GTHP on OTC
GUIDED THERAPEUTICS INC
In its 2026 annual report the company says: “We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device.”4 It is headquartered in Norcross, United States.2 Its shares trade on OTC under the symbol GTHP.2
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Last updated Oct 20, 2026.
Overview
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- TickerGTHP on OTC2
- IndustryElectromedical & Electrotherapeutic Apparatus2
- HeadquartersNorcross, United States2
- Incorporated inDE3
- Business address5835 Peachtree Corners East, Suite B, Peachtree Corners, Ga 300923
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300A0UBF5OC8O7M542
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 23138782
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We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue15¢$196.0K
- Research and development37¢$469.0K
- Interest48¢$617.0K
Out of $767.0K in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Sales - devices and disposables | $767.0K | $7.0K |
| Cost of goods sold | $196.0K | $5.0K |
| Gross profit | $571.0K | $2.0K |
| Research and development | $469.0K | $526.0K |
| Sales and marketing | $169.0K | $287.0K |
| General and administrative | $2.3M | $1.3M |
| Total operating expenses | $2.9M | $2.1M |
| Loss from operations | -$2.4M | -$2.1M |
| Interest expense | -$617.0K | -$381.0K |
| Interest income | $0 | $3.0K |
| Change in fair value of derivative liability | $65.0K | -$18.0K |
| Gain from forgiveness of debt | $96.0K | $69.0K |
| Loss on extinguishment of debt | -$533.0K | $0 |
| Other income | $165.0K | $18.0K |
| Total other income (expense) | -$824.0K | -$309.0K |
| Loss before income taxes | -$3.2M | -$2.4M |
| Provision for income taxes | $0 | $0 |
| Net loss | -$3.2M | -$2.4M |
| Preferred stock dividends | -$150.0K | -$174.0K |
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | -$3.3M | -$2.6M |
| Basic | -$0.04 | -$0.05 |
| Diluted | -$0.04 | -$0.05 |
| Basic | 78.4M shares | 57.3M shares |
| Diluted | 78.4M shares | 57.3M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $63.0K | $388.0K | $591.0K |
| Trade receivables, net of allowance for credit losses of $4 and $0.5 at December 31, 2025 and December 31, 2024, respectively. | $4.0K | $3.0K | |
| Inventory, net of reserves of $818 at December 31, 2025 and 2024. | $448.0K | $633.0K | |
| Other current assets | $90.0K | $173.0K | |
| Total current assets | $605.0K | $1.2M | |
| Property and equipment, net | $16.0K | $23.0K | |
| Operating lease right-of-use asset, net of amortization | $686.0K | $141.0K | |
| Other assets | $17.0K | $17.0K | |
| Total non-current assets | $719.0K | $181.0K | |
| TOTAL ASSETS | $1.3M | $1.4M | |
| Accounts Payable | $2.4M | $2.1M | |
| Accounts payable, related parties | $31.0K | $36.0K | |
| Accrued liabilities | $1.7M | $1.0M | |
| Deferred revenue | $189.0K | $849.0K | |
| Current portion of lease liability | $45.0K | $106.0K | |
| Short-term notes payable due to related parties | $0 | $70.0K | |
| Current portion of long-term debt, related parties | $621.0K | $532.0K | |
| Current portion of notes payable | $82.0K | $92.0K | |
| Short-term convertible debt, net of discounts | $347.0K | $117.0K | |
| Short-term convertible debt in default | $1.1M | $1.1M | |
| Derivative liability at fair value | $37.0K | $118.0K | |
| Total current liabilities | $6.6M | $6.2M | |
| Long-term lease liability | $651.0K | $49.0K | |
| Long-term notes payable | $23.0K | $47.0K | |
| Long-term convertible debt, net of discounts | $0 | $14.0K | |
| Long-term debt, related parties | $20.0K | $2.0K | |
| Total long-term liabilities | $694.0K | $112.0K | |
| Total liabilities | $7.3M | $6.3M | |
