Sign in

AXDX on NASDAQ

Accelerate Diagnostics

Diagnostics company based in Tucson, founded in 19871

In its 2025 annual report the company says: “Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions that improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. Our technology platform is intended to address these challenges by delivering significantly faster testing of infectious pathogens in various patient sample types. Our first system to address these challenges is the Accelerate Pheno® system.”6 It employed 275 people in 2019.1 Its shares trade on NASDAQ under the symbol AXDX.1

Price unavailable

Last updated Oct 21, 2026.

Overview

1987Founded1

Compare with Lifeloc Technologies, Inc, Seer, Inc or Precipio, Inc., or pick any stock.

  • TickerAXDX on NASDAQ1
  • IndustryLaboratory Analytical Instruments1
  • HeadquartersTucson1
  • Websiteacceleratediagnostics.com
  • Legal formDelaware corporation1
  • Incorporated inDE4
  • Business address3950 S. Country Club Road #470, Building 3-307, Tucson, Az 857144
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • LEI2549007HE5QY1QEQ8K433
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressc/o The Corporation Trust Company, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 52652913

See how the biggest companies compare on our leaderboards

Accelerate Diagnostics, Inc. (“Accelerate”) is an in vitro diagnostics company dedicated to providing solutions that improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. Microbiology laboratories need new tools to address what the U.S. Centers for Disease Control and Prevention (the “CDC”) calls one of the most serious healthcare threats of our time, antibiotic resistance. A significant contributing factor to the rise of resistance is the overuse and misuse of antibiotics, which is exacerbated by a lack of timely diagnostic results. The delay of identification and antibiotic susceptibility results is often due to the reliance by microbiology laboratories on traditional culture-based tests that often take two to three days to complete. Our technology platform is intended to address these challenges by delivering significantly faster testin…6 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 2024

23.1%Gross margin7
-301.8%Operating margin7
-427.8%Net margin7
-3.0%Revenue growth, 20247

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Cost of revenue19¢$9.0M
  • Research and development35¢$16.7M
  • Selling, general and admin45¢$21.3M
  • Income tax0¢$66.0K

Out of $11.7M in revenue.7 The company lost money this year.

Financial statements

Revenue8910117$11.7M in 2024+106% since 2018
0$5.0M$10.0M$15.0M2018: $5.7M$5.7M20182019: $9.3M$9.3M2019+64%2020: $11.2M$11.2M2020+20%2021: $11.8M$11.8M2021+6%2022: $12.8M$12.8M2022+8%2023: $12.1M$12.1M2023−5%2024: $11.7M$11.7M2024−3%
Gross profit8910117$2.7M in 2024+9% since 2018
-$2.0M0$2.0M$4.0M$6.0M2018: $2.5M$2.5M20182019: $4.4M$4.4M2019+77%2020: $4.5M$4.5M2020+1%2021: -$381.0K-$381.0K20212022: $3.3M$3.3M20222023: $2.5M$2.5M2023−23%2024: $2.7M$2.7M2024+6%
Operating income8910117-$35.3M in 2024−56% since 2018
-$100.0M-$75.0M-$50.0M-$25.0M02018: -$80.4M-$80.4M20182019: -$72.8M-$72.8M2019−9%2020: -$63.7M-$63.7M2020−13%2021: -$71.6M-$71.6M2021+12%2022: -$62.8M-$62.8M2022−12%2023: -$54.0M-$54.0M2023−14%2024: -$35.3M-$35.3M2024−35%
Net income8910117-$50.0M in 2024−43% since 2018
-$100.0M-$75.0M-$50.0M-$25.0M02018: -$88.3M-$88.3M20182019: -$84.3M-$84.3M2019−5%2020: -$78.2M-$78.2M2020−7%2021: -$77.7M-$77.7M2021−1%2022: -$62.5M-$62.5M2022−20%2023: -$61.6M-$61.6M2023−1%2024: -$50.0M-$50.0M2024−19%
Fiscal year2018201920202021202220232024
Revenue$5.7M8$9.3M9$11.2M10$11.8M11$12.8M11$12.1M7$11.7M7
Cost of revenue$3.2M8$4.9M9$6.7M10$12.2M11$9.4M11$9.5M7$9.0M7
Gross profit$2.5M8$4.4M9$4.5M10-$381.0K11$3.3M11$2.5M7$2.7M7
Research and development$27.6M8$25.3M9$21.3M10$21.9M11$26.9M11$25.4M7$16.7M7
Selling, general and admin$55.2M8$51.9M9$46.9M10$49.2M11$39.2M11$31.2M7$21.3M7
Operating expenses$71.2M11$66.1M11$56.6M7$38.0M7
Operating income-$80.4M8-$72.8M9-$63.7M10-$71.6M11-$62.8M11-$54.0M7-$35.3M7
Interest$14.3M9$15.6M9$15.5M9
Income before tax-$77.7M11-$62.6M11-$60.8M7-$50.1M7
Income tax$211.0K8-$111.0K9$5.0K10$45.0K11-$77.0K11$850.0K7-$66.0K7
Net income-$88.3M8-$84.3M9-$78.2M10-$77.7M11-$62.5M11-$61.6M7-$50.0M7
Earnings per share-$1.559-$1.4010-$12.5911-$7.6111-$4.947-$2.157
Earnings per share (diluted)-$1.559-$1.4010-$12.5911-$7.6111-$4.947-$2.157
Shares (weighted, basic)6.2M shares118.2M shares1112.5M shares723.3M shares7
Shares (weighted, diluted)6.2M shares118.2M shares1112.5M shares723.3M shares7

