SNWV on Nasdaq

SANUWAVE Health, Inc.

SANUWAVE Health, Inc. is a medical device company providing directed energy products into the wound care space.1 It is headquartered in Eden Prairie, Minnesota.1 Its shares trade on Nasdaq under the symbol SNWV.1

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Last updated Oct 21, 2026.

Overview

Compare with TriSalus Life Sciences, Inc., SS Innovations International, Inc. or KORU Medical Systems, Inc., or pick any stock.

  • TickerSNWV on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersEden Prairie, Minnesota1
  • Incorporated inNV2
  • Business address9600 W. 76Th Street, Eden Prairie, Mn2
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

Sanuwave is a medical device company providing directed energy products into the wound care space. Our mission is to improve patient lives and outcomes by developing and marketing effective, easy to use products to decrease wound burden, lessen healing times, and reduce patient pain.3 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

77.1%Gross margin4
11.2%Operating margin4
26.8%Net margin4
36.3%Revenue growth, 20254
729.6%Return on equity4
9.97×Debt to equity4
$1.9MFree cash flow4

What sells

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

Products and services

Consumables Parts And Accessories Revenue brought in 59% of the revenue SANUWAVE Health, Inc. broke down this way in fiscal 2025.

  1. Consumables Parts And Accessories Revenue$25.8M459%up 22% from 2024
  2. System Revenue$17.8M441%up 61% from 2024
  3. Other Revenue$206.0K40%down 33% from 2024
  4. Extended Warranty$172.0K40%up 81% from 2024
  5. License fees$20.0K40%down 56% from 2024
Products and services by year
Products and services20242025
Consumables Parts And Accessories Revenue$21.1M$25.8M
System Revenue$11.1M$17.8M
Other Revenue$306.0K$206.0K
Extended Warranty$95.0K$172.0K
License fees$45.0K$20.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue23¢$10.1M
  • Research and development3¢$1.4M
  • Other costs47¢$20.7M
  • Income tax0¢$86.0K
  • Profit27¢$11.8M

Out of $44.1M in revenue.4

Where each dollar of operating cash went, fiscal 2025

  • Capital spending50¢$1.9M
  • Kept or used elsewhere50¢$1.9M

Out of $3.9M of cash from operations.4

Financial statements

Revenue567894$44.1M in 2025+4182% since 2019
0$20.0M$40.0M$60.0M2019: $1.0M$1.0M20192020: $3.6M$3.6M2020+253%2021: $11.4M$11.4M2021+214%2022: $15.5M$15.5M2022+36%2023: $19.3M$19.3M2023+24%2024: $32.3M$32.3M2024+68%2025: $44.1M$44.1M2025+36%
Gross profit567894$34.0M in 2025+6835% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $489.8K$489.8K20192020: $2.9M$2.9M2020+491%2021: $8.0M$8.0M2021+177%2022: $12.4M$12.4M2022+55%2023: $14.4M$14.4M2023+16%2024: $24.6M$24.6M2024+71%2025: $34.0M$34.0M2025+38%
Operating income567894$4.9M in 2025
-$30.0M-$20.0M-$10.0M0$10.0M2019: -$8.8M-$8.8M20192020: -$25.2M-$25.2M2020+187%2021: -$14.1M-$14.1M2021−44%2022: -$9.0M-$9.0M2022−37%2023: -$540.0K-$540.0K2023−94%2024: $3.8M$3.8M20242025: $4.9M$4.9M2025+29%
Net income567894$11.8M in 2025
-$40.0M-$20.0M0$20.0M2019: -$10.4M-$10.4M20192020: -$30.9M-$30.9M2020+197%2021: -$27.3M-$27.3M2021−12%2022: -$10.3M-$10.3M2022−62%2023: -$25.8M-$25.8M2023+151%2024: -$33.1M-$33.1M2024+28%2025: $11.8M$11.8M2025

Every line of the income statement as filed: the last 2 fiscal years (annual) or 6 quarters (quarterly), latest first.4

