Overview
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- TickerNRXS on NYSE1
- IndustryElectromedical & Electrotherapeutic Apparatus1
- HeadquartersCarmel, Indiana1
- Incorporated inDE2
- Business address11611 N. Meridian St, Suite 330, Carmel, In 460322
- Filer category, Emerging growth company2
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This lack of evidence for drugs has been supported in by the American Academy of Pediatrics and NASPGHAN.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
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Regions
All Other States brought in 35% of the revenue Neuraxis, INC broke down this way in fiscal 2025.
Regions by year
| Regions | 2024 | 2025 |
|---|---|---|
| All Other States | $768.0K | $1.2M |
| CA [member] | $778.2K | $898.2K |
| OH | $431.3K | $578.8K |
| MAMember | $154.4K | $265.2K |
| Israel | $246.2K | $222.4K |
| WI | $157.8K | $215.4K |
| Florida | $150.0K | $143.9K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue16¢$562.9K
- Research and development14¢$493.6K
- Other costs68¢$2.4M
- Interest2¢$74.0K
Out of $3.6M in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net sales | $3.6M | $2.7M |
| Cost of goods sold | $562.9K | $362.0K |
| Gross profit | $3.0M | $2.3M |
| Selling expenses | $2.3M | $1.5M |
| Research and development | $493.6K | $433.6K |
| General and administrative | $8.1M | $7.6M |
| Operating loss | -$7.8M | -$7.2M |
| Financing charges | -$30.2K | -$230.8K |
| Interest expense | -$74.0K | -$174.3K |
| Change in fair value of warrant liability | -$7.6K | -$941 |
| Amortization of debt discount and issuance cost | -$126.4K | |
| Other income | $141.2K | $33.6K |
| Other expense | -$585.8K | |
| Total other income (expense), net | $29.4K | -$1.1M |
| Net loss | -$7.8M | -$8.2M |
| Preferred stock dividends | -$814.6K | -$211.3K |
| Net loss available to common stockholders | -$8.6M | -$8.5M |
| Basic loss per share | -$0.95 | -$1.22 |
| Diluted loss per share | -$0.95 | -$1.22 |
| Basic | 9.1M shares | 6.9M shares |
| Diluted | 9.1M shares | 6.9M 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.4
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.0M | $3.7M | |
| Accounts receivable, net of credit losses of $7,326 and $5,000 as of December 31, 2025 and 2024, respectively | $195.7K | $244.6K | |
| Inventories, net of reserves of $34,524 and $4,454 as of December 31, 2025 and 2024, respectively | $257.1K | $44.3K | |
| Prepaids and other current assets | $315.3K | $280.4K | |
| Total current assets | $5.7M | $4.3M | |
| Property and Equipment, at Cost: | $382.5K | $464.4K | |
| Less - accumulated depreciation | -$306.9K | -$374.4K | |
| Property and equipment, net | $75.6K | $90.0K | |
| Operating lease right of use asset, net | $261.6K | $284.7K | |
| Intangible assets, net | $274.8K | $96.6K | |
| Other non-current assets | $58.9K | $20.2K | |
| Total Assets | $6.4M | $4.8M | |
| Accounts payable | $139.4K | $596.9K | |
| Accrued expenses | $2.4M | $1.6M | |
| Notes payable | $148.3K | $154.2K | |
| Current portion of operating lease payable | $65.8K | $62.8K | |
| Customer deposits | $28.7K | $32.5K | |
| Warrant liabilities | $16.8K | $9.2K | |
| Total current liabilities | $2.8M | $2.4M | |
| Operating lease payable, net of current portion | $202.6K | $256.5K | |
| Other non-current liabilities | $10.0K | ||
| Total non-current liabilities | $212.6K | $256.5K | |
| Total liabilities | $3.0M | $2.7M | |
| Convertible Series B Preferred stock, $0.001 par value; 5,000,000 shares authorized; 3,796,907 and 4,280,939 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $3.8K | $4.3K | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 10,652,812 and 6,990,227 issued and outstanding as of December 31, 2025 and 2024, respectively | $10.7K | $7.0K | |
