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INGN on Nasdaq

Inogen Inc

In its 2026 annual report the company says: “Inogen, Inc. is a medical technology business that primarily focuses on respiratory health. We develop, manufacture, and market innovative respiratory health products, including portable oxygen concentrators, or POCs, used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions and the Simeox ® product for airway clearance treatment.”5 It is headquartered in Goleta, United States.2 Its shares trade on Nasdaq under the symbol INGN.2

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Last updated Oct 21, 2026.

Overview

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  • TickerINGN on Nasdaq2
  • IndustryOrthopedic, Prosthetic & Surgical Appliances & Supplies2
  • HeadquartersGoleta, United States2
  • Incorporated inDE3
  • Business address500 Cummings Center, Suite 2800, Beverly, Ma 019153
  • Filer categoryAccelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300J8WJIVTOJ8IH972
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 34609842

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Inogen, Inc. is a medical technology business that primarily focuses on respiratory health. We develop, manufacture, and market innovative respiratory health products, including portable oxygen concentrators, or POCs, used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions and the Simeox ® product for airway clearance treatment. In addition, we have started distributing the Inogen Voxi ® 5 stationary oxygen concentrator as well as the Aurora ® continuous positive airway pressure, or CPAP, masks in the United States. Our proprietary Inogen One ® and Inogen Rove ® POC systems concentrate the air around the patient to offer a source of supplemental oxygen 24 hours a day, seven days a week with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available. While often used together with …5 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

52.2%Gross margin6
-10.2%Operating margin6
-7.7%Net margin6
5.9%Revenue growth, 20256
-11.8%Return on equity6
-$13.7MFree cash flow6

What sells

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

Regions

United States brought in 53% of the revenue Inogen Inc broke down this way in fiscal 2025.

  1. United States$156.5M653%down 3% from 2024
  2. Outside the United States$138.8M647%up 18% from 2024
Regions by year
Regions202320242025
United States$162.2M$161.5M$156.5M
Outside the United States$89.4M$117.2M$138.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue66¢$194.4M
  • Research and development7¢$19.4M
  • Other costs27¢$80.9M
  • Income tax0¢$632.0K

Out of $295.3M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$295.3M in 2025−13% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $340.5M$340.5M20192020: $280.2M$280.2M2020−18%2021: $311.7M$311.7M2021+11%2022: $320.5M$320.5M2022+3%2023: $251.6M$251.6M2023−22%2024: $278.8M$278.8M2024+11%2025: $295.3M$295.3M2025+6%
Gross profit789106$154.3M in 2025−10% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $171.9M$171.9M20192020: $138.2M$138.2M2020−20%2021: $176.5M$176.5M2021+28%2022: $153.5M$153.5M2022−13%2023: $126.7M$126.7M2023−17%2024: $154.7M$154.7M2024+22%2025: $154.3M$154.3M2025−0%
Operating income789106-$30.2M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2019: $19.8M$19.8M20192020: -$12.0M-$12.0M20202021: $9.2M$9.2M20212022: -$85.2M-$85.2M20222023: -$109.4M-$109.4M2023+28%2024: -$42.5M-$42.5M2024−61%2025: -$30.2M-$30.2M2025−29%
Net income789106-$22.7M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2019: $20.9M$20.9M20192020: -$5.8M-$5.8M20202021: -$6.3M-$6.3M2021+9%2022: -$83.8M-$83.8M2022+1223%2023: -$102.4M-$102.4M2023+22%2024: -$35.9M-$35.9M2024−65%2025: -$22.7M-$22.7M2025−37%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Sales revenue$295.3M$278.8M$251.6M
Rental revenue$53.4M$56.9M$64.1M
Total revenue$348.7M$335.7M$315.7M
Cost of sales revenue$163.8M$148.7M$158.6M
Cost of rental revenue, including depreciation of $11,798, $12,592 and $12,893, respectively$30.6M$32.3M$30.3M
Total cost of revenue$194.4M$181.0M$189.0M
Gross profit-sales revenue$131.5M$130.1M$93.0M
Gross profit-rental revenue$22.8M$24.6M$33.7M
Total gross profit$154.3M$154.7M$126.7M
Research and development$19.4M$21.6M$20.8M
Sales and marketing$97.7M$103.1M$107.1M
General and administrative$67.4M$72.6M$75.3M
Impairment charges$32.9M
Total operating expense$184.5M$197.3M$236.1M
Loss from operations-$30.2M-$42.5M-$109.4M
Interest income, net$4.4M$5.2M$6.6M
Other income, net$2.4M$850.0K$468.0K
Total other income, net$6.8M$6.0M$7.0M
Loss before (benefit) provision for income taxes-$23.4M-$36.5M-$102.3M
(Benefit) provision for income taxes-$632.0K-$588.0K$105.0K
Net loss-$22.7M-$35.9M-$102.4M
Change in foreign currency translation adjustment$5.7M-$2.6M$1.4M
Change in net unrealized gains (losses) on foreign currency hedging$2.0M-$324.0K
Less: reclassification adjustment for net (losses) gains included in net loss-$2.0M$324.0K
Change in net unrealized gains (losses) on marketable securities$22.0K-$136.0K$110.0K
Total other comprehensive income (loss), net of tax$5.7M-$2.7M$1.5M
Comprehensive loss-$17.0M-$38.6M-$101.0M
Basic net loss per share attributable to common stockholders (Note 2)-$0.86-$1.52-$4.42
Diluted net loss per share attributable to common stockholders (Note 2)-$0.86-$1.52-$4.42
Basic shares of common stock26.6M shares23.7M shares23.2M shares
Diluted shares of common stock26.6M shares23.7M shares23.2M shares
Depreciation$11.8M$12.6M$12.9M

