OWLT on NYSE

Owlet, Inc.

In its 2026 annual report the company says: “Owlet is a leading pediatric health platform and the only company globally to offer U.S. FDA-cleared and internationally medically-certified wearable pediatric monitors for home use.”3 It is headquartered in Lehi, Utah.1 Its shares trade on NYSE under the symbol OWLT.1

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Last updated Oct 20, 2026.

Overview

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  • TickerOWLT on NYSE1
  • IndustryMeasuring & Controlling Devices, NEC1
  • HeadquartersLehi, Utah1
  • Incorporated inDE2
  • Business address2940 West Maple Loop Drive, Suite 203, Lehi, Ut 840482
  • Filer categoryNon-accelerated filer, Smaller reporting company2

Owlet is a leading pediatric health platform and the only company globally to offer U.S. FDA-cleared and internationally medically-certified wearable pediatric monitors for home use. By delivering hospital-grade technology through a consumer-friendly interface, we bridge the critical gap between clinical care and the home.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

50.9%Gross margin4
-7.0%Operating margin4
-36.6%Net margin4
37.1%Revenue growth, 20254
-203.9%Return on equity5
0.13×Debt to equity5
-$11.1MFree cash flow5

What sells

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

Regions

United States brought in 82% of the revenue Owlet, Inc. broke down this way in fiscal 2025.

  1. United States$86.5M582%up 37% from 2024
  2. Rest of the world$13.3M513%up 34% from 2024
  3. United Kingdoms$5.9M56%up 14% from 2024
Regions by year
Regions20242025
United States$62.9M$86.5M
Rest of the world$9.9M$13.3M
United Kingdoms$5.2M$5.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue49¢$52.2M
  • Research and development13¢$14.0M
  • Other costs38¢$40.0M
  • Income tax0¢$28.0K

Out of $106.2M in revenue.45 The company lost money this year.

Financial statements

Revenue67894$106.2M in 2025+41% since 2020
0$50.0M$100.0M$150.0M2020: $75.4M$75.4M20202021: $75.8M$75.8M2021+1%2022: $69.2M$69.2M2022−9%2023: $54.0M$54.0M2023−22%2024: $77.4M$77.4M2024+43%2025: $106.2M$106.2M2025+37%
Gross profit67894$54.0M in 2025+50% since 2020
0$20.0M$40.0M$60.0M2020: $35.9M$35.9M20202021: $35.1M$35.1M2021−2%2022: $23.3M$23.3M2022−34%2023: $22.6M$22.6M2023−3%2024: $38.7M$38.7M2024+71%2025: $54.0M$54.0M2025+40%
Operating income67894-$7.4M in 2025+6% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$7.0M-$7.0M20202021: -$55.8M-$55.8M2021+698%2022: -$84.6M-$84.6M2022+52%2023: -$28.6M-$28.6M2023−66%2024: -$20.7M-$20.7M2024−28%2025: -$7.4M-$7.4M2025−64%
Net income67894-$38.8M in 2025+269% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$10.5M-$10.5M20202021: -$71.7M-$71.7M2021+582%2022: -$79.3M-$79.3M2022+11%2023: -$32.9M-$32.9M2023−59%2024: -$12.7M-$12.7M2024−61%2025: -$38.8M-$38.8M2025+206%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenues$105.7M$78.1M
Cost of revenues$52.2M$38.7M
Gross profit$53.5M$39.3M
General and administrative$29.2M$34.0M
Sales and marketing$18.5M$15.8M
Research and development$14.1M$9.8M
Total operating expenses$61.8M$59.5M
Operating loss-$8.3M-$20.2M
Interest expense, net-$3.4M-$1.6M
Common stock warrant liability adjustment-$26.6M$9.3M
Other income (expense), net-$1.4M$75.0K
Total other income (expense), net-$31.4M$7.7M
Loss before income tax provision-$39.6M-$12.5M
Income tax provision-$28.0K-$54.0K
Net loss and comprehensive loss-$39.7M-$12.5M
Accretion on convertible preferred stock-$3.4M-$4.9M
Accretion on redeemable common stock-$84.0K-$25.0K
Net loss attributable to redeemable common stockholders-$1.2M-$245.0K
Net loss attributable to common stockholders, basic-$41.9M-$17.2M
Net loss attributable to common stockholders, diluted-$41.9M-$17.2M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$2.31-$1.57
Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic (in shares)18.1M shares11.0M shares
Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, diluted (in shares)18.1M shares11.0M shares

Compare Owlet, Inc. with another company

Corporate structure

Owlet, Inc. 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 Owlet, Inc.

