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What changed in EKSO BIONICS HOLDINGS, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of EKSO BIONICS HOLDINGS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+344 added−256 removedSource: 10-K (2026-02-23) vs 10-K (2025-03-03)

Top changes in EKSO BIONICS HOLDINGS, INC.'s 2025 10-K

344 paragraphs added · 256 removed · 211 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

57 edited+18 added−17 removed87 unchanged
Biggest changeFailure to comply with applicable regulatory requirements can result in compliance or enforcement action by FDA, which may include any or all of the following sanctions, including warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties; repair, replacement, withdrawal, administrative detention, refunds, recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing or delaying requests for 510(k) clearance of new products or modified products; withdrawing 510(k) clearance or other authorizations; refusal to grant export approvals; or criminal prosecution.
Biggest changeFailure to comply with applicable regulatory requirements can result in compliance or enforcement action by FDA, which may include any or all of the following sanctions, including warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties; repair, replacement, withdrawal, administrative detention, refunds, recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing or delaying requests for 510(k) clearance of new products or modified products; withdrawing 510(k) clearance or other authorizations; refusal to grant export approvals; or criminal prosecution. 6 Table of Contents Other U.S. regulatory matters Medical device companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business, including the FDA, CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments.
Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”), and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.
Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act”), and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.
Subsequently, Parker entered three amendments with Vanderbilt University and was granted license to additional patents and software from 2014 to 2019 by paying license issue fee and running royalties. The royalties were set to be calculated at 6% of Net Sales for Licensed Patent Products (or a minimum of $250,000) and 3% of Net Sales for Licensed Software products.
Subsequently, Parker entered three amendments with Vanderbilt and was granted license to additional patents and software from 2014 to 2019 by paying license issue fee and running royalties. The royalties were set to be calculated at 6% of Net Sales for Licensed Patent Products (or a minimum of $250,000) and 3% of Net Sales for Licensed Software products.
On March 1, 2022, Parker entered a license agreement (“P-H Knee License Agreement”) with Vanderbilt University and was granted exclusive license to specific licensed patents, licensed software and copyrightable technical information by paying a non-refundable, non-creditable license issue fee and running royalties. Included in this agreement was the right to sublicense beginning in March 2024.
On March 1, 2022, Parker entered a license agreement (“P-H Knee License Agreement”) with Vanderbilt and was granted exclusive license to specific licensed patents, licensed software and copyrightable technical information by paying a non-refundable, non-creditable license issue fee and running royalties. Included in this agreement was the right to sublicense beginning in March 2024.
In January 2025, HAWE notified us that they are not moving forward with the technology and therefore were terminating the license agreement. We did not receive any royalty revenue from this license in the years ended December 31, 2024 and 2023, and do not expect to receive any royalty revenue from this license in the future.
In January 2025, HAWE notified us that they are not moving forward with the technology and therefore were terminating the license agreement. We did not receive any royalty revenue from this license in the years ended December 31, 2025 and 2024, and do not expect to receive any royalty revenue from this license in the future.
On October 15, 2012, Parker entered a license agreement (“Exoskeleton License Agreement”) with Vanderbilt University and was granted exclusive license within the HMC field of use to specific licensed patents and licensed software by paying a non-refundable, non-creditable license issue fee and running royalties.
On October 15, 2012, Parker entered a license agreement (“Exoskeleton License Agreement”) with Vanderbilt and was granted exclusive license within the HMC field of use to specific licensed patents and licensed software by paying a non-refundable, non-creditable license issue fee and running royalties.
In the U.S. and most markets globally where we sell our products, payment for medical services provided by our customers (collectively “providers”) is determined by the government, commercial payors (insurers), or both. 6 Table of Contents Personal Health Within the Personal Health market, the VA provides our products to qualified veterans for individual use.
In the U.S. and most markets globally where we sell our products, payment for medical services provided by our customers (collectively “providers”) is determined by the government, commercial payors (insurers), or both. 5 Table of Contents Personal Health Within the Personal Health market, the VA provides our products to qualified veterans for individual use.
The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. Medical device manufacturers are subject to periodic scheduled or unannounced inspections by the FDA and other state and federal authorities, to determine compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of suppliers.
The QMSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. Medical device manufacturers are subject to periodic scheduled or unannounced inspections by the FDA and other state and federal authorities, to determine compliance with the QMSR and other regulations, and these inspections may include the manufacturing facilities of suppliers.
Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
Manufacturing processes for medical devices are required to comply with the applicable portions of the QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
Intellectual Property We have established an extensive intellectual property portfolio that includes various U.S. patents and patent applications. The table below provides a summary of U.S. patents by issuing status and ownership status as of December 31, 2024.
Intellectual Property We have established an extensive intellectual property portfolio that includes various U.S. patents and patent applications. The table below provides a summary of U.S. patents by issuing status and ownership status as of December 31, 2025.
In the year ended December 31, 2024, there were no reports of adverse events made to the FDA under the Manufacturer and User Facility Device Experience Database relating to any of our products.
In the year ended December 31, 2025, there were no reports of adverse events made to the FDA under the Manufacturer and User Facility Device Experience Database relating to any of our products.
There are a number of other companies that are developing competitive technology and devices related to our Enterprise Health and Personal Health products. Enterprise Health For our Enterprise Health products, we face competition from products that target lower extremity gait therapy, ambulation, and rehabilitation in IRF, LTACH, skilled nursing facility, and outpatient rehabilitation clinic settings.
There are a number of other companies that are developing competitive technology and devices related to our Enterprise Health and Personal Health products. 8 Table of Contents Enterprise Health For our Enterprise Health products, we face competition from products that target lower extremity gait therapy, ambulation, and rehabilitation in IRF, LTACH, skilled nursing facility, and outpatient rehabilitation clinic settings.
See "Personal Health Market" below for additional information. Within our Enterprise Health market we also sell our EVO product to commercial and industrial companies that are focused on solving ergonomic challenges for their workers. These challenges range from injury prevention, fatigue reduction, and/or improved worker productivity.
See "Personal Health Market" below for additional information. 4 Table of Contents Within our Enterprise Health market we also sell our EVO product to commercial and industrial companies that are focused on solving ergonomic challenges for their workers. These challenges range from injury prevention, fatigue reduction, and/or improved worker productivity.
As part of the acquisition from Parker Hannifin Corporation of certain assets related to Parker Hannifin Corporation's Human Motion Control (“HMC”) business, and software applications, support services and cloud environments related to such business in December 2022 (the "HMC Acquisition"), we are acquired and assumed certain intangible assets including license agreements with Vanderbilt University.
As part of the acquisition from Parker Hannifin Corporation ("Parker") of certain assets related to Parker's Human Motion Control (“HMC”) business, software applications, support services and cloud environments related to such business in December 2022 (the "HMC Acquisition"), we acquired and assumed certain intangible assets including license agreements with Vanderbilt.
Clinical Evidence Numerous research studies have been conducted focusing on safety and feasibility of exoskeletons and robotics in rehabilitation. As of February 28, 2025, a search for “robotic exoskeleton” on PubMed, a search engine for biomedical literature and life science journal articles, garners approximately 367 unique publications.
Clinical Evidence Numerous research studies have been conducted focusing on safety and feasibility of exoskeletons and robotics in rehabilitation. As of February 20, 2026, a search for “robotic exoskeleton” on PubMed, a search engine for biomedical literature and life science journal articles, garners approximately 409 unique publications.
We believe that sales of our Personal Health products have the potential to be a significant growth driver for us as we work to gain coverage by other insurance providers, expand the products' indications of use beyond SCI and optimize our reimbursement submission processes. See “Part I—Item 1A.
We believe that sales of our Personal Health products have the potential to be a significant growth driver for us as we work to gain coverage by other insurance providers, expand the products' indications of use beyond SCI and optimize our reimbursement submission processes. The U.S.
Third-party payers are typically not involved in the purchase of our EVO product. Enterprise Health Our customers, including inpatient and outpatient rehabilitation facilities, typically bill third-party payors for the costs and fees associated with the procedures in which our products are used.
These payment mechanisms vary by product line and are described below. Third-party payers are typically not involved in the purchase of our EVO product. Enterprise Health Our customers, including inpatient and outpatient rehabilitation facilities, typically bill third-party payors for the costs and fees associated with the procedures in which our products are used.
Issuing Status Issued Pending License Status Patents Applications Non-Exclusively licensed to the Company 3 — Exclusively licensed to the Company 14 1 Co-owned with a third party, exclusively licensed to the Company 4 — Co-owned with a third party 3 — Sole ownership by the Company 53 4 Total 77 5 Pending applications mean a complete application has been filed with the applicable patent authority and additional action is pending.
Issuing Status Issued Pending License Status Patents Applications Exclusively licensed to the Company 12 — Co-owned with a third party, exclusively licensed to the Company 4 — Co-owned with a third party 3 — Sole ownership by the Company 55 3 Total 74 3 Pending applications mean a complete application has been filed with the applicable patent authority and additional action is pending.
We continue to explore business development initiatives to fuel growth and long-term value and are committed to helping people improve mobility and live healthier lives through combining the use of technology with advanced rehabilitative programs.
In addition to our current products and services, we continue to explore business development initiatives to fuel growth and long-term value in our existing markets, and are committed to helping people improve mobility and live healthier lives through combining the use of technology with advanced rehabilitative programs.
Markets and Distribution Enterprise Health Market Our sales priority for Enterprise Health customers involves the education of clinical and executive stakeholders on the economic and clinical value of our robotic exoskeleton portfolio, including the EksoNR and the Ekso Indego Therapy devices.
Segment Disclosures in our notes to the consolidated financial statements. Markets and Distribution Enterprise Health Market Our sales priority for Enterprise Health customers involves the education of clinical and executive stakeholders on the economic and clinical value of our robotic exoskeleton portfolio, including the EksoNR and the Ekso Indego Therapy devices.
Many of these applications have also been filed internationally as appropriate for their respective subject matter. As of December 31, 2024, 277 applications have issued or have been allowed as patents internationally. Our patent portfolio contains 282 cases that have issued or are in prosecution in 22 countries outside the U.S.
Many of these applications have also been filed internationally as appropriate for their respective subject matter. As of December 31, 2025, 236 applications have been issued or have been allowed as patents internationally. Our solely owned patent portfolio contains 233 cases that have issued or are in prosecution in 23 countries outside the U.S.
EVO products are manufactured by a third-party contract manufacturing partner in Malaysia. 8 Table of Contents As part of our manufacturing process, we purchase both custom and off-the-shelf components from a large number of suppliers and subject them to stringent quality specifications and processes. Whenever possible, we seek to secure dual source suppliers for our components.
As part of our manufacturing process, we purchase both custom and off-the-shelf components from a large number of suppliers and subject them to stringent quality specifications and processes. Whenever possible, we seek to secure dual source suppliers for our components.
EksoCare includes a comprehensive warranty, loaner devices to minimize downtime, clinical support, access to our EksoPulse online portal to view statistics and device information gathered and transmitted during EksoNR walking sessions, and other benefits to customers. Device servicing and repair For devices not covered under warranty, we offer fee-for-service repairs and maintenance.
Services EksoCare For most of our products, we offer extended warranty and premium service options under our EksoCare program. EksoCare includes a comprehensive warranty, loaner devices to minimize downtime, clinical support, access to our EksoPulse online portal to view statistics and device information gathered and transmitted during EksoNR walking sessions, and other benefits to customers.
Our application for EU MDR with our notified body is currently pending technical review. 7 Table of Contents Regulatory requirements in the United Kingdom (“UK”) are also changing as a result of Brexit (the UK’s withdrawal from the EU), and regulatory requirements in Switzerland are changing as a result of the country’s withdrawal from its Mutual Recognition Agreement with the EU Commission.
Regulatory requirements in the United Kingdom (“UK”) are also changing as a result of Brexit (the UK’s withdrawal from the EU), and regulatory requirements in Switzerland are changing as a result of the country’s withdrawal from its Mutual Recognition Agreement with the EU Commission.
By the end of the first quarter of 2025, we expect to complete the transfer of partial production of our Ekso Indego Personal and Ekso Indego Therapy products to a third-party contract manufacturing partner located in the USA.
In the second quarter of 2025, we completed the transfer of partial production of our Ekso Indego Personal product to a third-party contract manufacturing partner located in the USA. EVO products are manufactured by a third-party contract manufacturing partner in Malaysia.
Corporate Information Our principal executive office is located at 101 Glacier Point, Suite A, San Rafael, California, 94901 and our telephone number is (510) 984-1761.
We believe our employees are fairly compensated. Our compensation program is designed to attract and retain talent. Corporate Information Our principal executive office is located at 101 Glacier Point, Suite A, San Rafael, California, 94901 and our telephone number is (510) 984-1761.
Our revenues are primarily generated through the sale and subscription of our EksoNR, Ekso Indego Therapy, and Ekso Indego Personal devices, along with the sale of support and maintenance contracts. For additional information, please refer to Note 16 . Segment Disclosures in our notes to the consolidated financial statements.
Segments We operate as one operating and reportable segment with two markets: Enterprise Health and Personal Health. Our revenues are primarily generated through the sale and subscription of our EksoNR, Ekso Indego Therapy, and Ekso Indego Personal devices, along with the sale of support and maintenance contracts. For additional information, please refer to Note 16.
DMEs are responsible for the Medicare reimbursement process, which requires a physician’s prescription and evidence of medical necessity to be submitted to and approved by Medicare before reimbursement is provided.
DMEs are responsible for the Medicare reimbursement process, which requires a physician’s prescription and evidence of medical necessity to be submitted to and approved by Medicare before reimbursement is provided. Throughout 2025, we continued to make progress on developing the go-to-market program for our Personal Health products.
