What the changes say
- Cloud Business now dominates revenue, with one customer contributing 99.5% and GPU-cluster deposits potentially refundable.
- Growth requires substantial external capital, causing dilution, debt restrictions, and higher fixed obligations.
- AI-cloud competition, GPU supply dependence, pricing pressure, and technological shifts threaten margins and demand.
- Legacy Ekso risks now emphasize held-for-sale operations, reimbursement, regulatory compliance, trade disruption, and international sales.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Operations
Combining our Legacy Ekso Business and Cloud Business may be more difficult, costly and time-consuming than expected, which may adversely affect our results and negatively affect the value of our common stock
Integrating Legacy Ekso with the Cloud Business could consume management time, increase costs, delay plans, and reduce expected revenue.
- NewRisks Related to Our Business and Operations
We expect to need to raise external funds to support our growth strategy. Such capital raises are expected to cause dilution to our stockholders
Expansion and working-capital needs require equity, convertible debt, or other financing that could dilute shareholders or impose restrictive obligations.
- NewRisks Related to Our Business and Operations
Commencing November 30, 2026 (the end of our second fiscal quarter), we will no longer qualify as a smaller reporting company and will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results
Losing smaller-reporting-company exemptions after November 30, 2026 will require additional controls, disclosures, audits, and compliance spending.
- NewRisks Related to Our Business and Operations
We have a history of net losses and may continue to incur net losses for the foreseeable future
The combined company reported $50.3 million of fiscal 2026 net losses and may remain unprofitable while integration and revenue growth continue.
- NewRisks Related to Our Business and Operations
Our Cloud Business has had, and is expected to continue to have, significant customer concentration
One customer generated all Cloud Business revenue and approximately 99.5% of total revenue, making termination or financial distress especially damaging.
- NewRisks Related to Our Business and Operations
Failure to attract, grow and retain a diverse and balanced customer base, including key magnet customers, could harm our business and operating results
Failure to attract diverse cloud-service-provider customers, including influential magnet customers, could limit revenue growth and customer retention.
- NewRisks Related to Our Business and Operations
Our Cloud Business’ customer has historically made advance deposits based on anticipated future usage, and may continue to do so
Cloud customers’ advance deposits for GPU clusters may need to be refunded or credited if delivery or contract requirements are not met.
- NewRisks Related to Our Business and Operations
We may face pricing pressures as our industry evolves, and any significant or sustained reductions in pricing may reduce our margins and adversely affect our business, operating results, financial condition and future prospects
Competition, older GPU capacity, shifting inference demand, and bundled offerings could force lower prices and compress margins.
- NewRisks Related to Our Business and Operations
Technological developments in generative AI and inference, such as the development of AI models that require less computation power than earlier models, may result in decreased or differing demand for our offerings
More efficient AI models, open-source software, devices, chips, or inference techniques could reduce or change demand for the company’s computing services.
- NewRisks Related to Our Business and Operations
Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, which could result in our business failing to meet its growth targets, which could negatively affect our financial condition, results of operations and future prospects
Inaccurate forecasts of AI adoption and AI-cloud infrastructure growth could cause the company to miss its growth targets.
- NewRisks Related to Our Business and Operations
Our Cloud Business faces significant and evolving competition, and any inability to adapt to new and changing technologies and customer requirements or specifications could negatively affect our financial condition, results of operations and future prospects
Rapidly changing AI technologies, standards, customer requirements, and competitors require costly product adaptation that may not generate adequate returns.
- NewRisks Related to Our Business and Operations
If we are not able to compete effectively with current and future players, our Cloud Business’ ability to generate income and sustainably fund development will be negatively impacted
Dependence on Nvidia and planned reliance on AMD expose Cloud Business growth to GPU shortages, supplier pricing, delivery delays, and technology changes.