Compare Accelerate Diagnostics with another company

Corporate structure

Accelerate Diagnostics sits at the top of its group. 4 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Accelerate Diagnostics

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Accelerate Diagnostics, latest May 15, 2025 (3 filings since Nov 14, 2024)
  • Indaba Capital Management, L.P. Filed SCHEDULE 13D/A on Accelerate Diagnostics, latest Feb 6, 2025 (3 filings since Jun 20, 2023)
  • GRIFFIN ASSET MANAGEMENT, INC. Filed SCHEDULE 13G/A on Accelerate Diagnostics, latest Jan 7, 2025 (2 filings since Mar 5, 2024)
  • Jack W. Schuler Filed SC 13D/A on Accelerate Diagnostics, latest Dec 5, 2024 (6 filings since Oct 5, 2021)
  • Larry N. Feinberg Filed SC 13G/A on Accelerate Diagnostics, latest Feb 24, 2022 (2 filings since Feb 11, 2022)
  • Accelerate Diagnostics Tucson, Arizona, United States
    • Accelerate Diagnostics S.L. Subsidiary · Spain
    • Accelerate Diagnostics S.r.l Subsidiary · Italy
    • Accelerate Diagnostics UK Limited Subsidiary · United Kingdom

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

What it owns

What Accelerate Diagnostics 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$14.0M7 Dec 31, 2024$13.4M7 Dec 31, 2023+4.2%
Accumulated depreciation$11.4M7 Dec 31, 2024$11.0M7 Dec 31, 2023+3.5%
Property and equipment, net$2.6M7 Dec 31, 2024$2.4M7 Dec 31, 2023+7.8%
Finance-lease assets$336.0K7 Dec 31, 2024$1.5M7 Dec 31, 2023−77.9%
Operating-lease assets (leased space)$2.9M7 Dec 31, 2024$1.2M7 Dec 31, 2023+147.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$15.1M7 Dec 31, 2024$12.1M7 Dec 31, 2023+24.4%
Marketable securities, current$1.2M7 Dec 31, 2024$1.1M7 Dec 31, 2023+10.9%
Equity securities at fair value$1.2M7 Dec 31, 2024$1.1M7 Dec 31, 2023+9.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$2.9M7 Dec 31, 2024$3.3M7 Dec 31, 2023−13.8%
Raw materials$1.1M7 Dec 31, 2024$1.3M7 Dec 31, 2023−11.0%
Work in process$447.0K7 Dec 31, 2024$648.0K7 Dec 31, 2023−31.0%
Finished goods$1.3M7 Dec 31, 2024$1.4M7 Dec 31, 2023−8.4%

