Overview
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- TickerACON on Nasdaq2
- IndustryServices-Medical Laboratories2
- HeadquartersBroomfield, United States2
- Incorporated inDE3
- Business address8181 Arista Place, Ste 100, Broomfield, Co 800213
- Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
- Legal formCorporation2
- LEI529900MGK6H51761Z5462
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o Corporation Service Company, 251 Little Falls Drive, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 44926182
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MRS capabilities with our NOCISCAN platform. This initial engagement exemplifies our plan to utilize MRS beyond SIEMENS.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 revenue6¢$68.9K
- Research and development94¢$1.0M
Out of $75.7K 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 |
|---|---|---|
| Revenue | $75.7K | $45.7K |
| Cost of revenue | $68.9K | $84.7K |
| Gross profit (loss) | $6.8K | -$38.9K |
| Sales and marketing | $1.9M | $976.6K |
| Research and development | $1.0M | $888.8K |
| General and administrative | $4.1M | $3.6M |
| Total operating expenses | $7.1M | $5.5M |
| Loss from operations | -$7.1M | -$5.5M |
| Interest expense | $0 | -$535.5K |
| Loss on exchange of debt | $0 | -$1.1M |
| Gain on extinguishment of debt | $73.3K | $6.1K |
| Changes in fair value of warrant and derivative liabilities | $11.8K | $335.0K |
| Penalties and settlements | -$672.6K | -$212.5K |
| Interest income | $411.1K | $318 |
| Other, net | -$4.8K | -$49 |
| Total other expense | -$181.2K | -$1.5M |
| Loss before income taxes | -$7.2M | -$7.0M |
| Income tax provision | $0 | $0 |
| Net loss | -$7.2M | -$7.0M |
| Dividends on preferred stock | -$6.7K | -$59.7K |
| Net loss allocable to common stockholders | -$7.2M | -$7.1M |
| Net loss per share allocable to common stockholders, basic | -$13.61 | -$7,478.90 |
| Net loss per share allocable to common stockholders, diluted | -$13.61 | -$7,478.90 |
| Weighted average shares of common stock outstanding, basic | 532.0K shares | 943 shares |
| Weighted average shares of common stock outstanding, diluted | 532.0K shares | 943 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 | $12.0M | $453.7K | |
| Restricted cash | $25.0K | $10.0K | |
| Accounts receivable, net | $29.7K | $18.3K | |
| Prepaid expense | $41.3K | $4.2K | |
| Other current assets | $0 | $158.7K | |
| Total current assets | $12.4M | $824.3K | |
| Property and equipment, net | $24.2K | $5.5K | |
| Intangible assets, net | $1.3M | $1.3M | |
| Total non-current assets | $1.3M | $1.3M | |
| Total assets | $13.7M | $2.1M | |
| Accounts payable | $333.0K | $6.0K | |
| Accrued and other liabilities | $10.0K | $529.2K | |
| Warrant liability | $63 | $11.9K | |
| Liability to issue equity | $0 | $80.8K | |
| Total current liabilities | $837.3K | $1.2M | |
| Total liabilities | $837.3K | $1.2M | |
| Additional paid-in capital | $71.3M | $52.2M | |
| Accumulated deficit | -$58.5M | -$51.3M | |
| Total stockholders equity | $12.8M | $970.1K | -$728.0K |
| Total liabilities and stockholders equity | $13.7M | $2.1M | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | |
| Common stock, shares issued | 854.4K shares | 1.4K shares | |
| Common stock, shares outstanding | 854.4K shares | 1.4K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $12.0M | $453.7K | |
| Restricted cash | $25.0K | $10.0K | |
| Accounts receivable, net | $29.7K | $18.3K | |
| Prepaid expense | $41.3K | $4.2K | |
| Other current assets | $0 | $158.7K | |
| Total current assets | $12.4M | $824.3K | |
| Property and equipment, net | $24.2K | $5.5K | |
