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IRIX on Nasdaq

IRIDEX CORP

American electromedical and electrotherapeutic apparatus company1

In its 2026 annual report the company says: “IRIDEX Corporation is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases. Our proprietary MicroPulse ® Technology and Endpoint Management™ Technology are used for the treatment of glaucoma and retina disorders.”12 It is headquartered in Mountain View, California.1 Its shares trade on Nasdaq under the symbol IRIX.1

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Last updated Oct 21, 2026.

Overview

$52.7MRevenue, fiscal 20262
-$4.4MNet income, fiscal 20262

Compare with EDAP TMS SA, Electromed, Inc. or Stereotaxis, Inc., or pick any stock.

  • TickerIRIX on Nasdaq1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersMountain View, California1
  • Incorporated inDE3
  • Business address1212 Terra Bella Ave, Mountain View, Ca 940433
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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Financials

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

Key numbers, fiscal 2026

36.5%Gross margin2
-4.9%Operating margin2
-8.4%Net margin2
-90.1%Return on equity2
-$2.3MFree cash flow2

What sells

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

Products and services

Retina brought in 57% of the revenue IRIDEX CORP broke down this way in fiscal 2025.

  1. Retina$30.3M257%up 9% from 2024
  2. Cyclo G Six$13.8M226%up 9% from 2024
  3. Product and Service, Other$8.6M216%up 5% from 2024
  4. Service$1.3K20%down 7% from 2024
Products and services by year
Products and services20242025
Retina$27.8M$30.3M
Cyclo G Six$12.7M$13.8M
Product and Service, Other$8.1M$8.6M
Service$1.4K$1.3K

Regions

United States brought in 44% of the revenue IRIDEX CORP broke down this way in fiscal 2025.

  1. United States$23.2M244%up 2% from 2024
  2. Europe, Middle East and Africa$14.4M227%up 22% from 2024
  3. Asia Pacific$13.0M225%up 8% from 2024
  4. Americas Excluding U S$2.1M24%down 4% from 2024
Regions by year
Regions20242025
United States$22.7M$23.2M
Europe, Middle East and Africa$11.8M$14.4M
Asia Pacific$11.9M$13.0M
Americas Excluding U S$2.2M$2.1M

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Cost of revenue63¢$33.4M
  • Research and development7¢$3.7M
  • Other costs29¢$15.5M
  • Income tax0¢$57.0K

Out of $52.7M in revenue.2 The company lost money this year.

Financial statements

Revenue56782$52.7M in 2026+21% since 2019
0$20.0M$40.0M$60.0M2019: $43.4M$43.4M20192021: $36.3M$36.3M2021−16%2022: $57.0M$57.0M2022+57%2023: $51.9M$51.9M2023−9%2024: $48.7M$48.7M2024−6%2026: $52.7M$52.7M2026+8%
Gross profit56782$19.2M in 2026+7% since 2019
0$10.0M$20.0M$30.0M2019: $17.9M$17.9M20192021: $15.6M$15.6M2021−13%2022: $25.4M$25.4M2022+63%2023: $21.8M$21.8M2023−14%2024: $19.5M$19.5M2024−11%2026: $19.2M$19.2M2026−1%
Operating income56782-$2.6M in 2026−71% since 2019
-$15.0M-$10.0M-$5.0M02019: -$9.0M-$9.0M20192021: -$6.6M-$6.6M2021−27%2022: -$7.5M-$7.5M2022+15%2023: -$10.0M-$10.0M2023+33%2024: -$8.3M-$8.3M2024−17%2026: -$2.6M-$2.6M2026−69%
Net income56782-$4.4M in 2026−50% since 2019
-$10.0M-$7.5M-$5.0M-$2.5M02019: -$8.8M-$8.8M20192021: -$6.3M-$6.3M2021−28%2022: -$7.5M-$7.5M2022+19%2023: -$9.6M-$9.6M2023+27%2024: -$8.9M-$8.9M2024−7%2026: -$4.4M-$4.4M2026−50%