| Common stock, $.001 par value; 500,000 shares authorized, 86,154 and 65,131 shares issued and outstanding as of December 31, 2025 and 2024, respectively. | $3.5M | $3.5M | |
| Additional paid-in capital | $146.1M | $142.5M | |
| Treasury stock at cost | -$132.0K | -$132.0K | |
| Accumulated deficit | -$157.1M | -$153.7M | |
| Total stockholders' deficit | -$6.0M | -$4.9M | -$3.8M |
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $1.3M | $1.4M | |
| Allowance for credit losses | $4.0K | $500 | |
| Inventory valuation reserve | $818.0K | $818.0K | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, authorized | 500.0M shares | 500.0M shares | |
| Common stock, issued | 86.2M shares | 65.1M shares | |
| Common stock, outstanding | 86.2M shares | 65.1M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $63.0K | $388.0K | $591.0K |
| Trade receivables, net of allowance for credit losses of $4 and $0.5 at December 31, 2025 and December 31, 2024, respectively. | $4.0K | $3.0K | |
| Inventory, net of reserves of $818 at December 31, 2025 and 2024. | $448.0K | $633.0K | |
| Other current assets | $90.0K | $173.0K | |
| Total current assets | $605.0K | $1.2M | |
| Property and equipment, net | $16.0K | $23.0K | |
| Operating lease right-of-use asset, net of amortization | $686.0K | $141.0K | |
| Other assets | $17.0K | $17.0K | |
| Total non-current assets | $719.0K | $181.0K | |
| TOTAL ASSETS | $1.3M | $1.4M | |
| Accounts Payable | $2.4M | $2.1M | |
| Accounts payable, related parties | $31.0K | $36.0K | |
| Accrued liabilities | $1.7M | $1.0M | |
| Deferred revenue | $189.0K | $849.0K | |
| Current portion of lease liability | $45.0K | $106.0K | |
| Short-term notes payable due to related parties | $0 | $70.0K | |
| Current portion of long-term debt, related parties | $621.0K | $532.0K | |
| Current portion of notes payable | $82.0K | $92.0K | |
| Short-term convertible debt, net of discounts | $347.0K | $117.0K | |
| Short-term convertible debt in default | $1.1M | $1.1M | |
| Derivative liability at fair value | $37.0K | $118.0K | |
| Total current liabilities | $6.6M | $6.2M | |
| Long-term lease liability | $651.0K | $49.0K | |
| Long-term notes payable | $23.0K | $47.0K | |
| Long-term convertible debt, net of discounts | $0 | $14.0K | |
| Long-term debt, related parties | $20.0K | $2.0K | |
| Total long-term liabilities | $694.0K | $112.0K | |
| Total liabilities | $7.3M | $6.3M | |
| Common stock, $.001 par value; 500,000 shares authorized, 86,154 and 65,131 shares issued and outstanding as of December 31, 2025 and 2024, respectively. | $3.5M | $3.5M | |
| Additional paid-in capital | $146.1M | $142.5M | |
| Treasury stock at cost | -$132.0K | -$132.0K | |
| Accumulated deficit | -$157.1M | -$153.7M | |
| Total stockholders' deficit | -$6.0M | -$4.9M | -$3.8M |
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $1.3M | $1.4M | |
| Allowance for credit losses | $4.0K | $500 | |
| Inventory valuation reserve | $818.0K | $818.0K | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, authorized | 500.0M shares | 500.0M shares | |
| Common stock, issued | 86.2M shares | 65.1M shares | |
| Common stock, outstanding | 86.2M shares | 65.1M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$3.2M | -$2.4M |
| Bad debt expense | $6.0K | $0 |
| Depreciation | $10.0K | $9.0K |
| Amortization of debt issuance costs and discounts | $244.0K | $110.0K |
| Stock-based compensation | $377.0K | $120.0K |
| Change in fair value of derivative liability | -$65.0K | $18.0K |
| Amortization of lease right-of-use-asset | $97.0K | $86.0K |
| Loss on extinguishment of debt | $533.0K | $0 |
| Gain from forgiveness of debt | -$96.0K | -$69.0K |
| Other non-cash expenses | $33.0K | $21.0K |