In the Europe, the Middle East, and Africa region (“EMEA”), we sell through a combination of direct and indirect channels, with German speaking countries handled direct, and other countries and regions served through distributors. In the Asia Pacific region (“APAC”) we also use a combination of direct and indirect channels depending on the country.
In the Americas geographic region, sales are primarily made through our direct salesforce. In the Europe, the Middle East, and Africa region (“EMEA”), we sell through a combination of direct and indirect channels, with German speaking countries handled direct, and other countries and regions served through distributors.
We currently run one shift per day at both of our facilities and believe we have the capacity to eventually run additional shifts should we deem it appropriate.
Through the remainder of 2025, we completed the transfer of all final assembly of such devices at our facility in San Rafael, California. We currently run one shift per day at both of our facilities and believe we have the capacity to eventually run additional shifts should we deem it appropriate.
Changes in healthcare policy, including changes in the implementation or the repeal of the Patient Protection and Affordable Care Act (the “ACA”) in the United States, could increase our costs, decrease our revenue and impact sales of and reimbursement and coverage for our current and future products.
The cost containment measures that payers and providers are instituting and the effect of any healthcare reform initiative implemented in the future could significantly reduce our revenues from the sale of our products. 7 Table of Contents Changes in healthcare policy, including changes in the implementation or the repeal of the Patient Protection and Affordable Care Act (the “ACA”) in the United States, could increase our costs, decrease our revenue and impact sales of and reimbursement and coverage for our current and future products.
The earliest priority date of the portfolio reaches back to 2003, and new applications may continue to be filed from time-to-time. 9 Table of Contents Licensors include the Regents of the University of California, or UC Berkeley, and Vanderbilt University.
The earliest priority date of the portfolio reaches back to 2003, and new applications may continue to be filed from time-to-time. Licensors include the Regents of the University of California, or UC Berkeley, and Vanderbilt University ("Vanderbilt"). The license with UC Berkeley consists of two agreements and one amendment to the agreement covering ten patent cases exclusively licensed to us.
In tandem, we continue to leverage our EksoNR and Ekso Indego Therapy customer base to educate and mentor strategic target centers that specialize in stroke, TBI, MS, and SCI rehabilitation and treatment in specific geographies.
In tandem, we continue to leverage our EksoNR and Ekso Indego Therapy customer base to educate and mentor strategic target centers that specialize in stroke, TBI, MS, and SCI rehabilitation and treatment in specific geographies. Starting in late 2025, we began marketing the MediTouch BalanceTutor to our Enterprise Health customers as a complimentary offering for treadmill-based gait training.
Personal Health Market Within the Personal Health market, we serve individual users with the Ekso Indego Personal, which is intended to provide overground ambulation in community and home settings. The primary use case for Ekso Indego Personal is for users with SCI.
In the Asia Pacific region (“APAC”) we also use a combination of direct and indirect channels depending on the country. Personal Health Market Within the Personal Health market, we serve individual users with the Ekso Indego Personal, which is intended to provide overground ambulation in community and home settings.
Third-Party Coverage and Payment In our Enterprise Health and Personal Health markets, third-party payers are often involved either to pay for procedures in which our products are used or to purchase our devices on behalf of an individual. These payment mechanisms vary by product line and are described below.
Subject to clinical and patient feedback from clinical trials, we expect to begin the general commercialization process for Nomad in late 2026. Third-Party Coverage and Payment In our Enterprise Health and Personal Health markets, third-party payers are often involved either to pay for procedures in which our products are used or to purchase our devices on behalf of an individual.
In the short-term, with the recent approval of CMS lump sum reimbursement for Ekso Indego Personal, there is a possibility that we will see increased demand for this device as we are able to more economically serve the larger U.S. patient population suffering from SCI.
On April 11, 2024, CMS approved a payment level of approximately $91,000 for Medicare reimbursement of the Ekso Indego Personal, which took effect on April 1, 2024. CMS reimbursement creates the possibility that we will see increased demand for this device as we are able to more economically serve the larger U.S. patient population suffering from SCI.
Subscription arrangements typically last for 12 months to 36 months. 5 Table of Contents We distribute our products to the Enterprise Health market in all of our geographic regions through a combination of direct and indirect (distributor) channels. In the Americas geographic region, sales are primarily made through our direct salesforce.
In certain circumstances, we elect to maintain ownership of a product sold as a subscription in lieu of selling it to a third-party financing partner. Subscription arrangements typically last for 12 months to 36 months. We distribute our products to the Enterprise Health market in all of our geographic regions through a combination of direct and indirect (distributor) channels.
As a result, UC Berkeley may license its rights in these patents to a third party. With respect to two of these co-owned patent applications, UC Berkeley has licensed their rights in the U.S. to an unrelated third party.
With respect to two of these co-owned patent applications, UC Berkeley has licensed their rights in the U.S. to an unrelated third party. 9 Table of Contents Pursuant to the UC Berkeley License Agreements, we are required to pay a 1% royalty on sales, including sales generated by sublicenses.
With 25 VA SCI centers, the VA has the largest single network of SCI care in the United States. Veterans who receive our products through the VA complete a screening, in-clinic training and a home trial prior to the VA purchasing a device for each eligible Veteran.
Veterans who receive our products through the VA complete a screening, in-clinic training and a home trial prior to the VA purchasing a device for each eligible Veteran. We provide products to the VA through distributors classified as Service-Disabled Veteran-Owned Small Businesses ("SDVOSB").
Some of these outcomes include faster gait speed, increased gait endurance, improvements in cardiometabolic responses, enhanced quality of life, more typical gait kinematics, increased function, and therapy session duration.
Some of these outcomes include faster gait speed, increased gait endurance, improvements in cardiometabolic responses, enhanced quality of life, more typical gait kinematics, increased function, and therapy session duration. Human Capital Resources and Management As of February 20, 2026, we had 50 full-time employees and five part-time employees, including 47 employees in the United States and eight employees in Europe.
Beginning July 1, 2027, minimum annual royalties will be set at $75,000 (for the 12 month period through June 30, 2028) and $100,000 for each 12 month period thereafter. In addition to the aforementioned agreements, various other subsidized research and development agreements have been entered into with Vanderbilt covering specific work product as articulated in those documents.
In addition to the aforementioned agreements, various other subsidized research and development agreements have been entered into with Vanderbilt covering specific work product as articulated in those documents.
Specifically, according to the National Spinal Cord Injury Statistical Center, an estimated 305,000 individuals are currently living with SCI and another 18,000 suffer from new SCI injuries each year. For this user population, confinement to a wheelchair can cause severe physical and psychological deterioration.
Specifically, as of December 31, 2025, according to the National Spinal Cord Injury Statistical Center ("NSCISC") in their 2025 SCI Data Sheet, approximately, an estimated 309,000 individuals are currently living with SCI and another 18,000 suffer from new SCI injuries each year.
Customers may also rent loaner devices on a short-term basis if the time required to service their device will interrupt their ongoing business. Training We offer a range of training programs that are aimed at demonstrating to customers how to use our products safely and effectively.
Device servicing and repair For devices not covered under warranty, we offer fee-for-service repairs and maintenance. Customers may also rent loaner devices on a short-term basis if the time required to service their device will interrupt their ongoing business.
Training is delivered as an online service, in-person, or as a combination of the two. Training is often included with the purchase of a new device, but training can also be purchased separately. 4 Table of Contents Segments We operate as one operating and reportable segment with two markets: Enterprise Health and Personal Health.
Training We offer a range of training programs that are aimed at demonstrating to customers how to use our products safely and effectively. Training is delivered as an online service, in-person, or as a combination of the two. Training is often included with the purchase of a new device, but training can also be purchased separately.
We believe there is additional potential in EMEA and APAC for future sales to private individuals and through government-funded healthcare systems. The sales cycle for the Ekso Indego Personal device averages eight to 12 months from the first interaction we have with the potential Ekso Indego Personal device user.
Outside of the VA and Medicare, we sell Ekso Indego Personal to individuals who pay out-of-pocket or have obtained coverage through a worker’s compensation claim. We believe there is additional potential in EMEA and APAC for future sales to private individuals and through government-funded healthcare systems.
According to the National Spinal Cord Injury Statistical Center, approximately 57% of individuals with SCI are enrolled in Medicare or Medicaid within five years post-injury. With Medicare reimbursement recently approved, we have begun selling products to individuals in this market through Durable Medical Equipment suppliers ("DMEs"). DMEs typically resell products from DME manufacturers to individual users.
With Medicare reimbursement approved, we began selling products to individuals in this market through Durable Medical Equipment suppliers ("DMEs"). DMEs typically resell products from DME manufacturers, like us, to individual users.
Supply of Components Our EksoNR device is currently manufactured at our facility in San Rafael, California.
Supply of Components Our EksoNR device is currently manufactured at our facility in San Rafael, California. In the first two quarters of 2025, our Ekso Indego Therapy, Ekso Indego Personal and Ekso Nomad devices were primarily manufactured at our facility in Brecksville, Ohio.
The FDA has issued a final rule replacing the QSR with a new regulation referred to as the Quality Management System Regulation (“QMSR”), though this final rule is not scheduled to go into effect until February 2026. Most Class I products are exempt from the premarket notification requirements.
The FDA's new regulation referred to as the Quality Management System Regulation (“QMSR”) went into effect in February 2026, which incorporates by reference the quality management system requirements of ISO 13485:2016. Most Class I products are exempt from the premarket notification requirements.
This final rule does not go into effect until February 2026, such that presently manufacturers must comply with the QSR while they prepare to ensure compliance with the QMSR once it becomes effective. Failure to maintain compliance with the QSR requirements could result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products.
Failure to maintain compliance with the QMSR requirements could result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products.
We currently have no regulatory restrictions on importation of our Ekso Indego Therapy and Ekso Indego Personal products into Europe. As of December 31, 2024, our EksoNR products continue to bear a CE mark and certificates which were obtained under EU MDD regulations.
We expect an updated CE certificate to be issued in the first half of 2026. As of December 31, 2025, our EksoNR products continue to bear a CE mark and certificates which were obtained under EU MDD regulations.
Risk Factors,” specifically the risk titled “Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products” for more information. Outside of the VA and Medicare, we sell Ekso Indego Personal to individuals who pay out-of-pocket or have obtained coverage through a worker’s compensation claim.
Risk Factors,” specifically the risk titled “Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products” for more information. Another key part of our growth strategy is seeking insurance coverage beyond CMS and seeking additional indications of use for our products.
Nomad is currently for sale in limited volumes in the Personal Health market for use in a non-Company-sponsored single clinical study. Subject to clinical and patient feedback, we expect Nomad to be more broadly available starting in 2026.
The sales cycle for the Ekso Indego Personal device averages six to 12 months from the first interaction we have with the potential Ekso Indego Personal device user. Nomad is currently for sale in limited volumes in the Personal Health market for use in a non-Company-sponsored single clinical study.
The license with UC Berkeley consists of two agreements and one amendment to the agreement covering ten patent cases exclusively licensed to us, nine of which have issued and one of which remains in prosecution. Inventions covered by a further three patent applications are co-owned by us and UC Berkeley, with no license agreement between us and UC Berkeley.
Inventions covered by a further three patent applications are co-owned by us and UC Berkeley, with no license agreement between us and UC Berkeley. As a result, UC Berkeley may license its rights in these patents to a third-party.
The Ekso Indego Personal device is regulated by the FDA and the patient must have an injury level of T3 to L5 and have a support person when utilizing the device. The U.S. Department of Veterans Affairs (the "VA") has an active program to provide products like Ekso Indego Personal to U.S. veterans with SCI.
According to the NSCISC in their SCI Model Systems 2024 Annual Statistical Report, approximately 57% of individuals with SCI are enrolled in Medicare or Medicaid within five years post-injury. The Ekso Indego Personal device is regulated by the FDA and the patient must have an injury level of T3 to L5 and have a support person when utilizing the device.
Ekso Nomad Ekso Nomad ("Nomad") is a power Knee Ankle Foot Orthosis, or KAFO. We expect that Nomad will continue to be available in limited volumes for non-Company-sponsored clinical studies in 2025. Ekso EVO Ekso EVO ("EVO") is a wearable upper body exoskeleton that elevates and supports a worker's arms to assist them with tasks from chest height to overhead.
Ekso EVO Ekso EVO ("EVO") is a wearable upper body exoskeleton that elevates and supports a worker's arms to assist them with tasks from chest height to overhead. EVO is intended to reduce worker fatigue and reduce on-site injuries while boosting productivity.
As of December 31, 2024, all of those conditions have been met.
As of December 31, 2025, all of those conditions have been met. Our application for EU MDR with our notified body is currently pending technical review.
We conduct annual training to prevent harassment and discrimination and monitor employee conduct year-round, including by providing employees with access to an anonymous whistleblower hotline to report any violations. The basis for recruitment, hiring, development, training, compensation and advancement at the Company includes qualifications, performance, skills, and experience.
None of our employees are covered by a collective bargaining agreement and we consider our relationship with our employees to be good. We endeavor to maintain a workplace that is free from discrimination or harassment. The basis for recruitment, hiring, development, training, compensation and advancement at the Company includes qualifications, performance, skills, and experience.
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EVO is intended to reduce worker fatigue and reduce on-site injuries while boosting productivity. EVO is intended primarily for use with able-bodied individuals and has not been registered with or evaluated by the FDA. Services EksoCare For most of our products, we offer extended warranty and premium service options under our EksoCare program.
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The majority of our sales are generated from our Enterprise Health products, which includes the sales of products and services related to neurorehabilitation in clinical settings. We also provide products and services from our Personal Health market to individual users.
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In certain circumstances, we elect to maintain ownership of a product sold as a subscription in lieu of selling it to a third-party financing partner.