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Corporate structure

Inogen Inc sits at the top of its group. 3 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Inogen Inc

  • Inogen Inc Goleta, California, United States
    • Inogen Europe, B.V. Subsidiary · Netherlands
    • Physio Assist GmbH Subsidiary · Germany

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Inogen 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$85.3M6 Dec 31, 2025$89.1M6 Dec 31, 2024−4.3%
Accumulated depreciation$49.0M6 Dec 31, 2025$44.7M6 Dec 31, 2024+9.5%
Property and equipment, net$36.4M6 Dec 31, 2025$44.4M6 Dec 31, 2024−18.1%
Operating-lease assets (leased space)$16.5M6 Dec 31, 2025$18.3M6 Dec 31, 2024−9.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$103.7M6 Dec 31, 2025$113.8M6 Dec 31, 2024−8.8%
Marketable securities, current$15.8M6 Dec 31, 2025$06 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$10.7M6 Dec 31, 2025$9.5M6 Dec 31, 2024+13.0%
Finite-lived intangibles, gross$46.9M6 Dec 31, 2025$40.9M6 Dec 31, 2024+14.9%
Accumulated amortization$16.2M6 Dec 31, 2025$10.4M6 Dec 31, 2024+56.2%
Finite-lived intangibles, net$30.8M6 Dec 31, 2025$30.5M6 Dec 31, 2024+0.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$26.0M6 Dec 31, 2025$24.8M6 Dec 31, 2024+4.7%
Finished goods$11.0M6 Dec 31, 2025$7.6M10 Dec 31, 2024+44.4%

Properties, in its own words

As of December 31, 2025, we lease approximately 18,000 square feet of office space in Goleta, California under a lease that expires in January 2028 and approximately 154,000 square feet of manufacturing and office space in Plano, Texas under a lease that expires in April 2031. In addition, we lease approximately 700 square feet of office space in Huntsville, Alabama under a lease that expires in June 2027; 1,200 square feet in Aurora, Colorado with a lease that expires in November 2026; approximately 3,700 square feet of office space in De Meern in the Netherlands with a lease that expires in May 2028; approximately 3,600 square feet of office and warehouse space in Montpellier, France under leases that expire in June 2029 and October 2032; and approximately 6,000 square feet of office space at our corporate headquarters in Beverly, Massachusetts with a lease term of three years that expires in July 2027. We believe that our existing facilities are adequate to meet our current business requirements and that if additional space is required, it will be available on commercially reasonable terms. In addition, we believe that our properties are in good condition and are adequate and suitable for their intended purposes.