- NewRisks Related to Our Business and Operations
Any disruption to colocation space or services from third-party providers, or our ineffective management of relationships with third parties could harm our business, financial condition, operating results, cash flows, and prospects
- NewRisks Related to Our Business and Operations
Cybersecurity, physical security, and infrastructure disruptions could materially adversely affect our business
- NewRisks Related to Our Business and Operations
Certain natural disasters or other external events, including climate change or mechanical failures, could harm our business, financial condition, results of operations, cash flows, and prospects
- NewRisks Related to Our Business and Operations
We may be unable to deploy GPU infrastructure on the timelines committed to Microsoft, or at all, and any such delays in deployment or failure to deploy could result in significant financial penalties against us, contract termination, or loss of some or substantially all of our anticipated revenue
- NewRisks Related to Our Business and Operations
As we invest in our expansion efforts, if we fail to effectively manage our growth, our business, financial condition and results of operations could be harmed
- NewRisks Related to Our Business and Operations
Our level of debt in the future may negatively impact our liquidity, restrict our operations and ability to respond to business opportunities, and increase our vulnerability to adverse economic and industry conditions
- NewRisks Related to Our Business and Operations
Joint ventures, joint ownership arrangements and other projects pose unique challenges and we may not be able to fully implement or realize synergies, expected returns or other anticipated benefits associated with such projects
- NewRisks Related to Our Business and Operations
The loss of any of our management team, our inability to execute an effective succession plan, or our inability to attract and retain qualified personnel, could adversely affect our business
- NewRisks Related to Our Business and Operations
We may become involved in litigation arising in the ordinary course of our business that may materially adversely affect us
- NewRisks Related to Our Business and Operations
Employee disputes or litigation and related unfavorable publicity may negatively affect our future business, financial condition, and operating results
- NewRisks Related to Our Business and Operations
Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock price
- NewRisks Related to Our Business and Operations
including reputational harm and penalties, and could adversely affect our business, operating results, financial condition, and future prospects
- NewRisks Related to Our Business and Operations
Our inability to market and close the sale of our Legacy Ekso Business that is currently held for sale and treated as discontinued operations may have a material adverse impact on our business and financial condition
- NewRisks Related to Our Common Stock
Our stock price may be subject to volatility; this volatility may affect your ability to, and the price at which you could, sell our common stock
- NewRisks Related to Our Common Stock
Future issuances of our equity securities may result in dilution to existing stockholders and could adversely affect the market price of our common stock
- NewRisks Related to Our Common Stock
We do not expect to declare or pay dividends in the foreseeable future, which may limit the return our shareholders realize on their investment
- NewRisks Related to Our Common Stock
Provisions in our Articles (as defined below), our Bylaws (as defined below), and Nevada law may discourage a takeover attempt even if a takeover might be beneficial to our stockholders
- NewRisks Related to our Legacy Ekso Business
Certain of our Legacy Ekso Business customers utilize federal funding to purchase our products, and recent federal policy changes have disrupted, and could continue to disrupt, that funding
- NewRisks Related to our Legacy Ekso Business
authority, which would be followed by further evaluation or investigation of the incident and a final report indicating whether further action is required. The events described above that were reported to the FDA were also reported to the relevant EU regulatory authorities
- NewRisks Related to our Legacy Ekso Business
Warranty claims and maintenance obligations for current Legacy Ekso products could result in additional operating costs
Dropped
- DroppedBusiness and Operational Risks
The acquisition and integration of other companies, businesses, or technologies could result in operating difficulties, dilution, and other harmful consequences
- DroppedBusiness and Operational Risks
We may not be able to enhance our product offerings through our research and development efforts
- DroppedBusiness and Operational Risks
obtain the necessary regulatory clearances and approvals for proposed products
- DroppedBusiness and Operational Risks
We may never complete the development of any of our proposed products or product improvements into marketable products
- DroppedBusiness and Operational Risks
Our success depends on our management team, and on our ability to hire, train, retain, and motivate employees
- DroppedBusiness and Operational Risks
Damage to our brand and reputation could have an adverse effect on our business and financial performance
- DroppedBusiness and Operational Risks
We may not be able to reduce the cost to manufacture or service our products as planned
- DroppedFinancial & Accounting Risks
We have incurred significant losses to date and anticipate continuing to incur losses in the future, and we may not achieve or maintain profitability
- DroppedFinancial & Accounting Risks
Our loan agreement imposes certain financial and operational restrictions on us, limiting the discretion of our management in operating our business
Potential acquisitions could create integration difficulties, operating costs, management distraction, and shareholder dilution.