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Ekso Nomad Ekso Nomad ("Nomad") is a power Knee Ankle Foot Orthosis, or KAFO. Subject to clinical and patient feedback from clinical trials, we expect to begin the general commercialization process for Nomad in late 2026.
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We provide products to the VA through distributors classified as Service-Disabled Veteran-Owned Small Businesses (SDVOSB). In April 2024, CMS approved a payment level of approximately $91,000 for Medicare reimbursement of the Ekso Indego Personal, which took effect on April 1, 2024.
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EVO is intended primarily for use with able-bodied individuals and has not been registered with or evaluated by the FDA. MediTouch BalanceTutor ™ The MediTouch BalanceTutor rehabilitation system is a multidirectional perturbation treadmill outfitted with multiple force and movement sensors that allows patients impacted by impaired balance to react to unanticipated disturbances while standing or walking.
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This regulatory change has the potential to put this technology within reach of thousands of Medicare enrollees currently living with a SCI.
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We believe that the BalanceTutor offers treatment options that are complementary to our rehabilitation exoskeletons and that the two can be used in combination for many patients. MediTouch BalanceTutor is developed and manufactured by MediTouch Inc. ("MediTouch") and will be exclusively distributed by us in the United States. We expect to begin the distribution of the BalanceTutor in early 2026.
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The Company is developing a scalable go-to-market strategy through establishing and building upon relationships with national and regional DMEs and engaging with recognized third parties who specialize in market access process refinement and claims support.
Added
The primary use case for Ekso Indego Personal is for users with SCI. For this user population, confinement to a wheelchair can cause severe physical and psychological deterioration.
Removed
Additionally, we work closely with our extensive network of neurorehabilitation partners across the country, focusing on education efforts on appropriate patient selection and process for patients prescribed an Ekso Indego Personal for the home and community setting. Another key part of our growth strategy is seeking insurance coverage beyond CMS and seeking additional indications of use for our products.
Added
Users of this technology are individuals living with an SCI who will either self-pay, or work through the currently established reimbursement programs involving worker’s compensation, VA, or Medicare. As in previous years, VA and worker’s compensation claims are well defined but traditionally are lower volumes.
Removed
The FDA issued a final rule in February 2024 replacing the QSR with the QMSR, which now incorporates by reference the quality management system requirements of ISO 13485:2016. The FDA has stated that the standards contained in ISO 13485:216 are substantially similar to those set forth in the existing QSR.
Added
For Medicare, we have continued to develop our channel partner program consisting of O&P and DME partners, and through the year ended December 31, 2025, our partners saw an increased number of Medicare claims submitted and reimbursed.
Removed
Other U.S. regulatory matters Medical device companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business, including the FDA, CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments.
Added
To date, most reimbursements have involved an appeals process, but for newer claims, reimbursements are occurring much earlier than was the case for initial claims submitted in the previous year.
Removed
The cost containment measures that payers and providers are instituting and the effect of any healthcare reform initiative implemented in the future could significantly reduce our revenues from the sale of our products.
Added
As this category of product is relatively new within CMS, we have taken a measured approach with respect to the volume and timing of CMS reimbursement submissions, focusing on continued refinement and improvement of our candidate screening and submission documentation. The improvements in this process have resulted in an increase in our partners' CMS reimbursement submissions.
Removed
Our Ekso Indego Therapy, Ekso Indego Personal and Ekso Nomad devices are currently manufactured at our facility in Brecksville, Ohio, though by the end of the second quarter of 2025, we expect to complete the transfer of all final assembly of such devices at our facility in San Rafael, California as well.
Added
In support of this effort, to date we have signed agreements with National Seating & Mobility for selling exclusivity into the Complex Rehabilitation Technology segment, with Bionic Prosthetics & Orthotics Group, a respected O&P provider serving 14 states, and recently with Ottobock Patient Care, a national provider of O&P services, and we continue to develop partnerships and pilots with other regional and national O&P suppliers that we believe will bear fruit in 2026 and beyond.
Removed
The third patent application will need to be fully prosecuted before it can be determined which claims are exclusive to us (through a previous license) and which claims UC Berkeley may license to other entities. Pursuant to the UC Berkeley License Agreements, we are required to pay a 1% royalty on sales, including sales generated by sublicenses.
Added
In addition to this work, we have ramped up our direct marketing efforts and continue to develop and grow a sales backlog for the Ekso Indego Personal device. As of December 31, 2025, we had over 50 people who we believe qualify for potential reimbursement.
Removed
We will pay Vanderbilt $100,000 as the second of two payments due April 30, 2023. In addition, royalties were set to be calculated at 3.75% of net sales of the licensed product.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

107 edited+83 added−19 removed248 unchanged
Biggest changeFor example, in 2018 and 2019 the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical FDA, SEC, and other government employees and stop critical activities. [Also, if the U.S. government cannot reach a new spending agreement by March 14, 2025, the U.S. government will shut down again.] If a prolonged government shutdown or budget sequestration occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Biggest changeIf a prolonged government shutdown or budget sequestration occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products.
In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products.
Failure to comply with regulatory requirements such as QSR may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
Failure to comply with regulatory requirements such as QMSR may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
If the FDA disagrees with our determinations for any future changes, or prior changes to previously marketed products, as the case may be, we may be required to cease marketing or to recall the modified products until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties. 20 Table of Contents We may introduce new products with enhanced features and extended capabilities from time to time.
If the FDA disagrees with our determinations for any future changes, or prior changes to previously marketed products, as the case may be, we may be required to cease marketing or to recall the modified products until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties. 19 Table of Contents We may introduce new products with enhanced features and extended capabilities from time to time.
This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2030 unless additional Congressional action is taken. In June 2024, the U.S.
This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2032 unless additional Congressional action is taken. In June 2024, the U.S.
If we cannot obtain coverage and adequate reimbursement from private and governmental payors such as Medicare and Medicaid for our current products or new products that we may develop in the future, demand for such products may decline or may not grow as we expect, which could limit our ability to generate revenue and have a material adverse effect on our financial condition, results of operations and cash flow.
If we cannot obtain coverage and adequate reimbursement from governmental and private sector payors, such as Medicare, Medicaid, Medicare Advantage, or commercial payors, for our current products or new products that we may develop in the future, demand for such products may decline or may not grow as we expect, which could limit our ability to generate revenue and have a material adverse effect on our financial condition, results of operations and cash flow.
Our manufacturing and design processes and those of our third-party component suppliers are required to comply with the FDA’s QSR, which covers procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of our products in the United States.
Our manufacturing and design processes and those of our third-party component suppliers are required to comply with the FDA’s QMSR, which covers procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of our products in the United States.
In the EU, we are required to comply with the EU MDR and obtain CE Certificates of Conformity in order to affix the CE Mark and market medical devices. As of December 31, 2024, our EksoNR product had yet been approved under the EU MDR.
In the EU, we are required to comply with the EU MDR and obtain CE Certificates of Conformity in order to affix the CE Mark and market medical devices. As of December 31, 2025, our EksoNR product had yet been approved under the EU MDR.
The market price of our common stock may continue to fluctuate significantly in response to numerous factors, some of which are beyond our control, such as our ability to grow our revenue and customer base; the announcement of new products or product enhancements by us or our competitors; developments concerning regulatory oversight and approvals; variations in our and our competitors’ results of operations; changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts; successes or challenges in our collaborative arrangements or alternative funding sources; developments in the rehabilitation and industrial robotics markets; the results of product liability or intellectual property lawsuits; future issuances of common stock or other securities; the addition or departure of key personnel; announcements by us or our competitors of acquisitions or divestments, investments or strategic alliances; and general market conditions and other factors, including factors unrelated to our operating performance or otherwise disclosed herein. 28 Table of Contents Trading of our common stock is limited, which may affect our stock price.
The market price of our common stock may continue to fluctuate significantly in response to numerous factors, some of which are beyond our control, such as our ability to grow our revenue and customer base; the announcement of new products or product enhancements by us or our competitors; developments concerning regulatory oversight and approvals; variations in our and our competitors’ results of operations; changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts; successes or challenges in our collaborative arrangements or alternative funding sources; developments in the rehabilitation and industrial robotics markets; the results of product liability or intellectual property lawsuits; future issuances of common stock or other securities; the addition or departure of key personnel; announcements by us or our competitors of acquisitions or divestments, investments or strategic alliances; and general market conditions and other factors, including factors unrelated to our operating performance or otherwise disclosed herein.
Furthermore, a substantial majority of the outstanding shares of our common stock are freely tradable without restriction or further registration under the Securities Act so long as we are generally current on our reporting obligations under the Securities Exchange Act of 1934 (the “Exchange Act”), unless these shares are owned or purchased by “affiliates” as that term is defined in Rule 144 under the Securities Act.
Furthermore, a substantial majority of the outstanding shares of our common stock are freely tradable without restriction or further registration under the Securities Act so long as we are generally current on our reporting obligations under the Exchange Act, unless these shares are owned or purchased by “affiliates” as that term is defined in Rule 144 under the Securities Act.
Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets, such as through the declaration of effectiveness of registration statements and obtain necessary capital in order to properly capitalize and continue our operations. Damage to our brand and reputation could have an adverse effect on our business and financial performance.
Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets, such as through the declaration of effectiveness of registration statements and obtain necessary capital in order to properly capitalize and continue our operations. 14 Table of Contents Damage to our brand and reputation could have an adverse effect on our business and financial performance.
Further, changes in the leadership of the FDA and other federal agencies under the new Trump administration can result in changes in the agencies’ operations and policies, which may impact our product development plans. Government payers, such as CMS as well as insurers, have increased their efforts to control the cost, utilization and delivery of healthcare services.
Further, changes in the leadership of the FDA and other federal agencies under the current administration can result in changes in the agencies’ operations and policies, which may impact our product development plans. Government payers, such as CMS as well as insurers, have increased their efforts to control the cost, utilization and delivery of healthcare services.
Any such event may adversely affect our business, operating results, and financial condition. We are subject to cybersecurity risks to our systems, infrastructure, and technology, and data processed by us or third-party vendors. Our business and operations involve the collection, storage, transmission, and other processing of personal data and certain other sensitive and proprietary data.
Any such event may adversely affect our business, operating results, and financial condition. 23 Table of Contents We are subject to cybersecurity risks to our systems, infrastructure, and technology, and data processed by us or third-party vendors. Our business and operations involve the collection, storage, transmission, and other processing of personal data and certain other sensitive and proprietary data.
Business and Operational Risks 11 Table of Contents If we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected. The sale of our Personal Health products primarily depends on reimbursements provided by third party payors. We distribute these products to end users through the VA hospitals.
Business and Operational Risks If we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected. The sale of our Personal Health products primarily depends on reimbursements provided by third party payors. We distribute these products to end users through the VA hospitals.
To the extent that the adoption of our products by our customers is dependent in the future on their ability to obtain adequate reimbursement for the products or treatments provided using our product from third-party payers, including government payors such as Medicare and Medicaid, managed care organizations and commercial payors, the coverage policies and reimbursement levels of these third-party payers may impact the decisions of healthcare providers, facilities, or end users to purchase our products or the prices they would be willing to pay for those products.
To the extent that the adoption of our products by our customers is dependent in the future on their ability to obtain adequate reimbursement for the products or treatments provided using our product from third-party payers, including government payors such as Veteran's Administration ("VA"), Medicare, and Medicaid, as well as private payors, such as managed care organizations and commercial payors, the coverage policies and reimbursement levels of these third-party payers may impact the decisions of healthcare providers, facilities, or end users to purchase our products or the prices they would be willing to pay for those products.
We may also make equity grants under one or more employee equity incentive plan or our employee stock purchase plan or issue common stock as matching contributions to our employees under our 401(k) Plan.
We will also make equity grants under one or more employee equity incentive plan or our employee stock purchase plan or issue common stock as matching contributions to our employees under our 401(k) Plan.
Significant delays in receiving clearance or approval, or the failure to receive clearance or approval, for any new products would have an adverse effect on our ability to expand our business. Healthcare changes in the United States and other countries, including recently enacted legislation reforming the U.S. healthcare system, could have a negative impact on our future operating results.
Significant delays in receiving clearance or approval, or the failure to receive clearance or approval, for any new products would have an adverse effect on our ability to expand our business. 21 Table of Contents Healthcare changes in the United States and other countries, including recently enacted legislation reforming the U.S. healthcare system, could have a negative impact on our future operating results.
To the extent we decide to conduct a financing in the future, the form of such financing may include one or more of the following: (i) underwritten offerings of shares of our common stock, (ii) sales of shares of our common stock under an "at the market" offering program, (iii) issuing shares of our common stock upon the exercise of warrants at reduced exercise prices, (iv) incurring indebtedness with one or more financial institutions, (v) sale of product line or technology, and (vi) the factoring of trade receivables.
To the extent we decide to conduct a financing in the future, the form of such financing may include one or more of the following: (i) registered offerings of shares of our common stock, (ii) sales of shares of our common stock under an "at the market offering" program, (iii) issuing shares of our common stock upon the exercise of warrants at reduced exercise prices, (iv) incurring indebtedness with one or more financial institutions, (v) sale of product line or technology, (vi) the factoring of trade receivables, and (vii) one or more strategic transactions.
There are increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs which may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our products.
There are increasing efforts by governmental and private sector payors in the United States and abroad to cap or reduce healthcare costs which may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our products.
Any factors that negatively impact sales of these products would adversely affect our business, financial condition and operating results. 14 Table of Contents We rely on independent distributors for the sale and marketing of our products in certain geographies.
Any factors that negatively impact sales of these products would adversely affect our business, financial condition and operating results. We rely on independent distributors for the sale and marketing of our products in certain geographies.