Period ending2025-12-312024-12-31
Revenue$44.1M$32.6M
Cost of revenues$10.1M$8.1M
Gross Margin$34.0M$24.6M
General and administrative$19.4M$12.9M
Selling and marketing$7.4M$6.3M
Research and development$1.4M$673.0K
Depreciation and amortization$880.0K$789.0K
Total Operating Expenses$29.0M$20.7M
Operating Income$4.9M$3.8M
Interest expense-$12.6M
(Loss) Gain on extinguishment of debt-$477.0K$6.3M
Change in fair value of derivative liabilities$8.1M-$31.4M
Loss on impairment of assets-$196.0K$0
Other expense-$42.0K-$893.0K
Other income (See Note 20)$5.8M$2.9M
Total Other Income (Expense)$7.0M-$36.9M
Net Income (Loss) Before Income Taxes$11.9M-$33.1M
Income tax expense$86.0K$27.0K
Net Income (Loss)$11.8M-$33.1M
Foreign currency translation adjustments$0$121.0K
Total Comprehensive Income (Loss)$11.8M-$33.0M
Basic (in dollars per share)$1.38-$7.41
Diluted (in dollars per share)$0.41-$7.41
Basic (in shares)8.6M shares4.5M shares
Diluted (in shares)9.1M shares4.5M shares

Compare SANUWAVE Health, Inc. with another company

Corporate structure

SANUWAVE Health, Inc. 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 SANUWAVE Health, Inc.

  • Solas Capital Management, LLC Filed SCHEDULE 13G/A on SANUWAVE Health, Inc., latest Aug 14, 2026 (5 filings since Nov 14, 2024)
  • Opaleye Management Inc. Filed SCHEDULE 13G/A on SANUWAVE Health, Inc., latest Jul 31, 2026 (6 filings since Jan 26, 2022)
  • BlackRock Filed SCHEDULE 13G/A on SANUWAVE Health, Inc., latest Jul 30, 2026 (2 filings since Oct 17, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on SANUWAVE Health, Inc., latest Mar 27, 2026 (2 filings since Jul 29, 2025)
  • MANCHESTER MANAGEMENT CO LLC Filed SCHEDULE 13D/A on SANUWAVE Health, Inc., latest Dec 15, 2025 (14 filings since Feb 10, 2022)
  • AWM Investment Company, Inc. Filed SCHEDULE 13G/A on SANUWAVE Health, Inc., latest May 9, 2025 (2 filings since Feb 13, 2025)
  • SANUWAVE Health, Inc. Eden Prairie, Minnesota

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

What it owns

What SANUWAVE Health, 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$2.3M4 Dec 31, 2025$763.0K4 Dec 31, 2024+205.4%
Accumulated depreciation$358.0K4 Dec 31, 2025$460.0K4 Dec 31, 2024−22.2%
Property and equipment, net$2.0M4 Dec 31, 2025$303.0K4 Dec 31, 2024+550.8%
Operating-lease assets (leased space)$390.0K4 Dec 31, 2025$429.0K4 Dec 31, 2024−9.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$12.0M4 Dec 31, 2025$10.2M4 Dec 31, 2024+16.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$7.3M4 Dec 31, 2025$7.3M4 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$3.0M4 Dec 31, 2025$3.7M4 Dec 31, 2024−18.9%
Finite-lived intangibles, gross$6.8M4 Dec 31, 2025$6.8M4 Dec 31, 20240%
Accumulated amortization$3.8M4 Dec 31, 2025$3.1M4 Dec 31, 2024+22.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.9M4 Dec 31, 2025$4.1M4 Dec 31, 2024+43.0%
Raw materials$135.0K4 Dec 31, 2025$3.8M4 Dec 31, 2024−96.4%
Finished goods$6.0M4 Dec 31, 2025$755.0K4 Dec 31, 2024+696.3%

Properties, in its own words

Our primary corporate and operations office is a leased facility in Eden Prairie, Minnesota, consisting of 20,019 square feet of space under a lease which expires on August 31, 2030. Under the terms of the lease, we pay monthly rent, subject to a 3.5% adjustment on an annual basis.

Item 2 of the 10-K filed Mar 26, 2026.3

Leadership

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

Board members and other officers (21)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerPeter C. Stegano named May 16, 2023 to Jul 2, 202442
  • Executive OfficerToni C. Rinow named Aug 19, 2022 to Feb 5, 202443
  • Executive OfficerJohn Schlechtweg named Aug 19, 2022 to Dec 27, 202244
  • DirectorA. Michael Stolarski named Aug 19, 2022 to Jul 2, 202442