We lease approximately 51,000 square feet of manufacturing and office space in Goleta, California under a lease that expires in March 2030. In July 2023, we entered into an Assignment and Assumption of Lease Agreement in which a third party, the Assignee, assumed the rights, title, and interest in the lease, including assumption of lease payments. Commencing February 1, 2024 and ending May 31, 2031, the Assignee assumed responsibility for the monthly lease payments. Notwithstanding the Assignee's assumption of lease payments, we remain the primary obligor under the lease to the landlord.

Item 2 of the 10-K filed Feb 27, 2026.5

Leadership

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

Chief executive

  1. Raymond Huggenberger2014–2017
  2. Scott Wilkinson2017–2020
  3. Nabil Shabshab2021–2023

Chair

  1. Heath Lukatch2014

President

  1. Raymond Huggenberger2014–2016
  2. Scott Wilkinson2016–2020
  3. Nabil Shabshab2021–2023

Chief financial officer

  1. Alison Bauerlein2014–2021
  2. Michael K. Sergesketter2021–2023
  3. Kristin A. Caltrider2022–2023
  4. Michael J. Bourque2024–now

Chief operating officer

  1. Scott Wilkinson2016–2017
  2. Andrew P. Reding2026–now
201520202025
Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Inogen Europe, B.V. Netherlands4
  • Physio Assist GmbH Germany4
  • Physio Assist SAS France4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 30, 20268-K Entered a material agreement; Regulation FD disclosure; Other events54
  2. Aug 6, 20268-K Results of operations55
  3. Jul 1, 20268-K Executive or director change; Regulation FD disclosure56
  4. Jun 11, 20268-K Executive or director change; Shareholder vote57
  5. May 7, 20268-K Results of operations58
  6. Apr 6, 20268-K Entered a material agreement; Executive or director change; Regulation FD disclosure59
  7. Mar 30, 20268-K Executive or director change; Regulation FD disclosure60
  8. Feb 24, 20268-K Results of operations; Regulation FD disclosure61
  9. Jan 12, 20268-K Results of operations62
  10. Nov 5, 20258-K Results of operations63
  11. Aug 7, 20258-K Results of operations64
  12. Jul 29, 20258-K Executive or director change65
  13. Feb 8, 2021New chief executive Nabil Shabshab becomes CEO14
  14. Mar 3, 2017New chief executive Scott Wilkinson becomes CEO15
  15. Apr 2, 2014New chief executive Raymond Huggenberger becomes CEO16
  16. Nov 27, 2001Founded Inogen Inc is founded2

Calendar

Coming up

  1. Nov 5, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.20) a share, on Nov 5, 2025.66

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results55
  2. May 7, 2026Reported quarterly or annual results58
  3. Feb 24, 2026Reported quarterly or annual results61
  4. Jan 12, 2026Reported quarterly or annual results62
  5. Nov 5, 2025Reported quarterly or annual results63
  6. Aug 7, 2025Reported quarterly or annual results64
  7. May 7, 2025Reported quarterly or annual results67
  8. Feb 25, 2025Reported quarterly or annual results68

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

Filings

274 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 133 insider forms, 23 large holders, 37 other. The latest 20:

  1. Sep 30, 20268-K EDGAR
  2. Sep 3, 20264 EDGAR
  3. Sep 3, 20264 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Aug 7, 202610-Q EDGAR
  6. Aug 6, 20268-K EDGAR
  7. Jul 24, 2026S-8 EDGAR
  8. Jul 9, 20264 EDGAR
  9. Jul 9, 20263 EDGAR
  10. Jul 6, 20264 EDGAR
  11. Jul 1, 2026144 EDGAR
  12. Jul 1, 20268-K EDGAR
  13. Jun 12, 2026S-8 EDGAR
  14. Jun 11, 20268-K EDGAR
  15. Jun 9, 20264 EDGAR
  16. Jun 9, 20264 EDGAR
  17. Jun 9, 20263 EDGAR
  18. Jun 9, 20264 EDGAR
  19. Jun 9, 20264 EDGAR
  20. Jun 9, 20264 EDGAR