| Additional paid in capital | $68.0M | $58.9M | |
| Accumulated deficit | -$64.6M | -$56.8M | |
| Total stockholders equity | $3.4M | $2.1M | -$1.4M |
| Total Liabilities and Stockholders Equity | $6.4M | $4.8M | |
| Accounts receivable, net of credit losses | $7.3K | $5.0K | |
| Inventories, net of reserves | $34.5K | $4.5K | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 10.7M shares | 7.0M shares | |
| Common stock, shares outstanding | 10.7M shares | 7.0M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.0M | $3.7M | |
| Accounts receivable, net of credit losses of $7,326 and $5,000 as of December 31, 2025 and 2024, respectively | $195.7K | $244.6K | |
| Inventories, net of reserves of $34,524 and $4,454 as of December 31, 2025 and 2024, respectively | $257.1K | $44.3K | |
| Prepaids and other current assets | $315.3K | $280.4K | |
| Total current assets | $5.7M | $4.3M | |
| Property and Equipment, at Cost: | $382.5K | $464.4K | |
| Less - accumulated depreciation | -$306.9K | -$374.4K | |
| Property and equipment, net | $75.6K | $90.0K | |
| Operating lease right of use asset, net | $261.6K | $284.7K | |
| Intangible assets, net | $274.8K | $96.6K | |
| Other non-current assets | $58.9K | $20.2K | |
| Total Assets | $6.4M | $4.8M | |
| Accounts payable | $139.4K | $596.9K | |
| Accrued expenses | $2.4M | $1.6M | |
| Notes payable | $148.3K | $154.2K | |
| Current portion of operating lease payable | $65.8K | $62.8K | |
| Customer deposits | $28.7K | $32.5K | |
| Warrant liabilities | $16.8K | $9.2K | |
| Total current liabilities | $2.8M | $2.4M | |
| Operating lease payable, net of current portion | $202.6K | $256.5K | |
| Other non-current liabilities | $10.0K | ||
| Total non-current liabilities | $212.6K | $256.5K | |
| Total liabilities | $3.0M | $2.7M | |
| Convertible Series B Preferred stock, $0.001 par value; 5,000,000 shares authorized; 3,796,907 and 4,280,939 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $3.8K | $4.3K | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 10,652,812 and 6,990,227 issued and outstanding as of December 31, 2025 and 2024, respectively | $10.7K | $7.0K | |
| Additional paid in capital | $68.0M | $58.9M | |
| Accumulated deficit | -$64.6M | -$56.8M | |
| Total stockholders equity | $3.4M | $2.1M | -$1.4M |
| Total Liabilities and Stockholders Equity | $6.4M | $4.8M | |
| Accounts receivable, net of credit losses | $7.3K | $5.0K | |
| Inventories, net of reserves | $34.5K | $4.5K | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 10.7M shares | 7.0M shares | |
| Common stock, shares outstanding | 10.7M shares | 7.0M 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.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$7.8M | -$8.2M |
| Amortization of debt discount and issuance cost | $126.4K | |
| Depreciation and amortization | $59.5K | $37.8K |
| Provisions for losses on accounts receivable | $2.3K | $7.4K |
| Provision for losses on inventory | $30.1K | $4.5K |
| Loss on disposal of property and equipment | $7.9K | |
| Non-cash lease expense | $23.1K | $32.1K |
| Stock based compensation | $596.9K | $227.0K |
| Issuance of common stock for non-cash consideration | $1.2M | |
| Fair value of warrants issued for non-cash consideration | $157.7K | |
| Finance charges | $30.2K | $230.8K |
| Change in fair value of warrant liabilities | $7.6K | $941 |
| Accounts receivable | $46.6K | -$178.8K |
| Inventory | -$242.9K | -$32.5K |
| Prepaids and other current assets | $241.0K | $56.2K |
| Accounts payable | -$457.6K | -$607.3K |
| Accrued expenses | $1.1M | $949.7K |
| Customer deposits | -$3.9K | -$42.4K |
| Operating lease liability | -$50.9K | -$3.4K |
