5 unchanged sentences
Risks Related to Our Financial Position and Capital Requirements
−Removed: We were formed in August 2011 and are thus subject to the risks associated with new businesses.
−Removed: We were formed in August 2011 as a new business and, commencing from 2015, we entered the commercialization stage of our technology.
−Removed: As such, this limited operating history may not be adequate to enable you to fully assess our ability to develop commercialize and achieve market acceptance of the Dario digital platform.
−Removed: We commenced a commercial launch of the free Dario Smart Diabetes Management application in the United Kingdom in late 2013 and commenced an initial soft launch of the full Dario Smart Diabetes Management Solution (including the app and the Dario Blood Glucose Monitoring System) in selected jurisdictions in March 2014 with the goal of collecting customer feedback to refine our longer-term roll-out strategy and continued to scale up launch during 2014 in the United Kingdom, the Netherlands and New Zealand, in 2015 in Australia, Israel and Canada and in 2016 in the United States.
−Removed: These efforts have not generated sufficient revenues, and we will need to generate additional revenues over the next years.
−Removed: Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties, inherent in a new business and the development and sale of new medical devices and related software applications.
−Removed: As a result, we may be unable to fully develop, obtain regulatory approval for, commercialize, manufacture, market, sell and derive material revenues in the timeframes we project, if at all, and our inability to do so would materially and adversely impact our viability as a company.
−Removed: In addition, we still must establish many functions necessary to operate a business, including finalizing our managerial and administrative structure, continuing product and technology development, assessing and commencing our marketing activities, implementing financial systems and controls and personnel recruitment.
−Removed: Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their initial revenue generating stages, particularly those in the medical device and mobile health fields.
−Removed: In particular, potential investors should consider that there is a significant risk that we will not be able to:
−Removed: ● implement or execute our current business plan, or that our business plan is sound;
−Removed: ● maintain our management team and the Company’s board of directors (the “Board of Directors”);
−Removed: ● raise sufficient funds in the capital markets or otherwise to effectuate our business plan;
−Removed: ● determine that our technologies that we have developed are commercially viable;
−Removed: ● attract, enter into or maintain contracts with, and retain customers.
−Removed: In the event that we do not successfully address these risks, our business, prospects, financial condition, and results of operations could be materially and adversely affected.
Given our limited revenue and lack of positive cash flow, we will need to raise additional capital, which may be unavailable to us or, even if consummated, may cause dilution or place significant restrictions on our ability to operate.
−Removed: According to our management’s estimates, based on our current cash on hand and further based on our budget and the assumption that initial commercial sales will commence during our anticipated timeframes, we believe that we will have sufficient resources to continue our activities through 202 5 .
+Added: According to our management’s estimates, based on our current cash on hand and further based on our budget and the assumption related to our commercial sales, we believe that we will have sufficient resources to continue our activities for at least a period of twelve months from the date of the issuance of this 10K.
Since we might be unable to generate sufficient revenue or cash flow to fund our operations for the foreseeable future, we will need to seek additional equity or debt financing to provide the capital required to maintain or expand our operations.
We may also need additional funding for developing products and services, increasing our sales and marketing capabilities, and promoting brand identity, as well as for working capital requirements and other operating and general corporate purposes.
−Removed: Moreover, the regulatory compliance arising out of being a publicly registered company has dramatically increased our costs.
−Removed: We currently have a credit facility in place with Avenue Venture Opportunities Fund L.P.
−Removed: and Avenue Venture Opportunities Fund II, L.P.
−Removed: , of which $30 million was made available in May 2023.
−Removed: However, there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all.
−Removed: If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be materially adversely affected.
−Removed: As of December 31, 2024, we have drawn down $30 million of the credit facility.
+Added: Moreover, the regulatory compliance that comes with being a publicly registered company incurs significant costs.
If we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution.
1 unchanged sentence
Given our need for cash and that equity raising is the most common type of fundraising for companies like ours, the risk of dilution is particularly significant for stockholders of our company.
−Removed: Debt financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, could increase our expenses and require that our assets be provided as a security for such debt.
−Removed: Debt financing would also be required to be repaid regardless of our operating results.
−Removed: If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies or candidate products, or to grant licenses on terms that are not favorable to us.
+Added: Debt financing obtained by us involves agreements that include liens on our assets, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt.
+Added: This increases our expenses and requires that our assets be provided as security for such debt.
+Added: Debt financing must be repaid regardless of our operating results.
+Added: We currently have a credit facility in place, of which $32.5 million was made available in April 2025.
+Added: However, there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all.
+Added: If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and our financial condition may be materially adversely affected.
+Added: As of December 31, 2025, we have drawn down $32.5 million of the credit facility.
+Added: If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies or products, or to grant licenses on terms that are not favorable to us.
Funding from any source may be unavailable to us on acceptable terms, or at all.
4 unchanged sentences
We have financed our operations primarily through private placements, public offerings of common stock and certain credit facilities, and have incurred losses in each year since inception including net losses of $41,714,000 and $42,747,000 in 2025 and 2024, respectively.
−Removed: Our accumulated deficit at December 31, 2024 was approximately $390,343,000.
+Added: Our accumulated deficit as of December 31, 2025 was approximately $452,078,000.
We do not know whether or when we will become profitable.
−Removed: Our ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to commercialize our digital health engagement platform.
−Removed: We may be unable to achieve this goal.
−Removed: We may be subject to claims for rescission or damages in connection with certain sales of shares of our securities.
−Removed: In March 2016, the Securities and Exchange Commission declared effective a registration statement that we filed to cover 66,667 shares 76,667 warrants to purchase common stock, 76,667 shares of common stock underlying such warrants, and underwriters’ warrants to purchase up to 7,172 shares of common stock.
−Removed: Sales of approximately 2,778 shares of common stock, approximately 12,778 shares of common stock underlying warrants and approximately 1,278 shares of common stock underlying underwriters’ warrants may not have been made in accordance with Section 5 of the Securities Act of 1933, as amended.
−Removed: Accordingly, the purchasers of those securities may have rescission rights or be entitled to damages.
−Removed: The amount of such liability, if any, is uncertain.
−Removed: In the event that we are required to make payments to investors as a result of these unregistered sales of securities, our liquidity could be negatively impacted.
−Removed: Our revenues are concentrated with a major customer, and our revenues may decrease significantly if we were to lose our major customer.
−Removed: Due to our limited operating history, we have a limited customer base and have depended on a major customer for a significant portion of our revenue.
−Removed: As of December 31, 2024, our major customer accounted for 41.6% of our accounts receivable balance.
−Removed: If the customer were to terminate the agreement, or if we fail to adequately perform under the agreement, and if we are unable to diversify our customer base, our revenue could decline, and our results of operations could be adversely affected.
+Added: Our ability to achieve profitability depends on, among other things, our ability to grow our contracted member base, expand utilization among
+Added: existing customers, retain and renew contracts, manage operating expenses.
+Added: There can be no assurance that we will achieve or sustain profitability.
+Added: Our indebtedness under the Callodine loan facility subjects us to financial covenants and other restrictions that could adversely affect our liquidity, operational flexibility and financial condition.
+Added: In April 2025, we entered into a credit facility with Callodine Commercial Finance, LLC (“Callodine”) providing for borrowings of up to $50.0 million, of which $32.5 million was funded at closing.
+Added: In November 2025, we entered into an amendment to the facility that, among other things, reset certain financial covenants, waived financial covenant testing for the second and third quarters of 2025, modified liquidity requirements to include a $10.0 million minimum consolidated unencumbered liquid assets covenant, imposed enhanced reporting obligations under certain liquidity thresholds, increased the exit fee and clarified that a portion of the remaining availability under the facility is uncommitted and subject to the lenders’ discretion.
+Added: Our ability to access the remaining availability under the facility is subject to the achievement of specified revenue thresholds and other conditions.
+Added: The credit agreement contains financial and operational covenants and other restrictions that may limit our ability to incur additional indebtedness, grant liens, make investments, or engage in certain strategic transactions.
+Added: If we fail to comply with the covenants or other requirements under the loan facility, or if our operating performance does not meet required thresholds, the lenders could declare an event of default and accelerate repayment of outstanding amounts, which could materially adversely affect our liquidity and financial condition.
+Added: There can be no assurance that we would be able to obtain additional waivers, amendments or refinancing on acceptable terms, or at all.
+Added: In addition, the facility includes warrant coverage and a conversion feature that may result in dilution to our stockholders.
+Added: Our ability to service our indebtedness and comply with the terms of the credit agreement depends on our future operating performance and our ability to generate sufficient cash flow, which are subject to economic, competitive, regulatory and other factors beyond our control.
Risks Related to Our Business
−Removed: There is no assurance that our digital health engagement platform will succeed or be adopted by healthcare providers.
−Removed: Our product offering consists of our digital health engagement platform, where we digitally engage with Dario users, assist them in monitoring their chronic illnesses and provide them with coaching, support, digital communications, and real-time alerts, trends and pattern analysis.
−Removed: We expect that our digital health engagement platform may be leveraged by our potential partners, such as clinics, health care service providers, employers, and payers for scalable monitoring of people with diabetes in a cost-effective manner, which we expect will open for us additional revenue streams.
−Removed: While we have begun to execute agreements with employers and health plans in the United States, we have not yet seen wide adoption of our platform.
−Removed: Therefore, the success of our digital health engagement platform will depend entirely on our potential partners’ adoption of the platform and we cannot assure you that our potential partners will do so, or, if adopted, that they will continue to use the platform continually and for an extended period of time.
−Removed: If we cannot encourage potential partners to utilize our digital health engagement platform we may not succeed in marketing the product to our potential partners, the failure of which may materially and adversely affect our business and operating results.
−Removed: The success of our Dario product will depend on the acceptance of Dario in the healthcare market.
−Removed: Dario has been CE marked since 2013, enabling us to commercialize in 32 countries across Europe as well as in certain other countries worldwide.
−Removed: It was also approved by the regulatory authorities in Australia, New Zealand, Canada, Israel and South Africa, and most recently in December 2015, we received FDA clearance.
−Removed: As a result, we have a limited history of commercializing Dario and commenced selling Dario in the United States in 2016.
−Removed: We have limited experience engaging in commercial activities and limited established relationships with physicians and hospitals as well as third-party suppliers on whom we depend for the manufacture of our product.
−Removed: We are faced with the risk that the marketplace will not be receptive to Dario over competing products and that we will be unable to compete effectively.
−Removed: Factors that could affect our ability to establish Dario or any potential future product include:
−Removed: ● the development of products or devices which could result in a shift of customer preferences away from our device and services and significantly decrease revenue;
−Removed: ● the increased use of improved diabetes drugs that could encourage certain diabetics to test less often, resulting in less usage of a self-monitoring test device for certain types of diabetics;
−Removed: ● the challenges of developing (or acquiring externally-developed) technology solutions that are adequate and competitive in meeting the requirements of next-generation design challenges, including interoperability with various electronic health records;
−Removed: ● the significant number of current competitors in the BGMS market who have significantly greater brand recognition and more recognizable trademarks and who have established relationships with healthcare providers and payors;
−Removed: ● intense competition to attract acquisition targets, which may make it more difficult for us to acquire companies or technologies at an acceptable price or at all.