Properties, in its own words

Our headquarters and reference laboratory space is located in Tucson, Arizona. As of December 31, 2024, we leased approximately 54,092 square feet of office/laboratory and manufacturing space in Tucson, Arizona. We believe that our currently leased facilities are adequate to meet our needs for the foreseeable future. See Part II, Item 8, Note 9, Leases for additional details regarding the leases.

Item 2 of the 10-K filed Mar 21, 2025.6

Leadership

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

Chief executive

  1. Thomas J. Geimer2007–2012
  2. Lawrence Mehren2012–2019

President

  1. David Howson2009–2012
  2. Lawrence Mehren2013–2019

Chief financial officer

  1. Thomas J. Geimer2007–2012
  2. Steven Reichling2012–2023
  3. David Patience2023–now
19901995200020052010201520202025
Board members and other officers (22)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorJohn J. Phillips named Apr 7, 202242
  • Executive OfficerRon J.M. Price named Apr 7, 202242
  • DirectorFrank J.M. ten Brink named Apr 7, 202242
  • DirectorThomas D. Brown named Apr 7, 202242

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Accelerate Diagnostics B.V. Netherlands5
  • Accelerate Diagnostics GmbH Germany5
  • Accelerate Diagnostics Pty Ltd Australia5
  • Accelerate Diagnostics S.L. Spain5
  • Accelerate Diagnostics S.r.l Italy5
  • Accelerate Diagnostics SARL France5
  • Accelerate Diagnostics UK Limited England5

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

Employees over time

  • 20192751

Former names

  • ACCELR8 TECHNOLOGY CORPDec 15, 1995 to Dec 26, 20124

Timeline

  1. Aug 18, 20258-K Entered a material agreement; Bankruptcy or receivership; Completed an acquisition or sale43
  2. Jun 4, 20258-K Entered a material agreement44
  3. May 28, 20258-K Executive or director change45
  4. May 12, 20258-K Listing notice or transfer46
  5. May 8, 20258-K Entered a material agreement; Bankruptcy or receivership; New debt or obligation47
  6. Apr 25, 20258-K Executive or director change48
  7. Apr 15, 20258-K Executive or director change49
  8. Mar 21, 20258-K Results of operations50
  9. Mar 21, 20258-K Other events51
  10. Jan 30, 20258-K Listing notice or transfer52
  11. Jan 10, 20258-K Results of operations53
  12. Nov 7, 20248-K Results of operations54
  13. Dec 26, 2012Went public Listed on NASDAQ1
  14. Jul 9, 2012New chief executive Lawrence Mehren becomes CEO16
  15. Jan 4, 2007New chief executive Thomas J. Geimer becomes CEO17
  16. 1987Founded Founded1

Calendar

When it reported results

  1. Mar 21, 2025Reported quarterly or annual results50
  2. Jan 10, 2025Reported quarterly or annual results53
  3. Nov 7, 2024Reported quarterly or annual results54
  4. Aug 8, 2024Reported quarterly or annual results55
  5. May 10, 2024Reported quarterly or annual results56
  6. May 8, 2024Reported quarterly or annual results57
  7. Mar 29, 2024Reported quarterly or annual results58
  8. Jan 8, 2024Reported quarterly or annual results59

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

Filings

311 filings to the SEC since October 2021: 5 annual reports, 13 quarterly reports, 77 major events, 162 insider forms, 16 large holders, 1 private raises, 37 other. The latest 20:

