INSP on NYSE

Inspire Medical Systems (United States)

Logo: inspiresleep.com3

In its 2026 annual report the company says: “We are a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Our proprietary Inspire system is the first FDA, European Union Regulation No. 2017/745, and Japan Pharmaceuticals and Medical Devices Agency-approved neurostimulation technology of its kind that provides a safe and effective treatment for patients with moderate to severe OSA.”5 It was founded in 2007.1 It is headquartered in Maple Grove.1

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Last updated Oct 21, 2026.

Overview

2007Founded1

Compare with Orthofix Medical Inc., Tandem Diabetes Care, Inc. or AbioMed, or pick any stock.

  • TickerINSP on NYSE1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersMaple Grove1
  • Websitewww.inspiresleep.com
  • Incorporated inDE4
  • Business address5500 Wayzata Blvd, Suite 1600, Golden Valley, Mn 554164
  • Filer categoryLarge accelerated filer4

We are a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea ("OSA"). Our proprietary Inspire system is the first FDA, European Union ("EU") Regulation No. 2017/745 ("MDR" or "EU Medical Devices Regulation"), and Japan Pharmaceuticals and Medical Devices Agency-approved neurostimulation technology of its kind that provides a safe and effective treatment for patients with moderate to severe OSA. We have developed a novel, closed-loop solution that continuously monitors a patient’s breathing and delivers mild hypoglossal nerve stimulation to maintain an open airway. A significant body of clinical data, which includes a publication in the New England Journal of Medicine , multiple publications in leading respiratory, ear, nose and throat ("ENT") and sleep medicine journals, and more…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

85.4%Gross margin6
5.6%Operating margin6
15.9%Net margin6
13.6%Revenue growth, 20256
18.6%Return on equity6
$78.5MFree cash flow6

What sells

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

Regions

United States brought in 96% of the revenue Inspire Medical Systems (United States) broke down this way in fiscal 2025.

  1. United States$872.1M696%up 13% from 2024
  2. Outside the United States$39.9M64%up 26% from 2024
Regions by year
Regions202320242025
United States$606.2M$771.0M$872.1M
Outside the United States$18.6M$31.8M$39.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue12¢$133.2M
  • Research and development9¢$103.2M
  • Selling, general and admin58¢$624.6M
  • Income tax7¢$79.7M
  • Profit13¢$145.4M

Out of $912.0M in revenue.6

Where each dollar of operating cash went, fiscal 2025

  • Capital spending18¢$38.5M
  • Share buybacks82¢$175.0M

Out of $117.0M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.6

Financial statements

Revenue789106$912.0M in 2025+1011% since 2019
0$250.0M$500.0M$750.0M$1.0B2019: $82.0M$82.0M20192020: $115.4M$115.4M2020+41%2021: $233.4M$233.4M2021+102%2022: $407.9M$407.9M2022+75%2023: $624.8M$624.8M2023+53%2024: $802.8M$802.8M2024+28%2025: $912.0M$912.0M2025+14%
Gross profit789106$778.8M in 2025+1038% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $68.4M$68.4M20192020: $97.8M$97.8M2020+43%2021: $200.1M$200.1M2021+105%2022: $341.7M$341.7M2022+71%2023: $528.2M$528.2M2023+55%2024: $679.8M$679.8M2024+29%2025: $778.8M$778.8M2025+15%
Operating income789106$51.0M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: -$34.9M-$34.9M20192020: -$56.2M-$56.2M2020+61%2021: -$39.9M-$39.9M2021−29%2022: -$47.6M-$47.6M2022+19%2023: -$40.3M-$40.3M2023−15%2024: $36.1M$36.1M20242025: $51.0M$51.0M2025+41%
Net income789106$145.4M in 2025
-$100.0M0$100.0M$200.0M2019: -$33.2M-$33.2M20192020: -$57.2M-$57.2M2020+72%2021: -$42.0M-$42.0M2021−27%2022: -$44.9M-$44.9M2022+7%2023: -$21.2M-$21.2M2023−53%2024: $53.5M$53.5M20242025: $145.4M$145.4M2025+172%