Former names

  • RUB MUSIC ENTERPRISES, INC.Dec 18, 2007 to Feb 1, 20102

Timeline

  1. Sep 25, 20268-K Listing notice or transfer45
  2. Aug 6, 20268-K Results of operations46
  3. Jul 13, 20268-K Results of operations47
  4. Jun 16, 20268-K Regulation FD disclosure48
  5. Jun 15, 20268-K Shareholder vote49
  6. May 12, 20268-K Results of operations50
  7. Apr 16, 20268-K Results of operations51
  8. Mar 26, 20268-K Results of operations52
  9. Mar 13, 20268-K Earlier financial statements no longer reliable53
  10. Jan 15, 20268-K Shareholder vote54
  11. Nov 7, 20258-K Results of operations55
  12. Oct 30, 20258-K Executive or director change56
  13. Feb 19, 2025New chief executive Morgan C. Frank becomes CEO12
  14. Aug 28, 2019New chief executive Kevin A. Richardson Ii. becomes CEO13
  15. Mar 7, 2013New chief executive Joseph Chiarelli becomes CEO14
  16. Oct 5, 2009New chief executive Christopher M. Cashman becomes CEO15

Calendar

Coming up

  1. Nov 6, 2026Reports results for the quarter ending Sep/202657

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results46
  2. Jul 13, 2026Reported quarterly or annual results47
  3. May 12, 2026Reported quarterly or annual results50
  4. Apr 16, 2026Reported quarterly or annual results51
  5. Mar 26, 2026Reported quarterly or annual results52
  6. Nov 7, 2025Reported quarterly or annual results55
  7. Aug 8, 2025Reported quarterly or annual results58
  8. Jul 14, 2025Reported 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

285 filings to the SEC since October 2021: 6 annual reports, 17 quarterly reports, 79 major events, 89 insider forms, 31 large holders, 7 private raises, 56 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Sep 25, 20268-K EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 6, 20268-K EDGAR
  9. Aug 6, 202610-Q EDGAR
  10. Jul 31, 2026SCHEDULE 13G/A EDGAR
  11. Jul 30, 2026SCHEDULE 13G/A EDGAR
  12. Jul 13, 20268-K EDGAR
  13. Jul 2, 20264 EDGAR
  14. Jul 2, 20264 EDGAR
  15. Jul 2, 20264 EDGAR
  16. Jul 2, 20264 EDGAR
  17. Jul 2, 20264 EDGAR
  18. Jun 16, 20268-K EDGAR
  19. Jun 15, 20268-K EDGAR
  20. May 29, 2026SD EDGAR

The 285 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

22 open-market trades by officers, directors and large owners since October 2021: 6 buys and 16 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 1, 2026Opaleye Management Inc.10% ownerSale10,581$16.11$170.5KForm 4
Apr 30, 2026Opaleye Management Inc.10% ownerSale25,000$16.15$403.8KForm 4
Apr 29, 2026Opaleye Management Inc.10% ownerSale24,360$17.25$420.2KForm 4
Apr 28, 2026Opaleye Management Inc.10% ownerSale46,288$18.47$854.9KForm 4
Apr 21, 2026Opaleye Management Inc.10% ownerSale202$20.50$4.1KForm 4
Apr 17, 2026Opaleye Management Inc.10% ownerSale16,267$20.46$332.8KForm 4
Dec 12, 2025MANCHESTER MANAGEMENT PR, LLCSale6,500$21.04$136.8KForm 4
Dec 11, 2025MANCHESTER MANAGEMENT PR, LLCSale13,500$31.28$422.3KForm 4
Dec 10, 2025BESSER JAMES ESale8,625$30.39$262.1KForm 4
Dec 10, 2025MANCHESTER MANAGEMENT CO LLCSale8,625$30.39$262.1KForm 4
Dec 9, 2025BESSER JAMES ESale8,785$30.58$268.6KForm 4
Dec 9, 2025MANCHESTER MANAGEMENT CO LLCSale8,785$30.58$268.6KForm 4
Dec 8, 2025BESSER JAMES ESale127,400$30.76$3.9MForm 4
Dec 8, 2025MANCHESTER MANAGEMENT CO LLCSale127,400$30.76$3.9MForm 4
Oct 6, 2025Opaleye Management Inc.10% ownerBuy1,267$30.28$38.4KForm 4
Jun 5, 2025Stegagno PeterChief Operating OfficerSale1,862$27.71$51.6KForm 4
May 15, 2025Cioanta IulianChief Sci. and Tech. OfficerSale3,639$31.60$115.0KForm 4
Apr 29, 2025Opaleye Management Inc.10% ownerBuy7,998$25.49$203.9KForm 4
Nov 1, 2024Opaleye Management Inc.10% ownerBuy16,000$15.20$243.2KForm 4
Oct 31, 2024Opaleye Management Inc.10% ownerBuy9,868$16.29$160.8KForm 4