The 274 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

8 open-market trades by officers, directors and large owners since October 2021: 2 buys and 6 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 1, 2026Yi Boyer Jennifer MEVP Entrprs Enblmnt, Ch HR OffSale10,938$6.60$72.2KForm 4
May 29, 2026Yi Boyer Jennifer MEVP Entrprs Enblmnt, Ch HR OffSale10,770$6.53$70.3KForm 4
Mar 3, 2025Bourque Michael J.EVP, CFO & TreasurerBuy3,000$8.32$25.0KForm 4
Mar 3, 2025Smith Kevin Raymond MerrillCEO and PresidentBuy11,709$8.56$100.2KForm 4
May 10, 2024Somer JasonEVP, Gen. Counsel & SecretarySale10,000$8.56$85.6KForm 4
Sep 1, 2022Glezer StanislavEVP, R&D & Chief Med. OfficerSale1,576$28.16$44.4KForm 4
Sep 1, 2022Somer JasonEVP, Gen. Counsel & SecretarySale1,145$28.16$32.2KForm 4
Mar 3, 2022Anderson Ray Benjamin MDirectorSale4,516$34.68$156.6KForm 4

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
2025Kevin R.M. Smith55$711.1K$2.6M75
2025Michael Bourque$450.1K$1.7M75
2025Jennifer Yi Boyer52$426.7K$1.5M75
2025Kevin P. Smith55$432.5K$1.5M75
2025Gregoire Ramade56$447.4K$1.4M75
2024Chief Executive Officer and PresidentDirector$705.4K$4.2M75
2024Former Executive Vice PresidentChief Financial Officer, and Corporate Treasurer$354.7K$1.9M75
2024General Counsel & EVP Business Development$189.0K$978.0K75
2024Executive Vice PresidentChief Commercial Officer$386.8K$873.0K75
2023Chief Executive Officer and PresidentDirector$107.7K$1.8M75

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.1,748,986$11.3M0.0%+101,902
Armistice Capital, LLC1,096,000$7.1M0.2%−104,000
Vanguard Capital Management LLC1,038,316$6.7M0.0%+1,611
Ameriprise Financial Inc983,028$6.3M0.0%+123,485
Aqr Capital Management LLC937,334$6.0M0.0%+510,216
DAFNA Capital Management LLC845,179$5.5M1.0%No change
Arrowstreet Capital, Limited Partnership743,252$4.8M0.0%+157,093
Morgan Stanley646,276$4.2M0.0%+105,111
Geode Capital Management, LLC641,521$4.1M0.0%+27,992
State Street Corp591,943$3.8M0.0%+18,739
Federated Hermes, Inc.534,936$3.5M0.0%+20,280
Jpmorgan Chase & Co480,308$3.3M0.0%+52,652
Dimensional Fund Advisors LP488,645$3.2M0.0%−21,177
Renaissance Technologies LLC476,700$3.1M0.0%−2,100
Goldman Sachs Group Inc435,585$2.8M0.0%−144,515
ExodusPoint Capital Management, LP393,803$2.5M0.0%+63,362
Jacobs Levy Equity Management, Inc388,788$2.5M0.0%+91,819
Prudential Financial Inc328,970$2.1M0.0%−40,100
UBS Group AG301,596$1.9M0.0%+117,087
Moore Capital Management, LP289,128$1.9M0.0%+9,229
Readystate Asset Management LP266,334$1.7M0.1%New
Peapod Lane Capital LLC262,775$1.7M1.1%+4,130
Vanguard Portfolio Management LLC252,756$1.6M0.0%+27,190
Mackenzie Financial Corp210,860$1.4M0.0%New
Steward Partners Investment Advisory, LLC201,531$1.3M0.0%New

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

SEC filer profile

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

  • Name on EDGARInogen Inc1
  • CIK0001294133
  • Employer ID (EIN)33-09893595
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3842 Orthopedic, Prosthetic & Surgical Appliances & Supplies1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address500 Cummings Center, Suite 2800, Beverly, MA 019151
  • Phone805-562-05001
  • Shares outstanding26,538,337 as of Aug 1, 202612
  • Public float$190.1M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, Los Angeles, California, USA PCAOB ID 34; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceJun 16, 20041
  • Filings1,006 in all: 4 (574), 8-K (139), SC 13G/A (45), 3 (44), 10-Q (38), S-8 (16), DEFA14A (14), 10-K (13)1
    All 36 form types