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

Period ending2025-12-312024-12-312023-12-31
Revenue$912.0M$802.8M$624.8M
Cost of goods sold$133.2M$123.0M$96.6M
Gross profit$778.8M$679.8M$528.2M
Research and development$103.2M$114.1M$116.5M
Selling, general and administrative$624.6M$529.6M$452.0M
Total operating expenses$727.8M$643.7M$568.5M
Operating income (loss)$51.0M$36.1M-$40.3M
Interest and dividend income-$17.5M-$23.2M-$20.6M
Interest expense$137.0K$22.0K$0
Other expense, net$2.7M$855.0K$195.0K
Total other income-$14.7M-$22.4M-$20.4M
Income (loss) before income taxes$65.7M$58.5M-$19.9M
Income tax (benefit) expense-$79.7M$4.9M$1.2M
Net income (loss)$145.4M$53.5M-$21.2M
Foreign currency translation (loss) gain-$296.0K-$65.0K$140.0K
Unrealized gain (loss) on investments$224.0K-$199.0K$746.0K
Total comprehensive income (loss)$145.3M$53.2M-$20.3M
Basic (in dollars per share)$4.95$1.80-$0.72
Diluted (in dollars per share)$4.89$1.75-$0.72
Basic (in shares)29.4M shares29.8M shares29.3M shares
Diluted (in shares)29.8M shares30.5M shares29.3M shares

Compare Inspire Medical Systems (United States) with another company

Corporate structure

Inspire Medical Systems (United States) 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 Inspire Medical Systems (United States)

  • Soleus Capital Master Fund, L.P. Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Aug 13, 2026 (2 filings since May 27, 2026)
  • AQR CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Inspire Medical Systems (United States), latest Aug 12, 2026
  • VANGUARD PORTFOLIO MANAGEMENT LLC Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Jul 31, 2026 (2 filings since Apr 29, 2026)
  • BlackRock Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Jul 28, 2026 (7 filings since Feb 3, 2022)
  • D. E. SHAW & CO, L.P. Filed SCHEDULE 13G on Inspire Medical Systems (United States), latest Jul 2, 2026
  • Wellington Management Company Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest May 15, 2026 (2 filings since Feb 10, 2026)
  • James E. Flynn Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest May 14, 2026 (2 filings since Nov 13, 2025)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Inspire Medical Systems (United States), latest Apr 30, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Mar 27, 2026 (6 filings since Feb 10, 2022)
  • CITADEL ADVISORS LLC Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Feb 17, 2026 (2 filings since Oct 6, 2025)
  • Dragoneer Investment Group, LLC Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Nov 14, 2025 (2 filings since Aug 14, 2025)
  • WASATCH ADVISORS LP Filed SCHEDULE 13G/A on Inspire Medical Systems (United States), latest Nov 12, 2025 (2 filings since May 13, 2025)
  • Inspire Medical Systems (United States) Maple Grove

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

What it owns

What Inspire Medical Systems (United States) 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$123.5M6 Dec 31, 2025$85.7M6 Dec 31, 2024+44.2%
Accumulated depreciation$25.6M6 Dec 31, 2025$13.8M6 Dec 31, 2024+86.4%
Property and equipment, net$97.9M6 Dec 31, 2025$71.9M6 Dec 31, 2024+36.1%
Operating-lease assets (leased space)$23.5M6 Dec 31, 2025$23.3M6 Dec 31, 2024+0.9%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate10,000 sq ft6 Oct 31, 2024106,000 sq ft9 Dec 31, 2023−90.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$104.8M6 Dec 31, 2025$150.2M6 Dec 31, 2024−30.2%
Marketable securities, current$203.5M6 Dec 31, 2025$295.4M6 Dec 31, 2024−31.1%
Marketable securities, non-current$96.3M6 Dec 31, 2025$71.0M6 Dec 31, 2024+35.7%
Debt securities available for sale$299.8M6 Dec 31, 2025$366.4M6 Dec 31, 2024−18.2%
Long-term investments$96.3M6 Dec 31, 2025$71.0M6 Dec 31, 2024+35.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$145.3M6 Dec 31, 2025$80.1M6 Dec 31, 2024+81.3%
Raw materials$19.1M6 Dec 31, 2025$22.4M6 Dec 31, 2024−14.9%
Work in process$13.8M6 Dec 31, 2025$06 Dec 31, 2024
Finished goods$112.4M6 Dec 31, 2025$57.7M6 Dec 31, 2024+94.8%

