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DRIO on Nasdaq

DarioHealth Corp.

In its 2026 annual report the company says: “We are a vertically integrated health intelligence platform with a mission to power the behavior changes that drive better health. We are committed to transforming healthcare by delivering a comprehensive and highly engaging whole-person health platform, which enables us to create a future where healthy change is effortless and accessible to all.”3 It is headquartered in New York, New York.1 Its shares trade on Nasdaq under the symbol DRIO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerDRIO on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersNew York, New York1
  • Incorporated inDE2
  • Business address322 W 57Th St. #33B, New York, Ny 100192
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a vertically integrated health intelligence platform with a mission to power the behavior changes that drive better health. Unlike software-only digital health platforms, Dario owns the complete chain of value in chronic care management - connected FDA-cleared hardware devices that generate continuous physiological data, AI built on that proprietary data, and a behavior change and coaching layer validated through over 100 peer-reviewed clinical studies. We are committed to transforming healthcare by delivering a comprehensive and highly engaging whole-person health platform, which enables us to create a future where healthy change is effortless and accessible to all.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

56.6%Gross margin4
-163.9%Operating margin4
-186.6%Net margin4
-17.3%Revenue growth, 20254
-61.4%Return on equity4
0.45×Debt to equity4
-$26.1MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Service brought in 67% of the revenue DarioHealth Corp. broke down this way in fiscal 2025.

  1. Service$14.9M467%down 26% from 2024
  2. Hardware and Consumable Products$7.4M433%up 9% from 2024
Products and services by year
Products and services20242025
Service$20.2M$14.9M
Hardware and Consumable Products$6.8M$7.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue41¢$9.7M
  • Research and development58¢$13.8M
  • Income tax0¢$105.0K

Out of $22.4M in revenue.4 The company lost money this year.

Financial statements

Revenue567894$22.4M in 2025+196% since 2019
0$10.0M$20.0M$30.0M2019: $7.6M$7.6M20192020: $7.6M$7.6M2020+0%2021: $20.5M$20.5M2021+171%2022: $27.7M$27.7M2022+35%2023: $20.4M$20.4M2023−26%2024: $27.0M$27.0M2024+33%2025: $22.4M$22.4M2025−17%
Gross profit567894$12.7M in 2025+388% since 2019
0$5.0M$10.0M$15.0M2019: $2.6M$2.6M20192020: $2.5M$2.5M2020−3%2021: $4.0M$4.0M2021+58%2022: $9.7M$9.7M2022+144%2023: $6.0M$6.0M2023−38%2024: $13.3M$13.3M2024+122%2025: $12.7M$12.7M2025−5%
Operating income567894-$36.7M in 2025+107% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$17.7M-$17.7M20192020: -$29.9M-$29.9M2020+69%2021: -$76.5M-$76.5M2021+156%2022: -$56.8M-$56.8M2022−26%2023: -$56.2M-$56.2M2023−1%2024: -$57.7M-$57.7M2024+3%2025: -$36.7M-$36.7M2025−37%
Net income567894-$41.7M in 2025+135% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$17.7M-$17.7M20192020: -$29.4M-$29.4M2020+66%2021: -$76.8M-$76.8M2021+161%2022: -$62.2M-$62.2M2022−19%2023: -$59.4M-$59.4M2023−4%2024: -$42.7M-$42.7M2024−28%2025: -$41.7M-$41.7M2025−2%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Total revenues$22.4M$27.0M
Total cost of revenues$9.7M$13.8M
Gross profit$12.7M$13.3M
Research and development$13.8M$24.2M
Sales and marketing$20.3M$26.4M
General and administrative$15.2M$20.5M
Total operating expenses$49.3M$71.0M
Operating loss$36.7M$57.7M
Interest expenses$3.0M
Other financial expenses (income), net$1.9M-$13.1M
Total financial expenses (income), net$5.0M-$13.1M
Loss before taxes$41.6M$44.6M
Income taxes (benefit)$105.0K-$1.9M
Net loss$41.7M$42.7M
Deemed dividend (contribution)$20.0M-$1.8M
Net loss attributable to common shareholders$61.7M$41.0M
Basic net loss per share of common stock (in dollars per share)$10.12$12.27
Diluted net loss per share of common stock (in dollars per share)$10.12$12.27
Weighted average number of common stock used in computing basic and diluted net loss per share4.0M shares2.5M shares
Weighted average number of common stock used in computing diluted net loss per share (in shares)4.0M shares2.5M shares

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Corporate structure

DarioHealth Corp. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of DarioHealth Corp.

