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New words:
abbreviated, abortive, abstract, ACA, adult, Aetna, AIMDD, AKS, algorithm, ambulatory, analytical, animal, Anonymized, answer, antidiabetic, Arnaud, ascertained, Avenue, avoiding, Bgm, bid, bifurcation, Bilal, binomial, biometric, BL, blocker, bona, boosting, bound, breathing, broader, cabinet, calcitonin, carbohydrate, cardiometabolic, CCPA, CDRH, Century, CGRP, CI, Cis, CJEU, clash, Clawback, clock, CMIA, comment, complementary, compromise, compromised, concealing, Congressional, convening, conveyed, costliest, CPRA, CUSTOMIZABLE, cybersecurity, Dataverse, DDS, deceptive, defraud, delete, deletion, deter, dialogue, discharged, Discretionary, Disney, dissemination, dose, downgrading, downstream, draft, edition, EEA, electrical, elicit, embodiment, emission, emphasize, endpoint, entry, EPO, ER, ergonomic, eSTAR, EVP, exact, expedite, explain, explicit, extinguishment, Facebook, faithfully, FCC, FDCA, FDORA, fide, FIDELITY, Finaly, fine, forgotten, frame, FSCA, FTC, funnel, gamma, gather, GCP, GDPR, GenAI, gender, genetic, graph, gratuity, greatest, harmonization, harmonize, harmonized, HCRU, HHS, highest, HITECH, hostile, Houthi, IIb, illegal, illuminate, Im, imposition, imprisonment, improper, improperly, inadequacy, inclined, infiltrated, inflation, inpatient, input, inputting, Inspector, installed, instant, instruction, interconnected, Interestingly, invoiced, Ir, IRR, ISPOR, IVD, IVDR, JDST, jurisdiction, Justice, justify, Khan, kind, laid, landmark, lawfully, Leak, Leidner, letter, liable, linear, lockup, logbook, logistic, LOS, LS, LSA, massive, maternal, Maximilian, MDR, media, Median, medium, MedWatch, memory, METH, metrology, migraine, mirroring, misappropriated, misleading, missing, modernize, module, Moody, necessity, negligence, negligent, nested, NIH, Nike, nominee, nonclinical, nongovernmental, nonuser, northern, Nov, Numerator, nursing, Oberon, Ofer, opt, outgoing, outpatient, output, outputting, Outsourcing, OV, overarching, Overweight, Palestinian, Parliament, Pat, payoff, penalty, personyear, PhD, PHI, Physiology, plurality, poised, Portal, poster, PPPY, pre, precursor, predefined, preempt, preempted, prepayment, prescription, prime, proactive, probing, proceed, processor, prompt, pt, pts, punishable, pursed, quartile, racial, radio, Radiological, rationale, readmission, reauthorization, recordkeeping, referenced, refinanced, regime, regimen, registry, Regitrsation, regression, regular, Reinvestment, reject, REM, reprice, restructuring, resume, retrieved, retrieving, reward, roadmap, Robert, room, safeguarding, scheme, Sea, Secondary, semantic, sequential, sequentially, server, sex, SH, Shaw, simultaneously, size, skeleton, skin, slope, southern, SSP, stay, stemming, sterility, sterilization, streamline, streamlined, strive, substantive, Subtitle, suitable, Sunshine, superfamily, supervisory, Switzerland, Symphony, tampering, tap, Tarshish, task, teaching, temporarily, thoughtful, threat, timelier, Titan, Tomer, top, traceability, transmission, transmit, transmitter, transposing, true, truthful, turnover, twill, unacceptable, unbilled, unchanged, unconstitutional, uncontrolled, undergo, undergoing, undesirable, unexpected, unfold, unknown, unlawfully, unlock, unmanaged, unreasonable, unsuccessful, unvested, usher, vasodilation, verify, Viking, visit, voluntarily, walking, Wall, watch, wealth, welfare, West, whichever, WhiteHawk, willfully, window, WP, writing, Yemen
Removed:
abnormal, accessory, accrual, allege, allegedly, antibiotic, anticonvulsant, archiving, arranging, ATRA, attempted, automatic, Barack, Bipartisan, bore, boycott, Brazil, bundling, cancer, cast, CeQur, claiming, Cohen, commensurate, Competent, denial, dictate, dictated, diplomatic, disability, divided, documented, Donald, doubtful, DRIOW, easier, ECG, efficiency, Egypt, eighteen, electrocardiography, elimination, Endeavour, epidemic, Eric, excise, extremist, faster, fifteen, forcing, founder, franchise, furnishing, gained, Geneva, globe, HaTokhen, heightening, hereinafter, hospital, hour, image, impossible, inorganic, invoked, Iraq, ISIL, Islamic, jihadist, JNJ, landscape, lapse, lawsuit, leasing, Levant, levofloxacin, mandated, McNeil, Miledge, militia, moving, Neuromedical, ninety, notify, NSR, nuclear, Obama, Oded, offered, ordering, organic, originally, Ortho, outage, overcome, oversaw, pari, Parity, participant, passu, peaceful, Peninsula, picture, preference, procure, rebel, recover, redeemed, referring, remote, remotely, repeal, researching, retiring, run, SA, sector, select, sequestration, Sinai, slowdown, solicitation, SR, Stark, startup, Syria, tablet, Taxpayer, tech, telehealth, telemarketing, tension, Topamax, tramadol, trillion, Trump, turbulence, twenty, tying, unaudited, unlawful, USA, vast, vi, viewing, violent, wage
Financial report summary
?Competition
Abbott Laboratories • QHSLab • Dexcom • Sanofi • Teladoc Health • Livongo Health • Cecelia Health • Hinge Health • Virta HealthRisks
- We were formed in August 2011 and are thus subject to the risks associated with new businesses.