−Removed: We cannot assure you that Dario or any future product will gain broad market acceptance.
−Removed: If the market for Dario or any future product fails to develop or develops more slowly than expected, or if any of the technology and standards
−Removed: supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.
+Added: There is no assurance that our digital health engagement platform will succeed or achieve broad adoption by healthcare providers, employers, health plans or other enterprise customers.
+Added: Our product offering consists of our digital health engagement platform, which is designed to provide digital health solutions across cardiometabolic and behavioral health conditions, through which we digitally engage users, assist them in monitoring chronic conditions and provide coaching, support, digital communications, connected devices, data analytics and alerts.
+Added: We primarily generate revenue under a Business-to-Business-to-Consumer (“B2B2C”) model by contracting with employers, health plans and other enterprise customers, who in turn make our solutions available to their eligible members.
+Added: While we have entered into agreements with employers and health plans in the United States, enterprise adoption of digital health solutions is subject to lengthy sales cycles, budget constraints, procurement processes, clinical validation requirements and competitive evaluations.
+Added: In addition, even where contracts are executed, revenue realization depends on member eligibility, enrollment rates, engagement levels, utilization and contract renewals, all of which are outside our direct control.
+Added: Accordingly, the success of our platform depends on our ability to attract new enterprise customers, retain and expand existing customer relationships, demonstrate clinical and economic value, and achieve sufficient enrollment and sustained utilization by members.
+Added: We cannot assure that prospective customers will adopt our platform, that existing customers will renew or expand their contracts, or that eligible members will enroll in or continue to use our solutions at anticipated levels.
+Added: If adoption, enrollment, engagement or renewal rates are lower than expected, or if customers reduce the scope of their agreements, our revenue growth may be adversely affected, and our business, financial condition and operating results could be materially and adversely impacted.
We cannot accurately predict the volume or timing of any future sales, making the timing of any revenues difficult to predict.
−Removed: We may be faced with lengthy customer evaluation and approval processes associated with the adoption of our digital health engagement platform.
−Removed: Consequently, we may incur substantial expenses and devote significant management effort and expense in developing customer adoption of our platform which may not result in revenue generation.
+Added: We are often faced with lengthy customer evaluation and approval processes associated with the adoption of our digital health engagement platform.
+Added: Consequently, we incur substantial expenses and devote significant management effort and expense to developing customer adoption of our platform which may not result in revenue generation.
We must also obtain regulatory approvals of Dario in certain jurisdictions as well as approval for insurance reimbursement in order to initiate sales of Dario, each of which is subject to risk and potential delays, and neither of which may actually occur.
As such, we cannot accurately predict the volume or timing of any future sales.
−Removed: If Dario fails to satisfy current or future customer requirements, we may be required to make significant expenditures to redesign the product, and we may have insufficient resources to do so.
−Removed: Dario is designed to address an evolving marketplace and must comply with current and evolving customer requirements in order to gain market acceptance.
−Removed: There is a risk that Dario will not meet anticipated customer requirements or desires.
−Removed: If we are required to redesign our products to address customer demands or otherwise modify our business model, we may incur significant unanticipated expenses and losses, and we may be left with insufficient resources to engage in such activities.
−Removed: If we are unable to redesign our products, develop new products or modify our business model to meet customer desires or any other customer requirements that may emerge, our operating results would be materially adversely affected, and our business might fail.
We expect to derive substantially all of our revenues from our principal technology, which leaves us subject to the risk of reliance on such technology.
We expect to derive substantially all of our revenues from sales of products derived from our principal technology, which is our digital health engagement platform.
−Removed: Our initial product utilizing this technology is Dario.
As such, any factor adversely affecting sales of our digital health engagement platform, including the product release cycles, regulatory issues, market acceptance, product competition, performance and reliability, reputation, price competition and economic and market conditions, would likely harm our operating results.
1 unchanged sentence
We are dependent upon third-party manufacturers and suppliers, making us vulnerable to supply shortages and problems and price fluctuations, which could harm our business.
−Removed: We do not own or operate manufacturing facilities for clinical or commercial production of the Dario Blood Glucose Monitoring System, and we lack the resources and the capability to manufacture the Dario Blood Glucose Monitoring System on a commercial scale.
−Removed: Therefore, we rely on a limited number of suppliers who manufacture and assemble certain components of the Dario Blood Glucose Monitoring System.
+Added: We do not own or operate manufacturing facilities for commercial production of our products, and we lack the resources and the capability to manufacture our products on a commercial scale.
+Added: Therefore, we rely on a limited number of suppliers who manufacture and assemble certain components of our products.
Our suppliers may encounter problems during manufacturing for a variety of reasons, including, for example, failure to follow specific protocols and procedures, failure to comply with applicable legal and regulatory requirements, equipment malfunction and environmental factors, failure to properly conduct their own business affairs, and infringement of third-party intellectual property rights, any of which could delay or impede their ability to meet our requirements.
3 unchanged sentences
● we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;
−Removed: ● our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of the Dario Blood Glucose Monitoring System or cause delays in shipment;
+Added: ● our suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipment;
● we may have difficulty locating and qualifying alternative suppliers;
● switching components or suppliers may require product redesign and possibly submission to FDA, European Economic Area Notified Bodies, or other foreign regulatory bodies, which could significantly impede or delay our commercial activities;
−Removed: ● one or more of our sole- or single-source suppliers may be unwilling or unable to supply components of the Dario Blood Glucose Monitoring System;
+Added: ● one or more of our sole- or single-source suppliers may be unwilling or unable to supply components of our products;
● other customers may use fair or unfair negotiation tactics and/or pressures to impede our use of the supplier;
4 unchanged sentences
Given our reliance on certain single-source suppliers, we are especially susceptible to supply shortages because we do not have alternate suppliers currently available.
−Removed: We rely in part on a small group of third-party distributors to effectively distribute our products.
−Removed: We depend in part on medical device distributors for the marketing and selling of our products in certain territories in which we have launched product sales.
−Removed: We depend on these distributors’ efforts to market our products, yet we are unable to control their efforts completely.
−Removed: These distributors typically sell a variety of other, non-competing products that may limit the resources they dedicate to selling Dario.
−Removed: In addition, we are unable to ensure that our distributors comply with all applicable laws regarding the sale of our products.
−Removed: If our distributors fail to effectively market and sell Dario, in full compliance with applicable laws, our operating results and business may suffer.
−Removed: Recruiting and retaining qualified third-party distributors and training them in our technology and product offering requires significant time and resources.
−Removed: To develop and expand our distribution, we must continue to scale and improve our processes and procedures that support our distributors.
−Removed: Further, if our relationship with a successful distributor terminates, we may be unable to replace that distributor without disruption to our business.
−Removed: If we fail to maintain positive relationships with our distributors, fail to develop new relationships with other distributors, including in new markets, fail to manage, train or incentivize existing distributors effectively, or fail to provide distributors with competitive products on attractive terms, or if these distributors are not successful in their sales efforts, our revenue may decrease and our operating results, reputation and business may be harmed.
Failure in our online and digital marketing efforts could significantly impact our ability to generate sales.
−Removed: In several of our principal target markets, we utilize online and digital marketing in order to create awareness to Dario.
−Removed: Our management believes that using online advertisement through affiliate networks and a variety of other pay-for-performance methods will be superior for marketing and generating sales of Dario rather than utilizing traditional, expensive retail channels.
+Added: In several of our principal target markets, we utilize online and digital marketing in order to create awareness of Dario and our products.
+Added: Our management believes that using online advertisement through affiliate networks and a variety of other pay-for-performance methods is superior for marketing and generating sales of our products rather than utilizing traditional, expensive retail channels.
However, there is a risk that our marketing strategy could fail.
−Removed: Because we plan to use non-traditional retail sales tools and to rely on healthcare providers to educate our customers about Dario, we cannot predict the level of success, if any, that we may achieve by marketing Dario via the internet.
+Added: Because we use non-traditional retail sales tools and rely on healthcare providers to educate our customers about our products, we cannot predict the level of success, if any, that we may achieve by marketing our products via the Internet.
The failure of our online marketing efforts would significantly and negatively impact our ability to generate sales.
−Removed: Our Dario application, which is a key to our business model, is available via Apple’s App Store and via Google’s Android platforms and maybe in the future via additional platforms.
−Removed: If we are unable to achieve or maintain a good relationship with each of Apple and Google or similar platforms, or if the Apple App Store or the Google Play Store or any other applicable platform were unavailable for any prolonged period of time, our business will suffer.
−Removed: A key component of the Dario Solution is an iPhone or Android application which includes tools to help diabetic patients manage their disease.
−Removed: This application is compatible with Apple’s iOS and with Google’s Android platforms and may in the future become compatible via additional platforms.
−Removed: If we are unable to make our Dario Smart Diabetes Management application compatible with these platforms, or if there is any deterioration in our relationship with either Apple or Google or others after our application is available, our business would be materially harmed.
−Removed: We are subject to each of Apple’s and Google’s standard terms and conditions for application developers, which govern the promotion, distribution, and operation of games and other applications on their respective storefronts.
−Removed: Each of Apple and Google has broad discretion to change its standard terms and conditions, including changes which could require us to pay to have our Dario application available for downloading.
+Added: Our Dario applications, which are a key to our business model, are currently available on the Apple App Store and the Google Play Store.
+Added: If we are unable to achieve or maintain a good relationship with each of Apple and Google or similar platforms, or if the Apple App Store or the Google Play Store or any other applicable platform, which we may use in the future, become unavailable for any prolonged period of time, our business will be negatively impacted.
+Added: A key component of our available solutions are iPhone or Android applications, which include tools to help our customers and users manage their conditions.
+Added: These applications are compatible with Apple’s iOS and with Google’s Android platforms and may in the future become compatible via additional platforms.
+Added: If we are unable to make our Dario applications compatible with these platforms, or if there is any deterioration in our relationship with either Apple or Google or others platforms we may offer our applications on, our business would be materially harmed.
+Added: We are subject to each of Apple’s and Google’s standard terms and conditions for application developers, which govern the promotion, distribution, and operation of applications on their respective stores.
+Added: Each of Apple and Google has broad discretion to change its standard terms and conditions, including changes which could require us to pay to have our Dario applications available for downloading.
In addition, these standard terms and conditions can be vague and subject to changing interpretations by Apple or Google.
−Removed: We may not receive any advance warning of such changes.
−Removed: In addition, each of Apple and Google has the right to prohibit a developer from distributing its applications on its storefront if the developer violates its standard terms and conditions.
−Removed: In the event that either Apple or Google ever determines that we are in violation of its standard terms and conditions, including by a new interpretation, and prohibits us from distributing our Dario Management application on its storefront, it would materially harm our business.
−Removed: Additionally, we will rely on the continued function of the Apple App Store and the Google Play Store as digital storefronts where our Dario application may be obtained.
−Removed: There have been occasions in the past when these digital storefronts were unavailable for short periods of time or where there have been issues with the in-app purchasing functionality within the storefront.
−Removed: In the event that either the Apple App Store or the Google Play Store is unavailable or if in-app purchasing functionality within the storefront is non-operational for a prolonged period of time, it would have a material adverse effect on the ability of our customers to secure the Dario Smart Diabetes Management application, which would materially harm our business.