  • AWM Investment Company, Inc. Filed SCHEDULE 13G/A on Owlet, Inc., latest Aug 14, 2026 (2 filings since Feb 13, 2026)
  • Granahan Investment Management, LLC Filed SCHEDULE 13G on Owlet, Inc., latest Aug 11, 2026
  • Eclipse Continuity GP I, LLC Filed SCHEDULE 13D/A on Owlet, Inc., latest Oct 15, 2025 (5 filings since Feb 27, 2023)
  • Trilogy Equity Partners, LLC Filed SCHEDULE 13D/A on Owlet, Inc., latest Oct 15, 2025 (4 filings since Feb 23, 2023)
  • Kinderhook 2 GP, LLC Filed SCHEDULE 13G/A on Owlet, Inc., latest Jul 10, 2025 (2 filings since Dec 26, 2024)
  • John W. Stanton Filed SC 13G/A on Owlet, Inc., latest Oct 24, 2024 (3 filings since Feb 27, 2023)
  • PACIFIC INVESTMENT MANAGEMENT CO LLC Filed SC 13G/A on Owlet, Inc., latest Feb 13, 2024 (2 filings since Feb 11, 2022)
  • Kurt Workman Filed SC 13D on Owlet, Inc., latest Feb 27, 2023
  • ARISTEIA CAPITAL, L.L.C. Filed SC 13G/A on Owlet, Inc., latest Feb 14, 2022
  • SCOPUS ASSET MANAGEMENT, L.P. Filed SC 13G/A on Owlet, Inc., latest Feb 14, 2022
  • BlueCrest Capital Management Ltd Filed SC 13G/A on Owlet, Inc., latest Feb 11, 2022
  • Linden Capital L.P. Filed SC 13G/A on Owlet, Inc., latest Feb 2, 2022
  • Owlet, Inc. Lehi, Utah

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

What it owns

What Owlet, Inc. 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$2.9M5 Dec 31, 2025$3.4M5 Dec 31, 2024−12.6%
Accumulated depreciation$2.7M5 Dec 31, 2025$3.3M5 Dec 31, 2024−18.8%
Property and equipment, net$295.0K5 Dec 31, 2025$102.0K5 Dec 31, 2024+189.2%
Operating-lease assets (leased space)$69.0K5 Dec 31, 2025$138.0K5 Dec 31, 2024−50.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.5M5 Dec 31, 2025$20.2M5 Dec 31, 2024+75.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$2.2M5 Dec 31, 2025$1.4M5 Dec 31, 2024+58.7%
Accumulated amortization$834.0K5 Dec 31, 2025$427.0K5 Dec 31, 2024+95.3%
Finite-lived intangibles, net$1.4M5 Dec 31, 2025$975.0K5 Dec 31, 2024+42.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$15.3M5 Dec 31, 2025$10.5M5 Dec 31, 2024+45.3%

Properties, in its own words

Our corporate headquarters are located at a leased site in Lehi, Utah. We use this leased space primarily for business meetings, research and development, engineering, quality and laboratory space. This lease is set to expire on April 30, 2027, subject to our option to extend the term.

Item 2 of the 10-K filed Mar 9, 2026.3

Leadership

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

Board members and other officers (17)

Former names

  • Sandbridge Acquisition CorpJul 20, 2020 to Jul 16, 20212

Timeline

  1. Aug 14, 20268-K Executive or director change; Shareholder vote33
  2. Aug 11, 20268-K Results of operations34
  3. Jul 1, 20268-K Entered a material agreement; New debt or obligation35
  4. Jun 5, 20268-K Other events36
  5. May 7, 20268-K Results of operations37
  6. Apr 6, 20268-K Executive or director change38
  7. Mar 5, 20268-K Results of operations39
  8. Feb 5, 20268-K Other events40
  9. Nov 13, 20258-K Results of operations41
  10. Oct 23, 20258-K Results of operations; Other events42
  11. Oct 14, 20258-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote43
  12. Oct 6, 20258-K Executive or director change44
  13. Jul 19, 2021New chief executive Kurt Workman becomes CEO11
  14. Sep 14, 2020New chief executive Kenneth Suslow becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.04) a share, on Nov 13, 2025.45