Properties, in its own words

Our principal offices are located in Golden Valley, Minnesota, where we lease approximately 116,000 square feet of office space. We also lease warehouse space adjacent to our principal office. We lease these spaces under non-cancelable operating lease agreements that expire May 31, 2035, with options to renew for two additional periods of five years each. We intend to add new facilities as we grow, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

Item 2 of the 10-K filed Feb 13, 2026.5

Leadership

Who has led Inspire Medical Systems (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (22)

Timeline

  1. Aug 3, 20268-K Results of operations; Regulation FD disclosure41
  2. Jul 24, 20268-K Executive or director change42
  3. Jul 22, 20268-K Executive or director change43
  4. Jun 26, 20268-K Regulation FD disclosure44
  5. May 5, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote45
  6. May 4, 20268-K Results of operations; Regulation FD disclosure46
  7. Feb 11, 20268-K Results of operations; Bylaws or fiscal year changed; Regulation FD disclosure47
  8. Jan 12, 20268-K Results of operations; Executive or director change; Regulation FD disclosure48
  9. Nov 17, 20258-K Other events49
  10. Nov 3, 20258-K Results of operations; Regulation FD disclosure50
  11. Oct 10, 20258-K Regulation FD disclosure51
  12. Aug 26, 20258-K Executive or director change; Regulation FD disclosure52
  13. May 2, 2018New chief executive Timothy P. Herbert becomes CEO15
  14. 2007Founded Founded1

Calendar

Coming up

  1. Nov 2, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported $0.38 a share, on Nov 3, 2025.53

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results41
  2. May 4, 2026Reported quarterly or annual results46
  3. Feb 11, 2026Reported quarterly or annual results47
  4. Jan 12, 2026Reported quarterly or annual results48
  5. Nov 3, 2025Reported quarterly or annual results50
  6. Aug 4, 2025Reported quarterly or annual results54
  7. May 5, 2025Reported quarterly or annual results55
  8. Feb 10, 2025Reported quarterly or annual results56

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

Filings

514 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 59 major events, 322 insider forms, 37 large holders, 76 other. The latest 20:

  1. Sep 2, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Aug 24, 2026144 EDGAR
  3. Aug 13, 2026SCHEDULE 13G/A EDGAR
  4. Aug 12, 2026SCHEDULE 13G EDGAR
  5. Aug 11, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Aug 7, 2026144 EDGAR
  7. Aug 4, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Aug 3, 202610-Q EDGAR
  9. Aug 3, 20268-K EDGAR
  10. Jul 31, 2026SCHEDULE 13G/A EDGAR
  11. Jul 28, 2026SCHEDULE 13G/A EDGAR
  12. Jul 27, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Jul 27, 20263 OWNERSHIP DOCUMENT EDGAR
  14. Jul 24, 20268-K EDGAR
  15. Jul 22, 20268-K EDGAR
  16. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Jul 17, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jul 2, 2026SCHEDULE 13G EDGAR

The 514 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

88 open-market trades by officers, directors and large owners since October 2021: 3 buys and 85 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 7, 2026Kelly Jason PSee RemarksSale963$59.55$57.3KForm 4
May 15, 2026Rondoni JohnSee RemarksSale2,641$43.28$114.3KForm 4
May 14, 2026Rondoni JohnSee RemarksSale700$43.01$30.1KForm 4
May 8, 2026mcCormick ShawnDirectorSale696$45.31$31.5KForm 4
Jan 9, 2026Rondoni JohnSee RemarksSale109$100.00$10.9KForm 4
Dec 2, 2025mcCormick ShawnDirectorSale1,200$139.00$166.8KForm 4
Nov 28, 2025mcCormick ShawnDirectorSale2,000$127.48$255.0KForm 4
Aug 29, 2025Buchholz RichardInterim CFOSale11,000$93.39$1.0MForm 4
Aug 8, 2025Curet MyriamDirectorSale4$77.28$309Form 4
May 19, 2025Rondoni JohnSee RemarksSale1,734$149.38$259.0KForm 4
May 8, 2025Curet MyriamDirectorSale2$153.22$306Form 4
May 2, 2025mcCormick ShawnDirectorSale360$160.00$57.6KForm 4
Apr 7, 2025Curet MyriamDirectorBuy1$148.26$148Form 4
Mar 20, 2025Curet MyriamDirectorBuy4$163.84$655Form 4
Mar 3, 2025Ban RandySee RemarksSale3,947$185.84$733.5KForm 4
Mar 3, 2025Rondoni JohnSee RemarksSale2,287$185.60$424.5KForm 4
Feb 13, 2025Ban RandySee RemarksSale25,584$183.50$4.7MForm 4
Feb 11, 2025Rondoni JohnSee RemarksSale583$170.49$99.4KForm 4
Jan 7, 2025Rondoni JohnSee RemarksSale58$215.00$12.5KForm 4
Nov 1, 2024Rondoni JohnSee RemarksSale8,703$193.47$1.7MForm 4