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

Period ending2025-12-312024-12-31
Total revenues$52.7M$48.7M
Cost of revenues$33.4M$29.2M
Gross profit$19.2M$19.5M
Research and development$3.7M$5.4M
Sales and marketing$10.4M$12.6M
General and administrative$7.7M$9.8M
Total operating expenses$21.8M$27.8M
Loss from operations-$2.6M-$8.3M
Other expense, net-$1.8M-$540.0K
Loss from operations before provision for income taxes-$4.4M-$8.8M
Provision for income taxes$57.0K$68.0K
Net loss-$4.4M-$8.9M
Basic-$0.26-$0.54
Diluted-$0.26-$0.54
Basic16.9M shares16.4M shares
Diluted16.9M shares16.4M shares

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Corporate structure

IRIDEX CORP 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 IRIDEX CORP

  • IRIDEX CORP Mountain View, California
    • IRIDEX Europe GmbH Subsidiary · Germany
    • Iridex Philippines BPO, Inc. The Republic of Subsidiary · Philippines

Built from 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 IRIDEX 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
Accumulated depreciation$14.2M2 Jan 3, 2026$14.0M2 Dec 28, 2024+1.4%
Property and equipment, net$58.0K2 Jan 3, 2026$115.0K2 Dec 28, 2024−49.6%
Operating-lease assets (leased space)$768.0K2 Jan 3, 2026$1.8M2 Dec 28, 2024−57.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$6.0M2 Jan 3, 2026$2.4M2 Dec 28, 2024+152.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$965.0K2 Jan 3, 2026$965.0K2 Dec 28, 20240%
Finite-lived intangibles, gross$2.5M2 Jan 3, 2026$2.5M2 Dec 28, 20240%
Accumulated amortization$1.6M2 Jan 3, 2026$1.2M2 Dec 28, 2024+26.2%
Finite-lived intangibles, net$984.0K2 Jan 3, 2026$1.3M2 Dec 28, 2024−24.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$7.9M2 Jan 3, 2026$10.8M2 Dec 28, 2024−27.2%
Raw materials$4.1M2 Jan 3, 2026$4.2M2 Dec 28, 2024−2.1%
Work in process$02 Jan 3, 2026$02 Dec 28, 2024
Finished goods$3.7M2 Jan 3, 2026$6.6M2 Dec 28, 2024−43.3%

Properties, in its own words

We leased a 37,166 square feet facility in Mountain View, California for our corporate headquarters pursuant to a Triple Net Lease dated April 26, 2017 that expired in February 2022. On April 30, 2021, the First Amendment to the Triple Net Lease (“First Amendment”) was executed, among other things, that reduced the portion of the premises leased by the Company to approximately 29,830 square feet and extended the lease term through August 31, 2024. On August 29, 2022 the Second Amendment to the Triple Net Lease (“Second Amendment”) was executed. On September 23, 2023, the Third Amendment to the Triple Net Lease (“Third Amendment”) was executed that extended the lease term through August 31, 2026.

We also lease other facilities internationally, primarily for offices to support international sales and perform general and administrative duties. The leased properties include space in the following locations: Germany and The Republic of The Philippines.

The rest of Item 2

Management believes that the facilities we currently lease are adequate for our current needs and that suitable additional space or an alternative space would be available as needed in the future on commercially reasonable terms.

Item 2 of the 10-K filed Apr 2, 2026.12

Leadership

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

Chief executive

  1. Barry G. Caldwell2006
  2. Theodore A. Boutacoff2008–2010
  3. Dominik Beck2011
  4. William M. Moore2012–2019
  5. David Bruce2019–2024
  6. Patrick Mercer2024–now

Chair

  1. Theodore A. Boutacoff2008–2010
  2. William M. Moore2012–2019

President

  1. Barry G. Caldwell2006
  2. Theodore A. Boutacoff2008–2010
  3. Dominik Beck2011
  4. David Bruce2019–2022
  5. Patrick Mercer2024–now

Chief financial officer

  1. Larry Tannenbaum2006
  2. Meryl Rains2007
  3. James H. Mackaness2008–2015
  4. Atabak Mokari2016–2018
  5. Fuad Ahmad2020
  6. Romeo R. Dizon2025–now