| Other non-current liabilities | -$4.9K | |
| Net cash used by operating activities | -$6.4M | -$6.1M |
| Additions to property and equipment | -$31.1K | -$27.8K |
| Additions to intangible assets | -$100.0K | |
| Net cash used by investing activities | -$131.2K | -$27.8K |
| Proceeds from issuance of common stock, net of issuance costs | $7.7M | |
| Proceeds from issuance of Series B preferred stock | $5.3M | |
| Deferred offering costs paid | -$712.7K | |
| Proceeds from exercised warrants | $1.1M | $26.2K |
| Principal payments on notes payable | -$281.8K | -$276.0K |
| Proceeds from convertible notes | $4.9M | |
| Financing fees paid | -$194.5K | |
| Net cash provided by financing activities | $7.8M | $9.7M |
| Net Increase in Cash and Cash Equivalents | $1.3M | $3.6M |
| Cash paid for interest | $11.9K | $33.8K |
| Cash refunded for state income taxes | $13.1K | $10.2K |
| Recognition of right of use asset | $38.0K | $284.3K |
| Derecognition of right of use asset | $29.0K | |
| Conversion of convertible promissory notes to Series B preferred stock | $4.9M | |
| Fair value of warrants from debt discount in convertible notes classified as additional paid in capital | $97.5K | |
| Write-off of debt discount on convertible notes classified as additional paid in capital | $165.6K | |
| Issuance of note payable to financing company for insurance premiums and software subscription | $292.3K | $282.1K |
| Common stock issued upon cashless exercise of warrants | $186 | |
| Common stock issued upon cashless conversion of Series B Preferred Stock | $484 | |
| Common stock issued for services accrued as of December 31, 2024 | $112.5K | |
| Common stock issued upon settlement of certain claims | $3.7K | |
| Intangible asset purchase | $100.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Neuraxis, 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 Neuraxis, INC
- BIGGER CAPITAL FUND L P Filed SCHEDULE 13G/A on Neuraxis, INC, latest Aug 3, 2026 (5 filings since Oct 9, 2025)
- Brian Hannasch Filed SCHEDULE 13G/A on Neuraxis, INC, latest Jul 2, 2025 (5 filings since Dec 26, 2023)
- Rosalind Advisors, Inc. Filed SC 13D on Neuraxis, INC, latest Dec 2, 2024 (2 filings since Dec 2, 2024)
- Neuraxis, INC Carmel, Indiana
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Neuraxis, 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 | $382.5K4 Dec 31, 2025 | $464.4K4 Dec 31, 2024 | −17.6% |
| Accumulated depreciation | $306.9K4 Dec 31, 2025 | $374.4K4 Dec 31, 2024 | −18.0% |
| Property and equipment, net | $75.6K4 Dec 31, 2025 | $90.0K4 Dec 31, 2024 | −16.0% |
| Operating-lease assets (leased space) | $261.6K4 Dec 31, 2025 | $284.7K4 Dec 31, 2024 | −8.1% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $5.0M4 Dec 31, 2025 | $3.7M4 Dec 31, 2024 | +34.3% |
| Deposits held (banks) | $28.7K4 Dec 31, 2025 | $32.5K4 Dec 31, 2024 | −11.9% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, gross | $332.3K4 Dec 31, 2025 | $133.3K4 Dec 31, 2024 | +149.3% |
| Accumulated amortization | $57.5K4 Dec 31, 2025 | $36.7K4 Dec 31, 2024 | +56.7% |
| Finite-lived intangibles, net | $274.8K4 Dec 31, 2025 | $96.6K4 Dec 31, 2024 | +184.5% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $257.1K4 Dec 31, 2025 | $44.3K4 Dec 31, 2024 | +480.1% |
| Raw materials | $34.5K4 Dec 31, 2025 | $4.5K4 Dec 31, 2024 | +675.1% |
Properties, in its own words
Our corporate headquarters are located in Carmel, Indiana, where we lease office space for employees. The term of this lease commenced on January 1, 2024 and is scheduled to end on May 31, 2029. Over the term of the lease, the monthly base rent is $6,721 with an annual 2.5% escalator. We received a 50% reduction in our monthly rent for the first 10 months of the lease.