| Accounts receivable | -$7.0K | $6.0K |
| Inventory | $185.0K | -$1.0K |
| Other current assets | $208.0K | $120.0K |
| Accounts payable and accrued liabilities | $1.4M | $545.0K |
| Lease liabilities | -$100.0K | -$92.0K |
| Deferred revenue | -$660.0K | $425.0K |
| NET CASH USED IN OPERATING ACTIVITIES | -$1.1M | -$1.1M |
| Purchase of property and equipment | -$2.0K | $0 |
| NET CASH USED FOR INVESTING ACTIVITIES | -$2.0K | $0 |
| Proceeds from the issuance of notes payable | $588.0K | $512.0K |
| Proceeds from the issuance of notes payable issued to related parties | $160.0K | $75.0K |
| Payments made on notes payable | -$499.0K | -$438.0K |
| Payments made on notes payable issued to related parties | -$41.0K | -$39.0K |
| Payments of debt issuance costs | -$30.0K | -$29.0K |
| Proceeds from issuance of common stock and warrants in private placement offerings | $567.0K | $835.0K |
| NET CASH PROVIDED BY FINANCING ACTIVITIES | $745.0K | $916.0K |
| NET CHANGE IN CASH | -$325.0K | -$203.0K |
| Cash paid for interest | $61.0K | $51.0K |
| Dividends on preferred stock | $150.0K | $174.0K |
| Common stock issued for payment of interest | $186.0K | $126.0K |
| Common stock issued for payment of accrued dividends | $183.0K | $177.0K |
| Conversion of Preferred Stock Series C to common stock | $105.0K | $0 |
| Conversion of Preferred Stock Series C1 to common stock | $109.0K | $0 |
| Conversion of Preferred Stock Series C2 to common stock | $439.0K | $0 |
| Conversion of Preferred Stock Series D to common stock | $140.0K | $0 |
| Conversion of Preferred Stock Series E to common stock | $550.0K | $0 |
| Conversion of Preferred Stock Series F to common stock | $0 | $21.0K |
| Conversion of Preferred Stock Series F-2 to common stock | $37.0K | $0 |
| Conversion of debt and accrued interest into common stock | $102.0K | $0 |
| Directors and Officers Insurance obtained with Financing | $125.0K | $130.0K |
| Non-cash lease liability remeasurement | $642.0K | |
| Warrants issued with debt | $17.0K | $136.0K |
| Inception of derivative liability | $50.0K | $100.0K |
| Accrued payroll liability exchanged for promissory note | $0 | $87.0K |
| Settlement of previously accrued professional fees through common stock issuance | $0 | $114.0K |
No quarter-by-quarter statement was filed.
Corporate structure
GUIDED THERAPEUTICS 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 GUIDED THERAPEUTICS INC
- Auctus Fund Management LLC Filed SCHEDULE 13G/A on GUIDED THERAPEUTICS INC, latest Nov 14, 2024 (4 filings since Oct 24, 2022)
- Rosalind Advisors, Inc. Filed SC 13G/A on GUIDED THERAPEUTICS INC, latest Feb 20, 2024 (2 filings since Jul 6, 2022)
- GUIDED THERAPEUTICS INC Norcross, Georgia, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What GUIDED THERAPEUTICS 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.6M10 Dec 31, 2024 | $1.6M10 Dec 31, 2023 | 0% |
| Accumulated depreciation | $1.6M5 Dec 31, 2025 | $1.6M5 Dec 31, 2024 | +0.6% |
| Property and equipment, net | $16.0K5 Dec 31, 2025 | $23.0K5 Dec 31, 2024 | −30.4% |
| Operating-lease assets (leased space) | $686.0K5 Dec 31, 2025 | $141.0K5 Dec 31, 2024 | +386.5% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $448.0K5 Dec 31, 2025 | $633.0K5 Dec 31, 2024 | −29.2% |
| Raw materials | $1.2M5 Dec 31, 2025 | $1.4M5 Dec 31, 2024 | −12.6% |
| Work in process | $71.0K5 Dec 31, 2025 | $46.0K5 Dec 31, 2024 | +54.3% |
| Finished goods | $4.0K5 Dec 31, 2025 | $43.0K5 Dec 31, 2024 | −90.7% |
Properties, in its own words
Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located at 5835 Peachtree Corners East, Suite B, Peachtree Corners, Georgia 30092, where we lease approximately 12,835 square feet under a lease that expires in July 2031.
