LUNG on Nasdaq

Pulmonx Corp

In its 2026 annual report the company says: “We are a commercial-stage medical technology company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease. Our solution, which is comprised of the Zephyr Endobronchial Valve, the Chartis Pulmonary Assessment System and the LungTraX Platform, is designed to treat severe emphysema patients who, despite medical management, are still profoundly symptomatic and either do not want or are ineligible for surgical approaches.”4 It is headquartered in Wilmington, United States.2

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Last updated Oct 21, 2026.

Overview

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  • TickerLUNG on Nasdaq2
  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersWilmington, United States2
  • Incorporated inDE3
  • Business address700 Chesapeake Drive, Redwood City, Ca 940633
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300WZMFR0ZK7RJY402
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 54320952

We are a commercial-stage medical technology company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease (“COPD”). Our solution, which is comprised of the Zephyr Endobronchial Valve (“Zephyr Valve”), the Chartis Pulmonary Assessment System (“Chartis System”) and the LungTraX Platform, is designed to treat severe emphysema patients who, despite medical management, are still profoundly symptomatic and either do not want or are ineligible for surgical approaches. Patients with severe emphysema generally experience a worse quality of life than patients with lung cancer, and we believe there is both an urgent clinical need and a strong market opportunity for a solution that is safe, effective and minimally invasive.4 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

74.2%Gross margin5
-59.3%Operating margin5
-59.7%Net margin5
8.0%Revenue growth, 20255
-99.8%Return on equity5
0.68×Debt to equity5
-$32.8MFree cash flow5

What sells

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

Regions

United States brought in 63% of the revenue Pulmonx Corp broke down this way in fiscal 2025.

  1. United States$57.0M563%up 1% from 2024
  2. EMEA$27.0M530%up 21% from 2024
  3. Asia Pacific$6.2M57%up 40% from 2024
  4. Other International Geographical Areas$260.0K50%down 53% from 2024
Regions by year
Regions20242025
United States$56.5M$57.0M
EMEA$22.3M$27.0M
Asia Pacific$4.4M$6.2M
Other International Geographical Areas$556.0K$260.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue16¢$23.4M
  • Research and development13¢$19.5M
  • Selling, general and admin70¢$101.3M
  • Income tax0¢$626.0K

Out of $90.5M in revenue.5 The company lost money this year.

Financial statements

Revenue6789105$90.5M in 2025+178% since 2019
0$25.0M$50.0M$75.0M$100.0M2019: $32.6M$32.6M20192020: $32.7M$32.7M2020+0%2021: $48.4M$48.4M2021+48%2022: $53.7M$53.7M2022+11%2023: $68.7M$68.7M2023+28%2024: $83.8M$83.8M2024+22%2025: $90.5M$90.5M2025+8%
Gross profit6789105$67.1M in 2025+200% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $22.4M$22.4M20192020: $21.2M$21.2M2020−5%2021: $35.6M$35.6M2021+68%2022: $39.9M$39.9M2022+12%2023: $50.8M$50.8M2023+27%2024: $62.0M$62.0M2024+22%2025: $67.1M$67.1M2025+8%
Operating income6789105-$53.7M in 2025+201% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$17.8M-$17.8M20192020: -$32.3M-$32.3M2020+81%2021: -$47.3M-$47.3M2021+46%2022: -$58.6M-$58.6M2022+24%2023: -$61.9M-$61.9M2023+6%2024: -$57.7M-$57.7M2024−7%2025: -$53.7M-$53.7M2025−7%
Net income6789105-$54.0M in 2025+161% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$20.7M-$20.7M20192020: -$32.2M-$32.2M2020+56%2021: -$48.7M-$48.7M2021+51%2022: -$58.9M-$58.9M2022+21%2023: -$60.8M-$60.8M2023+3%2024: -$56.4M-$56.4M2024−7%2025: -$54.0M-$54.0M2025−4%