Our international activities are subject to a number of risks inherent in selling and operating abroad, including failure of local laws to provide the same degree of protection against infringement of our intellectual property rights; protectionist laws and business practices that favor local competitors, which could slow our growth in international markets; the expense of establishing facilities and operations in new foreign markets; building an organization capable of supporting geographically dispersed operations; challenges caused by distance, language and cultural differences; challenges caused by differences in legal regulations, markets, and customer preferences, which may limit our ability to adapt our products or succeed in other regions; multiple, conflicting, and changing laws and regulations, including complications due to unexpected changes in regulatory requirements, foreign laws, tax schemes, international import and export legislation, trading and investment policies, exchange controls and tariff and other trade barriers; foreign tax consequences; fluctuations in currency exchange rates and foreign currency translation adjustments; foreign exchange controls that might prevent us from repatriating income earned outside the United States; imposition of public sector controls; differing payer reimbursement regimes, governmental payers or patient self-pay systems and price controls; political, economic and social instability; and restrictions on the export or import of technology.
Our international activities are subject to a number of risks inherent in selling and operating abroad, including failure of local laws to provide the same degree of protection against infringement of our intellectual property rights; protectionist laws and business practices that favor local competitors, which could slow our growth in international markets; the expense of establishing facilities and operations in new foreign markets; building an organization capable of supporting geographically dispersed operations; challenges caused by distance, language and cultural differences; challenges caused by differences in legal regulations, markets, and customer preferences, which may limit our ability to adapt our products or succeed in other regions; multiple, conflicting, and changing laws and regulations, including complications due to unexpected changes in regulatory requirements, foreign laws, tax schemes, international import and export legislation, trading and investment policies, exchange controls and tariff and other trade barriers; foreign tax consequences; fluctuations in currency exchange rates and foreign currency translation adjustments; foreign exchange controls that might prevent us from repatriating income earned outside the United States; imposition of public sector controls; differing payer reimbursement regimes, governmental payers or patient self-pay systems and price controls; political, economic and social instability; and restrictions on the export or import of technology. 13 Table of Contents In addition, policy changes that result in increased international sales may not continue or may increase cyclicality of our sales cycles.
In that event, our reputation could be damaged and adoption of the products would be impaired. 21 Table of Contents We may be subject to adverse medical device reporting obligations, voluntary corrective actions or agency enforcement actions.
In that event, our reputation could be damaged and adoption of the products would be impaired. We may be subject to adverse medical device reporting obligations, voluntary corrective actions or agency enforcement actions.
If we are slow or unable to adapt to any such changes, our business, operating results and financial condition could be adversely affected. Failure to comply with HIPAA or the HITECH Act and implementing regulations could result in significant penalties.
If we are slow or unable to adapt to any such changes, our business, operating results and financial condition could be adversely affected. 22 Table of Contents Failure to comply with HIPAA or the HITECH Act and implementing regulations could result in significant penalties.
If some investors find our securities less attractive as a result, there may be a less active trading market for our common stock and the price of our common stock may be more volatile.
If some investors find our securities less attractive as a result, there may be a less active trading market for our common stock and the price of our common stock may be more volatile. 26 Table of Contents
We have thus far been largely dependent on capital raised through the sale of equity securities in various public and private offerings, and we have incurred losses in each fiscal year since our incorporation in 2005. Our net losses were $11.3 million and $15.2 million for the years ended December 31, 2024 and 2023, respectively.
We have thus far been largely dependent on capital raised through the sale of equity securities in various public and private offerings, and we have incurred losses in each fiscal year since our incorporation in 2005. Our net losses were $11.7 million and $11.3 million for the years ended December 31, 2025 and 2024, respectively.
Medical devices regulated by the FDA are subject to “general controls” which include: registration with the FDA; listing commercially distributed products with the FDA; complying with all applicable requirements under the QSR, or QSMR when its goes into effect in February 2026; filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation; assuring that device labeling complies with device labeling requirements; reporting certain device field removals and corrections to the FDA; and obtaining pre-market notification 510(k) clearance for devices prior to marketing.
Medical devices regulated by the FDA are subject to “general controls” which include: registration with the FDA; listing commercially distributed products with the FDA; complying with all applicable requirements under the QMSR, which went into effect in February 2026; filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation; assuring that device labeling complies with device labeling requirements; reporting certain device field removals and corrections to the FDA; and obtaining pre-market notification 510(k) clearance for devices prior to marketing.
Some devices known as “510(k)-exempt” devices can be marketed without prior marketing-clearance or approval from the FDA. In addition to the “general controls,” some Class II medical devices are also subject to “special controls,” including adherence to a particular guidance document and compliance with the performance standard. Instead of obtaining 510(k) clearance, most Class III devices are subject to PMA.
Some devices known as “510(k)-exempt” devices can be marketed without prior marketing-clearance or approval from the FDA. In addition to the “general controls,” some Class II medical devices are also subject to “special controls,” including adherence to a particular guidance document and compliance with the performance standard.
The FDA enforces the QSR through periodic announced and unannounced inspections of manufacturing facilities.
The FDA enforces the QMSR through periodic announced and unannounced inspections of manufacturing facilities.
Notes Payable, net to the consolidated financial statements, we have material near-term indebtedness due to the BoC Loan Agreement and the $5 million unsecured, subordinated promissory note (the “Promissory Note”) we delivered to Parker Hannifin Corporation in connection with the HMC Acquisition. Servicing our debt requires a significant amount of cash.
Notes Payable, net to the consolidated financial statements, we have material near-term indebtedness due to the B. Riley Promissory Note and the $5 million unsecured, subordinated promissory note (the “Parker Hannifin Promissory Note”) we delivered to Parker Hannifin Corporation in connection with the HMC Acquisition. Servicing our debt requires a significant amount of cash.
Although our Class II medical devices have received regulatory clearance from FDA in the United States for a particular patient population, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, effectiveness and other post-market information, including both federal and state requirements in the United States and requirements of comparable non-U.S. regulatory authorities in any international markets we choose to enter.
Instead of obtaining 510(k) clearance, most Class III devices are subject to PMA. 18 Table of Contents Although our Class II medical devices have received regulatory clearance from FDA in the United States for a particular patient population, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, effectiveness and other post-market information, including both federal and state requirements in the United States and requirements of comparable non-U.S. regulatory authorities in any international markets we choose to enter.
If w e do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from Nasdaq.
If w e do not continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from Nasdaq.
As of December 31, 2024 and 2023, we had an accumulated deficit of $250.5 million and $239.2 million, respectively. The operation of our business and our growth efforts will require significant cash outlays to support our operations.
As of December 31, 2025 and 2024, we had an accumulated deficit of $262.4 million and $250.5 million, respectively. The operation of our business and our growth efforts will require significant cash outlays to support our operations.
The principal factors and uncertainties that make investing in our company risky include, among others: • If we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected. • The markets in which our products are sold are highly competitive and continue to develop, and important assumptions about the potential market for our current and future products may be inaccurate. • If we or our third-party manufacturers are unable to produce our products at a satisfactory quality, in a timely manner, in sufficient quantities or at an acceptable cost, our business could be negatively impacted. • Shortages in the materials used to manufacture our products and supply chain disruptions, including as a result of changes in trade policies, could impact our future results. • Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products. • The acquisition and integration of other companies, businesses, or technologies could result in operating difficulties, dilution, and other harmful consequences. • We may not be able to enhance our product offerings through our research and development efforts. • We have incurred significant losses to date and anticipate continuing to incur losses in the future, and we may not achieve or maintain profitability. • Our loan agreement imposes certain financial and operational restrictions on us, limiting the discretion of our management in operating our business. • Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain. • If we fail to obtain or maintain necessary regulatory clearances or approvals for our medical device products, or if clearances or approvals for future products or modifications to existing products are delayed or not issued, our commercial operations would be harmed. • Modifications to our current and our future products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained. • Our failure to meet strict post-market regulatory requirements with respect to our products could require us to pay fines, incur other costs or even close our facilities. • If we do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from Nasdaq.
We are incurring material costs in connection with our evaluation of strategic transactions, including such proposed business combination, which impacts our liquidity, prospects and our ability to survive as a standalone business, especially if no strategic transaction is consummated. • If we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected. • The markets in which our products are sold are highly competitive and continue to develop, and important assumptions about the potential market for our current and future products may be inaccurate. • If we or our third-party manufacturers are unable to produce our products at a satisfactory quality, in a timely manner, in sufficient quantities or at an acceptable cost, our business could be negatively impacted. • Shortages in the materials used to manufacture our products and supply chain disruptions, including as a result of changes in trade policies, could impact our future results. • Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products. • The acquisition and integration of other companies, businesses, or technologies could result in operating difficulties, dilution, and other harmful consequences. • We may not be able to enhance our product offerings through our research and development efforts. • We have incurred significant losses to date and anticipate continuing to incur losses in the future, and we may not achieve or maintain profitability. • Our promissory note agreement imposes certain financial and operational restrictions on us, limiting the discretion of our management in operating our business. • Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain. • If we fail to obtain or maintain necessary regulatory clearances or approvals for our medical device products, or if clearances or approvals for future products or modifications to existing products are delayed or not issued, our commercial operations would be harmed. • Modifications to our current and our future products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained. • Our failure to meet strict post-market regulatory requirements with respect to our products could require us to pay fines, incur other costs or even close our facilities. • If we do not continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from Nasdaq. • We might not be able to continue as a going concern.
In addition, sales or issuances of a substantial number of shares of our common stock, or other equity-related securities in the public markets, or the perception that such sales or issuances could occur, could depress the market price of our common stock.
In addition, sales or issuances of a substantial number of shares of our common stock, or other equity-related securities in the public markets, or the perception that such sales or issuances could occur, including in connection with a potential strategic transaction, could depress the market price of our common stock.
We currently rely, and in the future will rely, on sales of our EksoNR, Ekso Indego Therapy and Ekso Indego Personal for a large portion of our revenue.
We have historically relied, and in the future may rely, on sales of our EksoNR, Ekso Indego Therapy and Ekso Indego Personal for a significant portion of our revenue. We currently rely, and in the future will rely, on sales of our EksoNR, Ekso Indego Therapy and Ekso Indego Personal for a large portion of our revenue.
We have been subject to extensive pre-payment, and may be subject post-payment, audits by governmental and private payors that have resulted in material delays and may result in refunds of monies received or denials of claims submitted for payment under such third-party payor programs and contracts. Operating within the CMS reimbursement environment was new to us.
We have been subject to extensive pre-payment, and may be subject post-payment, audits by governmental and private payors that have resulted in material delays and may result in refunds of monies received or denials of claims submitted for payment under such third-party payor programs and contracts.
If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations. We may not be able to leverage our cost structure or achieve better margins.
If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.
In addition, all manufacturers bringing medical devices to market in the European Economic Area are legally bound to report any incident that led or might have led to the death or serious deterioration in the state of health of a patient, user or other person, and which the manufacturer’s device is suspected to have caused, to the competent authority in whose jurisdiction the incident occurred.
In each case, the required EU MDR report was filed with the FDA. 20 Table of Contents In addition, all manufacturers bringing medical devices to market in the European Economic Area are legally bound to report any incident that led or might have led to the death or serious deterioration in the state of health of a patient, user or other person, and which the manufacturer’s device is suspected to have caused, to the competent authority in whose jurisdiction the incident occurred.
If we, or our suppliers, fail to comply with the FDA’s QSR or QSMR when it goes into effect in February 2026, or other applicable foreign regulations, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
If we, or our suppliers, fail to comply with the FDA’s QMSR, which went into effect in February 2026, or other applicable foreign regulations, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
Reliance on third parties to manufacture our products presents significant risks to us, including the potential that manufacturing costs may be higher than if we had kept manufacturing in house, as well as risks of reduced control over delivery schedules and product reliability, manufacturing deviations from internal and regulatory specifications, failure of a manufacturer to perform its obligations to us for technical, market or other reasons, misappropriation of our intellectual property, and other risks in meeting schedules and satisfying requirements of our customers. 12 Table of Contents We have not entered into any long-term manufacturing or supply agreements for any of our products, and we may need to enter into additional agreements for the commercial development, manufacturing and sale of our products.
Reliance on third parties to manufacture our products presents significant risks to us, including the potential that manufacturing costs may be higher than if we had kept manufacturing in house, as well as risks of reduced control over delivery schedules and product reliability, manufacturing deviations from internal and regulatory specifications, failure of a manufacturer to perform its obligations to us for technical, market or other reasons, misappropriation of our intellectual property, and other risks in meeting schedules and satisfying requirements of our customers.
Moreover, the issuance of such additional shares of preferred stock to persons friendly to the Board of Directors could make it more difficult to remove incumbent officers and directors from office even if such change were to be favorable to stockholders generally. We have never paid and do not intend to pay cash dividends.
Moreover, the issuance of such additional shares of preferred stock to persons friendly to the Board of Directors could make it more difficult to remove incumbent officers and directors from office even if such change were to be favorable to stockholders generally.
For example, we have been informed of a limited number of events with respect to our EksoNR device that have been determined to be reportable pursuant to the EU MDR regulations. In each case, the required EU MDR report was filed with the FDA.
For example, we have been informed of a limited number of events with respect to our EksoNR device that have been determined to be reportable pursuant to the EU MDR regulations.
We will need to increase revenues substantially beyond levels that we have attained in the past in order to generate sustainable operating profit and sufficient cash flows to continue doing business without raising additional capital from time to time.
We do not believe that our cash is sufficient to fund our operations for the next 12 months. We will need to increase revenues substantially beyond levels that we have attained in the past in order to generate sustainable operating profit and sufficient cash flows to continue doing business without raising additional capital from time to time.
Due to the early-stage customer adoption of our products, our current sales and marketing, research and development, and general and administrative expenses are each a higher percentage of sales than they will need to be for us to reach profitability.