  1. Aug 18, 2025NT 10-Q EDGAR
  2. Aug 18, 20258-K EDGAR
  3. Jul 21, 202525-NSE EDGAR
  4. Jun 25, 20253 OWNERSHIP DOCUMENT EDGAR
  5. Jun 4, 20258-K EDGAR
  6. May 28, 20258-K EDGAR
  7. May 16, 2025NT 10-Q EDGAR
  8. May 15, 2025SCHEDULE 13G/A EDGAR
  9. May 12, 20258-K EDGAR
  10. May 8, 20258-K EDGAR
  11. May 1, 20253 OWNERSHIP DOCUMENT EDGAR
  12. Apr 30, 202510-K/A EDGAR
  13. Apr 25, 20258-K EDGAR
  14. Apr 15, 20258-K EDGAR
  15. Apr 7, 20254 OWNERSHIP DOCUMENT EDGAR
  16. Apr 7, 20254 OWNERSHIP DOCUMENT EDGAR
  17. Apr 2, 20254 OWNERSHIP DOCUMENT EDGAR
  18. Mar 21, 202510-K EDGAR
  19. Mar 21, 20258-K EDGAR
  20. Mar 21, 20258-K EDGAR

The 311 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

74 open-market trades by officers, directors and large owners since October 2021: 25 buys and 49 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 4, 2025Phillips JackChief Executive OfficerSale25,343$0.65$16.5KForm 4
Apr 4, 2025Mertz Larry MichaelChief Technology OfficerSale1,523$0.65$990Form 4
Apr 1, 2025Patience DavidChief Financial OfficerSale6,816$0.71$4.8KForm 4
Feb 26, 2025Patience DavidChief Financial OfficerSale535$1.09$583Form 4
Feb 3, 2025Phillips JackChief Executive OfficerSale485$1.35$655Form 4
Dec 3, 2024PATIENCE JOHNDirectorBuy200,000$1.57$314.0KForm 4
Dec 3, 2024SCHULER JACK WDirectorSale200,000$1.57$314.0KForm 4
May 20, 2024Mertz Larry MichaelChief Technology OfficerSale361$0.88$318Form 4
Apr 17, 2024Phillips JackChief Executive OfficerSale26,735$0.78$20.9KForm 4
Apr 12, 2024Phillips JackChief Executive OfficerSale26,545$0.86$22.8KForm 4
Apr 9, 2024Patience DavidChief Financial OfficerSale13,296$0.87$11.6KForm 4
Apr 9, 2024Mertz Larry MichaelChief Technology OfficerSale13,984$0.87$12.2KForm 4
Apr 4, 2024Mertz Larry MichaelChief Technology OfficerSale978$0.88$861Form 4
Apr 4, 2024Phillips JackChief Executive OfficerSale15,887$0.88$14.0KForm 4
Feb 26, 2024Patience DavidChief Financial OfficerSale350$0.96$336Form 4
Feb 1, 2024Phillips JackChief Executive OfficerSale494$1.30$642Form 4
Jan 23, 2024Strobeck MatthewDirectorBuy100,000Form 4
Jan 23, 2024FRANCESCONI LOUISEDirectorBuy13,333Form 4
Jan 23, 2024MASSARANY HANYDirectorBuy16,666Form 4
Jan 23, 2024PATIENCE JOHNDirectorBuy16,666Form 4

All 74 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.

Money raised

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

  1. Mar 24, 2022Raised $4 million in a private offering of equity Form D: 3 investors so far Form D

SEC filer profile

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

  • Name on EDGARAccelerate Diagnostics, Inc2
  • CIK0000727207
  • Employer ID (EIN)84-10722566
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)3826 Laboratory Analytical Instruments2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address3950 S. Country Club Road #470, Building 3-307, Tucson, AZ 857142
  • Phone303-863-80882
  • Shares outstanding25,210,392 shares as of Mar 17, 20256
  • Public float$15.9M as of Jun 28, 20246
  • AuditorWithumSmith+Brown, PC, East Brunswick, New Jersey PCAOB ID 100; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceDec 15, 19952
  • Filings1,117 in all: 4 (510), 8-K (200), 10-Q (52), 10QSB (36), 3 (31), DEF 14A (28), SC 13D/A (23), 4/A (22)2
    All 56 form types