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

Period ending2025-12-312024-12-31
Revenue$90.5M$83.8M
Cost of goods sold$23.4M$21.8M
Gross profit$67.1M$62.0M
Research and development$19.5M$17.6M
Selling, general and administrative$101.3M$102.1M
Total operating expenses$120.8M$119.7M
Loss from operations-$53.7M-$57.7M
Interest income$2.7M$5.1M
Interest expense-$3.2M-$3.5M
Other income, net$790.0K$256.0K
Net loss before tax-$53.4M-$55.9M
Income tax expense$626.0K$500.0K
Net loss-$54.0M-$56.4M
Currency translation adjustment$269.0K-$466.0K
Change in unrealized losses on marketable securities-$22.0K-$61.0K
Total other comprehensive income (loss)$247.0K-$527.0K
Comprehensive loss-$53.8M-$56.9M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$1.33-$1.44
Net loss per share attributable to common stockholders, diluted (in dollars per share)-$1.33-$1.44
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares)40.7M shares39.1M shares
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares)40.7M shares39.1M shares

Compare Pulmonx Corp with another company

Corporate structure

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

Major holders of Pulmonx Corp

  • Morgan Stanley Filed SCHEDULE 13G/A on Pulmonx Corp, latest Aug 13, 2026 (6 filings since Feb 10, 2023)
  • BlackRock Filed SCHEDULE 13G/A on Pulmonx Corp, latest Jul 29, 2026 (5 filings since Feb 4, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Pulmonx Corp, latest Mar 27, 2026 (4 filings since Feb 10, 2022)
  • Soleus Capital Master Fund, L.P. Filed SCHEDULE 13G on Pulmonx Corp, latest Mar 9, 2026
  • PRIMECAP MANAGEMENT CO/CA/ Filed SCHEDULE 13G/A on Pulmonx Corp, latest Nov 13, 2025 (6 filings since Dec 9, 2021)
  • FMR LLC Filed SCHEDULE 13G/A on Pulmonx Corp, latest Nov 7, 2025 (7 filings since Feb 9, 2024)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Pulmonx Corp, latest Nov 14, 2024 (4 filings since Jan 4, 2023)
  • Champlain Investment Partners, LLC Filed SC 13G/A on Pulmonx Corp, latest Feb 13, 2024 (3 filings since Feb 11, 2022)
  • James E. Flynn Filed SC 13G/A on Pulmonx Corp, latest Feb 12, 2024 (4 filings since Feb 11, 2022)
  • PURA VIDA INVESTMENTS, LLC Filed SC 13G/A on Pulmonx Corp, latest Feb 14, 2023 (2 filings since May 25, 2022)
  • Capital World Investors Filed SC 13G/A on Pulmonx Corp, latest Feb 13, 2023 (2 filings since Feb 11, 2022)
  • Fan Yu Filed SC 13G/A on Pulmonx Corp, latest Feb 11, 2022
  • Pulmonx Corp Wilmington, Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$8.9M5 Dec 31, 2025$8.6M5 Dec 31, 2024+2.8%
Accumulated depreciation$6.7M5 Dec 31, 2025$5.7M5 Dec 31, 2024+16.2%
Property and equipment, net$2.2M5 Dec 31, 2025$2.9M5 Dec 31, 2024−23.6%
Operating-lease assets (leased space)$18.0M5 Dec 31, 2025$18.5M5 Dec 31, 2024−2.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$69.8M5 Dec 31, 2025$70.9M5 Dec 31, 2024−1.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$2.3M5 Dec 31, 2025$2.3M5 Dec 31, 20240%
Finite-lived intangibles, net$010 Dec 31, 2024$31.0K10 Dec 31, 2023−100.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$15.8M5 Dec 31, 2025$16.9M5 Dec 31, 2024−6.3%
Raw materials$4.9M5 Dec 31, 2025$3.4M5 Dec 31, 2024+43.0%
Work in process$529.0K5 Dec 31, 2025$457.0K5 Dec 31, 2024+15.8%
Finished goods$14.0M5 Dec 31, 2025$14.7M5 Dec 31, 2024−4.6%

Properties, in its own words

Our corporate headquarters are located in Redwood City, California, where we lease and occupy approximately 50,000 square feet of office, manufacturing, and laboratory space. In addition, we lease various other office and warehouse spaces in Redwood City and Switzerland.