  • DarioHealth Corp. New York, New York

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What DarioHealth Corp. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$1.6M4 Dec 31, 2025$2.6M4 Dec 31, 2024−40.6%
Accumulated depreciation$1.0M4 Dec 31, 2025$1.9M4 Dec 31, 2024−47.3%
Property and equipment, net$549.0K4 Dec 31, 2025$709.0K4 Dec 31, 2024−22.6%
Operating-lease assets (leased space)$717.0K4 Dec 31, 2025$1.1M4 Dec 31, 2024−32.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$21.8M4 Dec 31, 2025$27.8M4 Dec 31, 2024−21.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$57.4M4 Dec 31, 2025$57.4M4 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$15.9M4 Dec 31, 2025$18.8M4 Dec 31, 2024−15.1%
Accumulated amortization$20.8M4 Dec 31, 2025$18.0M4 Dec 31, 2024+15.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$4.3M4 Dec 31, 2025$4.8M4 Dec 31, 2024−9.2%
Finished goods$3.6M4 Dec 31, 2025$4.2M4 Dec 31, 2024−14.9%

Properties, in its own words

We do not own any real property. Currently, we maintain offices at 5 Tarshish St., Caesarea Industrial Park, 3088900, Israel. On June 6, 2023, we signed a lease agreement for these facilities for a period of 5 years commencing upon the completion of adjustments of the office space. We moved into these offices during August 2023. The lease agreement will be extended automatically for an additional 60 months following expiration of the initial term. The monthly rent and management services under this lease are approximately $22,195.

We also maintain offices at Office Unit, Seventh Floor, IndiQube Unitech Cyber Park, Sector 39, Gurugram, Haryana, India. On June 1, 2024, we signed a lease agreement for these offices for a period of 2 years. The monthly rent and management services under this lease are approximately $16,790. On January 2, 2026, we signed a new lease

The rest of Item 2

agreement for offices on the fourth floor at Vatika Towers, Golf Course Road, Sector 54, Gurugram, Haryana 122003, India. The lease is for a period of 42 months starting in April 2026. The existing lease for our offices at IndiQube Unitech Cyber Park will be terminated at that time. The monthly rent, including management services, under the new lease will be approximately $18,900.

Item 2 of the 10-K filed Mar 19, 2026.3

Leadership

Who has led DarioHealth Corp., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Oren Fuerst2013
  2. Erez Raphael2016–now

President

  1. Shilo Ben-Zeev2013

Chief financial officer

  1. Mordechi Hershkowitz2013
  2. Zvi Ben-David2016–2024
  3. Chen Franco-Yehuda2025–now

Chief operating officer

  1. Shilo Ben-Zeev2013
  2. Dror Bacher2017–2022
  3. Tomer Ben-Kiki2024
  4. Lara Ann Sherman2026–now
201520202025
Board members and other officers (23)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Commercial OfficerSteven Nelson named Jan 17, 2025 to Oct 7, 202541
  • Chief Executive Officer and DirectorRaphael Erez named May 16, 2023 to Feb 29, 202442
  • PresidentRichard Anderson named May 16, 2023 to Feb 29, 202442
  • DirectorJon M. Kaplan named May 16, 2023 to Jan 17, 202543
  • DirectorDennis Matthesis named May 16, 202344

Former names

  • LabStyle Innovations Corp.Nov 1, 2011 to Jul 27, 20162

Timeline

  1. Sep 4, 20268-K Executive or director change45
  2. Aug 21, 20268-K Executive or director change46
  3. Jul 22, 20268-K Entered a material agreement; Other events47
  4. Jul 10, 20268-K Executive or director change48
  5. Apr 13, 20268-K Executive or director change; Other events49
  6. Mar 30, 20268-K Entered a material agreement50
  7. Feb 2, 20268-K Bylaws or fiscal year changed51
  8. Jan 29, 20268-K Shareholder vote52
  9. Nov 10, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares53
  10. Sep 25, 20258-K Entered a material agreement; Unregistered sale of shares; Bylaws or fiscal year changed54
  11. Sep 19, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed55
  12. Sep 12, 20258-K Other events56
  13. Mar 3, 2016New chief executive Erez Raphael becomes CEO12
  14. Feb 19, 2013New chief executive Oren Fuerst becomes CEO13

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.96) a share, on Nov 13, 2025.57

When it reported results

  1. Jul 24, 2023Reported quarterly or annual results58
  2. Feb 6, 2023Reported quarterly or annual results59
  3. Aug 15, 2022Reported quarterly or annual results60
  4. Jan 19, 2022Reported quarterly or annual results61