Item 2 of the 10-K filed Mar 31, 2026.4
Leadership
Who has led GUIDED THERAPEUTICS INC, and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief executive officerGene S. Cartwright Feb 7, 2014 to Jul 17, 201513
- Chief executive officerMark L. Faupel Jan 16, 2009 to Apr 9, 201314
- Chief executive officerMark A. Samuels Mar 31, 2006 to May 1, 200715
- PresidentGene S. Cartwright Jun 20, 2014 to Jul 17, 201516
- PresidentMark L. Faupel May 1, 2007 to Apr 9, 201317
- Chief financial officerMark L. Faupel Dec 28, 2010 to Dec 28, 201118
- Chief financial officerMark A. Samuels Mar 31, 2006 to May 1, 200715
- Chief operating officerMark L. Faupel May 1, 2007 to May 1, 200717
Board members and other officers (17)
- SecretaryWilliam D. Arthur Iii. May 1, 2007 to May 1, 200719
- V.P. of R & DShabbir Bakir Bambot Jun 21, 2007 to Jul 6, 201220
- Chief Accounting OfficerSiraj N. Noorani May 5, 2006 to May 5, 200621
- VP of OperationsWalter J. Pavlicek May 5, 2006 to May 5, 200622
- Board memberAlan Grujic Jun 20, 2023 to now23
- Board memberRichard P. Blumberg Nov 18, 2016 to now24
- Board memberGene S. Cartwright Jun 18, 2014 to Jul 17, 201525
- Board memberLinda Rosenstock Apr 19, 2012 to Aug 20, 201426
- Board memberShabbir Bakir Bambot Jul 6, 2012 to Jul 6, 201227
- Board memberJohn E. Imhoff Jun 9, 2011 to now28
- Board memberJonathan M. Niloff Nov 17, 2011 to Aug 20, 201429
- Board memberF. Landegger 2010 10-Year Grat George Dec 5, 2011 to Dec 5, 201130
- Board memberWilliam E. Zachary Jr. May 16, 2008 to Apr 1, 201031
- Board memberMark L. Faupel May 1, 2007 to Dec 28, 201117
- Board memberRonald W. Hart Sep 10, 2007 to Jul 17, 201532
- Board memberMichael C. James Oct 23, 2007 to now33
- Board memberMark A. Samuels Mar 31, 2006 to May 1, 200715
Former names
- SPECTRX INCNov 12, 1997 to Feb 28, 20083
Timeline
- Mar 10, 20268-K Entered a material agreement; Unregistered sale of shares; Other events34
- Dec 23, 20248-K Entered a material agreement35
- Sep 27, 20248-K Entered a material agreement36
- Mar 9, 20238-K Executive or director change37
- Sep 15, 20228-K Entered a material agreement; Unregistered sale of shares; Other events38
- Jul 29, 20228-K Change to shareholders' rights; Bylaws or fiscal year changed39
- Jan 7, 20228-K Change to shareholders' rights; Bylaws or fiscal year changed40
- Feb 7, 2014New chief executive Gene S. Cartwright becomes CEO13
- Jan 16, 2009New chief executive Mark L. Faupel becomes CEO14
- Mar 31, 2006New chief executive Mark A. Samuels becomes CEO15
- Oct 27, 1992Founded GUIDED THERAPEUTICS INC is founded2
Filings
89 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 7 major events, 47 insider forms, 6 large holders, 9 other. The latest 20:
- Aug 13, 202610-Q EDGAR
- May 15, 202610-Q EDGAR
- May 5, 20264 EDGAR
- Apr 7, 20264 EDGAR
- Apr 7, 20264 EDGAR
- Apr 7, 20264 EDGAR
- Mar 31, 202610-K EDGAR
- Mar 12, 20264 EDGAR
- Mar 10, 20268-K EDGAR
- Mar 4, 20264 EDGAR
- Nov 13, 202510-Q EDGAR
- Sep 5, 20254 EDGAR
- Sep 5, 20254 EDGAR
- Sep 5, 20254 EDGAR
- Sep 5, 20254 EDGAR
- Aug 14, 202510-Q EDGAR
- Jun 13, 20254 EDGAR
- Jun 12, 20254 EDGAR
- Jun 12, 20254 EDGAR
- May 23, 20254/A FORM 4 A EDGAR
The 89 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
15 open-market trades by officers, directors and large owners since October 2021: 15 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 29, 2025 | Grujic AlanDirector | Buy | 152,108 | Form 4 | ||
| Aug 29, 2025 | Imhoff John EDirector | Buy | 166,667 | $0.18 | $30.0K | Form 4 |
| Aug 29, 2025 | JAMES MICHAEL CDirector | Buy | 27,778 | $0.18 | $5.0K | Form 4 |