We believe our existing facilities are sufficient for our needs for the foreseeable future. To meet the future needs of our business, we may lease additional or alternate space, and we believe suitable additional or alternative space will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 10, 2026.4

Leadership

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

Board members and other officers (10)

Former names

  • PULMONXDec 9, 2003 to Feb 7, 20123

Timeline

  1. Jul 29, 20268-K Results of operations27
  2. Jun 4, 20268-K Shareholder vote28
  3. Apr 29, 20268-K Results of operations29
  4. Mar 5, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation30
  5. Mar 4, 20268-K Results of operations31
  6. Nov 12, 20258-K Results of operations32
  7. Oct 27, 20258-K Results of operations; Executive or director change33
  8. Jul 30, 20258-K Results of operations34
  9. May 23, 20258-K Shareholder vote35
  10. Apr 30, 20258-K Results of operations36
  11. Feb 19, 20258-K Results of operations37
  12. Oct 30, 20248-K Results of operations38
  13. Sep 30, 2020New chief executive Glendon E. French Iii. becomes CEO13

Calendar

Coming up

  1. Oct 27, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.34) a share, on Nov 12, 2025.39

When it reported results

  1. Jul 29, 2026Reported quarterly or annual results27
  2. Apr 29, 2026Reported quarterly or annual results29
  3. Mar 4, 2026Reported quarterly or annual results31
  4. Nov 12, 2025Reported quarterly or annual results32
  5. Oct 27, 2025Reported quarterly or annual results33
  6. Jul 30, 2025Reported quarterly or annual results34
  7. Apr 30, 2025Reported quarterly or annual results36
  8. Feb 19, 2025Reported quarterly or annual results37

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

Filings

327 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 32 major events, 164 insider forms, 46 large holders, 65 other. The latest 20:

  1. Sep 3, 20264 EDGAR
  2. Sep 3, 20264 EDGAR
  3. Sep 3, 20264 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Aug 13, 2026SCHEDULE 13G/A EDGAR
  6. Aug 4, 202610-Q EDGAR
  7. Jul 29, 2026SCHEDULE 13G/A EDGAR
  8. Jul 29, 20268-K EDGAR
  9. Jun 9, 20264 EDGAR
  10. Jun 9, 20264 EDGAR
  11. Jun 9, 20264 EDGAR
  12. Jun 9, 20264 EDGAR
  13. Jun 9, 20264 EDGAR
  14. Jun 9, 20264 EDGAR
  15. Jun 4, 20268-K EDGAR
  16. Jun 3, 20264 EDGAR
  17. Jun 3, 20264 EDGAR
  18. Jun 3, 20264 EDGAR
  19. Jun 3, 20264 EDGAR
  20. May 19, 2026SD EDGAR

The 327 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

117 open-market trades by officers, directors and large owners since October 2021: 4 buys and 113 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Radhakrishnan SrikanthChief Science & Techn. OfficerSale14,245$2.26$32.2KForm 4
Sep 1, 2026French Glendon E. IIIPresident and CEOSale41,882$2.26$94.7KForm 4
Sep 1, 2026Rose Geoffrey BeranChief Commercial OfficerSale7,879$2.26$17.8KForm 4
Sep 1, 2026Lehman David AaronGeneral CounselSale14,334$2.26$32.4KForm 4
Jun 2, 2026French Glendon E. IIIPresident and CEOSale13,511$1.57$21.2KForm 4
Jun 1, 2026Radhakrishnan SrikanthChief Science & Techn. OfficerSale14,497$1.54$22.3KForm 4
Jun 1, 2026French Glendon E. IIIPresident and CEOSale42,638$1.54$65.7KForm 4
Jun 1, 2026Rose Geoffrey BeranChief Commercial OfficerSale8,023$1.54$12.4KForm 4
Jun 1, 2026Lehman David AaronGeneral CounselSale14,594$1.54$22.5KForm 4
Mar 2, 2026Radhakrishnan SrikanthChief Science & Techn. OfficerSale10,483$1.43$15.0KForm 4
Mar 2, 2026French Glendon E. IIIPresident and CEOSale67,813$1.43$97.0KForm 4
Mar 2, 2026Rose Geoffrey BeranChief Commercial OfficerSale7,732$1.43$11.1KForm 4
Mar 2, 2026Lehman David AaronGeneral CounselSale12,237$1.43$17.5KForm 4
Dec 8, 2025Florin Daniel PDirectorSale23,321$1.99$46.4KForm 4
Dec 1, 2025French Glendon E. IIIPresident and CEOSale8,805$1.57$13.8KForm 4
Dec 1, 2025Rose Geoffrey BeranChief Commercial OfficerSale6,322$1.57$9.9KForm 4
Dec 1, 2025Lehman David AaronGeneral CounselSale10,278$1.57$16.1KForm 4
Sep 2, 2025Williamson Steven S.PRESIDENT AND CEOSale9,648$1.60$15.4KForm 4
Sep 2, 2025Joshi MehulChief Financial Officer & PAOSale7,936$1.60$12.7KForm 4
Sep 2, 2025Rose Geoffrey BeranChief Commercial OfficerSale6,543$1.60$10.5KForm 4