All 22 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
2025Daniel CoyleChief Operating Officer36$199.3K$1.5M66
2025David Timothy WernExecutive Vice President, Sales59$178.0K$1.1M66
2025Morgan FrankChief Executive Officer54$3.7K$414.1K66
2024Morgan FrankChief Executive Officer54$3.7K$1.4M66

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$32.6M 2022–2024
Money received by yearMoney received by year, 2022–2024: $32.6M in all. Private raises (Form D) $32.6M.$0$10M$20M$30M2022 · Private raises (Form D): $20.1M20222023 · Private raises (Form D): $6.1M20232024 · Private raises (Form D): $6.4M2024
Figures by year
YearPrivate raises (Form D)Total
2024$6.4M$6.4M
2023$6.1M$6.1M
2022$20.1M$20.1M

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. Jun 18, 2024Raised $1.8 million in a private offering of debt42 Form D: 9 investors so far Form D
  2. Jan 21, 2024Raised $4.6 million in a private offering of debt43 Form D: 19 investors so far Form D
  3. Dec 30, 2023Raised $1.9 million in a private offering of debt67 Form D: 15 investors so far Form D
  4. Jul 21, 2023Raised $3 million in a private offering of debt68 Form D: 17 investors so far Form D
  5. May 9, 2023Raised $1.2 million in a private offering of debt69 Form D: 11 investors so far Form D
  6. Nov 14, 2022Raised $4 million in a private offering of debt44 Form D: 32 investors so far Form D
  7. Aug 5, 2022Raised $16.2 million in a private offering of debt70 Form D: 46 investors 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 50. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Solas Capital Management, LLC610,968$6.1M3.3%+323,454
AWM Investment Company, Inc.454,550$4.5M0.4%No change
Praetorian PR LLC395,000$4.0M1.3%+45,000
Vanguard Capital Management LLC352,756$3.5M0.0%+3,882
Opaleye Management Inc.306,140$3.1M0.3%−675,127
UBS Group AG256,791$2.6M0.0%+46,528
BlackRock, Inc.159,867$1.6M0.0%−321,673
Geode Capital Management, LLC86,098$861.4K0.0%−85,700
Citadel Advisors LLC59,473$594.7K0.0%+41,375
Vanguard Fiduciary Trust Co43,097$431.0K0.0%−6,184
Marshall Wace, Llp42,125$421.2K0.0%New
Goldman Sachs Group Inc40,426$404.3K0.0%+1,921
Jpmorgan Chase & Co39,697$391.0K0.0%+36,649
Stonebridge Wealth Management, LLC38,434$384.3K0.3%+1,250
Luxor Capital Group, LP37,200$372.0K0.0%New
State Street Corp32,282$322.8K0.0%−107,807
Morgan Stanley31,619$316.2K0.0%+25,826
Kirtland Hills Capital Management, LLC3,100$308.6K0.1%+325
Jane Street Group, LLC23,847$238.5K0.0%New
Aqr Capital Management LLC22,908$229.1K0.0%New
XTX Topco Ltd21,834$218.3K0.0%+7,153
Bank Of America Corp /de/18,559$185.6K0.0%−6,944
Squarepoint Ops LLC18,243$182.4K0.0%New
Jain Global LLC17,352$173.5K0.0%New
Millennium Management LLC16,925$169.2K0.0%−7,744

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

SEC filer profile

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

  • Name on EDGARSANUWAVE Health, Inc.1
  • CIK0001417663
  • Employer ID (EIN)20-11760003
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inNevada3
  • 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 address9600 W. 76Th Street, Eden Prairie, MN1
  • Phone952-656-10291
  • Shares outstanding8,602,309 as of Aug 4, 202611
  • Public float$233.3M as of Jun 30, 20253
  • AuditorBaker Tilly US, LLP, Minneapolis, Minnesota PCAOB ID 23; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 18, 20071
  • Filings750 in all: 8-K (211), 4 (156), 10-Q (56), CORRESP (32), 3 (30), S-1/A (22), SC 13D/A (22), UPLOAD (21)1
    All 49 form types