Chief operating officer

  1. James H. Mackaness2012–2015
  2. Patrick Mercer2019–2024
2010201520202025
Board members and other officers (27)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorYu-Hao Chen named Apr 3, 202652

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • IRIDEX Europe GmbH Germany4
  • Iridex Philippines BPO, Inc. The Republic of the Philippines4

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

Timeline

  1. Sep 2, 20268-K Listing notice or transfer53
  2. Aug 18, 20268-K Results of operations54
  3. Jul 16, 20268-K Shareholder vote; Regulation FD disclosure55
  4. Jun 18, 20268-K Other events56
  5. May 19, 20268-K Results of operations57
  6. Mar 26, 20268-K Results of operations58
  7. Mar 13, 20268-K Entered a material agreement; New debt or obligation59
  8. Jan 12, 20268-K Results of operations60
  9. Dec 11, 20258-K Regulation FD disclosure61
  10. Nov 12, 20258-K Results of operations62
  11. Sep 9, 20258-K Other events63
  12. Aug 12, 20258-K Results of operations64
  13. Nov 8, 2024New chief executive Patrick Mercer becomes CEO13
  14. May 23, 2019New chief executive David Bruce becomes CEO14
  15. Sep 7, 2012New chief executive William M. Moore becomes CEO15
  16. Oct 12, 2011New chief executive Dominik Beck becomes CEO16
  17. Nov 21, 2008New chief executive Theodore A. Boutacoff becomes CEO17
  18. Jun 5, 2006New chief executive Barry G. Caldwell becomes CEO18

Calendar

Coming up

  1. Nov 10, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.09) a share, on Nov 11, 2025.65

When it reported results

  1. Aug 18, 2026Reported quarterly or annual results54
  2. May 19, 2026Reported quarterly or annual results57
  3. Mar 26, 2026Reported quarterly or annual results58
  4. Jan 12, 2026Reported quarterly or annual results60
  5. Nov 12, 2025Reported quarterly or annual results62
  6. Aug 12, 2025Reported quarterly or annual results64
  7. May 13, 2025Reported quarterly or annual results66
  8. Apr 14, 2025Reported quarterly or annual results67

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

Filings

273 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 54 major events, 157 insider forms, 5 large holders, 2 private raises, 35 other. The latest 20:

  1. Oct 13, 20264 EDGAR
  2. Oct 7, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  3. Oct 7, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  4. Oct 7, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  5. Oct 5, 20264 EDGAR
  6. Sep 16, 20264 EDGAR
  7. Sep 14, 20264 EDGAR
  8. Sep 10, 20264 EDGAR
  9. Sep 2, 20268-K EDGAR
  10. Aug 24, 20264 EDGAR
  11. Aug 18, 202610-Q EDGAR
  12. Aug 18, 20268-K EDGAR
  13. Jul 16, 20268-K EDGAR
  14. Jul 14, 20264 EDGAR
  15. Jul 14, 20264 EDGAR
  16. Jul 13, 2026SCHEDULE 13D/A EDGAR
  17. Jul 8, 20264 EDGAR
  18. Jun 18, 20268-K EDGAR
  19. Jun 16, 20264 EDGAR
  20. Jun 16, 20264 EDGAR