    4/A (13), DEF 14A (12), SC 13G (11), SD (11), 8-K/A (7), CORRESP (7), UPLOAD (7), REGDEX (6), REGDEX/A (6), S-1/A (6), ARS (5), 144 (4), CT ORDER (4), SCHEDULE 13G/A (4), 3/A (3), 424B4 (2), EFFECT (2), FWP (2), S-1 (2), 8-A12B (1), CERTNAS (1), D (1), D/A (1), DRS (1), NT 10-K (1), NT 10-K/A (1), PRE 14A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueINGNThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Inogen Inc names in Item 1A of its 10-K filed Feb 27, 2026: 57 risks under these headings, as written.5

  • Risks related to our business and strategy
  • We operate in a highly competitive industry and we may be unable to compete effectively.
  • We depend on a limited number of customers for a significant portion of our sales revenue.
  • Reduction or interruption in our supply of components and products may adversely affect our manufacturing operations and related product sales.
  • Tariffs, trade restrictions and Section 232 investigations could increase our costs and disrupt our supply chain.
  • If we are unable to continue to enhance our existing products, develop or acquire and market products that respond to customer needs and preferences and achieve market acceptance, we may experience a decrease in demand for our products and our business could suffer.
  • We may expand through acquisitions of, collaborations with, or investments in, other companies, each of which may divert our management’s attention, result in additional dilution to our stockholders, increase expenses, disrupt our operations, and harm our results of operations.
  • We depend upon reimbursement from Medicare, private payors, Medicaid, and payments from patients for a significant portion of our revenue, and if we fail to manage the complex and lengthy reimbursement process, our business and operating results could be adversely affected.
  • Increases in our operating costs could have a material adverse effect on our business, financial condition and results of operations.
  • An economic recession, downturn, period of inflation, or economic uncertainty in our key markets may adversely affect customer and consumer spending as well as demand for our products.
  • Public health crises have had, and may continue to have, an adverse effect on certain aspects of our business, results of operations, financial condition, and cash flows. The nature and extent of future impacts are highly uncertain and unpredictable.
  • Changes to reimbursement rates, payment methodologies, or coverage policies for our products by government or commercial payors may adversely affect our business and operating results.
The other 46 risks
  • The competitive bidding process or other reimbursement policy changes under Medicare or other third-party payors could negatively affect our business and financial condition.
  • Consolidation in the healthcare industry could have an adverse effect on our revenues and results of operations.
  • Healthcare reform measures may have a material adverse effect on our business and results of operations.
  • Failure to maintain or obtain new private payor contracts and future reductions in reimbursement rates from private payors could have a material adverse effect on our financial condition and results of operations.
  • If our manufacturing facilities become unavailable or inoperable, we could be unable to continue manufacturing our products and, as a result, our business, financial condition and results of operations could be adversely affected until we are able to secure a new facility.
  • We rely upon a third-party contract manufacturer for certain manufacturing operations and our business and results of operations may be adversely affected by risks associated with their business, financial condition and the geography in which they operate.
  • We are exposed to the credit and non-payment risk of our HME providers, distributors, private label collaborators and resellers, especially during times of economic uncertainty and tight credit markets, which could result in material losses.
  • We generate a substantial portion of our revenue internationally and are subject to various risks relating to such international activities, which could adversely affect our operating results. In addition, any disruption or delay in the shipping of our products, whether domestically or internationally, may have an adverse effect on our financial condition and results of operations.
  • Failure to comply with anti-bribery, and anti-corruption, including the U.S. Foreign Corrupt Practices Act and similar laws associated with our activities outside of the United States and anti-money-laundering laws could subject us to penalties and other adverse consequences.
  • If we fail to comply with U.S. and applicable foreign export control and economic sanctions or fail to expand and maintain an effective sales force or successfully develop our international distribution network, our business, financial condition and results of operations may be adversely affected.
  • We may be subject to substantial warranty or product liability claims or other litigation in the ordinary course of business that may adversely affect our business, financial condition and results of operations.
  • We depend on the services of our senior executives and other key technical personnel, the loss of whom could negatively affect our business.
  • We and our vendors and service providers rely on information technology networks and systems, and if we are unable to protect against service interruptions, data corruption, cybersecurity risks, data security incidents and/or network security breaches, our operations could be disrupted, and our business could be negatively affected, which could result in a material loss of business, substantial legal liability or significant harm to our reputation.
  • Increasing data privacy and data protection regulations could impact our business and expose us to increased liability.
  • Our financial condition and results of operations may vary significantly from quarter-to-quarter due to a number of factors, which may lead to volatility in our stock price.