We also lease office space in Batesville, Indiana, pursuant to an agreement that commenced August 1, 2025 for an inital term of three years with automatic one year renewal options subject to an annual 4% rent escalation, unless 60 day notice of vacating is given. The Company prepaid $25,200 of rent on June 13, 2025 which will be amortized over the initial lease term and thereby reduced the monthly base rent to $1,300.
Item 2 of the 10-K filed Mar 19, 2026.3
Leadership
Who has led Neuraxis, INC, and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerBrian Allen Carrico Aug 8, 2023 to now9
- Chief financial officerTimothy Robert Henrichs Sep 10, 2025 to now10
- Chief financial officerJohn G. Seale Aug 8, 2023 to Aug 8, 202311
- Chief operating officerDaniel Jerome Clarence Aug 9, 2023 to Aug 9, 202312
Board members and other officers (8)
- CHIEF REGULATORY OFFICERThomas Joeseph Carrico Aug 8, 2023 to now13
- DIR.OF DESIGN & ENGINEERINGGary Merril Peterson Aug 9, 2023 to Aug 9, 202314
- Chief Medical Officer, SVPAdrian Miranda Sep 13, 2023 to now15
- Board memberKristin A. Ferge Mar 15, 2024 to now16
- Board memberGil Aharon Nov 26, 2024 to now17
- Board memberBrian Allen Carrico Aug 8, 2023 to now9
- Board memberJane Elizabeth Keyser Aug 8, 2023 to now18
- Board memberTimothy Robert Henrichs Aug 8, 2023 to Aug 8, 202319
Timeline
- Oct 14, 20268-K Other events20
- Aug 19, 20268-K Executive or director change; Other events21
- Jul 10, 20268-K Other events22
- Jun 12, 20268-K Shareholder vote23
- Apr 22, 20268-K Other events24
- Apr 21, 20268-K Results of operations25
- Oct 24, 20258-K Other events26
- Oct 23, 20258-K Results of operations27
- Sep 2, 20258-K Entered a material agreement28
- Jul 3, 20258-K Entered a material agreement; Ended a material agreement; Executive or director change29
- Jun 4, 20258-K Shareholder vote30
- May 28, 20258-K Regulation FD disclosure31
- Aug 8, 2023New chief executive Brian Allen Carrico becomes CEO9
Calendar
Coming up
- Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.24) a share, on Nov 10, 2025.32
When it reported results
- Apr 21, 2026Reported quarterly or annual results25
- Oct 23, 2025Reported quarterly or annual results27
- Jan 8, 2025Reported quarterly or annual results33
- Nov 12, 2024Reported quarterly or annual results34
- Aug 9, 2024Reported quarterly or annual results35
- Apr 9, 2024Reported quarterly or annual results36
- Sep 21, 2023Reported quarterly or annual results37
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
193 filings to the SEC since October 2021: 3 annual reports, 10 quarterly reports, 36 major events, 61 insider forms, 12 large holders, 71 other. The latest 20:
- Oct 14, 20268-K EDGAR
- Oct 8, 20264 EDGAR
- Oct 8, 20264 EDGAR
- Oct 8, 20264 EDGAR
- Sep 29, 20263 EDGAR
- Aug 26, 20264 EDGAR
- Aug 26, 20264 EDGAR
- Aug 26, 20264 EDGAR
- Aug 19, 20268-K EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 17, 20264 EDGAR
- Aug 11, 202610-Q EDGAR
- Aug 6, 2026424B3 EDGAR
- Aug 3, 2026EFFECT EDGAR
The 193 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
10 open-market trades by officers, directors and large owners since October 2021: 8 buys and 2 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Apr 1, 2026 | Henrichs Timothy RobertChief Financial Officer | Buy | 7,593 | $1.96 | $14.9K | Form 4 |
| Apr 1, 2026 | Carrico Thomas JoesephCRO, CCO, CPO | Buy | 667 | $1.96 | $1.3K | Form 4 |