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results34
  2. May 7, 2026Reported quarterly or annual results37
  3. Mar 5, 2026Reported quarterly or annual results39
  4. Nov 13, 2025Reported quarterly or annual results41
  5. Oct 23, 2025Reported quarterly or annual results42
  6. Aug 7, 2025Reported quarterly or annual results46
  7. May 8, 2025Reported quarterly or annual results47
  8. Mar 4, 2025Reported quarterly or annual results48

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

Filings

316 filings to the SEC since October 2021: 9 annual reports, 15 quarterly reports, 64 major events, 100 insider forms, 26 large holders, 102 other. The latest 20:

  1. Oct 8, 20264 EDGAR
  2. Aug 21, 20264 EDGAR
  3. Aug 21, 20264 EDGAR
  4. Aug 14, 20264 EDGAR
  5. Aug 14, 20264 EDGAR
  6. Aug 14, 20264 EDGAR
  7. Aug 14, 20268-K EDGAR
  8. Aug 14, 202610-Q EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 11, 20268-K EDGAR
  11. Aug 11, 2026SCHEDULE 13G EDGAR
  12. Jul 9, 20264 EDGAR
  13. Jul 1, 20268-K EDGAR
  14. Jun 30, 2026ARS EDGAR
  15. Jun 30, 2026DEFA14A EDGAR
  16. Jun 30, 2026DEF 14A EDGAR
  17. Jun 5, 20268-K EDGAR
  18. May 11, 2026S-8 EDGAR
  19. May 11, 202610-Q EDGAR
  20. May 7, 20268-K EDGAR

The 316 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

60 open-market trades by officers, directors and large owners since October 2021: 4 buys and 56 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 27, 2026Crawford AmandaChief Financial OfficerSale6,892$11.50$79.3KForm 4
Feb 26, 2026Harris JonathanSale12,676$11.50$145.8KForm 4
Feb 17, 2026Harris JonathanSale3,540$10.65$37.7KForm 4
Jan 20, 2026Crawford AmandaChief Financial OfficerSale183$13.33$2.4KForm 4
Jan 20, 2026Harris JonathanSale2,311$13.33$30.8KForm 4
Nov 17, 2025Harris JonathanSale3,423$10.49$35.9KForm 4
Oct 16, 2025Crawford AmandaChief Financial OfficerSale149$8.75$1.3KForm 4
Oct 16, 2025Harris JonathanSale1,851$8.75$16.2KForm 4
Oct 3, 2025Workman KurtPresident & CEOSale49,056$8.46$415.0KForm 4
Sep 17, 2025Workman KurtPresident & CEOSale1,014$7.25$7.4KForm 4
Sep 10, 2025Crawford AmandaChief Financial OfficerSale4,225$7.06$29.8KForm 4
Aug 19, 2025Harris JonathanSale3,315$7.72$25.6KForm 4
Jul 17, 2025Crawford AmandaChief Financial OfficerSale157$8.03$1.3KForm 4
Jul 17, 2025Harris JonathanSale1,945$8.03$15.6KForm 4
Jun 16, 2025Workman KurtPresident & CEOSale1,119$6.88$7.7KForm 4
May 19, 2025Harris JonathanSale3,565$5.11$18.2KForm 4
Apr 16, 2025Crawford AmandaChief Financial OfficerSale142$3.20$454Form 4
Apr 16, 2025Harris JonathanSale1,817$3.20$5.8KForm 4
Apr 8, 2025Harris JonathanSale5,184$3.19$16.5KForm 4
Mar 18, 2025Workman KurtPresident & CEOSale1,044$4.26$4.4KForm 4

All 60 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
2025Jonathan Harris$419.2K$4.2M63
2025Amanda Twede Crawford$341.0K$2.4M63
2025Kurt Workman$300.0K$799.4K63
2024Former President and Chief Executive Officer$375.0K$1.4M63
2024President and Chief Executive Officer$375.0K$987.1K63
2024Chief Financial Officer$274.9K$688.6K63