    SC 13G/A (17), 10-K (16), CORRESP (14), UPLOAD (14), 10KSB (12), PRE 14A (10), S-8 (10), D (8), S-8 POS (8), SC 13G (8), 424B5 (7), SD (7), EFFECT (6), 10-Q/A (5), S-3 (5), 10-K/A (4), 10KSB/A (4), 424B3 (4), 8-K/A (4), NT 10-K (4), S-3/A (4), 10QSB/A (3), CT ORDER (3), DEFA14A (3), NT 10-Q (3), SCHEDULE 13G/A (3), 5 (2), 8-A12B (2), DEF 14C (2), DEFR14A (2), PRE 14C (2), S-1/A (2), SC 13D (2), 10-KT (1), 25 (1), 25-NSE (1), 3/A (1), 424B1 (1), CERTAMX (1), CERTNAS (1), D/A (1), DEFS14A (1), FWP (1), POS AM (1), REGDEX (1), S-1 (1), S-3ASR (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 21, 2025
    Quarterly report (10-Q) Nov 7, 2024
    Proxy statement (DEF 14A) Apr 11, 2024
    Latest 8-K (8-K) Aug 18, 2025

Securities registered for trading

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

From the cover page of the 10-K filed Mar 21, 2025 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Accelerate Diagnostics names in Item 1A of its 10-K filed Mar 21, 2025: 53 risks under these headings, as written.6