−Removed: We rely upon Software-as-a-Services, or SAAS, technologies from third parties to operate our business, and interruptions or performance problems with these technologies may adversely affect our business, financial condition and results of operations.
−Removed: We rely on hosted SaaS applications from third parties in order to operate critical functions of our business, including platform delivery, enterprise resource planning, customer relationship management, billing, project management and accounting and financial reporting.
−Removed: If these services become unavailable due to extended outages, interruptions or because they are no longer available on commercially reasonable terms, our expenses could increase, our ability to manage finances could be interrupted and our processes for managing sales of our platform and products and supporting our customers could be impaired until equivalent services, if available, are identified, obtained and implemented, all of which could adversely affect our business, financial condition and results of operations.
−Removed: The SaaS pricing model is evolving and our failure to manage its evolution and demand could lead to lower than expected revenue and profit.
−Removed: We derive most of our revenue growth from subscription offerings and, specifically, SaaS offerings.
−Removed: This business model depends heavily on achieving economies of scale because the initial upfront investment is costly and the associated revenue is recognized on a ratable basis.
−Removed: If we fail to achieve appropriate economies of scale or if we fail to manage or anticipate the evolution and demand of the SaaS pricing model, then our business and operating results could be adversely affected.
−Removed: Our results of operations may fluctuate significantly due to the timing of our recognition of SaaS revenues.
−Removed: We may experience volatility in our reported revenues and operating results due to the differences in timing of revenue recognition between our SaaS offerings and our traditional on-premise software and hardware sales.
−Removed: SaaS revenues are generally recognized ratably over the life of the subscriptions.
−Removed: In contrast, revenue from our on-premise
−Removed: software and hardware sales is generally recognized in full at the time of delivery.
−Removed: Accordingly, the SaaS delivery model creates risks related to the timing of revenue recognition not associated with our traditional on-premise software delivery model and hardware sales.
−Removed: A portion of our SaaS revenue results from the recognition of deferred revenue relating to subscription agreements entered into during prior reporting periods.
−Removed: A decline in new or renewed subscriptions in any period may not be immediately reflected in our reported financial results for that period, but may result in a decline in our revenue in future reporting periods.
−Removed: If any of our assumptions about revenue from our SaaS delivery model prove incorrect, our actual results may vary materially from those anticipated, estimated, or projected.
−Removed: Any damage, failure or disruption of our SaaS network infrastructure or data centers could impair our ability to effectively provide our solution, harm our reputation and adversely affect our business.
−Removed: Our SaaS network infrastructure is a critical part of our business operations.
−Removed: Our clients access our solution through standard web browsers, smart phones, tablets and other web-enabled devices and depend on us for fast and reliable access to our solution.
−Removed: We serve all of our clients from our data centers located in the United-States.
−Removed: Our SaaS network infrastructure and data centers are vulnerable to damage, failure and disruption.
−Removed: In the future, we may experience issues with our computing and communications infrastructure, or data centers caused by the following factors:
−Removed: • human error;
−Removed: • telecommunications failures or outages from third-party providers;
−Removed: • computer viruses or cyber-attacks;
−Removed: • break-ins or other security breaches;
−Removed: • acts of terrorism, sabotage, intentional acts of vandalism or other misconduct;
−Removed: • tornadoes, fires, earthquakes, hurricanes, floods and other natural disasters;
−Removed: • power loss;
−Removed: • other unforeseen interruptions or damages.
−Removed: If our SaaS network infrastructure or our clients’ ability to access our solution is interrupted, client and employee data from recent transactions may be permanently lost, and we could be exposed to significant claims by clients, particularly if the access interruption is associated with problems in the timely delivery of funds payable to employees or tax authorities.
−Removed: Further, any adverse changes in service levels at our data centers resulting from damage to or failure of our data centers could result in disruptions in our services.
−Removed: Any significant instances of system downtime or performance problems at our data centers could negatively affect our reputation and ability to attract new clients, prevent us from gaining new or additional business from our current clients, or cause our current clients to terminate their use of our solution, any of which would adversely impact our revenues.
−Removed: In addition, if our network infrastructure and data centers fail to support increased capacity due to growth in our business, our clients may experience interruptions in the availability of our solution.
−Removed: Such interruptions may reduce our revenues, cause us to issue refunds to clients or adversely affect our retention of existing clients, any of which could have a negative impact on our business, operating results or financial condition.
+Added: We may not receive any advance notice of such changes.
+Added: In addition, each of Apple and Google has the right to prohibit a developer from distributing its applications on its store if the developer violates its standard terms and conditions.
+Added: In the event that either Apple or Google ever determines that we are in violation of their standard terms and conditions, including by a new interpretation, and prohibits us from distributing our Dario applications on their store, it would materially harm our business.
+Added: Additionally, we will rely on the continued function of the Apple App Store and the Google Play Store as digital stores where our Dario applications may be obtained.
+Added: There have been occasions in the past when these digital stores were unavailable for short periods of time or where there have been issues with the in-app purchasing functionality within the store.
+Added: In the event that either the Apple App Store or the Google Play Store is unavailable or if in-app purchasing functionality within the stores is non-operational for a prolonged period of time, it would have a material adverse effect on the ability of our customers to secure the Dario applications, which would materially harm our business.
+Added: Our dependence on SaaS business model, third-party services and network infrastructure could adversely affect our business and results of operations.
+Added: Our business depends on the performance, availability, scalability and correct pricing of our SaaS offerings and related third-party and internal SaaS infrastructure, and any disruption, misalignment of pricing or demand, or revenue recognition impacts associated with our SaaS model could adversely affect our business, financial condition and results of operations.
+Added: We rely heavily on subscription-based SaaS offerings for a substantial portion of our revenue growth, and this model depends on achieving economies of scale because the initial upfront investments in infrastructure, implementation and customer acquisition are significant while associated revenues are recognized on a ratable basis over the subscription term.
+Added: If we fail to achieve appropriate economies of scale, or if we fail to anticipate or manage the evolution of SaaS pricing and packaging or customer demand for our SaaS solutions, our revenues, margins and overall operating results could be adversely affected.
+Added: In addition, our reported results may fluctuate due to the timing of revenue recognition under our SaaS delivery model.
+Added: SaaS revenues are generally recognized ratably over the life of the subscription or at engagement, and a meaningful portion of such revenues consists of the recognition of deferred revenues from prior periods.
+Added: As a result, a decline in new or renewed subscriptions in any period may not be immediately reflected in our financial results for that period, but may lead to lower revenues and operating income in future periods.
+Added: If our assumptions regarding customer adoption, renewal rates, usage patterns, or other inputs to our SaaS model prove incorrect, our actual results may differ materially from our expectations.
+Added: Our SaaS offerings also depend on both third-party hosted applications that support critical aspects of our operations - such as platform delivery, enterprise resource planning, customer relationship management, billing, project management, accounting and financial reporting - and on our own SaaS network infrastructure and data centers, which are vulnerable to damage, failure and disruption.
+Added: These systems and facilities could be affected by human error, telecommunications failures or outages (including from third-party providers), computer viruses or cyber-attacks, break-ins or other security incidents, acts of terrorism, sabotage or vandalism, natural disasters, power loss and other unforeseen events.
+Added: Any extended outage, degradation in performance, security breach or loss of data, or the unavailability of such services on commercially reasonable terms could interrupt or impair our ability to deliver our solutions, process and report financial information, manage sales and support functions, or otherwise operate our business.
+Added: Such events could damage our reputation, require us to provide service credits or refunds, increase our costs, delay or prevent us from gaining new or additional business from existing customers, or cause customers to reduce or terminate their use of our solutions, any of which could adversely affect our business, financial condition and results of operations.
Our products are subject to technological changes which may impact their use.
−Removed: Our Dario Blood Glucose Monitoring System is currently designed to be plugged into the Lighting jack for Apple devices or the USB-C jack for other mobile devices.
+Added: Our Dario Blood Glucose Monitoring System is currently designed to be plugged into the Lightning jack for Apple devices or the USB-C jack for other mobile devices.
As a result, our products are subject to future technological changes to mobile devices that may occur in the future.
−Removed: If we are unable to modify our products to keep pace with such technological changes, it would have a material adverse effect the ability of our customers to use our products, which would materially harm our business.
+Added: If we are unable to modify our products to keep pace with such technological changes, it would have a material adverse effect on the ability of our customers to use our products, which would materially harm our business.
As we conduct business internationally, we are susceptible to risks associated with international relationships.
−Removed: Outside of the United States, we operate our business internationally, presently in Europe, Australia and Canada.
+Added: Outside of the United States, we operate our business internationally, presently in Israel and India and offer our products in Europe, Canada, and Mexico.
The international operation of our business requires significant management attention, which could negatively affect our business if it diverts their attention from their other responsibilities.
In the event that we are unable to manage the complications associated with international operations, our business prospects could be materially and adversely affected.
−Removed: In addition, as a result of the crisis in Ukraine, both the United States and the EU have implemented sanctions against certain Russian individuals and entities, as well with respect to Belarus, and may impact the economic and political stability in the EU.
−Removed: If the EU experiences economic and political instability as a result of these current tensions, our business, including revenue, profitability and cash flows, and operations could be adversely affected.
+Added: In addition, ongoing geopolitical tensions and conflicts, including the Russia-Ukraine conflict and other regional conflicts, have resulted in sanctions, export controls, supply chain disruptions, and economic uncertainty in certain markets.
+Added: For example, the United States, the European Union and other jurisdictions have imposed sanctions against certain Russian and Belarusian individuals and entities.
+Added: Such geopolitical developments and related sanctions or trade restrictions may adversely affect economic and political stability in certain regions, including Europe, which could negatively impact our business, including our revenue, profitability, cash flows and operations.
In addition, doing business with foreign customers subjects us to additional risks that we do not generally face in the United States.
23 unchanged sentences
Specifically, the U.S.
−Removed: Dollar cost of our operations in Israel is influenced by any movements in the currency exchange rate of the New Israeli Shekel (NIS).
+Added: Dollar costs of our operations in Israel and India are influenced by any movements in the currency exchange rate of the New Israeli Shekel (“NIS”) and Indian Rupee, respectively.
Such movements in the currency exchange rate may have a negative effect on our financial results.
3 unchanged sentences
As exchange rates vary, sales and other operating results, when translated, may differ materially from our or the capital market’s expectations.
+Added: Changes in U.S.
+Added: laws or policies, including trade policies and tariffs, could adversely affect our business and results of operations.
+Added: Changes in U.S.
+Added: laws and policies, including those relating to international trade, tariffs, foreign affairs and healthcare regulation, could adversely affect our business, financial condition and results of operations.
+Added: Certain components of our solutions, including connected health devices and related materials, are sourced or manufactured
+Added: outside the United States.
+Added: As a result, tariffs, trade restrictions or other changes in trade policy could increase our costs, disrupt our supply chain, delay product availability or require modifications to our sourcing and logistics strategies.
+Added: In addition, evolving trade policies and geopolitical developments may create uncertainty in global markets and supply chains.
+Added: The extent and duration of any such policies, and their impact on our business and financial results, remain uncertain.
governments often impose strict price controls, which may adversely affect our future profitability.
−Removed: We intend to seek approval to market Dario and any future product in both the U.S.