The 273 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

100 open-market trades by officers, directors and large owners since October 2021: 100 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Dizon Romeo RChief Financial OfficerBuy7,900$0.63$5.0KForm 4
Sep 14, 2026Dizon Romeo RChief Financial OfficerBuy2,354$0.65$1.5KForm 4
Sep 10, 2026Dizon Romeo RChief Financial OfficerBuy5,100$0.68$3.5KForm 4
Aug 24, 2026Dizon Romeo RChief Financial OfficerBuy6,668$0.75$5.0KForm 4
Jun 12, 2026Dizon Romeo RChief Financial OfficerBuy975$1.14$1.1KForm 4
Jun 11, 2026Dizon Romeo RChief Financial OfficerBuy1,675$1.14$1.9KForm 4
Jun 8, 2026Dizon Romeo RChief Financial OfficerBuy2,400$1.12$2.7KForm 4
Jun 5, 2026Dizon Romeo RChief Financial OfficerBuy2,521$1.15$2.9KForm 4
Jun 3, 2026Dizon Romeo RChief Financial OfficerBuy2,400$1.17$2.8KForm 4
May 26, 2026Dizon Romeo RChief Financial OfficerBuy5,004$1.00$5.0KForm 4
Mar 6, 2026Dizon Romeo RChief Financial OfficerBuy1,110$1.26$1.4KForm 4
Feb 17, 2026Dizon Romeo RChief Financial OfficerBuy2,200$1.34$2.9KForm 4
Feb 12, 2026Dizon Romeo RChief Financial OfficerBuy1,500$1.43$2.1KForm 4
Feb 10, 2026Dizon Romeo RChief Financial OfficerBuy1,000$1.46$1.5KForm 4
Feb 3, 2026Dizon Romeo RChief Financial OfficerBuy2,500$1.38$3.5KForm 4
Jan 29, 2026Dizon Romeo RChief Financial OfficerBuy1,101$1.44$1.6KForm 4
Jan 28, 2026Dizon Romeo RChief Financial OfficerBuy1,300$1.46$1.9KForm 4
Jan 27, 2026Dizon Romeo RChief Financial OfficerBuy3,385$1.48$5.0KForm 4
Jan 26, 2026Dizon Romeo RChief Financial OfficerBuy1,243$1.52$1.9KForm 4
Jan 23, 2026Dizon Romeo RChief Financial OfficerBuy5,221$1.48$7.7KForm 4

All 100 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
2025Patrick Mercer54$384.6K$901.9K72
2025Bassem BouHabib50$248.1K$550.8K72
2025Romeo DizonChief Financial Officer68$10$526.2K72
2025Fuad Ahmad$10$133.2K72
2024PresidentChief Executive Officer and Chief Operating Officer$6$1.1M72
2024Former InterimChief Financial Officer$868.8K$868.8K72
2024David I. BruceFormer President and Chief Executive Officer$6$564.9K72
2024SeniorVice President of International Sales and Business Development$237.1K$529.3K72

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 19, 2025Raised $10 million in a private offering of securities Form D: $20 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 29. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC514,593$589.2K0.0%No change
Renaissance Technologies LLC423,542$485.0K0.0%+26,915
Morgan Stanley305,193$349.4K0.0%New
Weber Capital Management LLC /adv180,451$206.6K0.2%−79,107
Geode Capital Management, LLC138,960$159.2K0.0%−21,199
Citadel Advisors LLC98,950$113.3K0.0%+38,099
Perkins Capital Management Inc70,800$81.1K0.1%+15,500
Vanguard Fiduciary Trust Co60,155$68.9K0.0%No change
State Street Corp44,718$51.2K0.0%No change
Goldman Sachs Group Inc40,454$46.3K0.0%+2,833
United Capital Financial Advisors, LLC35,529$40.7K0.0%−22,000
XTX Topco Ltd29,190$33.4K0.0%New
Susquehanna International Group, Llp27,459$31.4K0.0%−1,460
Diversify Advisory Services, LLC33,840$30.1K0.0%New
Diversify Wealth Management, LLC33,840$30.1K0.0%No change
Bank of New York Mellon Corp25,649$29.4K0.0%No change
Northern Trust Corp23,983$27.5K0.0%+2,675
BlackRock, Inc.20,260$23.2K0.0%No change
Thompson Davis & Co., Inc.15,444$17.7K0.0%−32,000
Citigroup Inc14,172$16.2K0.0%New
Centiva Capital, LP13,920$15.9K0.0%New
HighTower Advisors, LLC10,000$11.4K0.0%No change
Vanguard Global Advisers, LLC3,963$4.5K0.0%No change
Tower Research Capital LLC (TRC)3,095$3.5K0.0%+1,003
Group One Trading LLC1,100$1.3K0.0%No change