All 117 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
2025Steven S. WilliamsonFormer Chief Executive Officer$493.5K$4.2M53
2025Glendon E. FrenchChief Executive Officer64$116.2K$3.5M53
2025Derrick SungChief Operating Officer and Chief Financial Officer53$83.3K$3.0M53
2025Mehul JoshiFormer Chief Financial Officer$381.2K$2.0M53
2025David LehmanGeneral Counsel65$472.4K$1.7M53
2024Steven S. WilliamsonFormer Chief Executive Officer$461.4K$5.2M53
2024Mehul JoshiFormer Chief Financial Officer$334.3K$3.2M53
2024David LehmanGeneral Counsel65$458.6K$1.5M53
2024Glendon E. FrenchChief Executive Officer64$195.6K$330.8K53

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
Primecap Management Co/ca/4,612,331$6.0M0.0%−112,660
Morgan Stanley2,922,921$3.8M0.0%−1,070,641
Soleus Capital Management, L.P.2,788,323$3.6M0.1%No change
Vanguard Capital Management LLC1,630,219$2.1M0.0%−4,045
ExodusPoint Capital Management, LP1,223,555$1.6M0.0%−720,279
Almitas Capital LLC1,064,202$1.4M0.3%New
BlackRock, Inc.882,490$1.1M0.0%−1,779,117
Stonepine Capital Management, LLC815,436$1.1M0.8%+47,148
Jane Street Group, LLC758,231$985.7K0.0%+624,961
Braidwell LP752,541$978.3K0.0%No change
Aqr Capital Management LLC744,963$968.5K0.0%+387,385
Parkman Healthcare Partners LLC646,564$840.5K0.1%−109,072
Geode Capital Management, LLC452,684$588.7K0.0%−491,808
Renaissance Technologies LLC425,110$552.6K0.0%+104,810
ADAR1 Capital Management, LLC404,497$525.8K0.0%+30,000
Deutsche Bank Ag\402,316$523.0K0.0%−761,362
D. E. Shaw & Co., Inc.327,528$425.8K0.0%−7,546
Jefferies Financial Group Inc.285,110$370.6K0.0%No change
Cfm Wealth Partners LLC264,039$343.3K0.0%No change
Vanguard Fiduciary Trust Co250,511$325.7K0.0%−30,737
Marshall Wace, Llp230,738$300.0K0.0%New
Millennium Management LLC209,556$272.4K0.0%New
UBS Group AG204,053$265.3K0.0%−5,648
Birchview Capital, LP200,543$260.7K0.1%−49,678
Centiva Capital, LP200,095$260.1K0.0%+46,213

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

SEC filer profile

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

  • Name on EDGARPulmonx Corp1
  • CIK0001127537
  • Employer ID (EIN)77-04244124
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address700 Chesapeake Drive, Redwood City, CA 940631
  • Phone650-364-04001
  • Shares outstanding42,948,269 as of Jul 31, 202612
  • Public float$101.4M as of Jun 30, 20254
  • AuditorBDO USA, P.C., San Francisco, California PCAOB ID 243; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 9, 20031
  • Filings448 in all: 4 (201), 8-K (39), 144 (30), SC 13G/A (24), 10-Q (18), 3 (18), SC 13G (13), SCHEDULE 13G/A (12)1
    All 37 form types

    S-8 (9), 4/A (7), 10-K (6), D (6), DEF 14A (6), DEFA14A (6), CORRESP (5), D/A (5), REGDEX (5), ARS (4), SD (4), EFFECT (3), S-1/A (3), UPLOAD (3), 3/A (2), DRS (2), DRS/A (2), S-1 (2), S-3 (2), S-3/A (2), 424B4 (1), 5 (1), 8-A12B (1), 8-K/A (1), CERT (1), FWP (1), REGDEX/A (1), RW (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Jul 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareLUNGThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Pulmonx Corp names in Item 1A of its 10-K filed Mar 10, 2026: 77 risks under these headings, as written.4