| Intangible assets, net | $1.3M | $1.3M | |
| Total non-current assets | $1.3M | $1.3M | |
| Total assets | $13.7M | $2.1M | |
| Accounts payable | $333.0K | $6.0K | |
| Accrued and other liabilities | $10.0K | $529.2K | |
| Warrant liability | $63 | $11.9K | |
| Liability to issue equity | $0 | $80.8K | |
| Total current liabilities | $837.3K | $1.2M | |
| Total liabilities | $837.3K | $1.2M | |
| Additional paid-in capital | $71.3M | $52.2M | |
| Accumulated deficit | -$58.5M | -$51.3M | |
| Total stockholders equity | $12.8M | $970.1K | -$728.0K |
| Total liabilities and stockholders equity | $13.7M | $2.1M | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | |
| Common stock, shares issued | 854.4K shares | 1.4K shares | |
| Common stock, shares outstanding | 854.4K shares | 1.4K 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 | -$7.2M | -$7.0M |
| Depreciation and amortization | $227.4K | $193.1K |
| Share-based compensation | $105.4K | $287.5K |
| Amendment of warrants | $48.1K | $0 |
| Non-cash settlements | $58.3K | $0 |
| Loss on exchange of debt | $0 | $1.1M |
| Loss on extinguishment of debt | $0 | $111.9K |
| Amortization of deferred issuance costs | $0 | $471.4K |
| Change in fair value related to warrants and derivative | -$11.8K | -$335.0K |
| Non-cash interest related to bridge funding | $0 | $58.0K |
| Non-cash expenses related to equity line agreement | $0 | $425.4K |
| Accounts receivable | -$11.4K | $7.3K |
| Prepaids and other current assets | $16.1K | -$287.7K |
| Accounts payable | -$198.6K | -$156.4K |
| Accrued and other liabilities | -$164.0K | -$127.4K |
| Net cash used in operating activities | -$7.2M | -$5.3M |
| Intangible assets Patents | -$182.4K | -$316.8K |
| Fixed assets | -$21.5K | -$5.1K |
| Net cash used in investing activities | -$203.9K | -$321.9K |
| Public offering of common stock and warrants | $14.6M | $3.0M |
| Registered direct offerings of common stock | $5.7M | $0 |
| Proceeds from direct offering of prefunded warrants | $2.0M | $0 |
| Proceeds from sale of preferred stock | $0 | $1.0M |
| Proceeds from sale of common stock and warrants, ATM | $0 | $288.3K |
| Common stock cash issuance costs | -$2.4M | -$788.1K |
| Exercise of Series C warrants | $336.4K | $0 |
| Redemption of Series B Preferred stock | -$1.2M | $0 |
| Proceeds from common stock and warrant RegA+ offering | $0 | $529.3K |
| Proceeds from equity line | $0 | $1.8M |
| Repayment of promissory notes | $0 | -$301.0K |
| Equity line cash issuance costs | $0 | -$367.9K |
| Preferred stock cash issuance costs | $0 | -$90.0K |
| Net cash provided by financing activities | $18.9M | $5.0M |
| Net increase (decrease) in cash and cash equivalents | $11.6M | -$567.4K |
| Cash paid for interest | $0 | $13.1K |
| Cash paid for income taxes | $1.7K | $0 |
| Capitalization of Series B preferred stock dividends | $5.4K | $0 |
| Capitalization of Series C preferred stock dividends | $1.3K | $0 |
| Conversion of Series C preferred stock to common stock | $548.5K | $0 |
| Cashless exercise of B warrants to common stock | $9.5M | $0 |
| Dividends accrued on preferred shares | $0 | $59.7K |
| Exchange of indebtedness for common shares | $0 | $1.8M |
| Exchange of indebtedness for preferred shares | $0 | $930.1K |
| Conversion of preferred stock to common stock | $0 | $130.0K |
| Issuance of common shares related to restricted stock units | $0 | $216.6K |
| Issuance of commitment shares related to bridge funding | $0 | $33.3K |
No quarter-by-quarter statement was filed.
Corporate structure
Aclarion, 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 Aclarion, Inc.