We may not be able to leverage our cost structure or achieve better margins. Due to the early-stage customer adoption of our products, our current sales and marketing, research and development, and general and administrative expenses are each a higher percentage of sales than they will need to be for us to reach profitability.
During the period from our initial listing on Nasdaq on August 9, 2016 through December 31, 2024, the closing price of our common stock fluctuated from a high of $93.15 per share to a low of $0.57 per share (on a split-adjusted basis), and our stock price continues to fluctuate.
During the period from our initial listing on Nasdaq on August 9, 2016 through December 31, 2025, the closing price of our common stock fluctuated from a high of $1,397.25 per share to a low of $2.82 per share (on a split-adjusted basis), and our stock price continues to fluctuate.
As a general matter, compliance with laws, regulations, contractual obligations, and other actual and asserted obligations, such as industry standards, and any rules or guidance from self-regulatory organizations, relating to privacy, data protection, and data security that apply, or are asserted to apply, to our operations can be rigorous and time-intensive, may result in substantial costs, and may necessitate changes to our policies and practices, which may compromise our growth strategy, adversely affect our ability to acquire customers, and otherwise adversely affect our business, results of operations, and financial condition. 25 Table of Contents With laws, regulations, and other obligations relating to privacy, data protection, and information security imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices.
As a general matter, compliance with laws, regulations, contractual obligations, and other actual and asserted obligations, such as industry standards, and any rules or guidance from self-regulatory organizations, relating to privacy, data protection, and data security that apply, or are asserted to apply, to our operations can be rigorous and time-intensive, may result in substantial costs, and may necessitate changes to our policies and practices, which may compromise our growth strategy, adversely affect our ability to acquire customers, and otherwise adversely affect our business, results of operations, and financial condition.
A successful claim or claims of patent or other intellectual property infringement against us could result in our payment of significant monetary damages and/or royalty payments or negatively impact our ability to sell current or future products in the affected category and could have a material adverse effect on our business, cash flows, financial condition or results of operations.
A successful claim or claims of patent or other intellectual property infringement against us could result in our payment of significant monetary damages and/or royalty payments or negatively impact our ability to sell current or future products in the affected category and could have a material adverse effect on our business, cash flows, financial condition or results of operations. 16 Table of Contents Because competition in our industry is intense, competitors may infringe or otherwise violate our issued patents, patents of our licensors or other intellectual property.
Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products.
Coverage policies and reimbursement levels of third-party payers, including Veteran's Administration, Medicare, Medicaid, and commercial payors may impact sales growth of our products.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs, additional integrity oversight and reporting obligations, contractual damages, reputational harm and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. 22 Table of Contents Changes in law or regulation could make it more difficult and costly for us to manufacture, market and distribute our products or obtain or maintain regulatory approval of new or modified products.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs, additional integrity oversight and reporting obligations, contractual damages, reputational harm and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
New health information standards, whether implemented pursuant to HIPAA, the HITECH Act, congressional action or otherwise, could have a significant effect on the manner in which we handle healthcare related data and communicate with payors, and the cost of complying with these standards could be significant. 24 Table of Contents Any liability from a failure to comply with the requirements of HIPAA or the HITECH Act could adversely affect our results of operations and financial condition.
New health information standards, whether implemented pursuant to HIPAA, the HITECH Act, congressional action or otherwise, could have a significant effect on the manner in which we handle healthcare related data and communicate with payors, and the cost of complying with these standards could be significant.
Supreme Court held that Texas and other challengers had no legal standing to challenge the ACA, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the ACA. Thus, the ACA will remain in effect in its current form. It is possible that the ACA will be subject to judicial or Congressional challenges in the future.
In June 2021, the U.S. Supreme Court held that Texas and other challengers had no legal standing to challenge the ACA, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the ACA. Thus, the ACA will remain in effect in its current form.
In addition, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section 404.
In addition, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section 404. Our compliance with Section 404 may require that we incur substantial accounting expense and expend significant management efforts.
We can provide no assurance that we will continue to remain in material compliance with the QSR, or QSMR when it goes into effect in February 2026.
We can provide no assurance that we will continue to remain in material compliance with the QMSR, which went into effect in February 2026, replacing the QSR.
We expect to incur significant costs in an effort to detect and prevent privacy and security breaches and other privacy- and security-related incidents, and may face increased costs and requirements to expend substantial resources in the event of an actual or perceived privacy or security breach or other incident. 26 Table of Contents While we maintain insurance that may cover certain liabilities in connection with certain disruptions, security breaches, and incidents, our insurance policies may not be adequate to compensate us for the potential losses arising from any disruption in or, failure or security breach or incident of or impacting our systems or third-party systems where information important to our operations or product development is stored or processed.
While we maintain insurance that may cover certain liabilities in connection with certain disruptions, security breaches, and incidents, our insurance policies may not be adequate to compensate us for the potential losses arising from any disruption in or, failure or security breach or incident of or impacting our systems or third-party systems where information important to our operations or product development is stored or processed.
On December 12, 2024, we received a written notice (the “Notice”) from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last 31 consecutive business days, the minimum bid price of our common stock had been below the $1.00 per share minimum requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
On December 12, 2024, we received a written notice (the “Notice”) from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) informing us that because the minimum bid price of our common stock listed on the Nasdaq was below $1.00 over the previous 30 consecutive business days, we did not meet the minimum bid price requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
Because there is no uniform policy of coverage and reimbursement in the United States, each payor generally determines for its own enrollees or insured patients whether to cover or otherwise establish a policy to reimburse our diagnostic tests, and seeking payor approvals is a time-consuming and costly process.
However, because there is no uniform policy of coverage and reimbursement in the United States, each payor generally determines for its own enrollees or insured patients whether to cover or otherwise establish a policy to reimburse based on its own medical relevance testing.
Continuation of these activities could have a material adverse effect on our results of operations, cash flows and liquidity. 27 Table of Contents Risks Related to Ownership of Common Stock You may be diluted from future issuances of our equity securities, including in future financings or strategic transactions, from compensatory equity awards and exercises of outstanding warrants, and such issuances, or perception that such issuances may occur, could depress the market price of our common stock.
Risks Related to Ownership of Common Stock You will be diluted from future issuances of our equity securities, including in strategic transactions or future financings, from compensatory equity awards and exercises of outstanding warrants, and such issuances, or perception that such issuances may occur, could depress the market price of our common stock.
The inability to attract and retain the necessary managerial, technical and sales and marketing personnel could have a material adverse effect on our business, results of operations and financial condition. 15 Table of Contents Shutdowns of the U.S. federal government could materially impair our business and financial condition.
The inability to attract and retain the necessary managerial, technical and sales and marketing personnel could have a material adverse effect on our business, results of operations and financial condition. Shutdowns of the U.S. federal government could materially impair our business and financial condition. Development of our product candidates or regulatory approval may be delayed for reasons beyond our control.
Future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities, amortization expenses, or write-offs of goodwill and intangible assets, any of which could harm our financial condition.
Future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities, amortization expenses, or write-offs of goodwill and intangible assets, any of which could harm our financial condition. Future acquisitions may also require us to obtain additional financing, which may not be available on favorable terms or at all.
Trading of our common stock is currently conducted on Nasdaq.
Trading of our common stock is limited, which may affect our stock price. Trading of our common stock is currently conducted on Nasdaq.
The U.S. federal government also is contemplating federal privacy legislation. The collection and use of health data and other personal data is governed in the EU by the General Data Protection Regulation (the "GDPR"), which imposes substantial obligations upon companies and rights for individuals, and by certain EU member state-level legislation.
Department of Justice has issued rules restricting certain bulk transfers of sensitive personal information. The collection and use of health data and other personal data is governed in the EU by the General Data Protection Regulation (the "GDPR"), which imposes substantial obligations upon companies and rights for individuals, and by certain EU member state-level legislation.
Failure to improve any of our technologies could delay or prevent their successful development for any of our target markets. Developing any technology into a marketable product is a risky, time-consuming and expensive process. You should anticipate that we will encounter setbacks, discrepancies requiring time-consuming and costly redesigns and changes and that there is the possibility of outright failure.
Developing any technology into a marketable product is a risky, time-consuming and expensive process. You should anticipate that we will encounter setbacks, discrepancies requiring time-consuming and costly redesigns and changes and that there is the possibility of outright failure. We may not meet our product development, manufacturing, regulatory, commercialization and other milestones.
You may also be subject to dilution from the exercise or settlement of outstanding options or restricted stock units under the Amended and Restated 2014 Equity Incentive Plan, and from the exercise of our warrants, including the exercise of any pre-funded warrants.
You will also be subject to dilution from the conversion of shares of Series B Preferred Stock, the exercise or settlement of outstanding options or restricted stock units under the Restated 2014 Plan, and from the exercise of our warrants.
We do not know when or whether we will successfully complete the development of the planned development-stage or next generation exoskeletal technologies, or any other proposed, developmental, or contemplated product for any of our target markets. We continue to seek to improve our technologies before we are able to produce a commercially viable product.
We may never complete the development of any of our proposed products or product improvements into marketable products. We do not know when or whether we will successfully complete the development of the planned development-stage or next generation exoskeletal technologies, or any other proposed, developmental, or contemplated product for any of our target markets.
Our failure to comply with these complex laws and regulations could have a material adverse effect on our business, results of operations, financial condition and cash flows. 19 Table of Contents In the United States, before we can market a new medical device, or a new use of, new claim for or significant modification to an existing product, we must first receive either clearance under Section 510(k) of the FDCA or approval of a premarket approval ("PMA") application from the FDA, unless an exemption applies.
In the United States, before we can market a new medical device, or a new use of, new claim for or significant modification to an existing product, we must first receive either clearance under Section 510(k) of the FDCA or approval of a premarket approval ("PMA") application from the FDA, unless an exemption applies.
In particular, these instruments limit our ability to, among other things, hold cash outside Banc of California, incur additional debt, grant liens on assets, sell or acquire assets outside the ordinary course of business, pay dividends and make certain fundamental business changes.
Riley Promissory Note”), contains, subject to certain carve-outs, various restrictive covenants that limit our management's discretion in operating our business. In particular, these instruments limit our ability to, among other things, incur additional debt, grant liens on assets, sell assets outside the ordinary course of business, pay dividends and make certain fundamental business changes.
It is unclear how any such challenges and healthcare measures promulgated by the new Trump administration will impact the ACA, our business, financial condition and results of operations. However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the United States in the future.
It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and healthcare measures promulgated by the new Trump administration will impact the ACA, our business, financial condition and results of operations.
Future operating or business decisions may cause dilution to our stockholders. For example, we may sell equity securities or issue securities exercisable or convertible into shares of our common stock in connection with strategic transactions or for financing purposes, including under our At The Market Offering Agreement (the "ATM Agreement") or otherwise through registered or unregistered offerings.
Future operating or business decisions will cause dilution to our existing stockholders. For example, we will issue a substantial amount of equity securities or securities exercisable or convertible into equity securities in connection with strategic transactions or for financing purposes, including through one or more registered or unregistered offerings.
These agencies enforce laws and regulations that govern the development, testing, clinical trials, manufacturing, labeling, advertising, marketing and distribution, recordkeeping, recalls and field safety corrective actions, and market surveillance of our medical products.
These agencies enforce laws and regulations that govern the development, testing, clinical trials, manufacturing, labeling, advertising, marketing and distribution, recordkeeping, recalls and field safety corrective actions, and market surveillance of our medical products. Our failure to comply with these complex laws and regulations could have a material adverse effect on our business, results of operations, financial condition and cash flows.
Our business strategy is based, in part, on our estimates of the number of individuals with physical limitations and disability, and it considers the occurrence of strokes, TBIs, SCIs and MS in our target markets and the percentage of those groups that would be able to use our current and future products.
If we are unable to successfully retain existing customers and attract new customers and achieve volume sales of our products, our business, prospects, financial condition and operating results will be materially and adversely affected. 11 Table of Contents Our business strategy is based, in part, on our estimates of the number of individuals with physical limitations and disability, and it considers the occurrence of strokes, TBIs, SCIs and MS in our target markets and the percentage of those groups that would be able to use our current and future products.
Our obligations, which become due in August 2026, are also secured by a security interest in all of our assets, exclusive of intellectual property. As a result, we may need to use our capital resources to repay the BoC Loan in order to undertake certain financing or strategic transactions.
("Guarantor") and are secured by a security interest in substantially all of our assets and Guarantor's assets. As a result, we may need to use our capital resources to repay the B. Riley Promissory Note in order to undertake certain financing or strategic transactions.
Our compliance with Section 404 may require that we incur substantial accounting expense and expend significant management efforts. 17 Table of Contents Intellectual Property Risks Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain. Our long-term success largely depends on our ability to market technologically competitive products.
Intellectual Property Risks Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain. Our long-term success largely depends on our ability to market technologically competitive products.
We might not be able to continue as a going concern. Our audited consolidated financial statements as of December 31, 2024 have been prepared under the assumption that we will continue as a going concern for the next twelve months.
Our audited consolidated financial statements as of December 31, 2025 have been prepared under the assumption that we will continue as a going concern for the next twelve months. As of December 31, 2025, we had cash of $1.2 million and an accumulated deficit of $262.4 million.
Other states have begun to propose and enact laws relating to privacy and information security matters, many of which are comprehensive privacy statutes similar to the CCPA. Further, other states have enacted laws that cover specific topics, such as the use and collection of biometric information or the collection, use, disclosure, and/or other processing of health-related information.
Other states have begun to propose and enact laws relating to privacy and information security matters, many of which are comprehensive privacy statutes similar to the CCPA.
There can be no assurance that we can do so on favorable terms, if at all. Our products have been produced in quantities, and on timelines, sufficient to meet commercial demand and for us to satisfy our delivery schedules.