- DroppedFinancial & Accounting Risks
We may be unable to generate sufficient cash flow to service our debt obligations and operate our business
Research and development may fail to improve exoskeleton products or expand Legacy Ekso’s market share.
- DroppedFinancial & Accounting Risks
We cannot assure our business will generate sufficient cash flow from operations, or future borrowings will be available to us in an amount sufficient to fund our liquidity needs
Proposed products may fail to obtain timely regulatory clearances or generate sufficient customer demand.
- DroppedFinancial & Accounting Risks
We might not be able to continue as a going concern
- DroppedFinancial & Accounting Risks
We may not be able to leverage our cost structure or achieve better margins
- DroppedFinancial & Accounting Risks
We could fail to maintain effective internal control over our financial reporting
Legacy Ekso may not complete development of marketable exoskeleton products, including the Nomad.
- DroppedFinancial & Accounting Risks
UC Berkeley has licensed their U.S. rights in two of these three co-owned patents to an unrelated third-party
- DroppedLegal 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
- DroppedLegal and Regulatory Compliance Risks
In addition, violations of the FDCA relating to the promotion of approved products may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws
Business performance depends on retaining management and hiring, training, and motivating qualified employees.
- DroppedLegal and Regulatory Compliance Risks
restrictions and criminal prosecutions, any of which would cause our business to suffer
- DroppedLegal and Regulatory Compliance Risks
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
Product problems, complaints, litigation, or adverse events could damage Legacy Ekso’s brands and reputation.
- DroppedLegal and Regulatory Compliance Risks
Additional changes may affect our business, including those governing enrollment in federal healthcare programs, reimbursement changes, fraud and abuse enforcement, and expansion of new programs, such as Medicare payment for performance initiatives
Legacy Ekso may be unable to reduce exoskeleton manufacturing and servicing costs as planned.
- DroppedLegal and Regulatory Compliance Risks
Pursuant to HIPAA, final regulations have been implemented to improve the efficiency and effectiveness of the healthcare system by facilitating the electronic exchange of information in certain financial and administrative transactions while protecting the privacy and security of the information exchanged
Legacy Ekso had persistent historical losses and might not achieve or maintain profitability.
- DroppedLegal and Regulatory Compliance Risks
We are subject to cybersecurity risks to our systems, infrastructure, and technology, and data processed by us or third-party vendors
Banc of California loan covenants restricted cash management, borrowing, liens, asset transactions, dividends, and other decisions.
- DroppedLegal and Regulatory Compliance Risks
Warranty claims and our accelerated maintenance program results in additional operating costs to us
Near-term bank and acquisition-related debt required substantial cash servicing, potentially straining operations.
- DroppedRisks 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
Insufficient operating cash or borrowing availability could force asset sales, delayed spending, additional financing, or debt restructuring.
- DroppedRisks Related to Ownership of Common Stock
The ability of our Board of Directors to issue additional stock may prevent us from making more difficult transactions, including a sale or merger
Legacy Ekso’s cash resources and accumulated deficit raised substantial doubt about funding operations for the following twelve months.
- DroppedRisks Related to Ownership of Common Stock
We have never paid and do not intend to pay cash dividends
- DroppedRisks Related to Ownership of Common Stock
The market price of our common stock has been, and may continue to be, highly volatile
- DroppedRisks Related to Ownership of Common Stock
Trading of our common stock is limited, which may affect our stock price
- DroppedRisks Related to Ownership of Common Stock
If we do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from Nasdaq
Reworded
- 100% rewrittenRisks Related to our Legacy Ekso Business
Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain
The wording now focuses on protecting or extending patents and the risk that competitors circumvent or invalidate them, rather than emphasizing cost.
