no event later than 60 calendar days after discovery of the breach.

In addition, if the PHI of 500 or more individuals is improperly used or disclosed, we would be required to report the improper use or disclosure to HHS which would post the violation on its website, and to the media.

Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $63,973 per violation, not to exceed an aggregate of $1.92 million per calendar year, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment.

HIPAA authorizes state attorneys general to file suit on behalf of their residents for violations.

Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases.

While HIPAA does not create a private right of action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities, and their business associates for compliance with the HIPAA privacy and security standards.

It also tasks HHS with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the civil monetary penalty paid by the violator.

In addition, California enacted the CCPA, effective January 1, 2020, which, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

Although the law includes limited exceptions, including for “protected health information” maintained by a covered entity or business associate, it may regulate or impact our processing of personal information depending on the context.

In the EEA, we may become subject to laws which restrict our collection, control, processing, and other use of personal data (i.e., data relating to an identifiable living individual) including the GDPR (and any national laws implementing the GDPR).

As part of our operations, we process personal data belonging to data subjects in the EEA, including employees, contractors, suppliers, distributors, service providers, customers, patients, or clinical trial participants.

For patients or clinical trial participants, we process special categories of personal data like health and medical information.

We need to ensure compliance with the GDPR (and any applicable national laws implementing the GDPR) in each applicable EEA jurisdiction.

In the future, we may also be subject to various federal, state, and foreign laws that govern the collection, use, storage, processing, disclosure, and protection of personal and other sensitive information including certain protected health information.

Such laws and regulations may include, among others, the E.U.

General Data Protection Regulation (“GDPR”), the California Consumer Privacy Act (“CCPA”) and similar state privacy laws, HIPAA, and analogous state laws, many of which may apply more broadly than HIPAA in the U.S.

Such laws and regulations are evolving and may impose significant compliance obligations, restrictions on our business practices, and increased costs.

Failure to comply with applicable data privacy and security requirements could result in regulatory investigations, enforcement actions, litigation, reputational harm, and other adverse effects on our business, financial condition, and results of operations.

Healthcare Reform.

and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.

Among policy makers and payors in the U.S.

and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.

Current and future legislative proposals, on both a national and state level, to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the use of our products.

The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our medical products, to the extent any are authorized for commercialization in the United States.

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In January 2023, the FDA stated that given the growing cannabidiol (CBD) products market, it had convened a high-level internal working group to explore potential regulatory pathways for CBD products and is prepared to find a new regulatory pathway for CBD to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.

Notwithstanding the actions of the Biden administration, it should be expected that the Department of Justice will continue to enforce the Controlled Substances Act with respect to cannabis under established principles in setting their law enforcement priorities to prevent:

In May 2024, the U.S.

Department of Justice and the Drug Enforcement Administration published a proposed rule to move marijuana from Schedule I to Schedule III under the Controlled Substances Act.

On December 18, 2025, President Trump issued an executive order directing the Attorney General to take all necessary steps to expeditiously move marijuana from Schedule I to Schedule III under the Controlled Substances Act.

As of the date of this Annual Report on Form 10-K, no final rule has been adopted, and the status and timing of any final rulemaking action remain uncertain.

Notwithstanding the actions of the current or prior administrations, it should be expected that the Department of Justice will continue to enforce the Controlled Substances Act with respect to cannabis under established principles in setting their law enforcement priorities to prevent:

the distribution of cannabis products, such as marijuana, to minors;

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The Justice Department maintains that it can still prosecute violations of the federal cannabis laws and continue cases already in the courts.

The Rohrabacher-Blumenauer Amendment must be re-enacted every year, and it is continued through September 30, 2023.

However, state laws do not supersede the prohibitions set forth in the federal drug laws.

The Rohrabacher-Blumenauer Amendment must be re-enacted every year.

In order to participate in either the medical or the adult use aspects of the cannabis industry, all businesses and employees must obtain licenses from the state and, for businesses, local jurisdictions as well.

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An investment in our securities involves a high degree of risk.

This annual report will contain a discussion of the risks applicable to an investment in our securities.

This annual report contains a discussion of the risks applicable to an investment in our securities.

Prior to making a decision about investing in our securities, you should carefully consider the specific factors discussed under the heading “Risk Factors” in this annual report.

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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.

What changed 10-K

Item 1. Business