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STXS on NYSE

Stereotaxis, Inc.

Stereotaxis, Inc. is an American electromedical and electrotherapeutic apparatus company.1 It is headquartered in St.Louis, Missouri.1 Its shares trade on NYSE under the symbol STXS.1

$1.03 down 0.02 (1.90%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerSTXS on NYSE1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersSt.Louis, Missouri1
  • Incorporated inDE3
  • Business address710 N Tucker Blvd, Ste 110, St.Louis, Mo 631013
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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Stereotaxis, Inc. All other trademarks that appear in this report are the property of their respective owners.5 From its latest annual report

Financials

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

Key numbers, fiscal 2025

52.7%Gross margin6
-68.3%Operating margin6
-66.8%Net margin6
20.3%Revenue growth, 20256
-160.5%Return on equity6

What sells

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

Products and services

Disposables Service and Accessories brought in 68% of the revenue Stereotaxis, Inc. broke down this way in fiscal 2025.

  1. Disposables Service and Accessories$22.2M668%up 21% from 2024
  2. Systems$10.2M632%up 18% from 2024
Products and services by year
Products and services20242025
Disposables Service and Accessories$18.3M$22.2M
Systems$8.6M$10.2M

Regions

Outside the United States brought in 60% of the revenue Stereotaxis, Inc. broke down this way in fiscal 2025.

  1. Outside the United States$19.5M660%up 45% from 2024
  2. United States$12.9M640%down 4% from 2024
Regions by year
Regions20242025
Outside the United States$13.5M$19.5M
United States$13.4M$12.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue47¢$15.3M
  • Research and development29¢$9.4M
  • Other costs24¢$7.7M

Out of $32.4M in revenue.6 The company lost money this year.

Financial statements

Revenue78910116$32.4M in 2025+12% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $28.9M$28.9M20192020: $26.6M$26.6M2020−8%2021: $35.0M$35.0M2021+32%2022: $28.1M$28.1M2022−20%2023: $26.8M$26.8M2023−5%2024: $26.9M$26.9M2024+1%2025: $32.4M$32.4M2025+20%
Gross profit78910116$17.1M in 2025−25% since 2019
0$10.0M$20.0M$30.0M2019: $22.8M$22.8M20192020: $19.0M$19.0M2020−17%2021: $23.2M$23.2M2021+22%2022: $18.5M$18.5M2022−20%2023: $14.9M$14.9M2023−20%2024: $14.6M$14.6M2024−2%2025: $17.1M$17.1M2025+17%
Operating income78910116-$22.1M in 2025+358% since 2019
-$30.0M-$20.0M-$10.0M02019: -$4.8M-$4.8M20192020: -$6.7M-$6.7M2020+39%2021: -$12.9M-$12.9M2021+92%2022: -$18.8M-$18.8M2022+46%2023: -$21.8M-$21.8M2023+16%2024: -$24.7M-$24.7M2024+13%2025: -$22.1M-$22.1M2025−11%
Net income78910116-$21.6M in 2025+371% since 2019
-$30.0M-$20.0M-$10.0M02019: -$4.6M-$4.6M20192020: -$6.6M-$6.6M2020+45%2021: -$10.7M-$10.7M2021+61%2022: -$18.3M-$18.3M2022+71%2023: -$20.7M-$20.7M2023+13%2024: -$24.0M-$24.0M2024+16%2025: -$21.6M-$21.6M2025−10%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Total revenue$32.4M$26.9M
Total cost of revenue$15.3M$12.3M
Gross margin$17.1M$14.6M
Research and development$9.4M$9.8M
Sales and marketing$12.4M$12.4M
General and administrative$17.8M$17.2M
Other-$492.0K
Total operating expenses$39.2M$39.3M
Operating loss-$22.1M-$24.7M
Other income$2.0K
Interest income, net$467.0K$694.0K
Net loss-$21.6M-$24.0M
Cumulative dividend on convertible preferred stock-$1.3M-$1.3M
Net loss attributable to common stockholders-$22.9M-$25.4M
Basic-$0.25-$0.30
Diluted-$0.25-$0.30
Basic91.0M shares85.2M shares
Diluted91.0M shares85.2M shares

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Corporate structure

Stereotaxis, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Stereotaxis, Inc.