- 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.
- We have incurred significant losses since inception. As such, you cannot rely upon our historical operating performance to make an investment decision regarding our company.
- We may be subject to claims for rescission or damages in connection with certain sales of shares of our securities.
- There is no assurance that our DarioEngage software platform will succeed or be adopted by healthcare providers.
- We only recently began commercializing Dario, and our success will depend on the acceptance of Dario in the healthcare market.
- We cannot accurately predict the volume or timing of any future sales, making the timing of any revenues difficult to predict.
- 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.
- 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 are dependent upon third-party manufacturers and suppliers making us vulnerable to supply shortages and problems and price fluctuations, which could harm our business.
- We rely in part on a small group of third-party distributors to effectively distribute our products.
- Failure in our online and digital marketing efforts could significantly impact our ability to generate sales.
- 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. 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.
- Our products are subject to technological changes which may impact their use.
- As we conduct business internationally, we are susceptible to risks associated with international relationships.
- We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations.
- Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.
- Our Dario Solution 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.
- Our future performance will depend on the continued engagement of key members of our management team.
- 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.
- 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.
- 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.
- We have conducted limited clinical trials of Dario. Clinical and nonclinical data is susceptible to varying interpretations, which could delay, limit or prevent additional regulatory clearances.
- 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.
- 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.
- We are subject to the risk of reliance on third parties to conduct our clinical trial work.
- 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.
- 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.
- 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.
- 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. These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance rates.
- 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.
- The failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively.
- 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.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- 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.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- 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.
- If we fail to respond quickly to technological developments our products may become uncompetitive and obsolete.
- 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.
- 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.
- Our operations may be disrupted as a result of the obligation of Israeli citizens to perform military service.
- Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws, against us, or our executive officers and directors or asserting U.S. securities laws claims in Israel.
- Our officers and directors may exert significant influence over our affairs, including the outcome of matters requiring stockholder approval.
- 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.
- The market price of our common stock may be significantly volatile.
- Shares eligible for future sale may adversely affect the market for our common stock and warrants.
- Our compliance with complicated U.S. regulations concerning corporate governance and public disclosure is expensive. Moreover, our ability to comply with all applicable laws, rules and regulations is uncertain given our management’s relative inexperience with operating U.S. public companies.
- If we fail to maintain effective internal control over financial reporting, the price of our common stock may be adversely affected.
- 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.
- 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.
- 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.
Management Discussion
- Revenues for the year ended December 31, 2023, amounted to $20,352,000 compared to $27,656,000 during the year ended December 31, 2022. The decrease in revenues for the year ended December 31, 2023, compared to the year ended December 31, 2022, is due to a decrease in revenues from sales to consumers and our strategic partnerships.
- Revenues generated during the year ended December 31, 2023, were derived from the sale of services to our strategic partners, commercial customers and consumers located mainly in the United States.
- During the years ended December 31, 2023 and 2022, we recorded costs related to revenues in the amount of $14,368,000 and $18,001,000, respectively. The decrease in cost of revenues was due to the decrease in revenues. Cost of revenues excluding amortization of acquired technology during the year ended December 31, 2023 and 2022, was $10,370,000 and $14,012,000, respectively.