+Added: We market our products in both the U.S.
and in non-U.S.
−Removed: jurisdictions.
−Removed: If we obtain approval in one or more non-U.S.
−Removed: jurisdictions, we will be subject to rules and regulations in those jurisdictions relating to our products.
+Added: jurisdictions and we may seek approval to market our products and any future product in additional jurisdictions.
+Added: We are subject to rules and regulations in those jurisdictions relating to our products.
In some countries, particularly countries of the European Union, each of which has developed its own rules and regulations, pricing may be subject to governmental control under certain circumstances.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a medical device candidate.
−Removed: To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available products.
+Added: To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical study that compares the cost-effectiveness of our product to other available products.
If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.
1 unchanged sentence
The Dario platform may contain undetected errors, defects or bugs.
−Removed: As a result, our customers or end users may discover errors or defects in our products, software or the systems we design, or the products or systems incorporating our designs and intellectual property may not operate as expected.
+Added: As a result, our customers or end users may experience errors or defects in our products, software or the systems we design, or the products or systems incorporating our designs and intellectual property may not operate as expected.
We may discover significant errors or defects in the future that we may not be able to fix.
1 unchanged sentence
In addition, we may utilize third-party technology or components in our products, and we rely on those third parties to provide support services to us.
−Removed: Failure of those third parties to provide necessary support services could materially adversely impact our business.
+Added: Failure of those third parties to provide necessary support services could have a significant negative impact on our business.
Our future performance will depend on the continued engagement of key members of our management team.
−Removed: Our future performance depends to a large extent on the continued services of members of our current management including, in particular, Erez Raphael, our Chief Executive Officer and a member of our Board of Directors and Zvi Ben David, our Chief Financial Officer, Treasurer and Secretary.
+Added: Our future performance depends largely on the continued services of members of our current management including, in particular, Erez Raphael, our Chief Executive Officer and a member of our Board of Directors, Steven Nelson, our Chief Commercial Officer and President, and Chen Franco-Yehuda, our Chief Financial Officer, Treasurer and Secretary.
In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse effect on our business, operations, and prospects.
−Removed: If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully.
−Removed: We believe that our management team must be able to act decisively to apply and adapt our business model in the rapidly changing markets in which we will compete.
−Removed: In addition, we will rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business.
−Removed: Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel.
−Removed: In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher compensation payments would have a negative effect on our operating results.
+Added: If we are unable to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully.
+Added: We believe that our management team must be able to act decisively to apply and adapt our business model in the rapidly changing markets in which we compete.
+Added: In addition, we rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business.
+Added: Consequently, we believe that our future viability will continue to depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel.
+Added: In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently do, and such higher compensation payments would have a negative effect on our operating results.
Competition for experienced, high-quality personnel is intense and we cannot assure that we will be able to recruit and retain such personnel.
−Removed: We may not be able to hire or retain the necessary personnel to implement our business strategy.
+Added: We may not be able to hire or retain the necessary personnel to continue implementing our business strategy.
Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively.
−Removed: We may not generate the expected benefits of our acquisition of Twill.
−Removed: Through our acquisitions of Twill, we expanded our product offering to include digital-first solutions with a mission to improve users mental and physical health.
−Removed: There can be no assurance that these acquisitions will provide the benefits we expect or that we will be able to develop the operations of Twill successfully.
−Removed: Any failure to do so could have a material adverse effect on our business, operating results and financial condition.
+Added: Our strategic review process may not result in a transaction and may create additional risks and uncertainties for our business.
+Added: In September 2025, we announced that our Board of Directors is conducting a strategic review of alternatives to maximize shareholder value, following multiple unsolicited inbound expressions of interest.
+Added: In relation to this review, our Board of Directors established the Special Committee of independent directors and engaged Perella Weinberg Partners as our financial advisor to assist with this process.
+Added: There can be no assurance that this strategic review process will result in the execution of a definitive agreement for any transaction, or that we will pursue or complete any particular strategic alternative.
+Added: The timing, structure, scope and outcome of the strategic review process are uncertain, and our Board of Directors may determine at any time to suspend, modify or terminate the process.
+Added: The strategic review process may also be disruptive to our business operations.
+Added: The attention of our management team and other employees may be diverted from day-to-day operations and the execution of our business strategy while the review process is ongoing.
+Added: In addition, uncertainty regarding the outcome of the process may adversely affect our ability to attract, retain and motivate key employees, including members of management and technical personnel who are critical to our operations.
+Added: Uncertainty surrounding the strategic review may also cause our customers, partners, suppliers and other business counterparties to delay, defer or reconsider their business relationships with us, which could negatively affect our revenue, operating results and growth prospects.
+Added: In addition, the process may result in the incurrence of substantial costs, including advisory, legal and other professional fees, regardless of whether any transaction is ultimately completed.
+Added: Even if a definitive agreement is executed in connection with the strategic review process, the consummation of such a transaction would be subject to various closing conditions, including stockholder approval, which may not be obtained.
+Added: If a proposed transaction is not approved by our stockholders or otherwise fails to close, our stock price may decline, we may experience increased volatility in our stock price and we might incur substantial costs and management distraction without realizing any benefits.
+Added: Our outcomes-based contracts and reimbursement arrangements may not achieve expected results and may expose us to financial and operational risks.
+Added: We enter into outcomes-based agreements with certain customers and payers that include performance guarantees, claims-based billing, or other arrangements in which reimbursement or payment is tied to specific clinical or economic outcomes.
+Added: These arrangements expose us to the risk that we may not achieve, accurately measure, or be able to verify the expected outcomes, including cost savings, improvements in patient health, or return on investment.
+Added: If we fail to meet the specified outcomes, we may be required to provide financial concessions, rebates, or other remedies under the terms of the agreements.
+Added: Any such events could materially adversely affect our business, financial condition, results of operations, and cash flows.
+Added: Furthermore, because many of our contracts emphasize projected savings or ROI, the presentation of these results in our business section should not be interpreted as a guarantee of future performance.
+Added: Actual outcomes may differ materially from projections, and our ability to deliver such outcomes depends on multiple factors, including patient adherence, provider engagement, regulatory approvals, and third-party payer practices.
Risks Related to Product Development and Regulatory Approval
−Removed: The regulatory clearance process which we must navigate is expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for the commercialization of Dario or our any future product.
−Removed: We are not permitted to market Dario in any jurisdiction until we receive marketing authorization from the applicable regulatory authority.
−Removed: To date, we have received regulatory authorization in Australia, Canada, Israel, Italy, the Netherlands, New Zealand, the United Kingdom, and the United States.
+Added: The regulatory clearance process which we must navigate is expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for the commercialization of our current or any future product.
+Added: We are not permitted to market our medical device products in any jurisdiction until we receive marketing authorization from the applicable regulatory authority.
+Added: To date, we have received regulatory authorization in Australia, Canada, Israel and the United States.
The research, design, testing, manufacturing, labeling, selling, marketing and distribution of medical devices are subject to extensive regulation by the FDA and non-U.S.
3 unchanged sentences
Obtaining authorization for a device in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory authorization in one country may negatively impact the regulatory process in others.
−Removed: There can be no assurance that even after such time and expenditures, we will be able to obtain necessary regulatory approvals for clinical testing or for the manufacturing or marketing of any products.
+Added: There can be no assurance that even after such time and expenditures, we will be able to obtain necessary regulatory approvals for clinical trials or for the manufacturing or marketing of any products.
In addition, during the regulatory process, other companies may develop other technologies with the same intended use as our products.
8 unchanged sentences
● imposing operating restrictions, suspension or shutdown of production;
−Removed: ● refusing our requests for marketing authorization of new products, new intended uses or modifications to Dario or future products;
+Added: ● refusing our requests for marketing authorization of new products, new intended uses or modifications to our current or future products;
● suspending or withdrawing marketing authorizations that have already been granted;
1 unchanged sentence
The occurrence of any of these events may have a material adverse effect on our business, financial condition and results of operations.
−Removed: We have conducted limited clinical trials of Dario.
+Added: We have conducted limited clinical trials of certain of our solutions.
Clinical and nonclinical data is susceptible to varying interpretations, which could delay, limit or prevent additional regulatory clearances.
−Removed: To date, we have conducted limited clinical trials on Dario.
+Added: To date, we have conducted limited clinical trials on certain of our solutions.
There can be no assurance that we will successfully complete additional clinical trials necessary to receive additional regulatory approvals in certain jurisdictions.
−Removed: While studies conducted by us have produced results we believe to be encouraging and indicative of the potential efficacy of Dario, data already obtained, or in the future obtained, from nonclinical studies and clinical trials do not necessarily predict the results that will be obtained from later nonclinical studies or clinical trials.
−Removed: Moreover, nonclinical and clinical data are susceptible to varying interpretations, which could delay, limit or prevent additional regulatory approvals.
−Removed: A number of companies in the medical device and pharmaceutical industries have suffered significant setbacks in advanced clinical trials, even after promising results in earlier studies.
−Removed: If we fail to adequately demonstrate the safety and effectiveness of a product candidate under development, it could delay or prevent regulatory authorization of the device, resulting in delays to commercialization, and could materially harm our business.
−Removed: Even though we have received CE mark and FDA clearance of Dario, there can be no assurance that we will be able to receive authorization for other potential applications of our principal technology, or that we will receive regulatory authorizations from other targeted regions or countries.
−Removed: We may be unable to complete required clinical trials, or we may experience significant delays in completing such clinical trials, which could significantly delay our targeted product launch timeframe and impair our viability and business plan.
−Removed: The completion of any future clinical trials for Dario or other trials that we may be required to undertake in the future could be delayed, suspended or terminated for several reasons, including:
−Removed: ● delay or failure in reaching agreement with regulatory authorities on a trial design that we are able to execute;
−Removed: ● delay or failure in obtaining authorization to commence a trial, including approval from the appropriate IRB to conduct testing of a product candidate on human subjects, or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;
−Removed: ● delay in reaching, or failure to reach, agreement on acceptable terms with prospective contract research organizations and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
−Removed: ● failure or inability to conduct the clinical trial in accordance with regulatory requirements;
−Removed: ● sites participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial;
−Removed: ● failure to initiate or delay of or inability to complete a clinical trial as a result of a clinical hold imposed by a regulatory authority due to observed safety findings or other reasons;
−Removed: ● delays that we may experience in patient enrollment or completion of certain trials;
−Removed: ● patients may not enroll in, remain in or complete, the clinical trial at the rates we expect;
−Removed: ● clinical investigators may not perform our clinical trial on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices.
−Removed: In addition, the U.S.
−Removed: Congress recently amended the FDCA to require sponsors of any pivotal study to support marketing authorization of a medical device to design and submit a diversity action plan for such clinical trial.
−Removed: The action plan must describe appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how
−Removed: the sponsor will meet them.
−Removed: For any future pivotal studies involving our device products or product candidates, we must submit a diversity action plan to the FDA by the time a pivotal study protocol is submitted to the agency for review, as applicable, unless we are able to obtain a waiver for some or all of the requirements for a diversity action plan.
−Removed: It is unknown at this time how the diversity action plan may affect the planning and timing of any future pivotal study for our products or product candidates or what specific information FDA will expect in such plan.