- SEG Opportunity Fund, LLC Filed SCHEDULE 13G on Aclarion, Inc., latest Mar 25, 2026 (3 filings since Jan 21, 2025)
- Joseph Reda Filed SC 13G/A on Aclarion, Inc., latest Nov 13, 2024 (2 filings since Sep 5, 2024)
- White Lion Capital LLC Filed SC 13G/A on Aclarion, Inc., latest Mar 29, 2024 (4 filings since Oct 30, 2023)
- INTRACOASTAL CAPITAL, LLC Filed SC 13G on Aclarion, Inc., latest Mar 6, 2024
- NuVasive Filed SC 13G on Aclarion, Inc., latest Feb 3, 2023
- Aclarion, Inc. Broomfield, Colorado, 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 Aclarion, 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 | $25.9K5 Dec 31, 2025 | $60.3K5 Dec 31, 2024 | −57.0% |
| Accumulated depreciation | $1.8K5 Dec 31, 2025 | $54.8K5 Dec 31, 2024 | −96.8% |
| Property and equipment, net | $24.2K5 Dec 31, 2025 | $5.5K5 Dec 31, 2024 | +339.5% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $12.0M5 Dec 31, 2025 | $453.7K5 Dec 31, 2024 | +2548.6% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $1.3M5 Dec 31, 2025 | $1.3M5 Dec 31, 2024 | −3.3% |
| Finite-lived intangibles, gross | $2.8M5 Dec 31, 2025 | $2.6M5 Dec 31, 2024 | +7.0% |
| Accumulated amortization | -$1.5M5 Dec 31, 2025 | -$1.3M5 Dec 31, 2024 | −17.3% |
| Finite-lived intangibles, net | $1.3M5 Dec 31, 2025 | $1.3M5 Dec 31, 2024 | −3.3% |
Properties, in its own words
The Company does not have any contractual obligations, not otherwise on our balance sheet as of December 31, 2025.
Rent expense for the year ended December 31, 2025 and 2024 was $0.
Item 2 of the 10-K filed Mar 18, 2026.4
Leadership
Who has led Aclarion, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerBrent Ness Apr 21, 2022 to now12
- ChairJeffrey John Thramann Apr 21, 2022 to now13
- Chief financial officerGregory A. Gould Sep 3, 2025 to now14
- Chief financial officerJohn Paul Lorbiecki Apr 22, 2022 to Dec 29, 202215
Board members and other officers (7)
- Chief Strategy OfficerRyan Bond Apr 22, 2022 to now16
- Board memberRyan Bond Aug 17, 2026 to now17
- Board memberAmanda Mae Sequira Apr 21, 2022 to now18
- Board memberBrent Ness Apr 21, 2022 to now12
- Board memberScott Breidbart Apr 21, 2022 to now19
- Board memberStephen Deitsch Apr 21, 2022 to now20
- Board memberWilliam Wesemann Apr 21, 2022 to now21
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- Nocimed, Inc.Mar 3, 2015 to Oct 26, 20213
Timeline
- Jun 4, 20268-K Shareholder vote25
- Apr 22, 20268-K Other events26
- Mar 19, 20268-K Entered a material agreement; Change to shareholders' rights; Bylaws or fiscal year changed27
- Jan 13, 20268-K Regulation FD disclosure28
- Jan 9, 20268-K Entered a material agreement29
- Oct 14, 20258-K Entered a material agreement30
- Sep 3, 20258-K Entered a material agreement; Executive or director change; Regulation FD disclosure31
- Jul 21, 20258-K Shareholder vote32
- Jul 7, 20258-K Shareholder vote; Regulation FD disclosure33
- Jun 20, 20258-K Executive or director change34
- Apr 23, 20258-K Regulation FD disclosure35
- Mar 28, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed36
- Apr 21, 2022New chief executive Brent Ness becomes CEO12
- Jan 18, 2008Founded Aclarion, Inc. is founded2
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.93) a share, on Nov 12, 2025.37
When it reported results
- Feb 21, 2024Reported quarterly or annual results38
- Aug 25, 2023Reported quarterly or annual results39
- May 23, 2023Reported quarterly or annual results40
- May 16, 2023Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
271 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 66 major events, 54 insider forms, 11 large holders, 3 private raises, 118 other. The latest 20:
- Aug 19, 20264 EDGAR
- Aug 18, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 6, 202610-Q FORM 10-Q FOR JUN 2026 EDGAR