All 88 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
2025Timothy P. HerbertPresident and Chief Executive Officer$750.6K$7.7M70
2025Carlton W. WeatherbyChief Strategy Officer$506.2K$2.8M70
2025Randall A. BanChief Commercial Officer$490.8K$2.7M70
2025Richard J. BuchholzChief Financial Officer$478.0K$2.7M70
2025Bryan K. PhillipsSVP, General Counsel, CCO and Corporate Secretary$475.2K$2.7M70
2024Timothy P. HerbertPresident and Chief Executive Officer$725.2K$8.1M70
2024Carlton W. WeatherbyChief Strategy Officer$465.2K$2.9M70
2024Randall A. BanChief Commercial Officer$474.2K$2.9M70
2024Bryan K. PhillipsSVP, General Counsel, CCO and Corporate Secretary$432.0K$2.8M70
2024Richard J. BuchholzChief Financial Officer$457.8K$2.8M70
2023Timothy P. HerbertPresident and Chief Executive Officer$690.0K$7.5M70
2023Richard J. BuchholzChief Financial Officer$447.2K$2.3M70
2023Carlton W. WeatherbyChief Strategy Officer$200.1K$2.3M70
2023Randall A. BanChief Commercial Officer$370.5K$2.3M70

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.4,737,519$211.3M0.0%+1,187,965
Wellington Management Group Llp2,382,660$106.3M0.0%−153,294
Vanguard Portfolio Management LLC2,088,961$93.2M0.0%+451,788
Soleus Capital Management, L.P.1,931,436$86.2M3.0%+1,355,137
Aqr Capital Management LLC1,856,800$80.9M0.0%+1,548,138
Assenagon Asset Management S.A.1,728,790$77.1M0.1%+1,208,616
UBS Group AG1,645,511$73.4M0.0%+1,006,583
D. E. Shaw & Co., Inc.1,470,462$65.6M0.0%+281,925
Nomura Holdings Inc1,369,410$61.1M0.3%New
Deerfield Management Company, L.P.1,296,862$57.9M0.7%−1,406,376
Vanguard Capital Management LLC1,270,928$56.7M0.0%+4,190
State Street Corp1,206,494$53.8M0.0%+250,483
Morgan Stanley791,222$35.3M0.0%−659,412
Artisan Partners Limited Partnership732,323$32.7M0.1%−48,252
Geode Capital Management, LLC700,836$31.3M0.0%+190,602
Braidwell LP677,570$30.2M1.2%No change
Goldman Sachs Group Inc645,858$28.8M0.0%−18,145
UBS AM, a distinct business unit of UBS ASSET MANAGEMENT AMERICAS LLC546,020$24.4M0.0%+97,233
Nantahala Capital Management, LLC538,948$24.0M0.7%New
Citadel Advisors LLC506,334$22.6M0.0%+112,258
Bnp Paribas Financial Markets428,069$19.1M0.0%+108,311
Renaissance Technologies LLC426,000$19.0M0.0%−43,968
ADAR1 Capital Management, LLC374,617$16.7M0.8%−30,580
Aberdeen Group plc358,968$16.0M0.0%−118,508
Northern Trust Corp334,039$14.9M0.0%+137,006