−Removed: However, initiation of such studies may be delayed if the FDA objects to a proposed diversity action plans for any future pivotal study of our product candidates, and we may experience difficulties recruiting a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.
−Removed: If our ongoing or future clinical trials are delayed it will take us longer to further commercialize Dario and generate additional revenues.
−Removed: Moreover, our development costs will increase if we have material delays in our clinical trial or if we need to perform more or larger clinical trials than planned.
−Removed: We may be faced with similar risks in connection with future trials we conduct.
−Removed: See “Business - Clinical Trials” for a description of our clinical trials performed to date.
−Removed: If we or our manufacturers fail to comply with the FDA’s Quality System Regulation or any applicable state equivalent, our operations could be interrupted, and our operating results could suffer.
+Added: If we fail to adequately demonstrate the safety and effectiveness of a product under development, it could delay or prevent regulatory authorization of the device, resulting in delays to commercialization, and could materially harm our business.
+Added: Even though we have received FDA clearance for our blood glucose monitoring system (“BGMS”) product, there can be no assurance that we will be able to receive authorization for other potential applications of our principal technology, or that we will receive regulatory authorizations from other targeted regions or countries.
+Added: If we or our manufacturers fail to comply with the FDA’s Quality System Regulation, pre-market notifications, or any applicable state equivalent, our operations could be interrupted, and our operating results could suffer.
We, our manufacturers, and suppliers must, unless specifically exempt by regulation, follow the FDA’s QSR, as well as similar regulations of foreign jurisdictions regarding the manufacturing process.
−Removed: In addition, we and certain of our manufacturers and suppliers are subject to inspection by regulatory authorities to assess regulatory compliance from time to time and may not be able to demonstrate adequate compliance with applicable regulations.
+Added: In addition, we and certain of our
+Added: manufacturers and suppliers are subject to inspection by regulatory authorities to assess regulatory compliance from time to time and may not be able to demonstrate adequate compliance with applicable regulations.
If we, our affiliates, our manufacturers or suppliers are found to be in significant non-compliance or fail to take satisfactory corrective action in response to adverse inspectional findings, the FDA or other applicable regulatory authority could take enforcement actions against us and our manufacturers which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands.
Accordingly, our operating results could suffer.
−Removed: We are subject to the risk of reliance on third parties to conduct our clinical trial work.
−Removed: We depend on independent clinical investigators to conduct our clinical trials.
−Removed: Contract research organizations may also assist us in the collection and analysis of data.
−Removed: These investigators and contract research organizations will not be our employees and we will not be able to control, other than by contract, the number of resources, including the time that they devote to products that we develop.
−Removed: Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the investigators or contract research organizations does not relieve us of our regulatory responsibilities.
−Removed: If the independent investigators or contract research organizations fail to devote sufficient resources to our clinical trials, or if their performance is substandard, it will delay the approval or clearance and commercialization of any products that we develop.
−Removed: Further, the FDA and other regulatory bodies around the world require that we comply with GCP standards for conducting, recording and reporting clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
−Removed: If our independent clinical investigators and contract research organizations fail to comply with GCP, the results of our clinical trials could be called into question and the clinical development of our product candidates could be delayed.
−Removed: Failure of clinical investigators or contract research organizations to meet their obligations to us or comply with federal regulations could adversely affect the clinical development of our product candidates and harm our business.
−Removed: Moreover, we intend to conduct several clinical trials in order to support our marketing efforts and business development purposes.
−Removed: Such clinical trials will be conducted by third parties as well.
−Removed: Failure of such clinical trials to meet their primary endpoints could adversely affect our marketing efforts.
−Removed: If any of our relationships with the investigators or contract research organizations conducting our ongoing or future trials terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all.
−Removed: Entering into arrangements with alternative contract research organizations, trial investigators or other third parties involves additional cost and requires management focus and time, in addition to requiring a transition period when a new contract research organization, trial investigator or other third party begins work.
−Removed: If third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any clinical trials such third parties are associated with may be extended,
−Removed: delayed or terminated, and we may not be able to obtain marketing authorization for or successfully commercialize our product candidates.
−Removed: Because we have relied on third parties to conduct our clinical trials, our internal capacity to perform these functions is limited.
−Removed: Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all.
−Removed: In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated.
−Removed: To the extent we are unable to identify and successfully manage the performance of third-party service providers in the future, our business may be adversely affected.
−Removed: Though we carefully manage our relationships with our contract research organizations and investigators, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
−Removed: Recent initiatives by the FDA to enhance and modernize various regulatory pathways for device products and its overall approach to safety and innovation in the medical technology industry creates the possibility of changing product development costs, requirements, and other factors and additional uncertainty for our future products and business.
+Added: FDA initiatives to enhance and modernize various regulatory pathways for device products and its overall approach to safety and innovation in the medical technology industry create the possibility of changing product development costs, requirements, and other factors and additional uncertainty for our future products and business.
Regulatory requirements may change in the future in a way that adversely affects us.
4 unchanged sentences
For example, in December 2022, the Congress enacted the Consolidated Appropriations Act for 2023, an omnibus appropriations bill, which included amendments to the FDCA under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”).
−Removed: In addition to the requirement that sponsors of pivotal trials submit diversity action plans for pivotal trials (see “ Government Regulation—Clinical Trials ”), FDORA included new requirements for cyber devices, defined as any medical device that is or includes software that is validated, installed, or authorized by the manufacturer;
+Added: The FDORA included new requirements for cyber devices, defined as any medical device that is or includes software that is validated, installed, or authorized by the manufacturer;
can connect to the internet;
and may be vulnerable to cybersecurity threats.
−Removed: Under the FDORA amendments to the FDCA, any application for marketing authorization of the cyber device must include a software bill of materials and a cybersecurity plan describing the methods by which the manufacturer will monitor, identify and address cybersecurity vulnerabilities.
−Removed: Any failure by a cyber device manufacturer to comply with applicable cybersecurity requirements is considered a violation of the FDCA and will subject the manufacturer to enforcement actions and possibly legal sanctions.
+Added: Additionally, under the FDORA amendments to the FDCA, any application for marketing authorization of the cyber device, such as our applications, must include a software bill of materials and a cybersecurity plan describing the methods by which the manufacturer will monitor, identify and address cybersecurity vulnerabilities.
+Added: Any failure by a cyber device manufacturer to comply with applicable cybersecurity requirements is considered a violation of the FDCA and is subject the manufacturer to enforcement actions and possibly legal sanctions.
Further regulatory efforts by the FDA or other federal or state regulatory authorities could lead to new, onerous cybersecurity requirements in the future as well as additional product liability or other litigation risks if any of our products is considered to be susceptible to third-party tampering.
−Removed: In addition, Congress passed the 21st Century Cures Act in December 2016, which made multiple changes to the FDA’s rules for medical devices as well as for clinical trials, and the Medical Device User Fee reauthorization package in September 2022, which affects medical device regulation both pre- and post-approval and could have certain impacts on our business.
−Removed: In recent years, the FDA has also considered a series of efforts to modernize and streamline the 510(k) notification and regulatory review process and monitoring post-market safety.
−Removed: For example, as of October 2023, all 510(k) applications (unless specifically exempted) must be submitted to the FDA electronically using the electronic submission template and resource, or eSTAR, and the Center for Devices and Radiological Health (“CDRH”) Portal.
−Removed: Further changes in the FDA 510(k) process could make clearance more difficult to obtain, increase delay, add uncertainty and have other significant adverse effects on our ability to obtain and maintain clearance for our products.
−Removed: Furthermore, the FDA issued a Final Rule on February 2, 2024 describing amendments to harmonize the QSR with ISO 13485:2016, which will become effective on February 2, 2026.
−Removed: The harmonization process is not expected to have a significant impact on the quality system compliance operations of device manufacturers because most requirements
−Removed: described in the QSR correspond to requirements set forth in ISO 13485:2016.
−Removed: However, device manufacturers will likely need to revise certain quality system procedures to ensure compliance with the harmonized regulations and any failure by us or our third-party manufacturers to make such revisions or adapt to the harmonized regulations, once they become effective, may result in observations of noncompliance during facility inspections by the FDA or comparable regulatory authorities.
+Added: Furthermore, the FDA issued a Final Rule on February 2, 2024 describing amendments to harmonize the QSR with ISO 13485:2016, which became effective on February 2, 2026.
+Added: The harmonization process is not expected to have a significant impact on the quality system compliance operations of device manufacturers because most requirements described in the QSR correspond to requirements set forth in ISO 13485:2016.
Broad-based domestic and international government initiatives to reduce spending, particularly those related to healthcare costs, may reduce reimbursement rates for medical procedures, or make it more difficult for customers to purchase our products and services, all of which could adversely affect our business.
1 unchanged sentence
healthcare system and both domestic and foreign healthcare cost containment legislation, and any future changes to such legislation, may affect demand for our products and services and may have a material adverse effect on our financial condition and results of operations.
−Removed: Reforms implemented under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, (the “ACA”) in the United States, as well as state-level healthcare reform proposals, could reduce medical procedure volumes and impact the demand for medical device products or the prices at which we can sell products.
+Added: Reforms implemented under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, (“ACA”) in the United States, as well as state-level healthcare reform proposals, could reduce medical procedure volumes and impact the demand for medical device products or the prices at which we can sell products.
The impact of healthcare reform legislation, and practices including price regulation, competitive pricing, comparative effectiveness of therapies, technology assessments, and managed care arrangements are uncertain.
−Removed: There can be no assurance that current levels of reimbursement will not be decreased in the future, or that future legislation, regulation, or reimbursement policies of third parties will not adversely affect the demand for our products and services or our ability to sell products and provide services on a profitable basis.
+Added: There can be no assurance that current levels of reimbursement will not be decreased in the future, or that future legislation, regulation, or reimbursement policies of third parties will not adversely affect the demand for our products and services or our ability to sell products and provide
+Added: services on a profitable basis.
The adoption of significant changes to the healthcare system in the United States, the EEA or other jurisdictions in which we may market our products and services, could limit the prices we are able to charge for our products and services or the amounts of reimbursement available for our products and services, could limit the acceptance and availability of our products and services, reduce medical procedure volumes and increase operational and other costs.
5 unchanged sentences
Individual states in the United States have also become increasingly active in implementing regulations designed to control healthcare product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation of healthcare products from other countries.
−Removed: Additionally, third-party payors and governmental authorities have become increasingly interested in reference pricing systems and publication of discounts and list prices.
+Added: Additionally, third-party payors and government authorities have become increasingly interested in reference pricing systems and publication of discounts and list prices.
We are subject to federal, state and foreign laws prohibiting “kickbacks” and false or fraudulent claims, and other fraud and abuse laws, transparency laws, and other healthcare laws and regulations, which, if violated, could subject us to substantial penalties.
Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
−Removed: Our relationships with customers and third-party payors are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and certain customer and product support programs, we may
−Removed: have with hospitals, physicians or other purchasers of medical devices.
+Added: Our relationships with customers and third-party payors are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and certain customer and product support programs, we may have with hospitals, physicians or other purchasers of medical devices.
Other federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or are for items or services that were not provided as claimed.
5 unchanged sentences
Department of Health and Human Services (HHS-OIG), CMS, and the Department of Justice, or may be subject to whistleblower lawsuits under federal and state false claims laws.