  • Risks Related to Our Business and Strategy
  • We have a history of significant net losses, which we expect to continue, and we may not be able to achieve or sustain profitability in the future.
  • We have limited experience marketing and selling our solution.
  • We currently rely on a single product, the Zephyr Valve, which can only be marketed for limited indications, and if we are not successful in commercializing the Zephyr Valve, our business, financial condition and results of operations will be negatively affected.
  • Our success depends in large part on the success of the Zephyr Valve. If we are unable to successfully market and sell the Zephyr Valves, as well as our overall solution, to patients with severe emphysema, it will negatively affect our business, financial condition and results of operations.
  • Our business is dependent on hospital, physician and patient adoption of our solution as a treatment for severe emphysema. If hospitals, physicians or patients are unwilling to change current practices to adopt our solution, it will negatively affect our business, financial condition and results of operations.
  • If we fail to receive access to hospital facilities, our sales may decrease.
  • Use of our solution requires appropriate physician training, and inadequate training may lead to negative patient outcomes and negatively affect our business, financial condition and results of operations.
  • Use of the Zephyr Valve involves risks and may result in complications, including pneumothorax or death, and is contraindicated in certain patients, which may limit adoption and negatively affect our business, financial condition and results of operations.
  • If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our solution, or any future products we may seek to commercialize, or if patients are left with significant out-of-pocket costs, our commercial success may be severely hindered.
  • Third-party payors and physicians who do not cover or use the Zephyr Valve may require additional clinical data prior to maintaining coverage of or adopting the Zephyr Valve.
  • If we fail to retain marketing and sales personnel and, as we grow, fail to increase our marketing and sales capabilities or develop broad awareness of our solution in a cost-effective manner, we may not be able to generate revenue growth.
The other 66 risks
  • We have limited long-term data regarding the safety and effectiveness of our solution, including the Zephyr Valve.
  • The continuing development of our products depends upon our maintaining strong working relationships with physicians.
  • We rely on third parties to perform certain aspects of the CT scan analysis within the LungTraX Platform.
  • We depend on a limited number of single-source suppliers to manufacture our products, which makes us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.
  • We have limited experience manufacturing our products in significant commercial quantities and we face manufacturing risks that may adversely affect our ability to manufacture our products, reduce our gross margins and negatively affect our business, financial condition and results of operations.
  • If our information technology systems or data, or those of third parties with whom we work, are or were compromised, we could experience adverse impacts resulting from such compromise, including, but not limited to, interruptions to our operations such as to our LungTraX Platform services or our clinical trials, claims that we breached our data protection obligations, harm to our reputation, business operations, and financial condition, as well as a loss of customers or sales.
  • Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for our solution and manage our inventory.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • The sizes of the markets for our current and future products have not been established with precision and may be smaller than we estimate and may decline. Certain patients may not have regions of the lung with little to no collateral ventilation, making them poor candidates for the Zephyr Valve. In addition, if the overall rate of smokers continues to decline, this may eventually decrease the number of patients suffering from COPD and emphysema and, accordingly, who would benefit from our solution.
  • Failure of our information technology system, process, or site, or those of the third parties with whom we work, could negatively affect our business, financial condition and results of operations.
  • Litigation against us could be costly and time-consuming to defend and could result in additional liabilities.
  • We face the risk of product liability claims that would be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • Our indebtedness may limit our flexibility in operating our business and negatively affect our business, financial condition, results of operations and competitive position.
  • Our industry is highly competitive, and we may not be able to compete successfully with larger companies, companies with longer operating histories or more established products, or companies with greater resources.
  • We have increased the size of our organization and expect to further increase it in the future. If we are unable to manage the anticipated growth, our business, financial condition and results of operations will be negatively affected.
  • We expect to continue to incur net losses for the next several years and we expect to require substantial additional capital to finance our planned operations, which may include future equity and debt financings. This additional capital may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our commercialization, sales and marketing efforts, product development programs or other operations.
  • If the quality of our solution does not meet the expectations of physicians or patients, then our business and reputation may be harmed.
  • If our facilities become damaged or inoperable, we will be unable to continue to research, develop and supply our solution which could negatively affect our business, financial condition and results of operations until we are able to secure a new facility and rebuild our inventory.
  • Performance issues, service interruptions or price increases by our shipping carriers could negatively affect our business, financial condition and results of operations and harm our reputation and the relationship between us and the hospitals with which we work.
  • We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees will negatively affect our business, financial condition and results of operations.
  • We have significant international operations, and to successfully market and sell our products in such international markets we must address international business risks with which we have limited experience.