- Jul 9, 2026S-8 REGISTRATION STATEMENT EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 12, 20264 EDGAR
- Jun 4, 20268-K CURRENT REPORT EDGAR
- May 13, 202610-Q FORM 10-Q FOR MAR 2026 EDGAR
- May 12, 20264 EDGAR
The 271 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
19 open-market trades by officers, directors and large owners since October 2021: 19 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 17, 2026 | Williams Amanda MDirector | Buy | 5,857 | $2.73 | $16.0K | Form 4 |
| Aug 14, 2026 | Gould Gregory ACFO | Buy | 10,000 | $2.45 | $24.5K | Form 4 |
| Aug 13, 2026 | Bond RyanDirector | Buy | 21,122 | $2.37 | $50.1K | Form 4 |
| Aug 13, 2026 | Wesemann WilliamDirector | Buy | 2,150 | $2.34 | $5.0K | Form 4 |
| Aug 13, 2026 | Neal David KDirector | Buy | 7,500 | $2.40 | $18.0K | Form 4 |
| Aug 13, 2026 | Ness BrentChief Executive Officer | Buy | 5,234 | $2.31 | $12.1K | Form 4 |
| May 12, 2026 | Breidbart ScottDirector | Buy | 5,664 | $3.18 | $18.0K | Form 4 |
| May 11, 2026 | Neal David KDirector | Buy | 2,500 | $3.10 | $7.8K | Form 4 |
| May 11, 2026 | Ness BrentChief Executive Officer | Buy | 6,289 | $3.18 | $20.0K | Form 4 |
| May 6, 2026 | Wesemann WilliamDirector | Buy | 1,562 | $3.30 | $5.2K | Form 4 |
| Nov 26, 2025 | Ness BrentChief Executive Officer | Buy | 10 | $6.20 | $62 | Form 4 |
| Feb 16, 2023 | Thramann Jeffrey JohnExecutive Chairman | Buy | 1 | $1,000.00 | $1.0K | Form 4 |
| Dec 29, 2022 | Ness BrentChief Executive Officer | Buy | 16,211 | $0.54 | $8.8K | Form 4 |
| Dec 29, 2022 | Lorbiecki John PaulChief Financial Officer | Buy | 22,404 | $0.45 | $10.0K | Form 4 |
| Dec 28, 2022 | Ness BrentChief Executive Officer | Buy | 2,289 | $0.42 | $961 | Form 4 |
| Apr 22, 2022 | Bond RyanDirector | Buy | 20,000 | $2.80 | $56.0K | Form 4 |
| Apr 21, 2022 | Wesemann WilliamDirector | Buy | 11,000 | $4.35 | $47.9K | Form 4 |
| Apr 21, 2022 | Ness BrentChief Executive Officer | Buy | 1,000 | $4.35 | $4.3K | Form 4 |
| Apr 21, 2022 | Neal David KDirector | Buy | 34,400 | $4.35 | $149.6K | 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.
- SEG Opportunity Fund, LLCSCHEDULE 13G, 3 filings Jan 21, 2025 to Mar 25, 202642
- Joseph RedaSC 13G/A, 2 filings Sep 5, 2024 to Nov 13, 202443
- White Lion Capital LLCSC 13G/A, 4 filings Oct 30, 2023 to Mar 29, 202444
- INTRACOASTAL CAPITAL, LLCSC 13G, 1 filing Mar 6, 202445
- NuVasiveSC 13G, 1 filing Feb 3, 202346
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.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Brent NessChief Executive Officer | 59 | $300.0K | $462.5K47 |
| 2025 | Jeff ThramannExecutive Director | 61 | $300.0K | $462.5K47 |
| 2025 | Ryan BondChief Strategy Officer | 54 | $200.0K | $254.2K47 |
| 2025 | John LorbieckiChief Financial Officer | $170.5K47 | ||
| 2025 | Gregory GouldChief Financial Officer | 60 | $87.5K | $126.6K47 |
| 2024 | Brent NessChief Executive Officer | 59 | $300.0K | $381.1K47 |
| 2024 | Jeff ThramannExecutive Director | 61 | $300.0K | $381.1K47 |
| 2024 | John LorbieckiChief Financial Officer | $225.0K | $285.9K47 | |
| 2024 | Ryan BondChief Strategy Officer | 54 | $200.0K | $226.9K47 |
Money raised
Private offerings the company reported to the SEC on Form D.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Bridgeway Capital Management, LLC | 19,480 | $56.1K | 0.0% | New |
| Captrust Financial Advisors | 17,059 | $49.1K | 0.0% | +2,500 |
| Vanguard Fiduciary Trust Co | 16,028 | $46.2K | 0.0% | New |
| Susquehanna International Group, Llp | 15,355 | $44.2K | 0.0% | New |
| Geode Capital Management, LLC | 12,128 | $34.9K | 0.0% | −19,087 |
| XTX Topco Ltd | 11,038 | $31.8K | 0.0% | New |
| Bank Of Montreal /can/ | 10,000 | $28.8K | 0.0% | No change |