Our products have been produced in quantities, and on timelines, sufficient to meet commercial demand and for us to satisfy our delivery schedules.
There is no assurance that we will be able to obtain a license to UC Berkeley’s rights in any such claims on commercially reasonable terms or at all, and UC Berkeley may choose to license its rights to third parties instead of us. 18 Table of Contents If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third-parties or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
There is no assurance that we will be able to obtain a license to UC Berkeley’s rights in any such claims on commercially reasonable terms or at all, and UC Berkeley may choose to license its rights to third parties instead of us.
The ability of our Board of Directors to issue additional stock may prevent us from making more difficult transactions, including a sale or merger. Our Board of Directors is authorized to issue up to 10 million shares of preferred stock with powers, rights and preferences designated by it.
Our Board of Directors is authorized to issue up to 10 million shares of preferred stock with powers, rights and preferences designated by it.
Legal and Regulatory Compliance Risks If we fail to obtain or maintain necessary regulatory clearances or approvals for our medical device products, or if clearances or approvals for future products or modifications to existing products are delayed or not issued, our commercial operations would be harmed.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. 17 Table of Contents Legal and Regulatory Compliance Risks If we fail to obtain or maintain necessary regulatory clearances or approvals for our medical device products, or if clearances or approvals for future products or modifications to existing products are delayed or not issued, our commercial operations would be harmed.
The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026. If we or any of our suppliers or contractors fail to meet the regulatory requirements or a regulatory inspection, our operations could be disrupted and our manufacturing interrupted.
The QMSR, which incorporates by reference the quality management system requirements of ISO 13485:2016, went into effect on February 2, 2026. If we or any of our suppliers or contractors fail to meet the regulatory requirements or a regulatory inspection, our operations could be disrupted and our manufacturing interrupted.
Certain policies are not yet known to us and may affect the number of individual purchases that are approved to receive reimbursement in the future. In addition, we may not be able to obtain insurance coverage beyond CMS.
In addition, the policies affecting the implementation of individual reimbursement decisions are made by regional DME Medicare Administrative Contractors. Certain policies are not yet known to us and may affect the number of individual purchases that are approved to receive reimbursement in the future.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. PROPERTIES Our principal executive office is currently located at 101 Glacier Point, Suite A, San Rafael, California, 94901, where we lease approximately 17,000 square feet. We currently lease a manufacturing facility in Brecksville, Ohio to support the production and service of the Ekso Indego Therapy and Ekso Indego Personal product lines.
Biggest changeItem 2. PROPERTIES Our principal executive office is currently located at 101 Glacier Point, Suite A, San Rafael, California, 94901, where we lease approximately 17,000 square feet. We currently lease an office in Brecksville, Ohio to support the service of the Ekso Indego Therapy and Ekso Indego Personal product lines.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe quotation of our common stock on the OTC market began on or about January 16, 2014. The closing price of EKSO stock as of February 28, 2025 was $0.52. As of February 28, 2025, we had approximately 175 stockholders of record of our common stock.
Biggest changeThe quotation of our common stock on the OTC market began on or about January 16, 2014. The closing price of EKSO stock as of February 20, 2026 was $11.18. As of February 20, 2026, we had approximately 173 stockholders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeRisk Factors,” specifically the risk titled “Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products,” for more information. 31 Table of Contents Results of Operations Consolidated Results of Operations: December 31, 2024 compared to the year ended December 31, 2023 (dollars in thousands): Years ended December 31, 2024 2023 Change % Change Revenue $ 17,925 $ 18,279 $ (354 ) (2 )% Cost of revenue 8,414 9,200 (786 ) (9 )% Gross profit 9,511 9,079 432 5 % Gross profit % 53 % 50 % Operating expenses: Sales and marketing 7,308 8,472 (1,164 ) (14 )% Research and development 3,874 5,025 (1,151 ) (23 )% General and administrative 8,789 10,694 (1,905 ) (18 )% Total operating expenses 19,971 24,191 (4,220 ) (17 )% Loss from operations (10,460 ) (15,112 ) 4,652 (31 )% Other (expense) income, net: Interest expense, net (269 ) (302 ) 33 (11 )% Gain (loss) on revaluation of warrant liabilities 474 (133 ) 607 (456 )% Loss on modification of warrant (109 ) — (109 ) * Unrealized (loss) gain on foreign exchange (965 ) 412 (1,377 ) (334 )% Other expense, net (1 ) (63 ) 62 (98 )% Total other (expense) income, net (870 ) (86 ) (784 ) 912 % Net loss $ (11,330 ) $ (15,198 ) $ 3,868 (25 )% (*) Not meaningful Revenue Revenue decreased $0.4 million, or 2%, for the year ended December 31, 2024, compared to the same period of 2023.
Biggest changeRisk Factors,” specifically the risk titled “Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products,” for more information. 29 Table of Contents Results of Operations Consolidated Results of Operations: December 31, 2025 compared to the year ended December 31, 2024 (dollars in thousands): Years ended December 31, 2025 2024 Change % Change Revenue $ 12,799 $ 17,925 $ (5,126 ) (29 )% Cost of revenue 5,954 8,414 (2,460 ) (29 )% Gross profit 6,845 9,511 (2,666 ) (28 )% Gross profit % 53 % 53 % Operating expenses: Sales and marketing 7,154 7,308 (154 ) (2 )% Research and development 3,031 3,874 (843 ) (22 )% General and administrative 9,986 8,789 1,197 14 % Total operating expenses 20,171 19,971 200 1 % Loss from operations (13,326 ) (10,460 ) (2,866 ) 27 % Other income (expense), net: Interest expense, net (309 ) (269 ) (40 ) 15 % Gain on revaluation of warrant liabilities 1 474 (473 ) (100 )% Loss on modification of warrant — (109 ) 109 (100 )% Unrealized gain (loss) on foreign exchange 1,965 (965 ) 2,930 (304 )% Other expense, net (26 ) (1 ) (25 ) * Total other income (expense), net 1,631 (870 ) 2,501 (287 )% Net loss $ (11,695 ) $ (11,330 ) $ (365 ) 3 % (*) Not meaningful Revenue Revenue decreased $5.1 million, or 29%, for the year ended December 31, 2025, compared to the same period of 2024.
Changes in management's estimate of future income in the timeframe during which the temporary differences and carryforwards comprising our deferred tax assets become deductible could result in a material impact to our financial position including the recognition of a net deferred tax asset. 36 Table of Contents Assets Acquired and Liabilities Assumed in Business Combinations We allocate the fair value of the purchase price of an acquisition to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values.
Changes in management's estimate of future income in the timeframe during which the temporary differences and carryforwards comprising our deferred tax assets become deductible could result in a material impact to our financial position including the recognition of a net deferred tax asset. 34 Table of Contents Assets Acquired and Liabilities Assumed in Business Combinations We allocate the fair value of the purchase price of an acquisition to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values.
During the measurement period, which may be up to one year from the acquisition date, we may record adjustments to the assets acquired and liabilities assumed, with the corresponding offset to goodwill. Upon the conclusion of the measurement period, any subsequent adjustments are included in the consolidated statement of operations.
When applicable, during the measurement period, which may be up to one year from the acquisition date, we may record adjustments to the assets acquired and liabilities assumed, with the corresponding offset to goodwill. Upon the conclusion of the measurement period, any subsequent adjustments are included in the consolidated statement of operations.
Off-Balance Sheet Arrangements As of December 31, 2024, we did not have any significant off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K promulgated under the Exchange Act. 35 Table of Contents Critical Accounting Estimates Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S.
Off-Balance Sheet Arrangements As of December 31, 2025, we did not have any significant off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K promulgated under the Exchange Act. 33 Table of Contents Critical Accounting Estimates Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S.
In particular, the effects of such increasing price-based competition may have an especially significant impact on certain products that we offer, including the EksoNR and Ekso Indego Therapy, which have a lengthy sale and purchase order cycle because they are major capital expenditure items and generally require the approval of senior management at purchasing institutions.
In particular, the effects of such increasing price-based competition have had an especially significant impact on certain products that we offer, including the EksoNR and Ekso Indego Therapy in the United States, which have a lengthy sale and purchase order cycle because they are major capital expenditure items and generally require the approval of senior management at purchasing institutions.
Summary of Significant Accounting Policies and Estimates — Recent Accounting Pronouncements in the notes to our consolidated financial statements for a discussion of new accounting pronouncements. 37 Table of Contents
Summary of Significant Accounting Policies and Estimates — Recent Accounting Pronouncements in the notes to our consolidated financial statements for a discussion of new accounting pronouncements. 35 Table of Contents
Unrealized loss on foreign exchange was $1.0 million for the year ended December 31, 2024, compared to unrealized gain on foreign exchange of $0.4 million for the same period of 2023, primarily due to foreign currency exchange rate fluctuations producing unrealized gains and losses on our inter-company monetary assets and liabilities.
Unrealized gain on foreign exchange was $2.0 million for the year ended December 31, 2025, compared to unrealized loss on foreign exchange of $1.0 million for the same period of 2024, primarily due to foreign currency exchange rate fluctuations producing unrealized gains and losses on our inter-company monetary assets and liabilities.
Management has not yet determined the form such additional financing may take, but management expects that the most likely forms include one or more of the following: (i) underwritten offerings of shares of our common stock, (ii) sales of shares of our common stock under an "at the market" offering program, (iii) issuing shares of our common stock upon the exercise of warrants at reduced exercise prices, (iv) incurring indebtedness with one or more financial institutions, (v) sale of product line or technology, and (vi) the factoring of trade receivables.
Management has not yet determined the form such additional financing may take, but management expects that the most likely forms include one or more of the following: (i) underwritten offerings of shares of our common stock, (ii) issuing shares of our common stock upon the exercise of warrants at reduced exercise prices, (iii) incurring indebtedness with one or more financial institutions, (iv) sale of product line or technology, and (v) the factoring of trade receivables.
Notes Payable, net in the notes to our consolidated financial statements included elsewhere in the Annual Report on Form 10-K), (5) operating lease payments (for additional information see Note 10. Lease Obligations in the notes to our consolidated financial statements included elsewhere in the Annual Report on Form 10-K), and (6) pursuing strategic initiatives.
Notes Payable, net in the notes to our consolidated financial statements included elsewhere in the Annual Report on Form 10-K), and (5) operating lease payments (for additional information see Note 10. Lease Obligations in the notes to our consolidated financial statements included elsewhere in the Annual Report on Form 10-K).
As described in Note 1. Organization: Liquidity and Going Concern of the notes to our consolidated financial statements, management believes that substantial doubt exists about our ability to meet cash requirements 12 months from the issuance of such financial statements, and such substantial doubt is not alleviated by our plans.
Organization: Liquidity and Going Concern of the notes to our consolidated financial statements, management believes that substantial doubt exists about our ability to meet cash requirements 12 months from the issuance of such financial statements, and such substantial doubt is not alleviated by our plans.
Loss on modification of warrant of $0.1 million for the year ended December 31, 2024 was due to the reduction of the exercise price of the May 2019 Warrants from $3.52 per share to $1.55 per share, in connection with the January 2024 Offering. There was no comparable amount for the year ended December 31, 2023.
Loss on modification of warrant of $0.1 million for the year ended December 31, 2024 was due to the reduction of the exercise price of the May 2019 Warrants, in connection with the January 2024 Offering. There was no comparable amount for the year ended December 31, 2025.
Commitments and Contingencies in our notes to the consolidated financial statements for additional information regarding our contractual obligations and lease commitments.
Notes Payable, net in our notes to the consolidated financial statements for additional information regarding our promissory notes, and Note 15. Commitments and Contingencies in our notes to the consolidated financial statements for additional information regarding our contractual obligations and lease commitments.
As a result, the secondary medical consequences of paralysis can include difficulty with bowel and urinary tract function, osteoporosis, loss of lean mass, gain in fat mass, insulin resistance, diabetes, and heart disease. The cost of treating these conditions is substantial.
For this user population, confinement to a wheelchair can cause severe physical and psychological deterioration. As a result, the secondary medical consequences of paralysis can include difficulty with bowel and urinary tract function, osteoporosis, loss of lean mass, gain in fat mass, insulin resistance, diabetes, and heart disease. The cost of treating these conditions is substantial.
Net Cash Used in Investing Activities Net cash used in investing activities decreased by $0.1 million for the year ended December 31, 2024, compared to the same period of 2023, primarily due to the reduction in manufacturing equipment purchases.
Net Cash Used in Investing Activities Net cash used in investing activities increased by $0.2 million for the year ended December 31, 2025, compared to the same period of 2024, primarily due to the purchase of manufacturing equipment.
In addition to our current products and services, we continue to explore business development initiatives to fuel growth and long-term value in our existing markets.
We also provide products and services from our Personal Health market to individual users. In addition to our current products and services, we continue to explore business development initiatives to fuel growth and long-term value in our existing markets.
We expect the majority of our revenue in 2025 will continue to come from Enterprise Health sales. Another key part of our growth strategy is seeking insurance coverage beyond CMS and seeking additional indications of use for our products.
Given this ramp, we expect the majority of our revenue in 2026 will continue to come from Enterprise Health sales, but with Personal Health product sales contributing more quarter over quarter. Another key part of our growth strategy is seeking insurance coverage beyond CMS and seeking additional indications of use for our products.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this Annual Report on Form 10-K titled “Risk Factors.” For a discussion related to the results of operations for 2023 compared to 2022, refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2023 Annual Report on Form 10-K filed with the SEC on March 4, 2024.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this Annual Report on Form 10-K titled “Risk Factors.” For a discussion related to the results of operations for 2024 compared to 2023, refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K filed with the SEC on March 3, 2025. 28 Table of Contents Overview Our Business We design, develop, and market exoskeleton and complementary products that augment human strength, endurance, and mobility.