  • Risks Related to Our Financial Condition, Liquidity and Indebtedness
  • Our financial condition, including our substantial indebtedness, raises substantial doubt regarding our ability to continue as a going concern.
  • We have substantial indebtedness, which could have important consequences to our business.
  • Servicing our debt will require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our debt.
  • To the extent we deliver shares upon conversion of the 5.00% Notes, the ownership interests of existing stockholders could be diluted and our stock price may be adversely impacted.
  • We may seek the protection of the Bankruptcy Court, which may harm our business, adversely affect our ability to retain key personnel, and result in a significant loss of value for our stockholders.
  • Risks Related to Our Business and Strategy
  • We have limited revenues from our products and no assurance of future revenues.
  • We have a history of losses and expect to continue to incur losses in the future, and we cannot be certain that we will achieve or sustain profitability.
  • Our future profitability and continued existence are dependent in large part upon the successful commercialization of the Accelerate Pheno system and Accelerate Arc system and further development and commercialization of associated test kits, and the Accelerate WAVE system.
  • We have entered into the Sales and Marketing Agreement with BD and will substantially depend on BD for the successful commercialization of our products.
  • Our future product candidates have not obtained marketing authorization from the FDA, and they may never obtain such marketing authorization or other regulatory clearance.
The other 43 risks
  • We may not be able to correctly estimate or control our future operating expenses, which could lead to cash shortfalls, and impact our ability to continue as a going concern.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
  • We may not be able to enhance the capabilities of our current and new products to keep pace with our industry’s rapidly changing technology and customer requirements.
  • The failure of our current or any future diagnostic products to perform as expected could significantly impair our reputation and the public image of our products, and we may be subject to legal claims arising from any defects or errors.
  • If treatment guidelines for bacterial infections change, or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA for our product candidates.
  • Breaches of our information technology systems could have a material adverse effect on our operations and potentially result in liability, depending on the type of breach and information compromised.
  • Failure to comply with a variety of U.S. and international privacy laws to which we are subject could harm the Company.
  • We are dependent on our key employees. If we are unable to recruit, train and retain qualified personnel, we may not achieve our goals.
  • Our industry is highly competitive, and we may not be successful in competing with our competitors. We currently face competition from new and established competitors and expect to face competition from others in the future, including those with new products, technologies or techniques.
  • We generate a portion of our future revenue internationally and are subject to various risks relating to our international activities which could adversely affect our operating results.
  • Our employees, independent contractors, principal investigators, consultants, commercial partners, vendors and other agents may engage in misconduct or other improper activities, including non-compliance with legal standards and requirements.
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar rates, if at all.
  • We are exposed to risks associated with long-lived assets that may become impaired and result in an impairment charge.
  • Providing instrument systems to our customers through reagent rental agreements may harm our liquidity.
  • If we fail to estimate customer demand properly, our financial results could be harmed.
  • The COVID-19 pandemic has adversely affected our business and a resurgence of COVID-19 or the occurrence of another health epidemic or pandemic may have an adverse impact on our business in the future.
  • Disruptions in the supply of raw materials, consumable goods or other key product components, or issues associated with their quality from our single source suppliers, could result in a significant disruption in sales and profitability.
  • If we fail to maintain effective internal control over financial reporting we may not be able to accurately or timely report our financial condition or results of operations.
  • Risks Related to Our Intellectual Property
  • If we are unable to effectively protect our intellectual property, our business would be harmed.
  • We may not be successful in our currently pending or future patent applications, and even if such applications are successful, we cannot guarantee that the resulting patents will sufficiently protect our products and proprietary technology.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive and time consuming.
  • We could face claims that our proprietary technologies infringe on the intellectual property rights of others.
  • We may be subject to claims by third parties asserting that our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Risks Related to Our Research and Development Activities
  • We have made and intend to make significant additional investments in research and development, but there is no guarantee that any of these investments will ultimately result in commercial products that will generate revenues.
  • We have a single research and development facility and we may be unable to continue to conduct our research and development activities if we lose this facility. If our facility or our equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed.
  • We use hazardous materials in some of our research, development and manufacturing processes and face the accompanying risks and regulations governing environmental safety.
  • Risks Related to Government Regulation
  • Legislative and Administrative Action May Have an Adverse Effect on Our Company
  • We and our suppliers, contract manufacturers and customers are subject to various governmental laws and regulations, and we may incur significant expenses to comply with, and experience delays in our product commercialization as a result of, these laws and regulations.
  • Maintaining adequate sales of our product may depend on the availability of adequate reimbursement to our customers from third-party payers, including government programs such as Medicare and Medicaid, private insurance plans, and managed care programs.
  • We may be adversely affected by healthcare policy changes, including additional healthcare reform and changes in managed healthcare.
  • The regulatory processes applicable to our products and operations are expensive, time-consuming, and uncertain and may prevent us from obtaining required authorizations for the commercialization of our products.
  • Modifications to our products, if cleared or approved, may require new 510(k) clearances or pre-market approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
  • We rely on third parties to conduct studies of our products that may be required by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.
  • A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse impact on us.
  • Risks Related to Our Common Stock
  • Our common stock may be delisted from The Nasdaq Capital Market, which could have a material adverse effect on our business and financial condition and could make it more difficult for you to sell your shares.
  • Related to Our Financial Condition, Liquidity and Indebtedness - We have substantial indebtedness, which could have important consequences to our business.”
  • We have significantly increased the total number of authorized shares of common stock under our certificate of incorporation, which could cause significant dilution.
  • Future issuances or sales of shares of our common stock may depress the price of our shares and be dilutive to our existing stockholders.
  • We are likely to require additional capital in the future, and you may incur dilution to your stock holdings.
  • Our stock price has been volatile and may continue to be volatile and traded on low volumes.
  • The ownership of our common stock is highly concentrated.
  • Provisions in our Amended and Restated Certificate of Incorporation (as amended, our “Charter”), our Amended and Restated Bylaws (as amended, our “Bylaws”) and Delaware law may delay or prevent acquisition of our Company, which could adversely affect the value of our common stock.
  • General Risk Factor
  • Current macroeconomic conditions and the uncertain economic outlook may remain challenging for the foreseeable future.

Legal proceedings

We are from time to time subject to various claims and legal actions in the ordinary course of our business. We believe that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on our results of operations or financial condition.

The opening of Item 3, Legal Proceedings.6

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
    SEC EDGAROther events
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64