  • Stereotaxis, Inc. St.Louis, Missouri
    • Access Point Technologies EP LLC Subsidiary · Minnesota, United States

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$7.8M6 Dec 31, 2025$8.0M6 Dec 31, 2024−2.2%
Accumulated depreciation$4.8M6 Dec 31, 2025$4.4M6 Dec 31, 2024+8.4%
Property and equipment, net$3.0M6 Dec 31, 2025$3.6M6 Dec 31, 2024−15.5%
Operating-lease assets (leased space)$4.9M6 Dec 31, 2025$5.5M6 Dec 31, 2024−10.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$13.4M6 Dec 31, 2025$12.2M6 Dec 31, 2024+9.9%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$3.8M6 Dec 31, 2025$3.8M6 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$7.4M11 Dec 31, 2024$1.4M14 Dec 31, 2014+433.3%
Finite-lived intangibles, gross$7.7M6 Dec 31, 2025$7.7M6 Dec 31, 20240%
Accumulated amortization$1.3M6 Dec 31, 2025$382.0K6 Dec 31, 2024+243.2%
Finite-lived intangibles, net$6.4M6 Dec 31, 2025$7.4M6 Dec 31, 2024−12.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$9.6M6 Dec 31, 2025$8.3M6 Dec 31, 2024+14.8%
Raw materials$6.5M6 Dec 31, 2025$5.2M6 Dec 31, 2024+24.7%
Work in process$2.2M6 Dec 31, 2025$1.1M6 Dec 31, 2024+102.2%
Finished goods$3.4M6 Dec 31, 2025$4.4M6 Dec 31, 2024−22.1%

Properties, in its own words

On March 1, 2021, the Company entered into an office lease agreement (the “Globe Lease”) with Globe Building Company, under which the Company leases executive office space and manufacturing facilities of approximately 43,100 square feet of rentable space located at 710 N. Tucker Boulevard, St. Louis, Missouri that serves as the Company’s new principal executive and administrative offices and manufacturing facility. Lease payments commenced January 1, 2022 and the lease has a term of ten years, with two renewal options of five years each. The new lease space includes approximately 23,000 square feet of office space and 20,100 square feet of demonstration and assembly space. The Company gained access to the Premises in the third quarter 2021 to begin constructing leasehold improvements. In the fourth quarter of 2021, the Company received an occupancy permit and relocated its operations to the new leased space.

On July 31, 2024, the Company entered into a lease agreement (the “Talulla Lease”) with Talulla Group LLC, under which the Company will lease office space and manufacturing facilities of approximately 11,300 square feet of rentable space located at 12560 Fletcher Lane, Rogers, Minnesota that will continue to serve as the APT’s office and manufacturing facility. Lease payments commenced on August 1, 2024, and the lease has a term of four years, with two renewal options of four years each.

The rest of Item 2

The Company also has leased office space in Beijing, China under a lease agreement through November 29, 2026.

Item 2 of the 10-K filed Mar 12, 2026.5

Leadership

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

Chief executive

  1. Bevil J. Hogg2006–2008
  2. Michael P. Kaminski2009–2013
  3. William C. Mills Iii.2013–2016

President

  1. Bevil J. Hogg2006–2007
  2. Michael P. Kaminski2007–2013

Chief financial officer

  1. James M. Stolze2006–2009
  2. Daniel J. Johnston2009–2011
  3. Samuel M. Duggan Ii.2011–2012
  4. Martin C. Stammer2013–2019
  5. Kimberly R. Peery2019–now

Chief operating officer

  1. Michael P. Kaminski2006–2008
2010201520202025
Board members and other officers (34)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorDavid L. Fischel named Aug 15, 202458
  • DirectorMyriam W. Curet named Aug 15, 202458

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Access Point Technologies EP LLC Minnesota4