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

SEC filer profile

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

  • Name on EDGARIRIDEX CORP1
  • CIK0001006045
  • Employer ID (EIN)77-021046712
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company12
  • Incorporated inDelaware12
  • Fiscal year endsJanuary 31
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address1212 Terra Bella Ave, Mountain View, CA 940431
  • Mailing address1212 Terra Bella Avenue, Mountain View, CA 940431
  • Phone65094047001
  • Shares outstanding17,564,912 as of Aug 13, 202610
  • Public float$14.2M as of Jun 27, 202512
  • AuditorBPM LLP, San Jose, California PCAOB ID 207; no auditor attestation of internal control over financial reporting12
  • On EDGAR sinceAug 14, 19961
  • Filings1,291 in all: 4 (555), 8-K (252), 10-Q (86), SC 13G/A (70), SC 13G (43), 3 (35), DEF 14A (30), 10-K (25)1
    All 40 form types

    S-8 (21), UPLOAD (20), 4/A (17), DEFA14A (16), ARS (14), CORRESP (14), SD (13), SC 13D/A (11), 8-K/A (7), SC 13D (7), NT 10-Q (6), 10-K405 (5), 10-Q/A (5), 10QSB (5), SC TO-I/A (4), 10-K/A (3), 424B5 (3), EFFECT (3), S-3 (3), 144 (2), 424B3 (2), NT 10-K (2), PRE 14A (2), SC TO-I (2), 10QSB/A (1), 424B4 (1), 5 (1), D (1), D/A (1), DEFR14A (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Apr 2, 2026
    Quarterly report (10-Q) Aug 18, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Sep 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareIRIXNasdaq

From the cover page of the 10-K filed Apr 2, 2026 (Section 12(b) of the Exchange Act).12

Risk factors and legal proceedings

The risks IRIDEX CORP names in Item 1A of its 10-K filed Apr 2, 2026: 48 risks under these headings, as written.12