| Mar 18, 2025 | Imhoff John EDirector | Buy | 1,263,069 | $0.10 | $126.3K | Form 4 |
| Mar 18, 2025 | Imhoff John EDirector | Buy | 1,263,069 | $0.10 | $126.3K | Form 4 |
| Mar 18, 2025 | JAMES MICHAEL CDirector | Buy | 412,945 | $0.10 | $41.3K | Form 4 |
| Mar 13, 2025 | Imhoff John EDirector | Buy | 150 | Form 4 | ||
| Mar 7, 2025 | Imhoff John EDirector | Buy | 286 | Form 4 | ||
| Mar 7, 2025 | Imhoff John EDirector | Buy | 286 | Form 4 | ||
| Dec 18, 2024 | Imhoff John EDirector | Buy | 1,615,385 | Form 4 | ||
| Sep 23, 2024 | Imhoff John EDirector | Buy | 1,666,667 | Form 4 | ||
| Aug 11, 2023 | Imhoff John EDirector | Buy | 500,899 | Form 4 | ||
| Sep 2, 2022 | Blumberg Richard P.Director | Buy | 1,000,000 | Form 4 | ||
| Sep 2, 2022 | Imhoff John EDirector | Buy | 500,000 | Form 4 | ||
| Sep 2, 2022 | JAMES MICHAEL CDirector | Buy | 100,000 | Form 4 |
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.
- Auctus Fund Management LLCSCHEDULE 13G/A, 4 filings Oct 24, 2022 to Nov 14, 202441
- Rosalind Advisors, Inc.SC 13G/A, 2 filings Jul 6, 2022 to Feb 20, 202442
SEC filer profile
How GUIDED THERAPEUTICS INC is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARGUIDED THERAPEUTICS INC1
- CIK0000924515
- Employer ID (EIN)58-20295434
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address5835 Peachtree Corners East, Suite B, Peachtree Corners, GA 300921
- Phone77024287231
- Shares outstanding96,537,349 as of Aug 7, 202612
- Public float$10.5M as of Jun 30, 20254
- AuditorUHY LLP, Sterling Heights, Michigan PCAOB ID 1195; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceFeb 27, 19971
- Filings1,160 in all: 4 (276), 8-K (258), 424B3 (127), 10-Q (80), SC 13G/A (29), NT 10-Q (26), SC 13G (25), 10-K (24)1
All 51 form types
DEF 14A (24), UPLOAD (23), CORRESP (22), EFFECT (21), S-1/A (19), 3 (18), 8-K/A (16), S-1 (16), 4/A (15), PRE 14A (13), POS AM (12), SC 13D/A (11), 10-Q/A (9), 10QSB (9), NT 10-K (8), S-8 (6), SC 13D (6), 10-K/A (5), PRER14A (5), 424B4 (4), D (4), REGDEX (4), RW (4), S-3/A (4), SC TO-I/A (4), 10-K405 (3), 10KSB (3), 3/A (3), REGDEX/A (3), 10-K405/A (2), 10QSB/A (2), 8-A12G (2), ARS (2), S-2/A (2), S-3 (2), SC TO-I (2), 10KSB/A (1), DEFA14A (1), DEFS14A (1), PRES14A (1), S-2 (1), SB-2 (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Jul 6, 2021
Latest 8-K (8-K) Mar 10, 2026
Risk factors and legal proceedings
The risks GUIDED THERAPEUTICS INC names in Item 1A of its 10-K filed Mar 31, 2026: 37 risks under these headings, as written.4
- We will be required to raise additional funds. There is no assurance that such funds can be raised on terms that we would find acceptable, on a timely basis, or at all.
- If we cannot obtain additional funds when needed, we will not be able to implement our business plan.
- We have a history of losses, and we expect losses to continue.
- Our ability to sell our products is controlled by government regulations, and we may not be able to obtain any necessary clearances or approvals.
- In foreign countries, including European countries, we are subject to government regulation, which could delay or prevent our ability to sell our products in those jurisdictions.
- Russia’s invasion of Ukraine, and sanctions brought by the United States and other countries against Russia, have caused disruptions in many business sectors outside of the medical sector and have resulted in significant market disruptions and increased volatility in the price of certain commodities, including oil and natural gas.
- Escalation of geopolitical conflicts in the Middle East could adversely affect our business, financial condition, and results of operations.