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

Timeline

  1. Aug 11, 20268-K Results of operations59
  2. Jul 16, 20268-K Other events60
  3. Jul 9, 20268-K Unregistered sale of shares; Regulation FD disclosure; Other events61
  4. May 15, 20268-K Shareholder vote62
  5. May 12, 20268-K Results of operations63
  6. Apr 15, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure64
  7. Mar 9, 20268-K Results of operations65
  8. Nov 12, 20258-K Results of operations66
  9. Aug 29, 20258-K Entered a material agreement67
  10. Aug 7, 20258-K Results of operations68
  11. Jul 17, 20258-K Results of operations; Other events69
  12. Jul 17, 20258-K Entered a material agreement; Regulation FD disclosure70
  13. Apr 16, 2013New chief executive William C. Mills Iii. becomes CEO15
  14. Jun 4, 2009New chief executive Michael P. Kaminski becomes CEO16
  15. Feb 24, 2006New chief executive Bevil J. Hogg becomes CEO17

Calendar

Coming up

  1. Nov 10, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.03) a share, on Nov 11, 2025.71

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results59
  2. May 12, 2026Reported quarterly or annual results63
  3. Mar 9, 2026Reported quarterly or annual results65
  4. Nov 12, 2025Reported quarterly or annual results66
  5. Aug 7, 2025Reported quarterly or annual results68
  6. Jul 17, 2025Reported quarterly or annual results69
  7. May 12, 2025Reported quarterly or annual results72
  8. Mar 3, 2025Reported quarterly or annual results73

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

Filings

201 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 34 major events, 92 insider forms, 7 large holders, 1 private raises, 46 other. The latest 20:

  1. Aug 19, 2026SCHEDULE 13G EDGAR
  2. Aug 13, 2026EFFECT EDGAR
  3. Aug 13, 2026EFFECT EDGAR
  4. Aug 13, 2026424B3 EDGAR
  5. Aug 13, 2026424B3 EDGAR
  6. Aug 12, 202610-Q EDGAR
  7. Aug 11, 20268-K EDGAR
  8. Jul 16, 20268-K EDGAR
  9. Jul 15, 2026S-3 EDGAR
  10. Jul 15, 2026S-3 EDGAR
  11. Jul 9, 20268-K EDGAR
  12. Jul 1, 20264 EDGAR
  13. Jul 1, 20264 EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jul 1, 20264 EDGAR
  16. Jul 1, 20264 EDGAR
  17. Jul 1, 20264 EDGAR
  18. May 29, 2026SD EDGAR
  19. May 15, 2026SCHEDULE 13G/A EDGAR
  20. May 15, 20268-K EDGAR

The 201 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

47 open-market trades by officers, directors and large owners since October 2021: 47 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 17, 2025Isaac Paul JDirectorBuy10,000$2.18$21.8KForm 4
Nov 14, 2025Isaac Paul JDirectorBuy20,000$2.24$44.8KForm 4
Mar 10, 2025Isaac Paul JDirectorBuy38,000$1.81$68.8KForm 4
Mar 7, 2025Isaac Paul JDirectorBuy1,489$1.79$2.7KForm 4
Mar 6, 2025Isaac Paul JDirectorBuy23,299$1.81$42.2KForm 4
Aug 20, 2024Isaac Paul JDirectorBuy442$1.88$831Form 4
Aug 19, 2024Isaac Paul JDirectorBuy812$1.88$1.5KForm 4
Aug 15, 2024Isaac Paul JDirectorBuy8,095$1.90$15.4KForm 4
Jun 14, 2024Isaac Paul JDirectorBuy7,000$1.86$13.0KForm 4
May 31, 2024Isaac Paul JDirectorBuy1,000$1.96$2.0KForm 4
May 29, 2024Isaac Paul JDirectorBuy3,026$1.90$5.7KForm 4
May 28, 2024Isaac Paul JDirectorBuy6,000$1.91$11.5KForm 4
Dec 15, 2023Isaac Paul JDirectorBuy11,060$1.72$19.0KForm 4
Nov 30, 2023Isaac Paul JDirectorBuy2,808$1.56$4.4KForm 4
Nov 22, 2023Isaac Paul JDirectorBuy18$1.50$27Form 4
Nov 21, 2023Isaac Paul JDirectorBuy6,000$1.53$9.2KForm 4
Nov 20, 2023Isaac Paul JDirectorBuy6,000$1.54$9.2KForm 4
Nov 17, 2023Isaac Paul JDirectorBuy6,000$1.55$9.3KForm 4
Nov 16, 2023Isaac Paul JDirectorBuy15,000$1.51$22.6KForm 4
Nov 15, 2023Isaac Paul JDirectorBuy20,000$1.44$28.8KForm 4