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 56. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Eclipse Operations, LLC7,700,835$44.2M1.7%No change
Granahan Investment Management, LLC1,595,419$9.2M0.3%+408,764
Cannell Capital LLC1,234,053$7.1M4.9%+235,888
AWM Investment Company, Inc.1,225,353$7.0M0.6%−753,117
Vanguard Capital Management LLC801,718$4.6M0.0%+20,197
Ameriprise Financial Inc512,655$2.9M0.0%−723,406
Jacobs Levy Equity Management, Inc330,824$1.9M0.0%+259,058
BlackRock, Inc.329,883$1.9M0.0%+7,360
Meros Investment Management, LP327,112$1.9M0.6%+189,665
Citadel Advisors LLC251,137$1.4M0.0%New
Geode Capital Management, LLC245,921$1.4M0.0%+27,510
Renaissance Technologies LLC207,741$1.2M0.0%−20,331
XTX Topco Ltd178,822$1.0M0.0%+84,942
Bleichroeder LP172,000$987.3K0.2%No change
Man Group plc143,996$826.5K0.0%+11,942
Vanguard Fiduciary Trust Co138,966$797.7K0.0%+13,016
Perkins Capital Management Inc106,495$611.3K0.5%+400
State Street Corp105,511$605.6K0.0%No change
Squarepoint Ops LLC98,191$563.6K0.0%+2,116
Potomac Capital Management, Inc.77,420$444.4K0.3%+6,920
Marshall Wace, Llp71,748$411.8K0.0%+46,231
Colter Lewis Investment Partners LLC67,093$385.1K0.2%New
Jane Street Group, LLC66,507$381.8K0.0%New
Millennium Management LLC65,852$378.0K0.0%−147,117
Dimensional Fund Advisors LP57,334$329.1K0.0%New

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

SEC filer profile

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

  • Name on EDGAROwlet, Inc.1
  • CIK0001816708
  • Employer ID (EIN)85-16150123
  • 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)3829 Measuring & Controlling Devices, NEC1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address2940 West Maple Loop Drive, Suite 203, Lehi, UT 840481
  • Phone84433453301
  • Shares outstanding29,221,677 as of Aug 6, 20264
  • Public float$95.6M as of Jun 30, 20253
  • AuditorPricewaterhouseCoopers LLP, Salt Lake City, Utah PCAOB ID 238; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJul 20, 20201
  • Filings414 in all: 4 (96), 8-K (73), 424B3 (31), 3 (24), 10-Q (18), CORRESP (14), 425 (13), 144 (12)1
    All 42 form types

    SC 13G/A (12), EFFECT (10), SC 13G (10), UPLOAD (10), S-8 (9), DEFA14A (7), SC 13D/A (7), 10-K (6), S-3 (6), 10-K/A (5), DEF 14A (5), 424B5 (4), ARS (4), 8-K/A (3), DRS (3), S-4/A (3), SC 13D (3), SCHEDULE 13G (3), 25-NSE (2), POS EX (2), PRE 14A (2), S-1 (2), S-1/A (2), SCHEDULE 13D/A (2), SCHEDULE 13G/A (2), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), FWP (1), NT 10-K (1), NT 10-Q (1), POS AM (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jun 30, 2026
    Latest 8-K (8-K) Aug 14, 2026

Securities registered for trading

ClassSymbolExchange
Class A Common stock, $0.0001 par value per shareOWLTNew York Stock Exchange