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

263 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 76 insider forms, 35 large holders, 5 private raises, 67 other. The latest 20:

  1. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  3. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  5. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 28, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Sep 28, 20263 OWNERSHIP DOCUMENT EDGAR
  10. Sep 4, 20268-K EDGAR
  11. Aug 21, 20268-K EDGAR
  12. Aug 11, 202610-Q EDGAR
  13. Jul 28, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Jul 22, 20268-K EDGAR
  15. Jul 22, 2026424B5 EDGAR
  16. Jul 10, 20268-K EDGAR
  17. May 13, 202610-Q EDGAR
  18. May 7, 2026SD EDGAR
  19. Apr 13, 20263 OWNERSHIP DOCUMENT EDGAR
  20. Apr 13, 20268-K EDGAR

The 263 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

32 open-market trades by officers, directors and large owners since October 2021: 18 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 23, 2026Matheis DennisDirectorBuy14,430$6.93$100.0KForm 4
Aug 27, 2025Nelson Steven CharlesPresident and CCOBuy40,000$0.53$21.2KForm 4
Nov 12, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.91$4.5KForm 4
Sep 11, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.80$4.0KForm 4
Sep 10, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.84$4.2KForm 4
Sep 9, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.80$4.0KForm 4
Sep 6, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.84$4.2KForm 4
Sep 5, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.82$4.1KForm 4
Aug 27, 2024Raphael ErezChief Executive OfficerBuy5,000$0.88$4.4KForm 4
Aug 23, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.95$4.8KForm 4
Aug 22, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.95$4.8KForm 4
Aug 21, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.93$4.7KForm 4
Aug 21, 2024Raphael ErezChief Executive OfficerBuy5,000$0.95$4.8KForm 4
Aug 20, 2024Raphael ErezChief Executive OfficerBuy5,000$0.93$4.7KForm 4
Aug 20, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.94$4.7KForm 4
Aug 19, 2024Nelson Steven CharlesPresident and CCOBuy5,000$0.92$4.6KForm 4
Aug 19, 2024Raphael ErezChief Executive OfficerBuy5,000$0.90$4.5KForm 4
Aug 16, 2024Raphael ErezChief Executive OfficerBuy5,000$0.90$4.5KForm 4
Jan 13, 2023Raphael ErezChief Executive OfficerSale1,200$6.21$7.5KForm 4
Dec 21, 2022MCGRATH DENNIS MDirectorSale9,872$3.97$39.2KForm 4

All 32 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2024Tomer Ben Kiki(Former Chief Operations Officer) $2.0M74
2024Erez Raphael(Chief Executive Officer)51$2.0M74
2024Richard Anderson(Former President)$1.4M74
2024Zvi Ben David(former Chief Financial Officer)$1.1M74
2024Steven Nelson(Chief Commercial Officer) 52$789.4K74
2023Erez Raphael(Chief Executive Officer)51$722.2K74
2023Richard Anderson(Former President)$536.6K74
2023Zvi Ben David(former Chief Financial Officer)$342.6K74