| Vanguard Capital Management LLC | 6,782 | $19.5K | 0.0% | No change |
| Osaic Holdings, Inc. | 5,000 | $14.4K | 0.0% | −29,945 |
| UBS Group AG | 1,968 | $5.7K | 0.0% | −7,679 |
| Barclays PLC | 283 | $815 | 0.0% | New |
| Clear Street Group Inc. | 103 | $297 | 0.0% | +100 |
| Wells Fargo & Company/mn | 100 | $288 | 0.0% | New |
| Caitong International Asset Management Co., Ltd | 4 | $12 | 0.0% | New |
| Danske Bank A/s | 1 | $3 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Aclarion, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAclarion, Inc.1
- CIK0001635077
- Employer ID (EIN)47-33247254
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)8071 Services-Medical Laboratories1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address8181 Arista Place, Ste 100, Broomfield, CO 800211
- Phone833 275 22661
- Shares outstanding2,882,371 as of Aug 4, 202610
- Public float$4.4M as of Jun 30, 20254
- AuditorHaynie & Company, Salt Lake City, Utah PCAOB ID 457; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceMar 3, 20151
- Filings275 in all: 8-K (64), 4 (38), CORRESP (20), 10-Q (14), UPLOAD (14), S-1/A (13), 3 (12), EFFECT (11)1
All 40 form types
424B3 (9), DEF 14A (7), PRE 14A (7), S-1 (7), D (6), 424B5 (5), SC 13G (5), 10-K (4), 3/A (3), 424B4 (3), S-3 (3), SC 13G/A (3), 8-A12B (2), 8-K/A (2), DEFA14A (2), NT 10-Q (2), POS AM (2), S-8 (2), SCHEDULE 13G (2), 1-A (1), 1-A/A (1), 10-K/A (1), 253G3 (1), 4/A (1), CERT (1), D/A (1), DRS (1), NT 10-K (1), QUALIF (1), S-1MEF (1), S-3/A (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 18, 2026
Quarterly report (10-Q) Aug 6, 2026
Proxy statement (DEF 14A) Apr 27, 2026
Latest 8-K (8-K) Jun 4, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.00001 per share | ACON | Nasdaq |
| Warrants, each exercisable for one share of Common Stock | ACONW | Nasdaq |
From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Aclarion, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 62 risks under these headings, as written.4
- Risks Related To Our Nasdaq Listing
- We may not be able to maintain compliance with the continued listing rules of the Nasdaq Capital Market and a delisting could limit the liquidity of our stock, increase its volatility and hinder our ability to raise capital.
- Risks Related to Financial, Operational, Commercial and Manufacturing Matters
- We identified a material weakness in our internal control over financial reporting as of December 31, 2024, which was remediated in fiscal 2025. Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.
- We will need additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies and product candidates.
- We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
- Our MR data post-processing products currently depend on compatible use with only a limited number of MR scanners that are provided only by one manufacturer of MR devices.
- If we are not successful in enhancing awareness of our technology, driving adoption across our current target population, increasing referrals from surgeons and clinicians, and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected.
- Our commercial success will continue to depend on attaining significant market acceptance of our technology among physicians, surgeons, patients, clinicians and imaging facilities, and increasing the number of patients diagnosed by our technology.
- We may be unable to compete successfully with other diagnostic options for low back pain, or may be unable to continue providing value for supporting new treatments that may not need the diagnostic information our products provide.
- Adoption of our technology depends on positive clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians would harm our sales, business, financial condition, and results of operations.