All 47 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
2025Kimberly R. Peery$232.5K$326.1K78
2025David L. Fischel$60.0K$64.4K78
2024Chief Financial Officer$226.8K$340.2K78
2024Chief Executive Officer$60.0K$62.2K78

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$3.0M 2024–2024
Money received by yearMoney received by year, 2024–2024: $3.0M in all. Private raises (Form D) $3.0M.$0$1M$2M$3M2024 · Private raises (Form D): $3.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$3.0M$3.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jul 31, 2024Raised $3 million in a private offering of equity58 Form D: 1 investor so far 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
DAFNA Capital Management LLC13,680,554$23.5M4.5%No change
BlackRock, Inc.4,396,835$7.6M0.0%+440,592
Lagoda Investment Management, L.P.4,122,600$7.1M3.9%−227,800
Vanguard Capital Management LLC3,044,820$5.2M0.0%+46,776
Arbiter Partners Capital Management LLC2,883,856$5.0M1.4%No change
Geode Capital Management, LLC1,895,243$3.3M0.0%+219,835
Essex Investment Management Co LLC1,521,966$2.6M0.3%−68,135
Archon Capital Management LLC1,226,044$2.1M0.9%No change
Warberg Asset Management LLC1,108,889$1.9M1.9%+14,766
State Street Corp916,780$1.6M0.0%−40,988
AlphaCentric Advisors LLC600,000$1.0M0.9%No change
Vanguard Fiduciary Trust Co589,110$1.0M0.0%+59,240
Bank Julius Baer & Co. Ltd, Zurich540,530$929.7K0.0%+1
Northern Trust Corp529,695$911.1K0.0%+32,769
Legato Capital Management LLC512,907$882.2K0.1%+15,384
Vanguard Portfolio Management LLC463,580$797.4K0.0%+94,951
Sequoia Financial Advisors, LLC381,355$655.9K0.0%+703
Morgan Stanley332,107$571.2K0.0%+201,304
UBS Group AG251,333$432.3K0.0%+14,055
Prescott Group Capital Management, L.L.C.237,495$408.5K0.0%No change
Goldman Sachs Group Inc234,971$404.2K0.0%−34,075
Sei Investments Co234,612$403.5K0.0%−284,272
Bank of New York Mellon Corp211,641$364.0K0.0%+15,665
Independent Advisor Alliance208,485$358.6K0.0%+7,500
Aqr Capital Management LLC196,622$338.2K0.0%+131,351

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

SEC filer profile

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

  • Name on EDGARStereotaxis, Inc.1
  • CIK0001289340
  • Employer ID (EIN)94-31203865
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
  • Incorporated indelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address710 N Tucker Blvd, Ste 110, St.Louis, MO 631011
  • Phone314-678-61001
  • Shares outstanding100,202,178 as of Jul 31, 202613
  • Public float$150.3M as of Jun 30, 20255
  • AuditorErnst & Young LLP, St. Louis, Missouri PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMay 7, 20041
  • Filings1,554 in all: 4 (687), 8-K (268), 424B3 (83), 10-Q (66), SC 13G/A (54), 3 (49), CORRESP (28), EFFECT (25)1
    All 48 form types