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$80.9M 2023–2025
Money received by yearMoney received by year, 2023–2025: $80.9M in all. Private raises (Form D) $80.9M.$0$20M$40M$60M2023 · Private raises (Form D): $15.4M20232024 · Private raises (Form D): $41.2M20242025 · Private raises (Form D): $24.3M2025
Figures by year
YearPrivate raises (Form D)Total
2025$24.3M$24.3M
2024$41.2M$41.2M
2023$15.4M$15.4M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Sep 22, 2025Raised $17.5 million in a private offering of equity41 Form D: 10 investors so far Form D
  2. Jan 7, 2025Raised $6.8 million in a private offering of equity75 Form D: 18 investors so far Form D
  3. Dec 16, 2024Raised $18.8 million in a private offering of equity43 Form D: 29 investors so far Form D
  4. Feb 15, 2024Raised $22.4 million in a private offering of equity42 Form D: 119 investors so far Form D
  5. May 1, 2023Raised $15.4 million in a private offering of equity44 Form D: 18 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Nantahala Capital Management, LLC1,221,382$8.1M0.2%+610,692
Vanguard Capital Management LLC65,675$433.5K0.0%−235
Geode Capital Management, LLC58,035$383.3K0.0%−3,843
BlackRock, Inc.37,796$249.5K0.0%+18,978
Vanguard Fiduciary Trust Co37,387$246.8K0.0%+7,317
Citadel Advisors LLC24,289$160.3K0.0%+3,829
Northern Trust Corp13,237$87.4K0.0%No change
Vanguard Global Advisers, LLC3,321$21.9K0.0%No change
Morgan Stanley3,000$19.8K0.0%+2,000
Osaic Holdings, Inc.1,900$12.5K0.0%+1,899
Royal Bank Of Canada658$4.0K0.0%+210
Trust Co Of Toledo Na /oh/352$2.3K0.0%No change
Fiduciary Financial Advisors159$1.0K0.0%New
UBS Group AG139$9170.0%−15,762
SBI Securities Co., Ltd.69$4550.0%−2
Barclays PLC26$1720.0%New
Steward Partners Investment Advisory, LLC10$660.0%No change
Bnp Paribas Financial Markets9$590.0%No change
Wells Fargo & Company/mn5$330.0%No change
Caitong International Asset Management Co., Ltd2$130.0%+1
Jpmorgan Chase & Co1$70.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How DarioHealth Corp. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARDarioHealth Corp.1
  • CIK0001533998
  • Employer ID (EIN)45-29731623
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address322 W 57Th St. #33B, New York, NY 100191
  • Phone972-4-770-63771
  • Shares outstanding9,799,481 as of Aug 11, 202611
  • Public float$28.0M as of Jun 30, 20253
  • AuditorKesselman & Kesselman, Tel Aviv, Israel PCAOB ID 1309; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceNov 1, 20111
  • Filings903 in all: 4 (339), 8-K (145), 10-Q (41), 3 (38), CORRESP (38), EFFECT (29), UPLOAD (29), D (23)1
    All 42 form types

    S-3 (20), SC 13G/A (19), S-8 (18), DEF 14A (16), SC 13G (14), SCHEDULE 13G/A (14), 10-K (13), 424B3 (12), PRE 14A (11), SD (11), 4/A (9), 424B5 (8), S-1 (7), S-3/A (7), S-1/A (6), 8-K/A (4), POS AM (4), SC 13D (4), SCHEDULE 13G (4), 10-Q/A (3), SC 13D/A (3), 424B7 (2), 25-NSE (1), 3/A (1), 424B4 (1), 8-A12B (1), ARS (1), CERTNAS (1), CT ORDER (1), D/A (1), DEL AM (1), DRS (1), PRER14A (1), SP 15D2 (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Dec 22, 2025
    Latest 8-K (8-K) Sep 4, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareDRIONasdaq

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks DarioHealth Corp. names in Item 1A of its 10-K filed Mar 19, 2026: 48 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Capital Requirements
  • 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.
  • 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.
  • Risks Related to Our Business
  • 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.
  • We cannot accurately predict the volume or timing of any future sales, making the timing of any revenues difficult to predict.
  • 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.
  • Failure in our online and digital marketing efforts could significantly impact our ability to generate sales.
  • Our Dario applications, which are a key to our business model, are currently available on the Apple App Store and the Google Play Store. 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.
  • Our dependence on SaaS business model, third-party services and network infrastructure could adversely affect our business and results of operations.
The other 38 risks
  • 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.
  • Changes in U.S. laws or policies, including trade policies and tariffs, could adversely affect our business and results of operations.
  • Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.
  • 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.
  • Our future performance will depend on the continued engagement of key members of our management team.
  • 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.
  • Our strategic review process may not result in a transaction and may create additional risks and uncertainties for our business.
  • Our outcomes-based contracts and reimbursement arrangements may not achieve expected results and may expose us to financial and operational risks.
  • Risks Related to Product Development and Regulatory Approval
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • Our employees, independent contractors, consultants, manufacturers and suppliers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • 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.
  • 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.
  • 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.
  • Risks Related to Our Industry
  • We face significant competition in the digital health and connected health device markets, which may limit our ability to grow our business.
  • If we fail to keep pace with technological change, our offerings may become less competitive.
  • Risks Related to Our Operations in Israel
  • 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.
  • 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.
  • Risks Related to the Ownership of Our Common Stock
  • There can be no assurance that we will be able to maintain continued Nasdaq listing criteria.
  • 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 has been extremely volatile and may continue to be volatile due to numerous circumstances beyond our control.
  • Future sales of our securities could depress the market price of our common stock.
  • Our compliance with U.S. regulations concerning corporate governance and public disclosure is expensive.
  • 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.

Legal proceedings

We are currently not a party to any pending legal proceeding, nor is our property the subject of a pending legal proceeding that we believe is not ordinary routine litigation incidental to our business or otherwise material to the financial condition of our business.

The opening of Item 3, Legal Proceedings.3

Sources

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