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Owlet, Inc. names in Item 1A of its 10-K filed Mar 9, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Business and Operations
  • We have a limited operating history at our current scale, which makes it difficult to evaluate our current business model and future prospects and may increase the risk of your investment.
  • We have a history of losses and may not achieve or sustain profitability. Operating losses could continue, which could materially and adversely affect our business, financial condition and results of operations.
  • We have experienced fluctuations in the growth of our business and anticipate this will continue. If we fail to manage our growth effectively, our business could be materially and adversely affected.
  • We may need to raise additional capital in the future in order to support our operations and strategic plans, which may not be available to us when needed, on acceptable terms, or at all.
  • Our debt arrangements contain certain covenants and restrictions that may limit our flexibility in operating our business and any failure to satisfy those covenants and restrictions could adversely affect our business and financial condition.
  • Our products and services rely on our mobile applications to function, and we depend on Apple’s App Store and the Google Play Store for distribution, updates, and continued availability of those applications.
  • A substantial portion of our sales comes through a limited number of retailers.
  • We currently rely on single-source contract manufacturers for the assembly of our sock monitor and camera products, and disruptions or cost increases could adversely affect our business.
  • Gray market activity, product diversion, and theft could harm our brand, customer experience, and results of operations.
  • Our reliance on NAND flash memory for our Dream Sight and Dream Duo product lines exposes us to significant supply shortages and cost volatility that could adversely affect our margins and product availability.
  • Any disruption of service at our third-party data and call centers or other cloud infrastructure services could interrupt or delay our ability to deliver our services to our customers.
The other 61 risks
  • We rely on the experience and expertise of our senior management team, other key officers, our engineers, marketing and field sales team and other highly skilled personnel.
  • If we are unable to successfully develop, introduce, and drive adoption of new products, services, and enhancements, our business, financial condition and results of operations could be adversely affected.
  • If we do not successfully develop and commercialize innovative products and services that remain competitive, we could lose revenue opportunities and customers, and our ability to grow our business would be impaired, adversely affecting our financial condition and results of operations.
  • We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could negatively affect our operating results, increase our costs and liabilities, require significant management attention, and adversely affect our financial condition and results of operations.
  • We are involved, and may become involved in the future, in disputes and other legal or regulatory proceedings that, if adversely decided or settled, could materially and adversely affect our business, financial condition and results of operations.
  • We have identified material weaknesses in our internal control over financial reporting and we may identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, which may result in material misstatements of our consolidated financial statements, cause us to fail to meet our periodic reporting obligations, or cause our access to the capital markets to be impaired.
  • We believe we will be required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act for our 2027 Annual Report on Form 10-K to be filed in early 2028. Failure to comply in a timely manner, or the identification of additional material weaknesses, could adversely affect our business and stock price.
  • Increases in tariffs, trade restrictions or taxes on our products could have an adverse impact on our operations.
  • Our distributors or retail customers may experience financial difficulties, and we may not be able to collect our receivables, which could materially or adversely affect our profitability, cash flows, working capital and business operations.
  • We are subject to risks associated with our distributors’ and retailers’ Owlet product inventories and sell-through to end consumers, which could adversely affect our revenues and results of operations.
  • Adapting our production capacities to evolving patterns of demand is expensive, time-consuming and subject to significant uncertainties. We may not be able to adequately predict consumer trends and may be unable to adjust our production in a timely manner.
  • The size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate.
  • We spend significant amounts on advertising and other marketing campaigns to acquire new customers, which may not be successful or cost effective.
  • If we are unable to continue to drive consumers to our website, it could adversely affect our revenue.
  • Our success depends substantially on our reputation and brand.
  • Increased use of social media could create or amplify the effects of negative publicity and adversely affect sales and operating results.
  • Defects or quality issues associated with our products could adversely affect the results of our operations.
  • Our products must be manufactured, and services provided, in accordance with federal, state and foreign regulations, and we or any of our suppliers could be forced to recall products or terminate production or services if we fail to comply with these regulations.
  • Operations in international markets expose us to additional business, political, regulatory, operational, financial and economic risks.
  • Our business and operations may suffer in the event of IT system failures, cyberattacks or deficiencies in our cybersecurity.
  • Development, maintenance, and use of AI technologies may not be beneficial to our business, and may result in the poor performance of our products, services and business, as well as damage our reputation and the reputations of our customers, or cause us to incur liability resulting from the violation of laws or contracts to which we are a party.
  • We are subject to a number of risks related to the credit extended by our manufacturing providers.
  • Changes in tax laws may impact our future financial position and results of operations.
  • The applicability of sales, use and other tax laws or regulations on our business is uncertain. Adverse tax laws or regulations could be enacted or existing laws could be applied to us or our customers, which could subject us to additional tax liabilities and related interest and penalties, increase the costs of our products and adversely impact our business.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We are subject to a number of risks related to the credit card and debit card payments we accept.
  • The increasing focus on environmental sustainability and social initiatives could increase our costs, harm our reputation and adversely impact our financial results.
  • We are subject to a series of risks regarding climate change.
  • Risks Related to Regulation of Our Industry and Products