−Removed: Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of Dario or our potential future products.
+Added: Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of our current products or our potential future products.
These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance rates.
−Removed: If Dario or any of our future products are defectively designed or manufactured, contain defective components, or are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.
−Removed: Misusing our device or failing to adhere to the operating guidelines or the device producing inaccurate meter readings could cause significant harm to patients, including death.
+Added: If our current products or any of our future products are defectively designed or manufactured, contain defective components, or are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.
+Added: Misusing our device or failing to adhere to the operating guidelines or any devices not functioning as intended, could cause significant harm to patients, including death.
In addition, if our operating guidelines are found to be inadequate, we may be subject to liability.
4 unchanged sentences
If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
−Removed: Part of our business plan includes the storage and potential monetization of medical data of users of Dario.
−Removed: There are a number of federal and state laws protecting the confidentiality of certain patient health information, including patient records, and restricting the use and disclosure of that protected information.
+Added: Part of our business operations includes the handling of medical data of users of our products.
+Added: There are a number of federal and state laws protecting the confidentiality of certain patient health and personal information, including patient records, and restricting the use and disclosure of that protected information.
In particular, the U.S.
6 unchanged sentences
states and foreign countries have implemented their own data protection laws, some of which may apply simultaneously and conflict with U.S.
−Removed: Many of these laws create consumer rights including the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request that a company delete personal information collected, the right to opt-out of the sale of personal information and the right to non-discrimination in terms
−Removed: of price or service when a consumer exercises a privacy right.
+Added: Many of these laws create consumer rights including the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request that a company delete personal information collected, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right.
If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance.
8 unchanged sentences
Data Privacy Framework.
−Removed: If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties and amounts could be significant.
+Added: If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties in amounts that could be significant.
Our employees, independent contractors, consultants, manufacturers and suppliers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
8 unchanged sentences
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally.
−Removed: Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.
−Removed: Although we have a code of business conduct and ethics, it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
+Added: Although we have a code of conduct, it is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other government healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations.
Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition and results of operations.
+Added: Our use of AI and machine learning, including in DarioIQ and DarioSHIFT, exposes us to risks related to model accuracy, bias, privacy, intellectual property, cybersecurity, third-party dependencies, evolving regulation, and reputational harm, any of which could materially adversely affect our business, results of operations, or stock price.
+Added: We incorporate AI and machine learning technologies into aspects of our platform, including DarioIQ, DarioSHIFT, our proprietary data assets, and certain decision-support capabilities.
+Added: The development and use of AI technologies present significant operational, legal and reputational risks.
+Added: AI models may produce inaccurate, unreliable, incomplete or misleading outputs, including so-called “hallucinations,” and their performance may be affected by data quality, training methodologies and real-world deployment conditions.
+Added: If our AI-enabled tools generate incorrect analyses or recommendations, our products may be less effective, which could adversely affect user outcomes, customer trust and our reputation.
+Added: AI systems may also reflect or amplify biases present in training data or algorithms, which could lead to unintended or discriminatory outcomes and expose us to regulatory scrutiny, litigation, or reputational harm.
+Added: Our AI capabilities rely on large datasets, including proprietary and third-party data, and the use of such data may raise privacy, data protection and intellectual property risks, including allegations that our models improperly use, reproduce or derive value from protected data or content.
+Added: In addition, we may rely on third-party models, tools and infrastructure to develop or operate certain AI capabilities.
+Added: These dependencies may introduce cybersecurity vulnerabilities, performance limitations, licensing restrictions or service disruptions outside of our control.
+Added: The legal and regulatory framework governing AI is rapidly evolving, and new or changing laws, regulations or industry standards may increase our compliance costs, require modifications to our technologies or business practices, or restrict our ability to develop or deploy certain AI capabilities.
+Added: Any of these factors could adversely affect our business, financial condition, results of operations and reputation.
Risks Related to Our Intellectual Property
The failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively.
−Removed: In order for our business to be viable and to compete effectively, we need to develop and maintain, and we will heavily rely on, our proprietary position with respect to our technologies and intellectual property.
−Removed: We filed a PCT application for a “Fluids Testing Apparatus and Methods of Use” in May 2011 which incorporates two U.S.
−Removed: provisional applications submitted in the preceding year.
−Removed: The PCT covers the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids and has subsequently been converted into several national phase patent applications.
−Removed: We have also filed patent applications for other aspects of the Dario Blood Glucose Monitoring Solution.
−Removed: We have also obtained numerous Web domains.
−Removed: However, to date, we have only been issued four patents (three of which were issued in the United States) relating to how the Dario Blood Glucose Monitoring System draws power from and transmits data to a smartphone via the audio jack port.
−Removed: None of our other patents have been granted by a patent office.
+Added: In order for our business to be viable and to compete effectively, we need to maintain and continue to develop, and we heavily rely on, our proprietary position with respect to our technologies and intellectual property.
+Added: To date, we have eleven patents, three of which were issued in the United States, relating to how the Dario Blood Glucose Monitoring System draws power from and transmits data to a smartphone via the audio jack port.
+Added: Our other patents were acquired through the acquisitions of other companies.
In addition, there are significant risks associated with our actual or proposed intellectual property.
−Removed: The risks and uncertainties that we face with respect to our pending patent and other proprietary rights principally include the following:
+Added: The risks and uncertainties that we face with respect to our pending patents and other proprietary rights principally include the following:
● pending patent applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued patents;
7 unchanged sentences
● enforcement of patents is complex, uncertain and very expensive.
−Removed: We cannot be certain that patents will be issued as a result of any of our pending or future applications, or that any of our patents, once issued, will provide us with adequate protection from competing products.
+Added: We cannot be certain that patents will be issued as a result of any of our pending or future applications, or that any of our future patents, once issued, will provide us with adequate protection from competing products.
For example, issued patents may be circumvented or challenged, declared invalid or unenforceable, or narrowed in scope.
In addition, since the publication of discoveries in scientific or patent literature often lags behind actual discoveries, we cannot be certain that we were the first to make our inventions or to file patent applications covering those inventions.
−Removed: It is also possible that others may have or may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses requiring the payment of significant fees or royalties in order to enable us to conduct our business.
+Added: It is also possible that others may have or may obtain issued patents that could prevent us from commercializing future products or require us to obtain licenses requiring the payment of significant fees or royalties in order to enable us to conduct our business.
As to those patents that we have licensed, our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so.
1 unchanged sentence
We may face significant expense and liability as a result of litigation or other proceedings relating to patents and intellectual property rights of others.
−Removed: In the event that another party has also filed a patent application or been issued a patent relating to an invention or technology claimed by us in pending applications, we may be required to participate in
−Removed: an interference proceeding declared by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.
+Added: In the event that another party has also filed a patent application or been issued a patent relating to an invention or technology claimed by us in pending applications, we may be required to participate in an interference proceeding declared by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.
We, or our licensors, also could be required to participate in interference proceedings involving issued patents and pending applications of another entity.
25 unchanged sentences
We rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third parties using our intellectual property to compete against us.
−Removed: Although we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to
−Removed: require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them, the agreements can be difficult and costly to enforce.
−Removed: Although we seek to enter into these types of agreements with our contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.
+Added: Although we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them, the agreements can be difficult and costly to enforce.
+Added: Although we seek to enter into these types of agreements with our employees, contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.
If a dispute arises, a court may determine that the right belongs to a third party.
−Removed: In addition, enforcement of our rights can be costly and unpredictable.
+Added: In addition, enforcement of our rights can
+Added: be costly and unpredictable.
We also rely on trade secrets and proprietary know-how that we seek to protect in part by confidentiality agreements with our employees, contractors, consultants, advisors or others.
5 unchanged sentences
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
−Removed: We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor.
−Removed: For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates.
+Added: We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as inventors or co-inventors.
+Added: For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product.
Litigation may be necessary to defend against these and other claims challenging inventorship.
2 unchanged sentences
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
−Removed: In addition, the Israeli Supreme Court ruled in 2012 that an employee who receives a patent or contributes to an invention during his employment may be allowed to seek compensation for such contributions from his or her employer, even if the employee’s contract of employment specifically states otherwise and the employee has transferred all intellectual property rights to the employer.
−Removed: The Israeli Supreme Court ruled that the fact that a contract revokes an employee’s right for royalties and compensation, does not rule out the right of the employee to claim their right for royalties.
−Removed: As a result, it is unclear whether and, if so, to what extent our employees may be able to claim compensation with respect to our future revenue.
−Removed: We may receive less revenue from future products if any of our employees successfully claim for compensation for their work in developing our intellectual property, which in turn could impact our future profitability.
+Added: In addition, under the Israeli Patents Law, 1967, inventions created by employees in the course of their employment are generally considered “service inventions” and are owned by the employer.
+Added: However, Israeli law provides that employees may be entitled to compensation for service inventions, even if the employee has assigned all intellectual property rights to the employer under an employment agreement.
+Added: The Israeli Supreme Court has ruled that contractual provisions purporting to waive an employee’s right to compensation may not necessarily prevent such claims.
+Added: As a result, it is uncertain whether, and to what extent, our employees may be entitled to additional compensation in connection with inventions developed during their employment with us.
+Added: Any such claims could result in additional payments to employees and could adversely affect our results of operations.
Risks Related to Our Industry
−Removed: We face intense competition in the digital support solution and the self-monitoring of blood glucose market, and as a result we may be unable to effectively compete in our industry.
−Removed: In recent years, a number of digitally supported solutions have emerged to manage diabetes and other chronic conditions.
−Removed: Competitors are developing new technologies rapidly and, in some cases, are also expanding to manage other chronic conditions.
−Removed: With our first product, Dario, we compete directly and primarily with large pharmaceutical and medical device companies such as Abbott Laboratories, Asensia (formerly Bayer Diabetes Care), Johnson & Johnson LifeScan, Roche Diagnostics and Sanofi.
−Removed: The first four of these companies has a combined majority market share of the BGMS business and strong research and development capacity for next-generation products.
−Removed: Their dominant market position since the late 1990s, and significant control over the market could significantly limit our ability to introduce Dario or effectively market and generate sales of the product.
−Removed: We will also compete with numerous second-tier and third-tier competitors.
−Removed: In addition, we only recently transformed our business to primarily focus on the sale of our digital support solution, which joins a crowded field of competitors such as Amazon, Apple and Google.
−Removed: Our competitors vary by intervention (devices, applications, coaching and analytics), by channel (health plan, pharma, provider, employer) and by condition (including, for example, diabetes, MSK, blood hypertension, and others).
−Removed: Certain of our competitors offer this
−Removed: integrated approach in varying degrees, including, among others, Teladoc Health, Inc.
−Removed: and MDLive, an Evernorth company, offer a full array of integrated virtual care solutions for primary care, chronic and behavioral health.
−Removed: While these companies have both scale and scope, they have not yet developed an operating model that deliver their services profitably at scale.
−Removed: There are other more narrowly focused companies such as Omada Health, Inc., Vida Health, Inc., Virta Health Corp, and Welldoc, Inc.
−Removed: that focus on the B2B market.
−Removed: And other D2C oriented companies such as Ro, Inc., Hims & Hers, Inc., Weight Watchers International, Inc., and Noom, Inc., that compete with us in the cardiometabolic and GLP-1 space.