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

Members of Congress who traded it

1 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Apr 10, 2023Daniel S. GoldmanDemocratic, HousePartial sale$1,001 - $15,000+158.2%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Inspire Medical Systems (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARInspire Medical Systems, Inc.2
  • CIK0001609550
  • Employer ID (EIN)26-13776745
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address5500 Wayzata Blvd, Suite 1600, Golden Valley, MN 554162
  • Phone763-957-50372
  • Shares outstanding28,910,375 as of Jul 30, 202612
  • Public float$3.8B as of Jun 30, 20255
  • AuditorErnst & Young LLP, Minneapolis, MN PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceMay 30, 20142
  • Filings890 in all: 4 (546), 8-K (101), 144 (56), 3 (34), 10-Q (26), SC 13G/A (21), SCHEDULE 13G/A (13), SC 13G (11)2
    All 34 form types

    SCHEDULE 13G (10), 10-K (8), DEF 14A (8), DEFA14A (8), 4/A (7), CORRESP (5), 424B5 (4), ARS (4), 424B4 (2), 5 (2), D (2), DRS (2), EFFECT (2), S-1 (2), S-1/A (2), S-8 (2), SD (2), UPLOAD (2), 8-A12B (1), CERT (1), DEFR14A (1), DRS/A (1), DRSLTR (1), FWP (1), PRE 14A (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Feb 13, 2026
    Quarterly report (10-Q) Aug 3, 2026
    Proxy statement (DEF 14A) Mar 20, 2026
    Latest 8-K (8-K) Aug 3, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par valueINSPNew York Stock Exchange

From the cover page of the 10-K filed Feb 13, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Inspire Medical Systems (United States) names in Item 1A of its 10-K filed Feb 13, 2026: 60 risks under these headings, as written.5