| Apr 1, 2026 | Carrico Brian AllenChief Executive Officer | Buy | 8,060 | $1.96 | $15.8K | Form 4 |
| Feb 12, 2026 | Hannasch Brian10% owner | Buy | 40,000 | $4.92 | $196.8K | Form 4 |
| Feb 11, 2026 | Hannasch Brian10% owner | Buy | 40,000 | $4.65 | $186.0K | Form 4 |
| Dec 23, 2025 | Aharon GilDirector | Buy | 286,138 | $3.52 | $1.0M | Form 4 |
| Jul 1, 2025 | Hannasch Brian10% owner | Buy | 355,556 | $2.25 | $800.0K | Form 4 |
| Jul 1, 2025 | MASIMO CORP10% owner | Sale | 821,327 | $2.25 | $1.8M | Form 4 |
| Apr 21, 2025 | Hannasch Brian10% owner | Buy | 18,065 | $1.73 | $31.3K | Form 4 |
| Dec 28, 2023 | Hannasch Brian10% owner | Sale | 76 | $2.61 | $198 | 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.
- BIGGER CAPITAL FUND L PSCHEDULE 13G/A, 5 filings Oct 9, 2025 to Aug 3, 202638
- Brian HannaschSCHEDULE 13G/A, 5 filings Dec 26, 2023 to Jul 2, 202539
- Rosalind Advisors, Inc.SC 13D, 2 filings Dec 2, 202440
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 | Brian CarricoChief Executive Officer | 44 | $345.1K | $936.4K41 |
| 2025 | Timothy HenrichsChief Financial Officer | 53 | $327.3K | $817.3K41 |
| 2025 | Dr. Adrian MirandaChief Medical Officer | 57 | $300.0K | $571.0K41 |
| 2025 | Dr. Thomas CarricoChief Regulatory Officer | 69 | $300.0K | $566.9K41 |
| 2024 | Timothy HenrichsChief Financial Officer | 53 | $274.1K | $628.9K41 |
| 2024 | Brian CarricoChief Executive Officer | 44 | $353.0K | $578.4K41 |
| 2024 | Dr. Adrian MirandaChief Medical Officer | 57 | $300.0K | $382.4K41 |
| 2024 | Dr. Thomas CarricoChief Regulatory Officer | 69 | $288.3K | $368.9K41 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 31. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Neuraxis, INC is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARNeuraxis, INC1
- CIK0001933567
- Employer ID (EIN)45-50796843
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address11611 N. Meridian St, Suite 330, Carmel, IN 460321
- Phone(812) 689-07911
- Shares outstanding12,557,765 as of Aug 6, 20268
- Public float$20.4M as of Jun 30, 20253
- AuditorRosenberg Rich Baker Berman, P.A., Somerset, New Jersey PCAOB ID 89; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceSep 27, 20221
- Filings193 in all: 4 (45), 8-K (36), 3 (15), CORRESP (12), 10-Q (10), S-1/A (8), UPLOAD (8), SCHEDULE 13G/A (6)1
All 34 form types
424B5 (4), FWP (4), 10-K (3), 424B3 (3), ARS (3), DEF 14A (3), DEFA14A (3), EFFECT (3), DRS/A (2), DRSLTR (2), NT 10-Q (2), PRE 14A (2), S-3 (2), S-3/A (2), S-8 (2), SC 13G (2), SC 13G/A (2), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), NT 10-K (1), S-1 (1), SC 13D (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 19, 2026
Quarterly report (10-Q) Aug 11, 2026
Proxy statement (DEF 14A) Apr 28, 2026
Latest 8-K (8-K) Oct 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | NRXS | NYSE American LLC |
From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Neuraxis, INC names in Item 1A of its 10-K filed Mar 19, 2026: 53 risks under these headings, as written.3
- Risks Relating to Our Business and Our Product
- Our business and prospects depend entirely on our current products, IB-Stim and RED. Even though we have received FDA clearance for our products, it will remain subject to ongoing regulatory review. If we are unable to maintain regulatory clearance and commercialize our product or are significantly delayed or limited in our commercialization efforts, our business and prospects will be materially harmed.