−Removed: Specialized mental health platforms like Spring Care, Inc., Lyra Health, Inc., Headspace, Inc., BetterHelp, Inc.
−Removed: (a division of Teladoc), Calm.com, Inc., and Talkspace, Inc., compete in the B2B behavioral health marketplace.
−Removed: Competition in the digitally supported solutions market and BGMS market is extremely intense, which can lead to, among other things, price reductions, longer selling cycles, lower product margins, loss of market share and additional working capital requirements.
−Removed: To succeed, we must, among other critical matters, gain consumer acceptance for Dario and potential future devices incorporating our principal technology and offer better strategic concepts, technical solutions, prices and response time, or a combination of these factors, than those of other competitors.
−Removed: If our competitors offer significant discounts on certain products, we may need to lower our prices or offer other favorable terms in order to compete successfully.
−Removed: Moreover, any broad-based changes to our prices and pricing policies could make it difficult to generate revenues or cause our revenues, if established, to decline.
−Removed: Some of our competitors may bundle certain software products offering competing applications for diabetes management at low prices for promotional purposes or as a long-term pricing strategy.
−Removed: These practices could significantly reduce demand for Dario or potential future products or constrain prices we can charge.
−Removed: Moreover, if our competitors develop and commercialize products that are more effective or desirable than Dario or the other products that we may develop, we may not convince our customers to use our products.
−Removed: Any such changes would likely reduce our commercial opportunity and revenue potential and could materially adversely impact our operating results.
−Removed: If we fail to respond quickly to technological developments our products may become uncompetitive and obsolete.
−Removed: The BGMS market and other markets in which we plan to compete experience rapid technological developments, changes in industry standards, changes in customer requirements and frequent new product introductions and improvements.
−Removed: If we are unable to respond quickly to these developments, we may lose competitive position, and Dario or any other device or technology may become uncompetitive or obsolete, causing revenues and operating results to suffer.
−Removed: In order to compete, we must develop or acquire new devices and improve our existing device on a schedule that keeps pace with technological developments and the requirements for products addressing a broad spectrum and designers and designer expertise in our industries.
−Removed: We must also be able to support a range of changing customer preferences.
−Removed: For instance, as non-invasive technologies become more readily available in the market, we may be required to adopt our platform to accommodate the use of non-invasive or continuous blood glucose sensors.
−Removed: We cannot guarantee that we will be successful in any manner in these efforts.
−Removed: If third-party payors do not provide adequate coverage and reimbursement for the use of our products and services, our revenue will be negatively impacted.
−Removed: In the United States and other jurisdictions such as Germany and England, we expect that our products and services should generally be available for full or partial patient reimbursement by third-party payers.
−Removed: Our success in marketing our services depend and will depend in large part on whether U.S.
−Removed: and international government health administrative authorities, private health insurers and other organizations adequately cover and reimburse customers for the cost of our products and services.
−Removed: In the United States, we expect to derive nearly all our sales from sales directly to consumers as well as retail pharmacy and DME distributors who typically bill various third-party payors, including Medicare, Medicaid, private commercial insurance companies, health maintenance organizations, health plans and other healthcare-related organizations, to cover all or a portion of the costs and fees associated with our products and services and bill patients for any applicable deductibles or co-payments.
−Removed: Access to adequate coverage and reimbursement for CMS procedures using our products and services (and our other products and services in development) by third-party payors is essential to the acceptance of our products by our customers.
−Removed: Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.
−Removed: In addition, in the United States, no uniform policy of coverage and reimbursement for medical device products and services exists among third-party payors.
−Removed: Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor.
−Removed: In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures.
−Removed: As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained, or maintained if obtained.
−Removed: Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis.
−Removed: In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country.
−Removed: Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures.
−Removed: In most markets, there are private insurance systems as well as government-managed systems.
−Removed: If sufficient coverage and reimbursement are not available for our current or future products, in either the United States or internationally, the demand for our products and our revenues will be adversely affected.
+Added: We face significant competition in the digital health and connected health device markets, which may limit our ability to grow our business.
+Added: The market for digital solutions addressing cardiometabolic and behavioral health conditions is highly competitive and continues to evolve.
+Added: Our primary business model focuses on providing digital cardiometabolic and behavioral health programs to health plans and self-insured employers, while we also sell connected health devices for chronic condition management directly to consumers.
+Added: In our enterprise business, we compete with a range of digital health vendors offering condition management, coaching and virtual care services, including companies such as Teladoc Health, Omada Health, Vida Health and Virta Health.
+Added: Some competitors offer broad virtual care platforms, while others focus on specific conditions such as diabetes, weight management or mental health.
+Added: Many of these companies have greater financial resources, larger sales organizations, broader product offerings or longer operating histories than we do.
+Added: In our D2C device business, we compete with manufacturers and sellers of blood glucose monitoring systems and other connected health devices, including large, established companies with greater brand recognition, broader distribution and substantially greater financial, marketing and research & development resources than we do.
+Added: Competition in our markets may result in pricing pressure, longer sales cycles, higher customer acquisition costs and lower margins.
+Added: Some competitors may bundle services or offer lower prices to gain market share.
+Added: In addition, large technology companies and new entrants may seek to enter digital health markets by leveraging existing consumer platforms or data assets.
+Added: To compete effectively, we must continue to demonstrate value to payers and employers, maintain engagement among members and differentiate our offerings.
+Added: If we are unable to compete successfully against current or future competitors, our ability to grow revenue and achieve profitability could be adversely affected.
+Added: If we fail to keep pace with technological change, our offerings may become less competitive.
+Added: The digital health and connected health device markets are characterized by rapid technological change, evolving customer expectations and frequent product introductions.
+Added: Our ability to compete depends on our ability to maintain and improve our platform, applications and devices, as well as to adapt our offerings to the needs of health plans, employers and consumers.
+Added: If we are unable to develop, acquire or integrate new technologies or enhancements in a timely and cost-effective manner, our offerings may become less competitive, which could adversely affect our business and results of operations.
Risks Related to Our Operations in Israel
2 unchanged sentences
In addition, most of our executive officers are residents of Israel, although the majority of our employees are located outside of Israel.
−Removed: Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors.
−Removed: On October 7, 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.
−Removed: Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.
−Removed: Following the attack, Israel’s security cabinet declared war against Hamas and the Israeli military began to call-up reservists for active duty.
−Removed: At the same time, and because of the war declaration against Hamas, the clash between Israel and Hezbollah in Lebanon had escalated to an armed conflict, which included daily attacks on Israel.
+Added: Accordingly, political, economic and military conditions in Israel and the surrounding region may directly affect our business.
+Added: Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or a significant downturn in the economic or financial condition of Israel, could affect adversely our operations.
+Added: Ongoing and revived hostilities or other Israeli political or economic factors could harm our operations and results of operations.
+Added: Following the October 7, 2023 attacks by Hamas terrorists in Israel’s southern border, Israel declared war against Hamas and since then, Israel has been involved in military conflicts with Hamas, Hezbollah, a terrorist organization based in Lebanon, and Iran, both directly and through proxies like the Houthi movement in Yemen and armed groups in Iraq and other terrorist organizations.
+Added: Additionally, following the fall of the Assad regime in Syria, Israel has conducted limited military operations targeting the Syrian army, Iranian military assets and infrastructure linked to Hezbollah and other Iran-supported groups.
+Added: Although certain a ceasefire agreement have been reached with Hamas and the level of hostilities has since decreased, the situation remains volatile, with the potential for escalation into a broader regional conflict involving additional terrorist organizations and possibly other countries, including as a result of instability arising from developments in Syria.
+Added: On June 13, 2025, Israel launched a strike against Iran, aimed to disrupt Iran’s capacity to coordinate or launch hostilities against Israel.
+Added: Iran has retaliated in response, firing missiles and drones at Israeli military and civilian infrastructure.
+Added: In February 2026, hostilities between Israel and Iran escalated again.
+Added: In late February 2026, Israel, together with the United States, conducted a major joint military campaign of air and missile strikes against targets in Iran, which triggered a broad Iranian response and contributed to significant regional instability.
+Added: The situation remains highly fluid, and we are unable to predict when, or on what terms, this escalation will be resolved.
+Added: Further escalation, whether involving direct confrontation between Israel and Iran or through regional proxy groups, could result in additional mobilization of reserve personnel, further restrictions on movement or commerce, damage to infrastructure, supply chain interruptions, disruptions to global energy markets, and heightened cybersecurity threats.
+Added: Any of the foregoing could materially and adversely affect our operations, financial condition, and results of operations, particularly if disruptions are prolonged or recur.
+Added: It is possible that other terrorist organizations, including from within territory administered by the Palestinian National Authority, as well as other hostile countries, will join in or resume hostilities.
+Added: Any hostilities involving Israel, or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations.
+Added: Since the multi-front conflict started on October 7, 2023, including the hostilities between Israel and Iran, our operations have not been materially adversely affected by this war.
+Added: However, at this time, it is not possible to predict the intensity or duration of the war, nor can we predict how this war will ultimately affect Israel’s economy in general and we continue to monitor the situation closely and examine the potential disruptions that could adversely affect our operations.
Furthermore, certain of our employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time.
5 unchanged sentences
Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages.
+Added: Several countries, principally in the Middle East, still restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies, whether as a result of hostilities in the region or otherwise.
+Added: Also, the Israeli government imposes restrictions on doing business with certain countries.
+Added: In addition, there have been increased efforts by activists to cause companies and consumers to boycott Israeli goods and cooperation with Israeli-related entities based on Israeli government policies.
+Added: Such actions, particularly if they become more widespread, may adversely impact our ability to collaborate with other third parties.
+Added: Any hostilities involving Israel, any interruption or curtailment of trade or scientific cooperation between Israel and its present partners, or a significant downturn in the economic or financial condition of Israel could adversely affect our business, financial condition and operations.
+Added: Moreover, we cannot predict how this war will ultimately affect Israel’s economy in general, which may involve a downgrade in Israel’s credit rating by rating agencies (such as the downgrade by Moody’s of its credit rating of Israel from A1 to A2 in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, which followed by an upgrade of its outlook rating from “negative” to “stable”, in January 2026).
+Added: We may also be targeted by cyber terrorists specifically because we are an Israeli-related company.
Investors may have difficulties enforcing a U.S.
10 unchanged sentences
Israeli courts may refuse to hear a claim based on a violation of U.S.
−Removed: securities laws against
−Removed: us or our officers and directors because Israel may not be the most appropriate forum to bring such a claim.
+Added: securities laws against us or our officers and directors because Israel may not be the most appropriate forum to bring such a claim.
In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S.
7 unchanged sentences
Risks Related to the Ownership of Our Common Stock
−Removed: Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
−Removed: On September 16, 2024, we received a written notice from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that we are not in compliance with Nasdaq Listing Rule 5550(a)(2), as our closing bid price for our common stock was below $1.00 per share for the last 30 consecutive business days.
−Removed: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have been granted a 180-calendar day compliance period, or until March 17, 2025, to regain compliance with the minimum bid price requirement.
−Removed: During the compliance period, our common stock will continue to be listed and traded on the Nasdaq Stock Market.
−Removed: To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period.