    424B3 (20), 10-K (19), D (18), 425 (14), EFFECT (13), S-1 (10), SC 13G/A (9), SCHEDULE 13G/A (9), NT 10-Q (8), POS AM (8), DEF 14A (7), SC 13D (6), PRE 14A (5), 4/A (4), 8-K/A (4), AW (4), SCHEDULE 13G (4), ARS (3), S-8 (3), SC 13G (3), 10-Q/A (2), CT ORDER (2), DEF 14C (2), DEFA14A (2), NT 10-K (2), PRE 14C (2), SCHEDULE 13D/A (2), SD (2), 10-K/A (1), 10SB12G (1), 144 (1), 8-A12B (1), CERT (1), D/A (1), DEFM14A (1), NT 10-K/A (1), NTN 10K (1), PREM14A (1), RW (1), S-8 POS (1), SC 14F1 (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Sep 25, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks SANUWAVE Health, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 31 risks under these headings, as written.3

  • Risks Related to our Business
  • We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting or disclosure controls and procedures, it may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations, which may adversely affect our business, financial condition, and results of operations.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Our history of operating losses and prior reliance on external financing has raised, and could again raise, substantial doubt about our ability to continue as a going concern.
  • If we are unable to successfully raise additional capital, our viability may be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business.
  • The medical device/therapeutic product industries are highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products that are safer and more effective than any products we may develop, our commercial opportunities will be reduced or eliminated.
  • Changes in reimbursement affecting the wound care market could adversely affect our customers and indirectly reduce demand for our products.
  • Many of our product component materials are only produced by a single supplier for such product component. If we are unable to obtain product component materials and other products from our suppliers that we depend on for our operations, or find suitable replacement suppliers, our ability to deliver our products to market will likely be impeded, which could have a material adverse effect on us.
  • The loss of our key management would likely hinder our ability to execute our business plan.
  • We face an inherent risk of liability if the use or misuse of our products results in personal injury or death.
  • We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.
  • If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be able to generate anticipated revenue.
The other 20 risks
  • If we fail to properly manage our growth effectively, our business could suffer.
  • We generate a portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results.
  • Provisions in our Articles of Incorporation, Bylaws and Nevada law might decrease the chances of an acquisition.
  • Regulatory Risks
  • We are subject to extensive governmental regulation, including the FDA.
  • Regulatory approval of our products may be withdrawn at any time.
  • If we fail to obtain an adequate level of reimbursement for our approved products by third party payors, there may be no commercially viable markets for our approved products, or the markets may be much smaller than expected.
  • Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad.
  • Uncertainty surrounding and future changes to healthcare law in the United States may have a material adverse effect on us.
  • If we fail to comply with the United States Federal Anti-Kickback Statute, False Claims Act, and similar state laws, we could be subject to criminal and civil penalties and exclusion from the Medicare and Medicaid programs, which would have a material adverse effect on our business and results of operations.
  • Failure to comply with the HIPAA and state-specific privacy laws, as such rules become applicable to our business, may increase our operational costs.
  • We face periodic reviews and billing audits from governmental and private payors, and these audits could have adverse results that may negatively impact our business.
  • Product quality or performance issues may be discovered through ongoing regulation by the FDA and by comparable international agencies, as well as through our internal standard quality process.
  • The use of hazardous materials in our operations may subject us to environmental claims or liability.
  • Risks Related to Intellectual Property
  • The protection of our intellectual property is critical to our success, and any failure on our part to adequately protect those rights could materially adversely affect our business.
  • Patent applications owned by us or licensed to us may not result in issued patents, and our competitors may commercialize the discoveries we attempt to patent.
  • Our patents may not be valid or enforceable and may be challenged by third parties.
  • Issued patents and patent licenses may not provide us with any competitive advantage or provide meaningful protection against competitors.
  • The ability to market the products we develop is subject to the intellectual property rights of third parties.
  • Risks Related to our Common Stock
  • Our stock price is volatile.
  • We have not paid dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock.

Legal proceedings

In the ordinary course of business, the Company from time to time becomes involved in various legal proceedings involving a variety of matters. We do not believe there are any pending legal proceedings that will have a material adverse effect on our business, consolidated financial position, results of operations, or cash flows. However, the outcome of such legal matters is inherently unpredictable and subject to significant uncertainties. The Company expenses legal fees in the period in which they are incurred.

There are no material proceedings known to us to be contemplated by any governmental authority.

There are no material proceedings known to us, pending, or contemplated, in which any of our directors, officers or affiliates or any of our principal security holders, or any associate of any of the foregoing, is a party or has an interest adverse to us.

The opening of Item 3, Legal Proceedings.3

Sources

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