    DEF 14A (23), SC 13G (23), 10-K (22), UPLOAD (21), 4/A (20), 424B5 (20), DEFA14A (17), S-1/A (17), S-3 (14), SD (13), S-8 (12), POS AM (11), 8-K/A (9), 10-K/A (6), S-1 (6), 3/A (5), D (5), 424B2 (4), PRE 14A (4), SC 13D (4), SC 13D/A (4), 25-NSE (3), 8-A12B (3), CT ORDER (3), S-3/A (3), SC TO-I/A (3), 10-Q/A (2), ARS (2), CERTNAS (2), DEFR14A (2), SCHEDULE 13G (2), 424B4 (1), 5 (1), 8-A12G (1), CERT (1), POS462B (1), S-3MEF (1), S-8 POS (1), SC TO-I (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 3, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareSTXSNYSE American

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

Risk factors and legal proceedings

The risks Stereotaxis, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 57 risks under these headings, as written.5

  • Risks Related to Our Business and Business Operations
  • Risks Related to our Recently Completed Acquisition of APT
  • Risks Relating to Technology and Intellectual Property Matters
  • Risks Relating to Regulatory and Legal Matters
  • Risks Related to Our Common Stock
  • Risks Related to the February 2021 CEO Performance Stock Unit Grant
  • We may not generate cash from operations or be able to raise the necessary capital to continue operations.
  • Macroeconomic and geopolitical factors, as well as pandemics, epidemics or outbreaks of infectious disease could have an adverse effect on our supply chain, our hospital customers buying patterns, and our ability to raise capital and could otherwise disrupt our normal business operations.
  • We may not be able to fund our business operations in the same manner as we have done historically if we do not improve the operating performance of the Company or raise additional capital.
  • Hospital decision-makers may not purchase our robotic magnetic navigation systems or related products or may think that such systems and products are too expensive.
  • If we are unable to fulfill our current purchase orders and other commitments on a timely basis or at all, we may not be able to achieve future sales growth.
  • We will likely experience long and variable sales and installation cycles, which could result in substantial fluctuations in our quarterly results of operations.
The other 51 risks
  • Physicians may not use our products if they do not believe they are safe, efficient and effective.
  • Our collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other parties may fail, or we may not be able to enter into additional collaborations in the future.
  • The complexity associated with selling, marketing, and distributing products could impair our ability to increase revenue.
  • Our marketing strategy is dependent on collaboration with physician “thought leaders.”
  • Physicians may not commit enough time to sufficiently learn our system.
  • Customers may choose to purchase competing products and not ours.
  • If the magnetic fields generated by our system are not compatible with, or interfere with, other widely used equipment in the interventional labs, sales of our products would be negatively affected.
  • The use of our products could result in product liability claims that could be expensive, divert management’s attention and harm our reputation and business.
  • We have incurred substantial losses in the past and may not be profitable in the future.
  • Our reliance on contract manufacturers and on suppliers, and in some cases, a single supplier, could harm our ability to meet demand for our products in a timely manner or within budget.
  • Risks associated with international manufacturing and trade could negatively impact the availability and cost of our products because materials used to manufacture our magnets, one of our key system components, are sourced from overseas.
  • We may encounter problems at our manufacturing facilities or those of our subcontractors or otherwise experience manufacturing delays that could result in lost revenue.
  • Our growth may place a significant strain on our resources, and if we fail to manage our growth, our ability to develop, market, and sell our products will be harmed.
  • We may be unable to successfully integrate APT into our business and may fail to realize any or all of the anticipated benefits of the acquisition, or those benefits may take longer to realize than expected.
  • Our future results may be adversely impacted if we do not effectively manage APT’s catheter manufacturing business following the completion of the acquisition.
  • The issuance of the Earnout Consideration will result in dilution to our stockholders and may adversely affect us, including the market price of our securities.
  • Under certain circumstances, we may take certain actions to achieve the milestones under the Purchase Agreement that we would not have undertaken if we had not completed the acquisition, which may have an adverse effect on the historical business of Stereotaxis.
  • The rate of technological innovation of our products might not keep pace with the rest of the market.
  • Security breaches and other disruptions to our information technology infrastructure could interfere with our operations, compromise confidential information, and expose us to liability which could materially adversely impact our business and reputation.
  • We may be unable to protect our technology from use by third parties, which may allow them to compete with us and harm our business.