The other 52 risks
- If adequate reimbursement is not available for the procedures implementing our technology, or for clinicians to provide ongoing care for patients diagnosed with our technology, it could diminish our sales or affect our ability to sell our technology.
- If adequate reimbursement for our temporary Category III CMS Code designation for our products cannot be obtained or we are not successful in obtaining conversion to permanent Category I codes at an adequate reimbursement level, it would diminish our sales and would affect our ability to market our technology.
- Use of our technology requires appropriate training for proper use of our products, and inadequate training may lead to negative patient outcomes, which could harm our business, financial condition, and results of operations.
- We expect to increase the size of our organization in the future, and we may experience difficulties in managing this growth. If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.
- We may not be able to achieve or maintain satisfactory pricing and margins for our NOCISCAN disc MRS diagnostic software products and related services, which could harm our business and results of operations.
- Our results of operations may be harmed if we are unable to accurately forecast customer demand for our technology.
- Risks Related to Government Regulation and Our Industry
- Our operations and technology are subject to pervasive and continuing FDA regulatory requirements, and failure to comply with these requirements could harm our business, financial condition and results of operations.
- If we are unable to expand the labeling claims for using our technology to include additional indications, our growth potential could be harmed.
- Our medical device products may be subject to recalls, which could divert managerial and financial resources, harm our reputation and our business.
- We may experience difficulties outside the US in obtaining or maintaining regulatory clearance or approval, or exemptions therefrom, or in successfully gaining third-party reimbursement or marketing our technology, even if approved or otherwise legally marketed.
- If we fail to comply with fraud and abuse and other healthcare laws and regulations in the U.S. and internationally including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business, financial condition and results of operations could be harmed.
- We have financial relationships with certain physicians and health care providers, research investigators, and authors for our clinical or scientific publications that may be deemed a conflict of interest and may be subject to certain statutory or regulatory requirements, under which a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
- Regulatory compliance is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
- Our current CLARITY Trial or other future clinical studies may be delayed, suspended or terminated for many reasons, including those conducted to support reimbursement coverage and certain potential label expansions for additional indications, which will increase our expenses and delay the time it takes to secure reimbursement coverage or support label expansion for additional indications.
- A failure to comply with governmental regulatory requirements would have a negative impact upon our business.
- If we become subject to enforcement action by governmental regulatory agencies, our business would be negatively affected.
- If certain of our medical device products cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, or MDRs, which can result in voluntary corrective actions or agency enforcement actions and harm our reputation, business, financial condition and results of operations.
- From time to time, we engage outside parties to perform services related to certain of our clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to complete our clinical studies on our planned timelines, or at all, and may incur significant additional costs.
- Healthcare reform initiatives and other administrative and legislative proposals may harm our business, financial condition, results of operations and cash flows in our key markets.
- Our collection, use, storage, disclosure, transfer and other processing of sensitive and personal information could give rise to significant costs, liabilities and other risks, including as a result of investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data protection practices, which may harm our business, financial conditions, results of operations and prospects.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business, financial condition and results of operations.
- Significant disruptions in our information technology systems, whether through breaches or failures of our technology, unauthorized access or otherwise, may result in both an adverse impact to our products, as well as the unauthorized use, disclosure, modification or misappropriation of patient personal information, the occurrence of fraudulent activity, or other data security-related incidents, all of which could have a material and adverse impact on our business, financial condition and results of operations.
- We face potential liability related to the privacy of health information we obtain.
- Risks Related To Our Intellectual Property
- If we are unable to obtain, maintain, protect, enforce and defend patents or other intellectual property protection for our technology, or if the scope of our patents and other intellectual property protections is not sufficiently broad, or as a result of our existing or any future out-licenses of our intellectual property, our competitors could develop and commercialize products similar to or competitive with our products and services, our ability to continue to commercialize our technology, or our other products and services, may be harmed.
- We may not be successful in obtaining or maintaining necessary rights to any products or processes we may have or develop through acquisitions and in-licenses.
- Patents directing to our technology could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, which could harm our business, financial condition and results of operations.