−Removed: If we are not in compliance by March 17, 2025, we may be afforded a second 180-calendar day compliance period.
−Removed: To qualify for this additional time, we will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq with the exception of the minimum bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period.
−Removed: If we do not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting.
−Removed: We intend to monitor the closing bid price of our common stock between now and March 17, 2025, and will consider available options to resolve our noncompliance with the minimum bid price requirement as may be necessary.
−Removed: There can be no assurance that we will be able to regain compliance with the minimum bid price requirement or that we will otherwise be in compliance with other Nasdaq listing criteria.
−Removed: Our officers and directors may exert significant influence over our affairs, including the outcome of matters requiring stockholder approval.
−Removed: As of the date of this Annual Report, our officers and directors collectively have a beneficial ownership interest of approximately 14.4% of our Company.
−Removed: As a result, such individuals will have the ability, acting together, to control the election of our directors and the outcome of corporate actions requiring stockholder approval, such as:
−Removed: (i) a merger or a sale of our company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our certificate of incorporation and bylaws.
−Removed: This concentration of voting power and control could have a significant effect in delaying, deferring or preventing an action that might otherwise be beneficial to our other stockholders and be disadvantageous to our stockholders with interests different from those individuals.
−Removed: Certain of these individuals also have significant control over our business, policies and affairs as officers or directors of our company.
−Removed: Therefore, you should not invest in reliance on your ability to have any control over our company.
+Added: There can be no assurance that we will be able to maintain continued Nasdaq listing criteria.
+Added: On September 16, 2024, we received a letter from the listing qualifications staff (the “Staff”) of the Nasdaq Stock Market notifying us that we were not in compliance with the minimum bid price requirement set forth in Nasdaq Listing
+Added: Rule 5550(a)(2) for continued listing.
+Added: On September 12, 2025, we received a letter from the Staff that it has determined that for the last 10 consecutive business days, from August 28, 2025 to September 11, 2025, the closing bid price of our common stock had been at $1.00 per share or greater and that accordingly, we have regained compliance with Nasdaq Listing Rule 5550(a)(2) and the matter is now closed.
+Added: However, there can be no assurance that we will be able to maintain compliance with the minimum bid price requirement or that we will otherwise be in compliance with other Nasdaq listing criteria.
+Added: In addition, on August 28, 2025, we announced a reverse stock split of our outstanding shares of common stock at a ratio of twenty -for- one.
+Added: There can be no assurance that this reverse share split will result in sustained compliance with the minimum bid price requirement.
+Added: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), because we have effected a reverse stock split within the prior one-year period, if our common stock again has a closing bid price below $1.00 per share for 30 consecutive business days, we would not be eligible for an additional compliance period and the Staff may issue a delisting determination without providing a further cure period.
+Added: As a result, if our common stock again trade below $1.00 per share for 30 consecutive business days, we could be subject to immediate delisting from Nasdaq.
+Added: If, for any reason, Nasdaq delists our securities from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect that our securities could be quoted on an over-the-counter market.
+Added: If this were to occur, we could face significant material adverse consequences, including:
+Added: a limited availability of market quotations for our securities;
+Added: reduced liquidity for our securities;
+Added: a decrease in the number of institutional and general investors that will consider investing in our common stock;
+Added: and, a determination that our shares of common stock are a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the price of our common stock and trading volume could decline.
−Removed: The trading market for our common stock may be influenced by the research and reports that securities or industry analysts may publish about us, our business, our market or our competitors.
−Removed: If any of the analysts who may cover us change their recommendation regarding our common stock adversely, or provide more favorable relative recommendations about our competitors, the price of our common stock would likely decline.
−Removed: If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.
+Added: The trading market for our common stock may be influenced by research and reports that securities or industry analysts may publish about us, our business, our market or our competitors.
+Added: If any of the analysts who cover us change their recommendation regarding our common stock adversely, or provide more favorable relative recommendations about our competitors, the price of our common stock would likely decline.
+Added: If any analyst who cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.
The market price of our common stock has been extremely volatile and may continue to be volatile due to numerous circumstances beyond our control.
6 unchanged sentences
● changes in foreign currency exchange rates;
−Removed: ● the commencement, enrollment or results of our planned or future clinical trials of our product candidates or those of our competitors;
−Removed: ● the success of competitive drugs or therapies;
● regulatory or legal developments in the United States and other countries;
2 unchanged sentences
● the recruitment or departure of key personnel;
−Removed: ● the level of expenses related to our product candidates or clinical development programs;
−Removed: ● litigation matters, including amounts which may or may not be recoverable pursuant to our officer and director insurance policies, regulatory actions affecting the Company and the outcome thereof;
−Removed: ● the results of our efforts to discover, develop, acquire or in-license additional product candidates;
−Removed: ● actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
+Added: ● the level of expenses related to our products or clinical development programs;
+Added: ● litigation matters, including amounts which may or may not be recoverable pursuant to our officer and director insurance policies, regulatory actions affecting us and the outcome thereof;
+Added: ● the results of our efforts to discover, develop, acquire or license additional products;
+Added: ● actual or anticipated changes in estimates as to financial results and development timelines;
● disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
5 unchanged sentences
Stock markets in general and our stock price in particular have recently experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies and our company.
−Removed: For example, the closing sale prices of our Common Stock from January 1, 2024 through December 31, 2024, ranged from a high of $2.55 per share (on February 15, 2024) to a low of $0.65 per share (on December 18, 2024).
+Added: For example, the closing sale prices of our common stock from January 1, 2025 through December 31, 2025, ranged from a high of $30.60 per share (on January 7, 2025) to a low of $6.17 per share (on September 18, 2025).
During that time, we have not experienced any material changes in our financial condition or results of operations that would explain such price volatility or trading volume;
2 unchanged sentences
Additionally, these and other external factors have caused and may continue to cause the market price and demand for our common stock to fluctuate substantially, which may limit or prevent our stockholders from readily selling their shares of our common stock and may otherwise negatively affect the liquidity of our common stock.
−Removed: In addition, if the stock price of our common stock continues to trade at its current level, it may imply as a negative indicator of the valuation of our intangible assets and our goodwill, which could result in an impairment for these assets.
−Removed: Shares eligible for future sale may adversely affect the market for our common stock and warrants.
−Removed: From time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144, promulgated under the Securities Act, subject to certain limitations.
−Removed: Specifically, we have 49,585 shares of various classes of preferred stock that are convertible into 39,142,798 shares of common stock, and which are also entitled to receive dividends of up to 4,072,297 shares of common stock.
−Removed: In general, pursuant to Rule 144, after satisfying a six month holding period:
−Removed: (i) affiliated stockholder (or stockholders whose shares are aggregated) may, under certain circumstances, sell within any three month period a number of securities which does not exceed the greater of 1% of the then outstanding shares of common stock or the average weekly trading volume of the class during the four calendar weeks prior to such sale and (ii) non-affiliated stockholders may sell without such limitations, provided we are current in our public reporting obligations.
−Removed: Rule 144 also permits the sale of securities by non-affiliates that have satisfied a one year holding period without any limitation or restriction.
−Removed: Any substantial sale of our common stock pursuant to Rule 144 or pursuant to any resale report may have a material adverse effect on the market price of our securities.
−Removed: Our compliance with complicated U.S.
+Added: Future sales of our securities could depress the market price of our common stock.
+Added: Future sales of substantial amounts of our common stock or other securities in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock.
+Added: Certain of our stockholders may be able to sell shares of our common stock pursuant to Rule 144 under the Securities Act or pursuant to registration rights that permit resale of their securities.
+Added: These sales, or the availability of such securities for sale, could cause the market price of our securities to decline.
+Added: Our compliance with U.S.
regulations concerning corporate governance and public disclosure is expensive.
−Removed: Moreover, our ability to comply with all applicable laws, rules and regulations is uncertain given our management’s relative inexperience with operating U.S.
−Removed: public companies.
−Removed: As a publicly reporting company, we are faced with expensive and complicated and evolving disclosure, governance and compliance laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act and the Dodd-Frank Act, and, to the extent we complete our anticipated public offering, the rules of the Nasdaq Stock Market.
+Added: As a public reporting company, we are faced with expensive, complicated, and evolving disclosure, governance and compliance laws, regulations and standards relating to corporate governance and public disclosure, including the Exchange Act, Sarbanes-Oxley Act and the Dodd-Frank Act, and the rules of the Nasdaq Stock Market.
New or changing laws, regulations and standards are subject to varying interpretations in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
As a result, our efforts to comply with evolving laws, regulations and standards of a U.S.
−Removed: public company are likely to continue to result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.
−Removed: Moreover, our executive officers have little experience in operating a U.S.
−Removed: public company, which makes our ability to comply with applicable laws, rules and regulations uncertain.
+Added: public company are likely to continue to result in increased general and administrative expenses
+Added: and a diversion of management time and attention from revenue-generating activities to compliance activities.
Our failure to company with all laws, rules and regulations applicable to U.S.
1 unchanged sentence
If we fail to maintain effective internal control over financial reporting, the price of our common stock may be adversely affected.
−Removed: Our internal control over financial reporting may have weaknesses and conditions that could require correction or remediation, the disclosure of which may have an adverse impact on the price of our common stock.
−Removed: We are required to establish and maintain appropriate internal control over financial reporting.
−Removed: Failure to establish those controls, or any failure of those controls once established, could adversely affect our public disclosures regarding our business, prospects, financial condition or results of operations.
−Removed: In addition, management’s assessment of internal control over financial reporting may identify weaknesses and conditions that need to be addressed in our internal control over financial reporting or other matters that may raise concerns for investors.
+Added: Our internal control over financial reporting may have weaknesses and conditions that could require correction or remediation.
+Added: The disclosure of these issues could have an adverse impact on the price of our common stock.
+Added: We have established and are required to maintain appropriate internal control over financial reporting.
+Added: Failure to maintain those controls could adversely affect our public disclosures regarding our business, prospects, financial condition or results of operations, which may also raise concerns for investors.
Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting or disclosure of management’s assessment of our internal control over financial reporting may have an adverse impact on the price of our common stock.
2 unchanged sentences
In addition, our certificate of incorporation and bylaws may discourage, delay or prevent a change in our management or control over us that stockholders may consider favorable.
−Removed: Our certificate of incorporation and bylaws:
−Removed: ● authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to thwart a takeover attempt;
−Removed: ● provide that vacancies on our Board of Directors, including newly created directorships, may be filled only by a majority vote of directors then in office;
+Added: Our certificate of incorporation and by-laws, among other things:
● provide that special meetings of stockholders may only be called by our Chairman, Chief Executive Officer and/or President or other executive officer, our Board of Directors or a super-majority (66 2/3%) of our stockholders;
−Removed: ● place restrictive requirements (including advance notification of stockholder nominations and proposals) on how special meetings of stockholders may be called by our stockholders;
−Removed: ● do not provide stockholders with the ability to cumulate their votes;
● provide that our Board of Directors or a super-majority of our stockholders (66 2/3%) may amend our bylaws;
+Added: ● provide the Board of Directors with the exclusive authority to fix the number of directors constituting the whole Board;
+Added: ● provide that vacancies on the Board of Directors may be filled by a majority of directors then in office, although less than a quorum.
We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
8 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.