- 100% rewrittenRisks Related to our Legacy Ekso Business
If we fail to obtain or maintain necessary regulatory clearances or approvals for our Legacy Ekso medical device products, our Legacy Ekso Business could be harmed
The risk now names EksoNR, Ekso Indego, and Nomad, broadens regulatory obligations globally, and ties consequences to Legacy Ekso being held for sale.
Was: 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
- 99% rewrittenRisks Related to our Legacy Ekso Business
Coverage policies and reimbursement levels of third-party payors, including VA, Medicare, Medicaid, and commercial payors may affect current demands for Legacy Ekso products
The update adds Medicare Advantage and stresses inconsistent payor policies, delays, denials, pricing, cash flow, and sale-value effects while held for sale.
Was: Coverage policies and reimbursement levels of third-party payers, including Medicare or Medicaid, may impact sales of our products
- 98% rewrittenRisks Related to our Legacy Ekso Business
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 current operations
The update specifically adds tariffs and retaliatory tariffs, linking shortages and trade policies to costs, margins, exports, and Legacy Ekso’s sale value.
Was: 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
- 98% rewrittenRisks Related to our Legacy Ekso Business
International sales of current Legacy Ekso products are subject to factors outside of our control
The international-sales risk is condensed and now specifically includes reimbursement, currency, technology-export restrictions, and held-for-sale consequences.
Was: International sales of our products are subject to factors outside of our control
- 96% rewrittenRisks Related to our Legacy Ekso Business
If we fail to manage the complex and lengthy reimbursement process, our Legacy Ekso Business and operating results could be adversely affected
The reimbursement risk now adds filing deadlines, audits, refunds, and claim denials, with effects on near-term results, sale value, and obligations.
Was: If we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected
- 96% rewrittenRisks Related to our Legacy Ekso Business
Failure to comply with Health Insurance Portability and Accountability Act (HIPAA) or the HITECH Act and implementing regulations could result in significant penalties
The update identifies criminal or civil sanctions, higher compliance costs, operational complexity, and reimbursement disruption as consequences of HIPAA or HITECH failures.
Was: Failure to comply with HIPAA or the HITECH Act and implementing regulations could result in significant penalties
- 92% rewrittenRisks Related to our Legacy Ekso Business
We must obtain certain regulatory approvals in the EU, which could be costly and time-consuming and subject us to unanticipated delays or prevent us from marketing certain devices
The EU risk updates the EksoNR status to December 31, 2025 and ties EU MDR delays or denial to sales and Legacy Ekso’s sale value.