  • Despite having received 510(k) clearance from the FDA for our prescription-required BabySat pediatric monitor, and having received de novo authorization (classification) for Dream Sock, such marketing authorizations do not ensure commercial success of these products, which will require us to implement processes, procedures and operations necessary to market and sell medical devices. We may not be successful in implementing these requirements, which could subject us to new risks and could adversely affect our business, financial condition and results of operations.
  • We are required to obtain and maintain marketing authorizations or certifications from the FDA, foreign regulatory authorities or notified bodies for medical device products in the U.S. or in foreign jurisdictions, which can be a lengthy and time-consuming process, and a failure to do so on a timely basis, or at all, could severely harm our business.
  • We have relied and expect to continue to rely on third parties to conduct our non-clinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain marketing authorization or other required certifications to commercialize our medical device products and our business could be substantially harmed.
  • We rely on third party manufacturers and suppliers to produce our products in compliance with applicable quality system and regulatory requirements, and failure to do so could result in enforcement actions, recalls, and supply disruptions.
  • Regulatory reforms may impact our ability to develop and commercialize our products and services and technologies.
  • Promotion of any medical devices using claims that are off-label, unsubstantiated, false or misleading could subject us to substantial penalties and enforcement action.
  • Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
  • Changes in and actual or perceived failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • Our relationships with customers, physicians and third-party payors may be subject to federal, state and foreign healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners, or vendors violate these laws, we could face substantial penalties.
  • Expanding our commercial strategy based on third-party payor coverage and reimbursement may not be successful and will subject us to new risks, including, without limitation, changes in third-party payor coding, coverage and reimbursement rates for our products that obtain FDA or foreign regulatory authorities authorization or notified bodies certification which could affect the adoption of such products and negatively impact our future revenue.
  • Legislative and regulatory changes in the healthcare industry could have a negative impact on our financial performance. Furthermore, our business, financial condition, results of operations and cash flows could be significantly and adversely affected by healthcare reform legislation in the U.S. or in potential key international markets.
  • We may be subject to regulatory reporting requirements if our products and services cause or contribute to a death or serious injury or malfunction in a way that would likely cause or contribute to a death or serious injury, or in certain other scenarios, and we may need to initiate voluntary corrective actions such as the recall of our products.
  • We face the risk of product liability claims and the amount of insurance coverage we hold now or in the future may not be adequate to cover all liabilities we might incur.
  • We may incur environmental and personal injury liabilities related to certain hazardous materials used in our operations.
  • Risks Related to Our Intellectual Property
  • Our success depends in part on our proprietary technology, and if we are unable to obtain, maintain or successfully enforce our intellectual property rights, the commercial value of our products and services will be adversely affected, our competitive position may be harmed and we may be unable to operate our business profitably.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
  • We rely on third-party technology solutions, including software and software services, to support our IT infrastructure and in our products and services.
  • The laws of foreign countries may not adequately protect our intellectual property rights.
  • If third parties claim that we infringe their intellectual property rights, we may incur liabilities and costs and may have to redesign or discontinue selling certain products and services.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
  • Our proprietary software may not operate properly, which could damage our reputation, give rise to claims against us, or divert application of our resources from other purposes, any of which could harm our business and operating results.
  • We may be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
  • If we fail to execute enforceable invention assignment and confidentiality agreements with our employees and contractors involved in the development of intellectual property or are unable to protect the confidentiality of our trade secrets, the value of our products and services and our business and competitive position could be harmed.
  • Risks Related to Our Securities
  • The market price of our common stock and warrants may be volatile. In addition, any trading market for our public warrants may be limited, and the market price of the public warrants (if any) may be more volatile and less liquid than the market for our common stock.
  • Our failure to meet the NYSE’s continued listing requirements could result in a delisting of our common stock.
  • If securities or industry analysts issue an adverse or misleading opinion regarding our common stock or warrants, the price and trading volume of our common stock and warrants could decline.
  • Concentration of ownership among our existing directors, executive officers and principal stockholders may prevent new investors from influencing significant corporate decisions.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • The redemption of our outstanding Convertible Preferred Stock or exercise of the WTI Redemption Option may require us to make a significant cash payment.
  • Our corporate documents and Delaware law contain provisions that could discourage or delay a change in control, prevent attempts to replace or remove current management and reduce the market price of our securities.
  • We are a “smaller reporting company" and the reduced disclosure requirements applicable to smaller reporting companies may make our securities less attractive to investors.
  • Our organizational documents designate courts of the State of Delaware as the exclusive forum for certain stockholder litigation matters and include officer exculpation provisions, which could limit our stockholders’ ability to obtain a favorable judicial forum or monetary remedies in disputes with us or our directors or officers.
  • You may only be able to exercise our public warrants on a “cashless basis” under certain circumstances, and if you do so, you will receive fewer shares of common stock from such exercise than if you were to exercise such warrants for cash.

Legal proceedings

In the ordinary course of business we face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation, and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.

For a description of our legal proceedings, see Note 7, “Commitments and Contingencies,” to our audited consolidated financial statements included elsewhere in this Report, which is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.3

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