- To date, we have not generated any operating profits, and due to our long-term research and development efforts, we have a history of incurring substantial operating losses.
- Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients.
- If we are unable to develop an adequate sales and marketing organization or contract with third parties to assist us, we may not be able to successfully commercialize our products for current and future indications.
- The success of our business may be dependent on the actions of our collaborative partners.
- We may not be successful in achieving market acceptance of our products by healthcare professionals, patients and/or third-party payers in the timeframes we anticipate, or at all, which could have a material adverse effect on our business, prospects, financial condition and results of operations.
- Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our products and reduce our revenues.
- We may not be successful in maintaining reimbursement codes necessary to facilitate accurate and timely billing for our products or physician services attendant to our products.
- We may depend on single-source suppliers for some of our components. The loss of these suppliers could prevent or delay shipments of our products, delay our clinical studies or otherwise adversely affect our business.
- Quality control problems with respect to devices and components supplied by third-party suppliers could have a material adverse effect on our reputation, our clinical studies or the commercialization of our products and, as a result, a material adverse effect on our business, prospects, financial condition and results of operations.
- We currently do not own a manufacturing facility and rely on contract manufacturers for the production of our products. Any significant disruption to the contract manufacturer’s operations or facilities could have a material adverse effect on our business, financial condition and results of operations.
The other 42 risks
- Continued testing of our products may not yield successful results and could reveal currently unknown aspects or safety hazards associated with our products.
- As we expand, we may experience difficulties managing our growth.
- The size and expected growth of our available market has not been established with precision and may be smaller than we estimate.
- If physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any.
- Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may prevent us from successfully operating our business, including developing our products, conducting clinical studies, commercializing our products and obtaining any necessary financing.
- Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand.
- Adverse global economic conditions could have a negative effect on our business, results of operations and financial condition and liquidity.
- A pandemic could materially adversely impact our business.
- Developing medical technology entails significant technical, regulatory and business risks.
- Our Company has an evolving business strategy and investors must be willing to accept a substantial degree of uncertainty.
- We may not be able to compete with treatments now being marketed and developed, or which may be developed and marketed in the future by other companies.
- Due in part to our limited financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates, and/or we may be unable to pursue the clinical trials that we would like to pursue.
- We had material weaknesses in our internal control over financing reporting during the years ended December 31, 2025 and 2024, that are unremediated as of December 31, 2025. If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
- Risks Related to Legal and Regulatory Matters
- Product liability suits, whether or not meritorious, could be brought against us due to alleged defective devices or for the misuse of our products, which could result in expensive and time-consuming litigation, payment of substantial damages and/or expenses and an increase in our insurance rates.
- Other future litigation and regulatory actions could have a material adverse impact on the Company.
- We are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business, and changes in such regulations or laws could require us to modify our products or marketing or advertising efforts.
- We are increasingly dependent on information technology systems and are subject to privacy and security laws. Our products and our systems and infrastructure face certain risks, including cyber security breaches and data leakage.
- We may choose to, or may be required to, suspend, repeat or terminate our clinical studies if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the studies are not well designed.
- Legislative and regulatory changes in the U.S. and in other countries regarding healthcare insurance and government-sponsored reimbursement programs (such as Medicare in the United States) may adversely affect our business and financial results.
- We are subject to extensive post-marketing regulation by the FDA and comparable authorities in other jurisdictions, which could impact the sales and marketing of our products and could cause us to incur significant costs to maintain compliance. In addition, we may become subject to additional regulation in other jurisdictions if we market and sell our products outside of the U.S.