  • If the market opportunities for our products are smaller than we believe they are, our revenues may be adversely affected, and our business may suffer.
  • The adoption and interpretation of new tax legislation, tax rulings, or exposure to additional tax liabilities, could materially affect our financial condition, results of operations, and cash flows.
  • Our ability to recognize the benefits of deferred tax assets is dependent on future cash flows and taxable income.
  • Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.
  • Risks related to the regulatory environment
  • We are subject to extensive federal and state regulation, and if we fail to comply with applicable regulations, we could suffer severe criminal or civil sanctions and be required to make significant changes to our operations that could adversely affect our business, financial condition and results of operations.
  • We are subject to significant regulation by numerous government agencies, including the FDA. We cannot market or commercially distribute our products without obtaining and maintaining necessary regulatory clearances or approvals and such approvals may be revoked or revised if an agency like the FDA believes it necessary.
  • If we modify our FDA cleared devices, we may need to seek additional clearances, authorizations, or approvals, which, if not granted, would prevent us from selling such modified products.
  • If we fail to comply with FDA or state regulatory requirements, we can be subject to enforcement action.
  • A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse effect on us.
  • If we or our contract manufacturers fail to comply with the FDA’s Quality System Regulation, our manufacturing operations could be interrupted, and our product sales and operating results could suffer.
  • If we fail to obtain and maintain regulatory approval in foreign jurisdictions, our market opportunities will be limited.
  • If the FDA disagrees with us that certain of our data collection and analysis methods do not constitute clinical trials, our business may be harmed.
  • Clinical development is a long, expensive, and uncertain process and is subject to delays and the risk that products may ultimately prove unsafe or ineffective in treating the indications for which they are designed.
  • We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses, resulting in damage to our reputation and business.
  • Failure to comply with the Federal Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act, and implementing regulations could result in significant penalties.
  • If we fail to comply with state and federal fraud and abuse laws, including anti-kickback, Physician Self-Referral Law, false claims and anti-inducement laws, we could face substantial penalties and our business, results of operations and financial condition could be adversely affected.
  • Foreign governments tend to impose strict price controls, which may adversely affect our future profitability.
  • Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.
  • The implementation of prior authorization rules for DMEPOS under Medicare could negatively affect our business and financial condition.
  • Risks related to our intellectual property
  • If we are unable to secure and maintain patent or other intellectual property protection for the intellectual property used in our products, we will lose a significant competitive advantage, which may adversely affect our future profitability.
  • Our patents may not adequately protect our products from third party competitors
  • Our products could infringe or appear to infringe the intellectual property rights of others, which may lead to patent and other intellectual property litigation that could itself be costly, could result in the payment of substantial damages or royalties, prevent us from using technology that is essential to our products, and/or force us to discontinue selling our products.
  • If we are unable to prevent unauthorized use or disclosure of trade secrets, unpatented know-how and other proprietary information, our ability to compete will be harmed.
  • We may be subject to damages resulting from claims that our employees, agents or we have wrongfully used or disclosed alleged trade secrets of other companies.
  • Risks related to being a public company
  • We will incur increased costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
  • Risks related to our common stock
  • We expect that our stock price will fluctuate significantly, you may have difficulty selling your shares, and you could lose all or part of your investment.
  • Our certificate of incorporation and our amended and restated bylaws designate the Court of Chancery of the Delaware as the exclusive forum for substantially all disputes between us and our stockholders, and our amended and restated bylaws also provide that the federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, each of which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, stockholders, or employees.
  • Future sales of shares could cause our stock price to decline.
  • Our directors, executive officers and principal stockholders will continue to have substantial control over us and could limit your ability to influence the outcome of key transactions, including changes of control.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
  • We have never paid any dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

Legal proceedings

We are party to various legal proceedings and investigations arising in the normal course of business. We carry insurance, subject to specified deductibles under the policies, to protect against losses from certain types of legal claims. At this time, we do not anticipate that any of these other proceedings arising in the normal course of business will have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact us because of defense and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.5

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