- 90% rewrittenRisks Related to our Legacy Ekso Business
We rely on independent distributors for the sale and marketing of our products in certain geographies
- 81% rewrittenRisks Related to our Legacy Ekso Business
Some Legacy Ekso patents and patent applications are not within our complete control, which could reduce the value of those assets
Was: Some of the patents and patent applications in the intellectual property portfolio are not within our complete control, which could reduce the value of such patents
- 65% rewrittenRisks Related to our Legacy Ekso Business
We may be subject to adverse medical device reporting obligations, voluntary corrective actions or agency enforcement actions
- 49% rewrittenRisks Related to Our Common Stock
We are currently a “smaller reporting company” and the reduced reporting requirements applicable to such companies may make our common stock less attractive to investors
Was: We are a “smaller reporting company” and the reduced reporting requirements applicable to such companies may make our common stock less attractive to investors
- 46% rewrittenRisks Related to our Legacy Ekso Business
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
- 33% rewrittenRisks Related to our Legacy Ekso Business
Shutdowns of the U.S. federal government could materially impair our Legacy Ekso Business and financial condition
Was: Shutdowns of the U.S. federal government could materially impair our business and financial condition
- 29% rewrittenRisks Related to our Legacy Ekso Business
Our Legacy Ekso products and operations are subject to extensive government regulation and oversight in the United States and other countries where we commercialize our medical devices
Was: Our products and operations are subject to extensive government regulation and oversight in the United States and other countries where we commercialize our medical devices
All 61 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business and Operations
- 01Combining our Legacy Ekso Business and Cloud Business may be more difficult, costly and time-consuming than expected, which may adversely affect our results and negatively affect the value of our common stockNew
- 02We expect to need to raise external funds to support our growth strategy. Such capital raises are expected to cause dilution to our stockholdersNew
- 03Commencing November 30, 2026 (the end of our second fiscal quarter), we will no longer qualify as a smaller reporting company and will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating resultsNew
- 04We have a history of net losses and may continue to incur net losses for the foreseeable futureNew
- 05Our Cloud Business has had, and is expected to continue to have, significant customer concentrationNew
- 06Failure to attract, grow and retain a diverse and balanced customer base, including key magnet customers, could harm our business and operating resultsNew
- 07Our Cloud Business’ customer has historically made advance deposits based on anticipated future usage, and may continue to do soNew
- 08We may face pricing pressures as our industry evolves, and any significant or sustained reductions in pricing may reduce our margins and adversely affect our business, operating results, financial condition and future prospectsNew
- 09Technological developments in generative AI and inference, such as the development of AI models that require less computation power than earlier models, may result in decreased or differing demand for our offeringsNew
- 10Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, which could result in our business failing to meet its growth targets, which could negatively affect our financial condition, results of operations and future prospectsNew
- 11Our Cloud Business faces significant and evolving competition, and any inability to adapt to new and changing technologies and customer requirements or specifications could negatively affect our financial condition, results of operations and future prospectsNew
- 12If we are not able to compete effectively with current and future players, our Cloud Business’ ability to generate income and sustainably fund development will be negatively impactedNew
- 13Any disruption to colocation space or services from third-party providers, or our ineffective management of relationships with third parties could harm our business, financial condition, operating results, cash flows, and prospectsNew
- 14Cybersecurity, physical security, and infrastructure disruptions could materially adversely affect our businessNew
- 15Certain natural disasters or other external events, including climate change or mechanical failures, could harm our business, financial condition, results of operations, cash flows, and prospectsNew
- 16We may be unable to deploy GPU infrastructure on the timelines committed to Microsoft, or at all, and any such delays in deployment or failure to deploy could result in significant financial penalties against us, contract termination, or loss of some or substantially all of our anticipated revenueNew
- 17As we invest in our expansion efforts, if we fail to effectively manage our growth, our business, financial condition and results of operations could be harmedNew
- 18Our level of debt in the future may negatively impact our liquidity, restrict our operations and ability to respond to business opportunities, and increase our vulnerability to adverse economic and industry conditionsNew
- 19Joint ventures, joint ownership arrangements and other projects pose unique challenges and we may not be able to fully implement or realize synergies, expected returns or other anticipated benefits associated with such projectsNew
- 20The loss of any of our management team, our inability to execute an effective succession plan, or our inability to attract and retain qualified personnel, could adversely affect our businessNew
- 21We may become involved in litigation arising in the ordinary course of our business that may materially adversely affect usNew