- Risks related to tariffs and international trade policies could adversely affect our business, financial condition, and results of operations.
- In the United States, our products would be subject to regulation by the U.S. FDA, which could prevent us from selling our products domestically.
- Even if we obtain clearance or approval to sell our products, we are subject to ongoing requirements and inspections that could lead to the restriction, suspension or revocation of our clearance.
- We depend on a limited number of distributors and any reduction, delay or cancellation of an order from these distributors or the loss of any of these distributors could cause our revenue to decline.
- To successfully market and sell our products internationally, we must address many issues with which we have limited experience.
The other 25 risks
- To market and sell LuViva internationally, we depend on distributors and they may not be successful.
- Our success largely depends on our ability to maintain and protect the proprietary information on which we base our products.
- We may not be able to generate sufficient sales revenues to sustain our growth and strategy plans.
- Because our products, which use different technology or apply technology in different ways than other medical devices, are or will be new to the market, we may not be successful in launching our products and our operations and growth would be adversely affected.
- If we are unable to compete effectively in the highly competitive medical device industry, our future growth and operating results will suffer.
- We have limited manufacturing experience, which could limit our growth.
- Since we rely on sole source suppliers for several of the components used in our products, any failure of those suppliers to perform would hurt our operations.
- Because we operate in an industry with significant product liability risk, and we have not specifically insured against this risk, we may be subject to substantial claims against our products.
- The availability of third-party reimbursement for our products is uncertain, which may limit consumer use and the market for our products.
- We have a substantial amount of indebtedness, which may adversely affect our cash flow and our ability to operate our business.
- Our success depends on our ability to attract and retain scientific, technical, managerial and finance personnel.
- Certain provisions of our certificate of incorporation that authorize the issuance of additional shares of preferred stock may make it more difficult for a third party to effect a change in control.
- Risks Related to Our Securities
- The market prices for our common stock are volatile and will fluctuate.
- There is a limited market for our securities.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies.
- Future offerings of debt or equity securities may rank senior to common stock.
- Common stockholders are subordinated to our lenders.
- Future sales of common stock by officers and directors may negatively impact the market price for our common stock.
- We do not currently pay dividends on our common stock and have no intention to pay dividends on our common stock for the foreseeable future.
- In connection with the audits of our financial statements as of and for the years ended December 31, 2025 and 2024, material weaknesses in our internal control over financial reporting were identified and we may identify additional material weaknesses in the future.
- Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control, or make it more difficult for our stockholders to replace management.
- If securities or industry analysts publish inaccurate or unfavorable research about our business, our share price and trading volume may decline.
- The number of shares of our common stock issuable upon the conversion of our outstanding convertible debt and preferred stock or exercise of outstanding warrants and options is substantial.
- Adjustments to the conversion price of some of our convertible debt and preferred stock, and the exercise price for certain of our warrants, will dilute the ownership interests of our existing stockholders.
- Our need to raise additional capital in the near future or to use our equity securities for payments could have a dilutive effect on your investment.
Legal proceedings
Although we may, from time to time, be involved in various legal claims arising out of our operations in the normal course of business, we are not currently subject to any claims or actions that we believe would have a material adverse effect on our financial position or results of operations.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 16SEC EDGARGene S. Cartwright, President
- 17SEC EDGARMark L. Faupel, President
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- 19SEC EDGARWilliam D. Arthur Iii., Secretary
- 20SEC EDGARShabbir Bakir Bambot, V.P. of R & D
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- 22SEC EDGARWalter J. Pavlicek, VP of Operations
- 23SEC EDGARAlan Grujic, Board member
- 24SEC EDGARRichard P. Blumberg, Board member
- 25SEC EDGARGene S. Cartwright, Board member
- 26SEC EDGARLinda Rosenstock, Board member
- 27SEC EDGARShabbir Bakir Bambot, Board member
- 28SEC EDGARJohn E. Imhoff, Board member
- 29SEC EDGARJonathan M. Niloff, Board member
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- 31SEC EDGARWilliam E. Zachary Jr., Board member
- 32SEC EDGARRonald W. Hart, Board member
- 33SEC EDGARMichael C. James, Board member
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- 35SEC EDGAREntered a material agreement
- 36SEC EDGAREntered a material agreement
- 37SEC EDGARExecutive or director change
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