  • We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products, product improvements or the generation of significant future revenues.
  • Significant changes or developments in U.S. and international laws or policies, including changes in U.S. trade policies and tariffs and the reaction of other countries thereto, could have a material adverse effect on our business and financial condition.
  • Unfavorable global economic conditions, including as a result of geopolitical conflict, could negatively affect our business, financial condition or results of operations.
  • We may acquire other companies or technologies, which could divert our management’s attention, result in additional dilution to our stockholders and otherwise negatively affect our business, financial condition and results of operations.
  • 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.
  • Our long-term growth depends on our ability to enhance our solution, expand our indications and develop and commercialize additional products. If we fail to identify, acquire and develop other products, we may be unable to grow our business.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • 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 negatively affect our business, financial condition and results of operations.
  • Our results may be impacted by changes in foreign currency exchange rates.
  • Our ability to utilize our net operating loss carryforwards and research and development credit may be limited.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our products.
  • Governmental export or import controls could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Public health crises have in the past and may in the future have a material adverse impact on our business, financial condition and results of operations.
  • Potential natural disasters could damage, destroy or disrupt clinical study sites, our office spaces, manufacturing facilities, and/or warehouses, which could have a significant negative impact on our operations.
  • Risks Related to Government Regulation and Our Industry
  • Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad. If we fail to obtain and maintain necessary regulatory approvals for the Zephyr Valve and
  • related products, or if approvals for future products and indications are delayed or not issued, it will negatively affect our business, financial condition and results of operations.
  • Changes in the regulatory environment may constrain or require us to restructure our operations, which may harm our revenue and operating results.
  • Changes in funding for, or disruptions caused by global health concerns impacting, the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed, cleared or approved or commercialized in a timely manner, which could negatively impact our business.
  • A recall of our products, either voluntarily or at the direction of the FDA or another regulatory authority, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse impact on us.
  • We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties and negatively affect our business, financial condition and results of operations.
  • If we modify the Zephyr Valve, we may need to seek additional clearances, certification or approvals, which, if not granted, would prevent us from selling our modified products.
  • 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.
  • If treatment guidelines for severe emphysema or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA or comparable foreign regulatory authorities, or certification from Notified Bodies, for one or more of our products.
  • If we or our suppliers fail to comply with the FDA’s QMSR or the European Union MDR, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
  • The misuse or off-label use of our solution will harm our image in the marketplace, result in injuries that lead to product liability suits or result in costly investigations and sanctions by regulatory bodies if we are deemed to
  • have engaged in the promotion of these uses, any of which will negatively affect our business, financial condition and results of operations.
  • We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our products.
  • The clinical trial process required to obtain regulatory approvals and certification is lengthy and expensive with uncertain outcomes. If clinical studies of our future products do not produce results necessary to support regulatory clearance, certification or approval in the United States or, 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.
  • 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 comparable foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could negatively affect our business, financial condition and results of operations.
  • If we do not obtain and maintain international regulatory registrations, certification or approvals for our products, we will be unable to market and sell our products outside of the United States.
  • Healthcare reform measures could hinder or prevent the commercial success of our solutions.
  • We and the third parties with whom we work are subject to stringent and evolving obligations related to data privacy and information security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; a disruption of our business operations; reputational harm; loss of revenue or profits; loss of customers; and other adverse business impacts.
  • We face potential liability related to the privacy of health information we obtain.
  • Our employees, consultants, and other commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability.
  • Risks Related to Our Intellectual Property
  • We may become involved in intellectual property litigation, infringement claims, or administrative proceedings that could be costly and could interfere with our ability to sell and market our products.
  • Our success will depend on our, and any of our current and future licensors’, ability to obtain, maintain and protect our intellectual property rights.
  • If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non‑compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • 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.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products.
  • The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
  • If our trademarks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.

Legal proceedings

We are not a party to any material legal proceedings at this time. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Please see also the matters under the caption Contingencies in Note 8 to the consolidated financial statements.

The opening of Item 3, Legal Proceedings.4

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