Net cash provided by financing activities of $0.3 million for the year ended December 31, 2023, was generated from the sale of common stock through our ATM Agreement, which was partially offset by a principal payment related to our Promissory Note. 34 Table of Contents Material Cash Requirements and Going Concern Our material cash requirements include the following items, some of which are represented in the table of Contractual Obligations and Commitments: (1) employee wages, benefits and incentives, (2) the procurement of raw materials and components to support the manufacturing and sale of our products, (3) expenditures for the ongoing improvement and development of existing and new technologies, (4) debt repayments (for additional information see Note 9.
Net cash provided by financing activities of $7.8 million for the year ended December 31, 2024, was related to net proceeds of approximately $5.0 million from the September 2024 Offering after deducting the underwriting discount and commissions and offering expenses paid by us, net proceeds of approximately $3.9 million from the January 2024 Offering after deducting placement agent fees and offering expenses, proceeds of approximately $0.1 million from shares of common stock sold under the ATM Agreement, partially offset by approximately $1.3 million of principal payments towards the Parker Hannifin Promissory Note. 32 Table of Contents Material Cash Requirements and Going Concern Our material cash requirements include the following items, some of which are represented in the table of Contractual Obligations and Commitments: (1) employee wages, benefits and incentives, (2) the procurement of raw materials and components to support the manufacturing and sale of our products, (3) expenditures for the ongoing improvement and development of existing and new technologies, (4) debt repayments (for additional information see Note 9.
Difficult and challenging economic conditions, including an increasingly inflationary environment, could lead to increased price-based competition.
Difficult and challenging economic conditions, including an increasingly inflationary environment and federal funding and policy changes, have led to increased price-based competition.
Specifically, according to the National Spinal Cord Injury Statistical Center, an estimated 305,000 individuals are currently living with SCI and another 18,000 suffer from new SCI injuries each year. According to the National Spinal Cord Injury Statistical Center, approximately 57% of individuals with SCI are enrolled in Medicare or Medicaid within five years post-injury.
Specifically, as of December 31, 2025, according to the National Spinal Cord Injury Statistical Center ("NSCISC") in their 2025 SCI Data Sheet, approximately, an estimated 309,000 individuals are currently living with SCI and another 18,000 suffer from new SCI injuries each year.
Cash and Restricted Cash The following table summarizes the sources and uses of cash for the periods stated (in thousands): Years ended December 31, 2024 2023 Cash and restricted cash, beginning of year $ 8,638 $ 20,525 Net cash used in operating activities (9,846 ) (12,054 ) Net cash used in investing activities (37 ) (157 ) Net cash provided by financing activities 7,769 348 Effect of exchange rate changes on cash (31 ) (24 ) Cash and restricted cash, end of year $ 6,493 $ 8,638 Net Cash Used in Operating Activities Net cash used in operating activities decreased by $2.2 million for the year ended December 31, 2024, compared to the same period of 2023, primarily due to the absence of payments related to the acquisition and integration of HMC, cost savings on supply chain, reduction in service costs and other efficiencies in operating activities.
Cash and Restricted Cash The following table summarizes the sources and uses of cash for the periods stated (in thousands): Years ended December 31, 2025 2024 Cash and restricted cash, beginning of year $ 6,493 $ 8,638 Net cash used in operating activities (11,801 ) (9,846 ) Net cash used in investing activities (188 ) (37 ) Net cash provided by financing activities 6,629 7,769 Effect of exchange rate changes on cash 36 (31 ) Cash and restricted cash, end of year $ 1,169 $ 6,493 Net Cash Used in Operating Activities Net cash used in operating activities increased by $2.0 million for the year ended December 31, 2025, compared to the same period of 2024, primarily due to lower revenues, partially offset by cost savings in supply chain, manufacturing, and service, efficiencies in operating activities including headcount reductions, and the receipt of the ERC.
Nomad is currently for sale in limited volumes in the Personal Health market for use in a non-Company-sponsored single clinical study. Subject to clinical and patient feedback from clinical trials, we expect Nomad to be more broadly available starting in 2026. Economic and Industry Trends Our revenue is highly dependent on market demand for our exoskeleton products.
Nomad is currently for sale in limited volumes in the Personal Health market for use in a non-Company-sponsored single clinical study. Subject to clinical and patient feedback from clinical trials, we expect to begin the general commercialization process for Nomad in late 2026.
Total Other (Expense) Income, Net Interest expense, net decreased 11% for the year ended December 31, 2024, compared to the same period of 2023, primarily due to lower interest expense related to the Promissory Note.
Total Other Income (Expense), Net Interest expense, net increased 15% for the year ended December 31, 2025, compared to the same period of 2024. This increase is primarily related to interest expense related to the B.
Liquidity and Capital Resources As of December 31, 2024, $6.5 million of cash was held domestically and by our foreign subsidiaries. Cash consisted of bank deposits with third-party financial institutions. As described in Note 9.
Liquidity and Capital Resources As of December 31, 2025, $1.2 million of cash was held domestically and by our foreign subsidiaries. Cash consisted of bank deposits with third-party financial institutions, none of which was restricted. As of December 31, 2025, we had working capital of $5.4 million, compared to working capital of $11.3 million as of December 31, 2024.
During the year ended December 31, 2024, we sold 105,049 shares of common stock under the ATM Agreement at an average price of $1.43, for aggregate proceeds of $0.1 million, net of commission and issuance costs. As of December 31, 2024, we had $4.1 million available for future offerings under the prospectus filed with respect to the ATM Agreement.
During the year ended December 31, 2025, we sold 238,154 shares of common stock under the ATM Agreement at an average price of $4.34, for aggregate proceeds of $0.9 million, net of commission and issuance costs. On October 28, 2025, we terminated the ATM Prospectus.
Contractual Obligations and Commitments The following table summarizes our outstanding contractual obligations as of December 31, 2024, and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Payments Due By Period Total Less than one year 1-3 Years Term loan $ 2,260 $ 156 $ 2,104 Promissory Note 3,437 1,250 2,187 Facility operating leases 953 481 472 Purchase obligations 1,263 1,263 — Total $ 7,913 $ 3,150 $ 4,763 Refer to Note 15.
Contractual Obligations and Commitments The following table summarizes our outstanding contractual obligations as of December 31, 2025, and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Payments Due By Period Total Less than one year 1-3 Years 3-5 Years B.
Gross margin increased to approximately 53% for the year ended December 31, 2024, compared to a gross margin of 50% for the same period in 2023, primarily driven by cost savings in supply chain and a reduction in service costs. 32 Table of Contents Operating Expenses Sales and marketing expenses decreased $1.2 million, or 14%, for the year ended December 31, 2024, compared to the same period of 2023.
Gross margin remained flat at approximately 53% for the year ended December 31, 2025, compared to a consistent gross margin of 53% for the same period in 2024 30 Table of Contents Operating Expenses Sales and marketing expenses decreased $0.2 million, or 2%, for the year ended December 31, 2025, compared to the same period of 2024.
The decrease in working capital was primarily due to cash outflows from operations of $9.8 million. We have funded our operations primarily through the issuance and sale of equity securities and bank debt.
We have funded our operations primarily through the issuance and sale of equity securities and bank debt.
DMEs are responsible for the Medicare reimbursement process, which requires a physician’s prescription and evidence of medical necessity to be submitted to and approved by Medicare before reimbursement is provided. Operating within the CMS reimbursement environment was new to us.
DMEs are responsible for the Medicare reimbursement process, which requires a physician’s prescription and evidence of medical necessity to be submitted to and approved by Medicare before reimbursement is provided. Throughout 2025, we continued to make progress on developing the go-to-market program for our Personal Health products.
With Medicare reimbursement recently approved, we have begun selling products to individuals in this market through Durable Medical Equipment suppliers ("DMEs"). DMEs typically resell products from DME manufacturers, like us, to individual users.
According to the NSCISC in their SCI Model Systems 2024 Annual Statistical Report, approximately 57% of individuals with SCI are enrolled in Medicare or Medicaid within five years post-injury. With Medicare reimbursement approved, we began selling products to individuals in this market through Durable Medical Equipment suppliers ("DMEs"). DMEs typically resell products from DME manufacturers, like us, to individual users.
Overview Our Business We design, develop, and market exoskeleton products that augment human strength, endurance, and mobility. The primary end market for our exoskeleton technology is healthcare, where our technology primarily serves people with physical disabilities or impairments in both physical rehabilitation and mobility.
The primary end market for our exoskeleton technology is healthcare, where our technology primarily serves people with physical disabilities or impairments in both physical rehabilitation and mobility. The majority of our sales are generated from our Enterprise Health products, which include the sales of products and services related to neurorehabilitation in clinical settings.
We are using the net proceeds from the September 2024 Offering for general corporate purposes, which may include growth and expansion of our Personal Health products as we work to increase our revenue following the establishment of Medicare CMS reimbursement of the Ekso Indego Personal device, research and development activities, selling, general and administrative costs, pursuing strategic initiatives, and meeting our other working capital needs.
We used the net proceeds from the October 2025 Offering for general corporate purposes, which included research and development activities, selling, general and administrative costs, pursuing strategic initiatives, and meeting our other working capital needs.
Furthermore, we do business in the Americas, EMEA and APAC, which results in our business being impacted by demand changes in each of those regions, as well as changes in the strength of the local currencies relative to the U.S. Dollar. See “Part I—Item 1A.
The timing of executing sales contracts with large hospital networks can be unpredictable, which has and may continue to impact the timing and amounts of device sales. Furthermore, we do business in the Americas, EMEA and APAC, which results in our business being impacted by changes in the strength of the local currencies relative to the U.S. Dollar.
The decrease was primarily due to lower headcount, discretionary payroll and consultant costs. Research and development expenses decreased $1.2 million, or 23%, for the year ended December 31, 2024, compared to the same period of 2023, primarily due to lower discretionary payroll costs and decreases in the Company's use of product development consultants.
Research and development expenses decreased $0.8 million, or 22%, for the year ended December 31, 2025, compared to the same period of 2024, primarily due to lower headcount, lower payroll expense from the receipt of the ERC and lower payroll expense related to discretionary payroll, partially offset by severance expense.
General and administrative expenses decreased $1.9 million, or 18%, for the year ended December 31, 2024, compared to the same period of 2023, primarily due to lower discretionary payroll, accounting and legal costs.
General and administrative expenses increased $1.2 million, or 14%, for the year ended December 31, 2025, compared to the same period of 2024, primarily due to higher legal and audit costs, higher payroll expense related to discretionary payroll and due to a loss on impairment of a finite-lived intangible asset, partially offset by the receipt of the ERC.
Gain on revaluation of warrant liabilities of $0.5 million and loss on revaluation of warrant liabilities of $0.1 million for the years ended December 31, 2024 and December 31, 2023, respectively, were associated with the revaluation of warrants issued in 2019, 2020 and 2021. Gains and losses on revaluation of warrants are primarily driven by changes in our stock price.
Gain on revaluation of warrant liabilities was de minimis for the year ended December 31, 2025 as compared to a gain on revaluation of warrant liabilities of $0.4 million for the year ended December 31, 2024, and was associated with the revaluation of warrants issued in 2019, 2020, and 2021.
On January 16, 2024, we sold an aggregate of 3.0 m illion shares of common stock in a registered direct offering (the "January 2024 Offering") at a price of $1.55 per share, which generated net proceeds of approximately $3.9 million after deducting placement agent fees and our estimated offering expenses. 33 Table of Contents In October 2020, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.
On October 30, 2025, we issued and sold an aggregate of 769,490 shares of our common stock in a registered direct offering (the “October 2025 Offering”) at an offering price of $4.81 per share. We received net proceeds of approximately $3.2 million in the October 2025 Offering, after deducting the placement agent fees and offering expenses paid by us.
While EVO is a general-purpose product, we currently target specific vertical markets, including aerospace, automotive, general manufacturing, and certain construction trades. Personal Health Market Within the Personal Health market, we serve individual users with the Ekso Indego Personal, which is intended to provide overground ambulation in community and home settings.
While EVO is a general-purpose product, we currently target specific vertical markets, including aerospace, automotive, general manufacturing, and certain construction trades. Starting in late 2025, we began marketing the MediTouch BalanceTutor to our Enterprise Health customers under an exclusive distribution agreement with MediTouch.
At the end of February 2025, we had approximately 25 people who we believe qualify for reimbursement. We anticipate submitting those claims to CMS over the next six to nine months, though we expect our processes and procedures to continue to be refined as we work to scale up this sales channel over time.
We anticipate that many of these individuals will have their claims submitted to CMS by our partners over the next 12 months, though we expect our processes and procedures to continue to be refined as we continue to scale this sales channel over time.
Gross Profit and Gross Margin Gross profit increased $0.4 million, or 5%, for the year ended December 31, 2024, compared to the same period of 2023, primarily driven by cost savings in supply chain and a reduction in service costs.
Gross Profit and Gross Margin Gross profit decreased $2.7 million, or 28%, for the year ended December 31, 2025, compared to the same period of 2024, driven by a decrease in revenue associated with our Enterprise Health devices, partially offset by an increase in revenues associated with our Personal Health device and reduction in service costs.
The decrease in revenue was driven by a decrease in the average selling price for our Enterprise Health and Personal Health devices on an aggregate basis across all regions and a decrease in the volume of EksoNR subscriptions, partially offset by an increase in service revenue.
The decrease in revenue was primarily driven by a decrease in the volume of Enterprise Health device sales in the EMEA region, partially offset by an increase in the volume of Personal Health device sales in the Americas region.
We expect that our operating cash requirements in the near term will continue to exceed cash provided by operations with the significant research and development activities related to the development of our advanced technology and commercialization of such technology into its medical device business and with the service of our Promissory Note with Parker Hannifin Corporation.