  • Third parties may assert that we are infringing their intellectual property rights, and any defense of such assertions may be unsuccessful and expensive, even if we are successful.
  • Expensive intellectual property litigation is frequent in the medical device industry and may cause us to incur substantial expenses to defend.
  • We may not be able to maintain all the licenses or rights from third parties necessary for the development, manufacture, or marketing of new and existing products.
  • Our products and related technologies can be applied in different medical applications, and we may fail to focus on the most profitable areas.
  • We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
  • Software errors or other defects may be discovered in our products and the resulting performance issues may damage our business and our reputation in the industry in which we operate.
  • Risks Related to Regulatory and Legal Matters
  • If we or the parties in our strategic collaborations fail to obtain or maintain necessary FDA clearances or approvals for our medical device products, or if such clearances or approvals are delayed, we will be unable to continue to commercially distribute and market our products.
  • If our strategic collaborations elect not to or we fail to obtain regulatory approvals in other countries for products under development, we will not be able to commercialize these products in those countries.
  • We may fail to comply with continuing regulatory requirements of the FDA and other authorities and become subject to enforcement action, which may include substantial penalties.
  • Our suppliers, subcontractors, or we may fail to comply with the FDA, EU and other state and foreign government authorities quality system regulation or other quality standards.
  • If we fail to comply with health care regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • Healthcare policy changes, including the potential repeal or amendment of any existing legislation, may have a material adverse effect on us. Such changes could, among other things, reduce reimbursement for procedures using our products, change coverage policies, increase compliance costs, and delay or reduce hospital capital spending.
  • The application of state certificate of need regulations and compliance by our customers with federal and state licensing or other international requirements could substantially limit our ability to sell our products and grow our business.
  • Hospitals or physicians may be unable to obtain reimbursement from third-party payors for procedures using our products, or reimbursement for procedures may be insufficient to recoup the costs of purchasing our products.
  • Our costs could substantially increase if we receive a significant number of warranty claims or have other significant, uninsured liabilities.
  • Our principal stockholders continue to own a large percentage of our voting stock, and they could substantially influence matters requiring stockholder approval.
  • Future issuances of our securities could dilute current stockholders’ ownership.
  • We have never paid dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future.
  • Our certificate of incorporation and bylaws, the Company’s Performance Share Unit Agreement with Our CEO, and Delaware law, contain provisions that could discourage a takeover.
  • Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty.
  • Our future operating results may be below securities analysts’ or investors’ expectations, which could cause our stock price to decline.
  • We expect that the price of our common stock could fluctuate substantially, possibly resulting in class action securities litigation.
  • If we fail to continue to meet all applicable NYSE American Market requirements and the NYSE American determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock, which would impair the value of your investment and ultimately harm our business by limiting our access to equity markets for capital raising.
  • We will incur significant additional stock-based compensation expense over the term of the CEO Performance Award regardless of whether any of the milestones are achieved.
  • Our stockholders may experience substantial dilution upon payout of shares under the CEO Performance Award.
  • Certain provisions in the PSU Agreement may discourage a change in control of the Company even if such a transaction would otherwise be beneficial to our stockholders.
  • We are highly dependent on the services of Mr. Fischel, and our compensation package, including the CEO Performance Award, may fail to retain him.
  • General Risk Factors
  • General economic conditions could materially adversely impact us.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • We may lose key personnel or fail to attract and retain replacement or additional personnel.
  • We face currency and other risks associated with international operations.

Legal proceedings

The Company is involved from time to time in various lawsuits and claims arising in the normal course of business. Although the outcomes of these lawsuits and claims are uncertain, the Company does not believe any of them are presently likely to have a material adverse effect on our business, financial condition or results of operations.

The opening of Item 3, Legal Proceedings.5

Sources

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