- 22Employee disputes or litigation and related unfavorable publicity may negatively affect our future business, financial condition, and operating resultsNew
- 23Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock priceNew
- 24including reputational harm and penalties, and could adversely affect our business, operating results, financial condition, and future prospectsNew
- 25Our inability to market and close the sale of our Legacy Ekso Business that is currently held for sale and treated as discontinued operations may have a material adverse impact on our business and financial conditionNew
Risks Related to Our Common Stock
- 26Our stock price may be subject to volatility; this volatility may affect your ability to, and the price at which you could, sell our common stockNew
- 27Future issuances of our equity securities may result in dilution to existing stockholders and could adversely affect the market price of our common stockNew
- 28We do not expect to declare or pay dividends in the foreseeable future, which may limit the return our shareholders realize on their investmentNew
- 29Provisions in our Articles (as defined below), our Bylaws (as defined below), and Nevada law may discourage a takeover attempt even if a takeover might be beneficial to our stockholdersNew
- 30We are currently a “smaller reporting company” and the reduced reporting requirements applicable to such companies may make our common stock less attractive to investors49% rewritten
Risks Related to our Legacy Ekso Business
- 31If we fail to manage the complex and lengthy reimbursement process, our Legacy Ekso Business and operating results could be adversely affected96% rewritten
- 32The 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
- 33If 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 Legacy Ekso Business could be negatively impacted
- 34We 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. There can be no assurance that we can do so on favorable terms, if at all
- 35Shortages in the materials used to manufacture our products and supply chain disruptions, including as a result of changes in trade policies, could impact our current operations98% rewritten
- 36Certain of our Legacy Ekso Business customers utilize federal funding to purchase our products, and recent federal policy changes have disrupted, and could continue to disrupt, that fundingNew
- 37Coverage policies and reimbursement levels of third-party payors, including VA, Medicare, Medicaid, and commercial payors may affect current demands for Legacy Ekso products99% rewritten
- 38We will experience long and variable sales cycles
- 39International sales of current Legacy Ekso products are subject to factors outside of our control98% rewritten
- 40We 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 Legacy Ekso Business revenue
- 41We rely on independent distributors for the sale and marketing of our products in certain geographies90% rewritten
- 42Shutdowns of the U.S. federal government could materially impair our Legacy Ekso Business and financial condition33% rewritten
- 43Protecting our intellectual proprietary rights can be costly, and our success in doing so is not certain100% rewritten
- 44Intellectual property litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products
- 45Some Legacy Ekso patents and patent applications are not within our complete control, which could reduce the value of those assets81% rewritten
- 46If 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
- 47Patent terms may be inadequate to protect our competitive position on our devices for an adequate amount of time
- 48If we fail to obtain or maintain necessary regulatory clearances or approvals for our Legacy Ekso medical device products, our Legacy Ekso Business could be harmed100% rewritten
- 49Our Legacy Ekso products and operations are subject to extensive government regulation and oversight in the United States and other countries where we commercialize our medical devices29% rewritten
- 50Modifications to our current and future Legacy Ekso 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
- 51We must obtain certain regulatory approvals in the EU, which could be costly and time-consuming and subject us to unanticipated delays or prevent us from marketing certain devices92% rewritten
- 52Our 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 facilities46% rewritten
- 53We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses
- 54We may be subject to adverse medical device reporting obligations, voluntary corrective actions or agency enforcement actions65% rewritten
- 55authority, which would be followed by further evaluation or investigation of the incident and a final report indicating whether further action is required. The events described above that were reported to the FDA were also reported to the relevant EU regulatory authoritiesNew
- 56Failure to comply with anti-kickback and fraud regulations could result in substantial penalties and changes in our business operations
- 57Changes 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
- 58Failure to comply with Health Insurance Portability and Accountability Act (HIPAA) or the HITECH Act and implementing regulations could result in significant penalties96% rewritten
- 59Our Legacy Ekso products may become subject to voluntary or involuntary recall
- 60Our product liability insurance may not adequately cover potential claims or recalls
- 61Warranty claims and maintenance obligations for current Legacy Ekso products could result in additional operating costsNew
Other ChronoScale Holdings 10-Ks
- FY2024 10-K risk factors58 risks
ChronoScale faces going concern doubts with $6.5M in cash and a $250.5M accumulated deficit. The business relies heavily on VA hospitals, DME suppliers, and third-party reimbursement for EksoNR and Ekso Indego products. Strict FDA, EU MDR, and debt covenants under the Banc of California agreement constrain operations.
Filed Mar 03, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.