  • Risks Related to Our Business
  • Our revenue is primarily generated from sales of our Inspire system and we are, therefore, highly dependent on it for our success.
  • Our financial results and the market price of our common stock may fluctuate significantly and may not fully reflect the underlying performance of our business.
  • We may not be able to sustain profitability, we have historically incurred significant operating losses, and we may incur operating losses in the future.
  • If patients or physicians are not willing to change practices to adopt our Inspire therapy to treat moderate to severe OSA, our Inspire therapy may fail to gain increased market acceptance, and our business will be adversely affected.
  • If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system, or any future products we may seek to commercialize, our business, financial condition or results of operations may be adversely affected.
  • We currently compete and will in the future continue to compete against other companies, some of which have longer operating histories, more established products or greater resources than we do, which may prevent us from achieving increased market penetration and improved operating results.
  • 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.
  • Our long-term growth depends on our ability to enhance our Inspire system, expand our indications, and develop and commercialize additional products.
  • Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our Inspire system and manage our inventory.
  • We rely on a limited number of third-party suppliers and contract manufacturers for the manufacture and assembly of our products, and a loss or degradation in performance of these suppliers and contract manufacturers could have a material adverse effect on our business, financial condition, and results of operations.
  • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
The other 49 risks
  • Consolidation in the healthcare industry or group purchasing organizations could lead to demands for price concessions, which may affect our ability to sell our products at prices necessary to support our current business strategies.
  • If we are unable to effectively size, manage and maintain our direct sales and marketing organization we may not be able to generate revenue growth.
  • To successfully market and sell our Inspire system in markets outside of the U.S., we must address many international business risks.
  • We primarily rely on our own direct sales force for our Inspire system, which may result in higher fixed costs than our competitors and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • If the quality of our Inspire system does not meet the expectations of physicians or patients, then our brand and reputation or our business could be adversely affected.
  • If we choose to acquire new and complementary businesses, products or technologies, we may be unable to complete these acquisitions or to successfully integrate them in a cost-effective and non-disruptive manner.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • Failure of a key information technology system, process or site, cyberattacks, or other deficiencies in our cybersecurity could have an adverse effect on our business and operations.
  • If our facilities are damaged or become inoperable, we may be unable to continue to research, develop, and supply our Inspire system and, as a result, there could be an adverse effect on our business until we are able to secure a new facility and rebuild our inventory.
  • We rely on third-party distributors to effectively distribute our products in certain markets.
  • We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.
  • We bear the risk of warranty claims on our Inspire system.
  • We may need substantial additional funding beyond our existing cash resources and may be unable to raise capital when needed, which could force us to delay or reduce our commercialization efforts or product development programs.
  • Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to certain limitations.
  • Fluctuations in our tax obligations and effective tax rate and realization of our net deferred tax assets may result in volatility of our operating results and materially impact our financial condition or financial results.
  • If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition and results of operations.
  • The evolving focus on sustainability and environmental, social, and governance initiatives from regulators and stakeholders could increase our costs, expose us to new risks, harm our reputation and adversely impact our financial results.
  • Climate-related events, geopolitical and global events, and other events could harm our business.
  • Risks Related to Government Regulation
  • Our products and operations are subject to extensive and changing laws, government regulation and oversight both in the U.S. and abroad, and our failure to comply with applicable requirements could harm our business.
  • We may not receive the necessary approvals or certifications for our future products or expanded indications, and failure to timely obtain necessary approvals or certifications for our future products or expanded indications would adversely affect our ability to grow our business and our results of operations.
  • Modifications to our products or manufacturing processes may require us to obtain new PMAs or approvals of a PMA supplement or certification, and if we market modified products without obtaining necessary approvals or certifications, we may be required to cease marketing or recall the modified products until required approvals are obtained.
  • 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.
  • Our products must be manufactured in accordance with foreign, federal and state regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall our installed systems or terminate production if we fail to comply with these regulations.
  • The misuse or off-label use of our Inspire system may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA and foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • If we do not obtain and maintain international regulatory registrations, approvals or certifications for our products, we will be unable to market and sell our products outside of the U.S.
  • The FDA may modify its enforcement policies with respect to medical software products, and our software products may become subject to extensive regulatory requirements, which may increase the cost of conducting, or otherwise harm, our business.
  • Legislative or regulatory reforms in the U.S. or the EU may make it more difficult and costly for us to obtain regulatory clearances, approvals or certification for our products or to manufacture, market or distribute our products after clearance, approval or certification is obtained.
  • We are subject to federal, state and foreign fraud and abuse laws, and transparency laws, 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.
  • We are or may be subject to U.S. federal, state, and foreign laws and regulations which impose obligations on how we collect, store and process health-related and other personal information. Our actual or perceived failure to comply with such obligations could harm our business, operations, and financial condition. Ensuring compliance with such laws could also impair our efforts to maintain and expand our customer base, and thereby decrease our revenue.
  • Our business may be affected by the evolving regulatory framework for AI Technologies.
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our products and could harm our business, financial condition and results of operations.
  • Our business involves the use of hazardous materials and our third-party manufacturers must comply with environmental laws and regulations, which may be expensive and restrict how we do business.
  • The clinical study process required to obtain regulatory approvals or certifications is lengthy and expensive with uncertain outcomes. If clinical studies of our future products do not produce results necessary to support regulatory clearance or approval in the U.S. or foreign approval or certification, with respect to our current or future products, elsewhere, we will be unable to expand the indications for or commercialize these products and may incur additional costs or experience delays in completing, or ultimately be unable to complete, the commercialization of those products.
  • Disruptions at the FDA, other government agencies or notified bodies caused by funding shortages, staffing limitations, or policy changes could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • Risks Related to Intellectual Property Matters
  • If we are unable to adequately protect our intellectual property rights, or if we are accused of infringing on the intellectual property rights of others, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.
  • Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our products or affect our stock price.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • Third parties may assert ownership or commercial rights to inventions we develop.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Changes in U.S. and foreign patent laws may limit our ability to obtain, defend and/or enforce our patents.
  • Risks Related to Our Common Stock
  • Provisions in our governing documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • 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.
  • General Risk Factors
  • Changes in U.S. and foreign tax laws could have a material adverse effect on our business, cash flow, results of operations and financial condition.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline.

Legal proceedings

From time to time we may be involved in claims and proceedings arising in the ordinary course of our business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain.

The information contained in “Note 12 — Commitments and Contingencies” in the Notes to the Consolidated Financial Statements is incorporated by reference into this Item 3.

The opening of Item 3, Legal Proceedings.5

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