We expect that our operating cash requirements in the near term will continue to exceed cash provided by operations. As described in Note 1.
Net Cash Provided by Financing Activities Net cash provided by financing activities of $7.8 million for the year ended December 31, 2024 was related to net proceeds of approximately $5.0 million from the September 2024 Offering after deducting the underwriting discount and commissions and offering expenses paid by us, net proceeds of approximately $3.9 million from the January 2024 Offering after deducting placement agent fees and offering expenses, proceeds of approximately $0.1 million from shares of common stock sold under the ATM Agreement, partially offset by approximately $1.3 million of principal payments towards the Promissory Note.
Net Cash Provided by Financing Activities Net cash provided by financing activities of $6.6 million for the year ended December 31, 2025 was related to net proceeds of $3.2 million from the October 2025 Offering, after deducting the transaction expenses, net proceeds of $1.9 million from the B.
Removed
The majority of our sales are generated from our Enterprise Health products, which include the sales of products and services related to neurorehabilitation in clinical settings. We also provide products and services from our Personal Health market to individual users.
Added
The BalanceTutor rehabilitation system includes a patented multidirectional perturbation treadmill and multiple force and movement sensors that allow patients impacted by impaired balance to react to unanticipated disturbances while standing or walking. We believe that the BalanceTutor offers treatment options that are complementary to our rehabilitation exoskeletons and that the two can be used in combination for many patients.
Removed
The primary use case for Ekso Indego Personal is for users with SCI. For this user population, confinement to a wheelchair can cause severe physical and psychological deterioration.
Added
We expect to begin the sales and distribution of the BalanceTutor in early 2026. Personal Health Market Within the Personal Health market, we serve individual users with the Ekso Indego Personal, which is intended to provide overground ambulation in community and home settings. The primary use case for Ekso Indego Personal is for users with SCI.
Removed
Our DME submitted the first Ekso Indego Personal CMS reimbursement claim in May 2024, which claim was reimbursed in July 2024. All other ongoing CMS reimbursement claims for our devices are currently being managed through the appeals process.
Added
Users of this technology are individuals living with an SCI who will either self-pay, or work through the currently established reimbursement programs involving worker’s compensation, VA, or Medicare. As in previous years, VA and worker’s compensation claims are well defined but traditionally are lower volumes.
Removed
During the pendency of such appeals, we decided to put a hold on selling devices to DMEs for CMS reimbursement, instead focusing on refining and improving the CMS reimbursement process for our devices, naming National Seating & Mobility as the Company’s exclusive distributor of the Ekso Indego Personal device within the U.S. complex rehabilitation technology industry, ramping up pilots and partnerships with both regional and national DME suppliers, and building up a sales backlog for the Ekso Indego Personal device.
Added
For Medicare, we have continued to develop our channel partner program consisting of O&P and DME partners, and through the year ended December 31, 2025, our partners saw an increased number of Medicare claims submitted and reimbursed.
Removed
Notes Payable, net in the notes to our consolidated financial statements, borrowings under our secured term loan agreement with Banc of California are subject to a liquidity covenant requiring minimum cash on hand equivalent to the current outstanding principal balance, which is due in full in August 2026.
Added
To date, most reimbursements have involved an appeals process, but for newer claims, reimbursements are occurring much earlier than was the case for initial claims submitted in the previous year.
Removed
As of December 31, 2024, $2.0 million of cash must remain as restricted. After considering cash restrictions, effective unrestricted cash as of December 31, 2024 was approximately $4.5 million. As of December 31, 2024, we had working capital of $11.3 million, compared to working capital of $12.1 million as of December 31, 2023.
Added
As this category of product is relatively new within CMS, we have taken a measured approach with respect to the volume and timing of CMS reimbursement submissions, focusing on continued refinement and improvement of our candidate screening and submission documentation. The improvements in this process have resulted in an increase in our partners' CMS reimbursement submissions.
Removed
On September 3, 2024, we sold 3,100,000 shares of common stock, a Pre-Funded Warrant to purchase 2,900,000 shares of common stock, Series A Warrants to purchase an aggregate of 6,000,000 shares of common stock, and Series B Warrants to purchase an aggregate of 6,000,000 shares of common stock in an underwritten public offering (the "September 2024 Offering"), which generated net proceeds of approximately $5.0 million after deducting the underwriting discount and commissions and offering expenses paid by the Company.
Added
In support of this effort, to date we have signed agreements with National Seating & Mobility for selling exclusivity into the Complex Rehabilitation Technology segment, with Bionic Prosthetics & Orthotics Group, a respected O&P provider serving 14 states, and recently with Ottobock Patient Care, a national provider of O&P services, and we continue to develop partnerships and pilots with other regional and national O&P suppliers that we believe will bear fruit in 2026 and beyond.
Removed
In June 2023, we entered into an amendment to the ATM Agreement that removed the requirement that shares of our common stock may not be sold for a price lower than $6.75 per share.
Added
In addition to this work, we have ramped up our direct marketing efforts and continue to develop and grow a sales backlog for the Ekso Indego Personal device. As of December 31, 2025, we had over 50 people who we believe qualify for potential reimbursement.
Added
Recent Developments On January 22, 2026, we issued and sold (i) an aggregate of 5,852 shares of Series B Preferred Stock convertible into an aggregate of 711,922 shares of common stock issuable upon conversion of the Series B Preferred Stock at an initial conversion price of $8.22 per share and (ii) warrants (the “2026 Warrants”), which are exercisable to purchase up to an aggregate of 355,960 shares of our common stock at an exercise price of $8.22 per share of common stock (the “Private Placement”).
Added
The net proceeds of the Private Placement are expected to be approximately $5.3 million, after deducting placement agent fees and expenses and other estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital and general corporate purposes.
Added
Business Combination On February 15, 2026, we entered into a Contribution and Exchange Agreement (the “Contribution Agreement”) with APLD Intermediate HoldCo LLC, a Delaware limited liability company (“APLD Intermediate”), APLD ChronoScale HoldCo LLC, a Delaware limited liability company and a wholly owned subsidiary of APLD Intermediate (“Contributor”), each a wholly owned direct or indirect subsidiary of Applied Digital Corporation, a Nevada corporation, and Applied Digital Cloud Corporation, a Nevada corporation, which at the time of the Closing (as defined below), will be a wholly owned subsidiary of Contributor (“Cloud”), for purposes of consummating a business combination (the “Business Combination”), as a result of which (i) Cloud will become our wholly owned subsidiary, (ii) we will, immediately after the consummation of the Business Combination (the “Closing”), continue as the parent of the combined company, and (iii) we will change our name to ChronoScale Corporation.
Added
Subject to the satisfaction or waiver of the conditions set forth in the Contribution Agreement, Contributor will contribute all of its right, title and interest in and to 1,200 shares of the common stock of Cloud, constituting 100% of the issued and outstanding equity of Cloud, to us in exchange for 138,216,820 newly issued shares of our common stock (the “Exchanged Shares”).
Added
As a result of and upon the consummation of the Business Combination, Contributor is expected to own approximately 97% of the combined company’s outstanding equity before giving effect to the other transactions contemplated by the Contribution Agreement.
Added
The Contribution Agreement provides that the Closing is subject to certain conditions, including, among other things: (i) stockholder approval of the Business Combination as set forth in the Contribution Agreement and related proposals; (ii) an Information Statement or a Proxy Statement must be cleared by the SEC and sent to our stockholders in accordance with Regulation 14A under the Securities and Exchange Act of 1934, as amended, and in the case of the Information Statement, such mailing must be at least twenty (20) calendar days prior to Closing; (iii) no order or law shall have been entered, adopted, enacted, issued, promulgated or enforced, in each case, by a governmental entity that prevents, enjoins, prohibits, restrains or makes illegal the consummation of the Business Combination or the other transactions contemplated by the Contribution Agreement; (iv) all requisite approvals or waivers as required by the terms of the Contribution Agreement shall have been obtained; (v) we shall have cash and cash equivalents equal to at least $15,000,000; and (vi) our Second Amended and Restated Articles of Incorporation (the “Second Restated Articles”) shall have been duly adopted by all necessary corporate action on our part, filed with the Secretary of State of the State of Nevada, and shall be in full force and effect as of immediately prior to the Closing.
Added
The obligation of each party to consummate the Business Combination is also conditioned upon (i) performance and compliance by the other party in all material respects with its pre-Closing obligations and covenants under the Contribution Agreement; (ii) the accuracy of the representations and warranties of the other party as of the Closing (subject to customary materiality qualifiers); (iii) in both Cloud’s and our case, the absence of a continuing material adverse effect with respect to the other party; (iv) in Cloud’s case, that (a) a private placement transaction for gross proceeds of an amount to be determined by APLD Intermediate and on terms acceptable to APLD Intermediate, shall have been consummated concurrently with the Closing (the securities to be issued in such private placement transaction, the “PIPE Securities”), (b) certain third-party consents as required by the terms of the Contribution Agreement shall have been obtained, (c) the Nasdaq listing application shall have been submitted and approved, (d) the Investor Rights Agreement (the “Investor Rights Agreement”) between us and Contributor shall be in full force and effect at Closing, and (e) certain tail insurance policies as described in the Contribution Agreement have been bound, paid for and in effect.
Added
See “Part I—Item 1A. Risk Factors,” specifically the risks under the heading “Risks Related to the Proposed Business Combination,” for more information. We are continuing to explore one or more strategic transactions with certain third parties with respect to our medical device business.
Added
There can be no assurances that any such transaction will occur, and we expect to continue executing on our growth strategy during this process. We have not set a timetable for the strategic review process, and we do not intend to provide updates until we determine that disclosure is appropriate or required.
Added
Economic and Industry Trends Our revenue is highly dependent on market demand for our exoskeleton products.
Added
The decrease was primarily due to lower headcount, lower payroll expense related to discretionary payroll and from the receipt of the employee retention credits ("ERC"), partially offset by a loss on impairment of our indefinite-lived trade name intangible asset and severance expense.
Added
Riley Promissory Note and lower interest income from cash deposits, partially offset by lower interest expense related to the Parker Hannifin Promissory Note and interest income related to receiving late ERC payments.
Added
Gains and losses on revaluation of warrants are primarily driven by changes in our stock price, stock price volatility, time to maturity, and the risk-free interest rate.
Added
The decrease in working capital was primarily due to a lower cash balance and a higher convertible promissory note balance, partially offset by a higher inventory balance, a higher prepaid expenses and other current assets balance, a lower accrued liabilities balance, and a lower deferred revenues, current balance.
Added
On January 22, 2026, we issued and sold (i) an aggregate of 5,852 shares of Series B Preferred Stock convertible into an aggregate of 711,922 shares of common stock issuable upon conversion of the Series B Preferred Stock at an initial conversion price of $8.22 per share and (ii) the 2026 Warrants, which are exercisable to purchase up to an aggregate of 355,960 shares of our common stock at an exercise price of $8.22 per share of common stock.
Added
The net proceeds of the Private Placement are expected to be approximately $5.3 million, after deducting placement agent fees and expenses and other estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital and general corporate purposes.
Added
On October 30, 2025, in connection with the October 2025 Offering, we issued to Lake Street Capital Markets, LLC, a warrant (the “October 2025 Placement Agent Warrant”) to purchase up to 15,389 shares of our common stock, at an exercise price equal to $4.81 per share. 31 Table of Contents In October 2020, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.
Added
As a result, we expensed deferred issuance costs of $125 thousand related to the ATM Agreement during the year ended December 31, 2025.
Added
Riley Promissory Note, after deducting the transaction expenses, net proceeds of $3.9 million from the March 2025 Inducement Warrant, after deducting the transaction expenses, and $0.9 million from sales of our common stock under our ATM Agreement, net of commission and issuance costs, which were partially offset by $2.0 million of the payoff of our BoC Loan Agreement and $1.3 million of principal payments towards the Parker Hannifin Promissory Note.
Added
We are seeking additional financing and evaluating financing alternatives in the near term in order to meet our cash requirements for the next 12 months.
Added
Management currently estimates that the Company's cash on hand as of December 31, 2025, in addition to the net proceeds from the Private Placement, will fund its operations until the end of the second quarter of 2026.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

2 edited+2 added−1 removed4 unchanged
Biggest changeInterest Rate Risk Our exposure to market rate risk for changes in interest rates relates primarily to our term loan. The variable interest rate related to our long-term debt is charged at the greater of the variable rate of interest announced by the lender as its “prime rate” then in effect or 4.50%.
Biggest changeNotes Payable, net — BoC Term Loan in our notes to the consolidated financial statements for additional information regarding the term loan. Prior to the term loan payoff, the loan's variable interest rate was charged at the greater of the variable rate of interest announced by the lender as its “prime rate” then in effect or 4.50%.
For the year ended December 31, 2024, sales denominated in foreign currencies were approximately 43% of total revenue. A hypothetical 10% increase in the United States dollar exchange rate used would have resulted in a $0.7 million decrease to revenues for 2024.
For the year ended December 31, 2025, sales denominated in foreign currencies were approximately 42% of total revenue. A hypothetical 10% increase in the United States dollar exchange rate used would have resulted in a $0.5 million decrease to revenues for 2025.
Removed
A hypothetical 10% change in the lender's prime rate would have an immaterial impact on our annualized interest expense. 38 Table of Contents
Added
Interest Rate Risk Our exposure to market rate risk for changes in interest rates related primarily to our term loan. On September 12, 2025, we paid off the entire amount of $2,000 of our secured term loan agreement to Banc of California using the $2,000 of restricted cash. Refer to Note 9.
Added
As of December 31, 2025, we have no outstanding variable-rate debt, and therefore, we are no longer exposed to significant interest rate risk. 36 Table of Contents

Other EKSO 10-K year-over-year comparisons