- The medical device industry is characterized by patent litigation and in the future we could become subject to actual or threatened patent or other intellectual property litigation alleging our products or services infringe or misappropriate third party rights, which could be costly to address and defend, result in the diversion of management’s time and efforts, require us to pay damages, or prevent us from making, using, or selling our existing or future products.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- If we fail to comply with our obligations in any current or future agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- If we are unable to obtain patent term extension under the Hatch-Waxman Amendments, our business may be materially harmed.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world, which could harm our business, financial condition and results of operations.
- Changes in U.S. patent laws, or patent laws in other countries and jurisdictions, could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may be subject to claims, including third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators, challenging the ownership or inventorship of our intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization of one or more of our products.
- We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed.
- Intellectual property rights do not necessarily address all potential threats, and limitations in intellectual property rights could harm our business, financial condition and results of operations.
- If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed.
- Our inability to use software licensed from third parties, or our use of open-source software under license terms that interfere with our proprietary rights, could disrupt our business.
- Other Risks Facing Our Company
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our technology. The expense and potential unavailability of insurance coverage for liabilities resulting from our technology could harm our business and our ability to sell our technology.
- The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
- Litigation and other legal proceedings may harm our business.
- Our operating results may fluctuate across periods, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- We will incur increased costs as a result of operating as a public company, and our management and board of directors will be required to devote substantial time to compliance with our public company responsibilities and corporate governance practices.
- Risks Related to the Ownership of Our Common Stock and IPO Warrants
- Our stock price may be volatile, and the value of our common stock and IPO Warrants may decline.
- A significant portion of our total outstanding shares may be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is performing well.
- You may experience additional dilution if any of our outstanding common stock warrants are exercised.
- The price of our common stock and IPO Warrants may be volatile and fluctuate substantially, which could result in substantial losses for investors in our common stock.
- Because we do not expect to pay dividends in the foreseeable future, investors seeking cash dividends should not purchase shares of our common stock.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
- We are an emerging growth company and a smaller reporting company, and our compliance with the reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock and IPO Warrants less attractive to investors.
- Provisions in our corporate charter and our bylaws and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware or, under certain circumstances, the federal district courts of the United States of America will be the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
Legal proceedings
From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any material legal proceedings, the adverse outcome of which, in our management’s opinion, individually or in the aggregate, could have a material adverse effect on the results of our operations or financial position. There are no material proceedings in which any of our directors, officers or affiliates or any registered or beneficial stockholder of more than 5% of our common stock is an adverse party or has a material interest adverse to our interest.
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.
- 1SEC EDGARAclarion, Inc. filings on SEC EDGAR
- 2
- 3SEC EDGARAclarion, Inc. filings on SEC EDGAR
- 4
- 5SEC EDGARAclarion, Inc. 10-K for fiscal 2025
- 6SEC EDGARAclarion, Inc. 10-K for fiscal 2021
- 7SEC EDGARAclarion, Inc. 10-K for fiscal 2022
- 8SEC EDGARAclarion, Inc. 10-K for fiscal 2023
- 9SEC EDGARAclarion, Inc. 10-Q for fiscal 2026
- 10SEC EDGARAclarion, Inc. 10-Q for fiscal 2026
- 11SEC EDGARAclarion, Inc. 10-K for fiscal 2021
- 12SEC EDGARBrent Ness, Chief executive officer
- 13SEC EDGARJeffrey John Thramann, Chair
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- 15
- 16SEC EDGARRyan Bond, Chief Strategy Officer
- 17SEC EDGARRyan Bond, Board member
- 18SEC EDGARAmanda Mae Sequira, Board member
- 19SEC EDGARScott Breidbart, Board member
- 20SEC EDGARStephen Deitsch, Board member
- 21SEC EDGARWilliam Wesemann, Board member
- 22
- 23
- 24
- 25SEC EDGARShareholder vote
- 26SEC EDGAROther events
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- 28SEC EDGARRegulation FD disclosure
- 29SEC EDGAREntered a material agreement
- 30SEC EDGAREntered a material agreement
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- 32SEC EDGARShareholder vote
- 33
- 34SEC EDGARExecutive or director change
- 35SEC EDGARRegulation FD disclosure
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- 37NasdaqNasdaq calendar
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- 46SEC EDGARNuVasive SC 13G on Aclarion, Inc.
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