  • General economic factors
  • Operational factors
  • Regulatory and legal factors
  • Financing and transactional risks
  • Governance risks and risks related to ownership of our common stock
  • Factors That May Affect Future Results
  • Risks Relating to our Business
  • Servicing our existing and future debt, including the Initial Novel Note and any Novel Growth Notes we issue in the future, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness.
  • We may not have the ability to raise the funds necessary to settle repayments of the Initial Novel Note or any Novel Growth Notes issued in the future in cash, and our future debt may contain limitations on our ability to make cash payments as required by the Novel Notes.
  • Novel has conversion rights under the Novel Notes, the exercise of which, in addition to the issuance of common stock in connection with the payment of interest under the Novel Notes, could result in the issuance of a substantial amount of our common stock at a significant discount to the trading price of our common stock.
  • We may not be successful in our strategic partnership with Topcon and the relationship may divert resources away from existing operations or expose us to liabilities, which could adversely affect our business, results of operations and financial condition.
  • Some of our laser systems are complex in design and may contain defects that are not detected until deployed by our customers, which could increase our costs and reduce our revenues.
The other 42 risks
  • We rely on our direct and independent sales forces and international distributors to sell our products and if we lose our sales force or distributor relationships, it could harm our business.
  • We depend on international sales for a significant portion of our operating results.
  • Our operating results may be adversely affected by uncertainty regarding healthcare reform measures and changes in third-party coverage and reimbursement policies.
  • If we fail to develop and successfully introduce new products and applications or fail to improve our existing products, our business prospects and operating results may suffer.
  • We are exposed to risks associated with worldwide economic slowdowns and related uncertainties.
  • Significant developments resulting from recent and potential changes in U.S. trade policies could have a material adverse effect on us.
  • Our ability to raise capital in the future may be limited, and future sales and issuances of securities could negatively affect our stock price and dilute the ownership interest of our existing investors.
  • We maintain cash deposits in excess of federally insured limits. Adverse developments affecting financial institutions, including bank failures, could adversely affect our liquidity and financial performance.
  • Our operating results may fluctuate from quarter to quarter and year to year.
  • We rely on continued market acceptance of our existing products and any decline in sales of our existing products would adversely affect our business and results of operations.
  • We face strong competition in our markets and expect the level of competition to grow in the foreseeable future.
  • If we lose key personnel or fail to integrate replacement personnel successfully, our ability to manage our business could be impaired.
  • If we fail to comply with healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.
  • We depend on collaborative relationships to develop, introduce and market new products, product enhancements and applications.
  • If we cannot increase our sales volumes, reduce our costs or introduce higher margin products to offset potential reductions in the average unit price of our products, our operating results may suffer.
  • Our promotional practices are subject to extensive government scrutiny. We may be subject to governmental, regulatory and other legal proceedings relative to advertising, promotion and marketing that could have a significant negative effect on our business.
  • We rely on patents and proprietary rights to protect our intellectual property and business.
  • If we fail to accurately forecast demand for our product and component requirements for the manufacture of our product, we could incur additional costs or experience manufacturing delays and may experience lost sales or significant inventory carrying costs.
  • We depend on sole source or limited source suppliers.
  • If our facilities were to experience catastrophic loss, our operations would be seriously harmed.
  • If we experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.
  • If we fail to maintain our relationships with health care providers, customers may not buy our products and our revenue and profitability may decline. At the same time, relationships with these individuals and entities are the subject of heightened scrutiny and may present the potential for healthcare compliance risks.
  • We are subject to government regulations which may cause us to delay or withdraw the introduction of new products or new applications for our products.
  • Any clinical trials necessary that we may undertake for regulatory approval or marketing reasons will be an expensive, lengthy, costly, and uncertain process, and could result in delays in new product introductions or even an inability to release a product.
  • If we fail to comply with the FDA’s quality system regulation and laser performance standards, our manufacturing operations could be halted, and our business would suffer.
  • If we modify one of our FDA cleared devices, we may need to submit a new 510(k), or potentially a PMA, and if clearance or approval is not obtained, it would prevent us from selling our modified products or cause us to redesign our products.
  • Efforts to acquire additional companies or product lines may divert our managerial resources away from our business operations, and if we complete additional acquisitions, we may incur or assume additional liabilities or experience integration problems.
  • Divestitures of our product lines may materially and adversely affect our financial condition, results of operations or cash flows and require us to raise additional capital to replace revenue from those product lines.
  • Our products may be misused, which could harm our reputation and our business.
  • Inability of customers to obtain credit or material increases in interest rates may harm our sales.
  • Our products could be subject to recalls even after receiving FDA approval or clearance. A recall would harm our reputation and adversely affect our operating results.
  • If product liability claims are successfully asserted against us, we may incur substantial liabilities that may adversely affect our business or results of operations.
  • Changes in U.S. tax laws could have a material adverse effect on our business, consolidated cash flow, results of operations or financial conditions.
  • We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties. Additionally, challenges to or investigation into our practices could cause adverse publicity and be costly to respond to and thus could harm our business.
  • If we fail to comply with environmental requirements, our business, financial condition, operating results and reputation could be adversely affected.
  • Risks Relating to Ownership of Our Common Stock
  • Our stock price has been and may continue to be volatile and an investment in our common stock could suffer a decline in value.
  • Our amended and restated certificate of incorporation grants our Board of Directors the power to issue additional shares of common and preferred stock and to designate series of preferred stock, all without stockholder approval.
  • Because we do not intend to pay dividends, stockholders will benefit from an investment in our common stock only if it appreciates in value.
  • If securities or industry analysts do not continue to publish research or publish incorrect or unfavorable research about our business, our stock price and trading volume could decline.
  • Ownership of our common stock is concentrated among a few investors, which may affect the ability of a third party to acquire control of us. Substantial sales by such investors could cause our stock price to decline.
  • As a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting. We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.
  • Our charter documents, anti-takeover provisions of Delaware law, and contractual provisions could delay or prevent an acquisition or sale of our company.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse effect on our business, consolidated operating results, financial condition or cash flows. 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. We are not currently party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.12

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