▸ Changes in U.S. laws or policies, including trade policies and tariffs, could adversely affect our business and results of operations.· · · · ● 1 ▸ Future sales of our securities could depress the market price of our common stock.· · · · ● 1 ▸ If we fail to keep pace with technological change, our offerings may become less competitive.· · · · ● 1 ▸ 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.· · · · ● 1 ▸ 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· · · · ● 1 ▸ Our compliance with U.S. regulations concerning corporate governance and public disclosure is expensive.· · · · ● 1 ▸ Our dependence on SaaS business model, third-party services and network infrastructure could adversely affect our business and results of operations.· · · · ● 1 ▸ 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.· · · · ● 1 ▸ Our outcomes-based contracts and reimbursement arrangements may not achieve expected results and may expose us to financial and operational risks.· · · · ● 1 ▸ Our strategic review process may not result in a transaction and may create additional risks and uncertainties for our business.· · · · ● 1 ▸ There can be no assurance that we will be able to maintain continued Nasdaq listing criteria.· · · · ● 1 ▸ 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.· · · · ● 1 ▸ We face significant competition in the digital health and connected health device markets, which may limit our ability to grow our business.· · · · ● 1 ▸ 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. In addition, we and certain of our· · · · ● 1 ▸ Our principal executive offices and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel, including a multi front war against Israel.· · · ● ● 2 ▸ Our employees, independent contractors, consultants, manufacturers and suppliers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.· · ● ● ● 3 ▸ 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.· ● ● ● ● 4 ▸ 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· · · ● · 1 ▸ 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.· · · ● · 1 ▸ Our revenues are concentrated with a major customer, and our revenues may decrease significantly if we were to lose our major customer.· · · ● · 1 ▸ There is no assurance that our digital health engagement platform will succeed or be adopted by healthcare providers.· · · ● · 1 ▸ We may not generate the expected benefits of our acquisition of Twill.· · · ● · 1 ▸ 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. Our success in· · ● · · 1 ▸ We may not be able to quickly establish additional or alternative suppliers if necessary, in part because we may need to undertake additional activities to establish such suppliers as required by the regulatory approval process. Any· ● · · · 1 ▸ A pandemic, epidemic or outbreak of an infectious disease in the United States, Israel or elsewhere may adversely affect our business.● ● · · · 2 ▸ 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.● ● ● ● · 4 ▸ 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.● ● ● ● · 4 ▸ 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.● ● ● ● · 4 ▸ If we fail to respond quickly to technological developments our products may become uncompetitive and obsolete.● ● ● ● · 4 ▸ 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.● ● ● ● · 4 ▸ Legislative reforms to the United States healthcare system may adversely affect our revenues and business.● ● · · · 2 ▸ Our common stock has less liquidity than many other stocks listed on the Nasdaq Capital Market.● · · · · 1 ▸ Our officers and directors may exert significant influence over our affairs, including the outcome of matters requiring stockholder approval.● ● ● ● · 4 ▸ Our operations may be disrupted as a result of the obligation of Israeli citizens to perform military service.● ● ● · · 3 ▸ Our results of operations may fluctuate significantly due to the timing of our recognition of SaaS revenues.● ● ● ● · 4 ▸ Potential political, economic and military instability in the State of Israel, where our management team and our research and development facilities are located, may adversely affect our results of operations.● ● ● · · 3 ▸ Shares eligible for future sale may adversely affect the market for our common stock and warrants.● ● ● ● · 4 ▸ The SaaS pricing model is evolving and our failure to manage its evolution and demand could lead to lower than expected revenue and profit.● ● ● ● · 4 ▸ The success of our Dario product will depend on the acceptance of Dario in the healthcare market.● ● ● ● · 4 rw ▸ There is no assurance that our DarioEngage software platform will succeed or be adopted by healthcare providers.● ● ● · · 3 ▸ Through our acquisitions of Upright and PsyInnovations, we expanded our product offering to include solutions for MSK as well as behavioral conditions. We believe that the successful integration of Upright and PsyInnovations● · · · · 1 ▸ We are subject to the risk of reliance on third parties to conduct our clinical trial work.● ● ● ● · 4 ▸ 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.● ● ● ● · 4 ▸ We may be subject to claims for rescission or damages in connection with certain sales of shares of our securities.● ● ● ● · 4 ▸ We may be subject to federal, state and foreign healthcare fraud and abuse laws and regulations.● ● · · · 2 ▸ 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.● ● · ● · 3 ▸ We may not generate the expected benefits of our acquisition of Twill, and the integration of this business could disrupt our ongoing business, distract our management and increase our expenses.● ● ● · · 3 rw ▸ We rely in part on a small group of third-party distributors to effectively distribute our products.● ● ● ● · 4 ▸ 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.● ● ● ● · 4 ▸ We were formed in August 2011 and are thus subject to the risks associated with new businesses.● ● ● ● · 4 ▸ The occurrence of any or all of these risks could adversely affect our international business and, consequently, our results of operations and financial condition.● ● · · ● 3 ▸ Anti-takeover provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our company and may affect the trading price of our common stock and warrants.● ● ● ● ● 5 ▸ As we conduct business internationally, we are susceptible to risks associated with international relationships.● ● ● ● ● 5 ▸ Costly litigation may be necessary to protect our intellectual property rights and we may be subject to claims alleging the violation of the intellectual property rights of others.● ● ● ● ● 5 ▸ Failure in our online and digital marketing efforts could significantly impact our ability to generate sales.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ If we fail to maintain effective internal control over financial reporting, the price of our common stock may be adversely affected.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.● ● ● ● ● 5 ▸ Our Dario platform and associated business processes may contain undetected errors, which could limit our ability to provide our services and diminish the attractiveness of our service offerings.● ● ● ● ● 5 rw ▸ Our future performance will depend on the continued engagement of key members of our management team.● ● ● ● ● 5 ▸ Our products are subject to technological changes which may impact their use.● ● ● ● ● 5 ▸ group Risks Related to Our Business● ● ● ● ● 5 ▸ group Risks Related to Our Financial Position and Capital Requirements● ● ● ● ● 5 ▸ group Risks Related to Our Industry● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Operations in Israel● ● ● ● ● 5 ▸ group Risks Related to Product Development and Regulatory Approval● ● ● ● ● 5 ▸ group Risks Related to the Ownership of Our Common Stock● ● ● ● ● 5 ▸ The failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively.● ● ● ● ● 5 ▸ The occurrence of any of these events may have a material adverse effect on our business, financial condition and results of operations.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ We cannot accurately predict the volume or timing of any future sales, making the timing of any revenues difficult to predict.● ● ● ● ● 5 ▸ We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.● ● ● ● ● 5 ▸ We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ We may be subject to claims challenging the inventorship of our patents and other intellectual property.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 