- In addition to FDA requirements, we will spend considerable time and money complying with other federal, state, local and foreign rules, regulations and guidance and, if we are unable to fully comply with such rules, regulations and guidance, we could face substantial penalties.
- Our products may in the future be subject to recalls that could harm our reputation, business and financial results.
- If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
- We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or off-label uses.
- We are affected by and subject to environmental laws and regulations that could be costly to comply with or that may result in costly liabilities.
- The pediatrics and medical device industries are characterized by patent and other intellectual property litigation and disputes, and any litigation, dispute or claim against us may cause us to incur substantial costs, could place a significant strain on our financial resources, divert the attention of management from our business, harm our reputation and require us to remove certain devices from the market.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our devices.
- Future regulatory action remains uncertain.
- Our product candidates will remain subject to ongoing regulatory review even after they receive marketing clearances, and if we fail to comply with continuing regulations, we could lose these clearances and the sale of any of our approved commercial products could be suspended.
- Intellectual property litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products.
- We depend extensively on our patents and proprietary technology and the patents, and we must protect those assets in order to preserve our business.
- Due to legal and factual uncertainties regarding the scope and protection afforded by patents and other proprietary rights, we may not have meaningful protection from competition.
- If the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates.
- Risks Related to Our Common Stock
- We may not be able to maintain a listing of our common stock on NYSE American.
- We do not expect to declare or pay dividends in the foreseeable future.
- If securities industry analysts publish unfavorable reports on us, then the market price and market trading volume of our common stock could be negatively affected.
- Future issuances of our common stock or securities convertible into, or exercisable or exchangeable for, our common stock, or the expiration of lock-up agreements that restrict the issuance of new common stock or the trading of outstanding common stock, could cause the market price of our common stock to decline and would result in the dilution of your holdings.
- Future issuances of debt securities, which would rank senior to our common stock upon our bankruptcy or liquidation, and future issuances of preferred stock, which could rank senior to our common stock for the purposes of dividends and liquidating distributions, may adversely affect the level of return you may be able to achieve from an investment in our common stock.
- If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.
- We are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies, and our stockholders could receive less information than they might expect to receive from more mature public companies.
- Because the Company is a “smaller reporting company,” we may take advantage of certain scaled disclosures available to us, resulting in holders of our securities receiving less Company information than they would receive from a public company that is not a smaller reporting company.
- As a “smaller reporting company,” we may at some time in the future choose to exempt our Company from certain corporate governance requirements that could have an adverse effect on our public shareholders.
Legal proceedings
From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of the date of issuance, other than those described below, there were no pending or threatened legal proceedings that could reasonably be expected to have a material effect on the results of the Company’s operations. There are also no proceedings in which any of the Company’s directors, officers or affiliates is an adverse party to the Company or has a material interest adverse to the Company’s interest.
On February 6, 2019, plaintiff Ritu Bhambhani, M.D., initiated a lawsuit against Innovative Health Solutions, Inc. and others in the United States District Court for the District of Maryland. Plaintiffs Bhambhani and Sudhir Rao subsequently amended the complaint, with the Third Amended Complaint (“Complaint”) containing the most recent set of allegations. The Complaint asserted claims under the RICO Act, as well as of fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and sought compensatory damages in excess of $5 million, pre-judgment interest, punitive damages, attorney’s fees, court costs and designation of the case as a class action. The Complaint stated that the Company, distributors of the Company’s product, and medical billing and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARNeuraxis, INC filings on SEC EDGAR
- 2SEC EDGARNeuraxis, INC filings on SEC EDGAR
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- 4SEC EDGARNeuraxis, INC 10-K for fiscal 2025
- 5SEC EDGARNeuraxis, INC 10-K for fiscal 2022
- 6SEC EDGARNeuraxis, INC 10-K for fiscal 2023
- 7SEC EDGARNeuraxis, INC 10-Q for fiscal 2026
- 8SEC EDGARNeuraxis, INC 10-Q for fiscal 2026
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- 16SEC EDGARKristin A. Ferge, Board member
- 17SEC EDGARGil Aharon, Board member
- 18SEC EDGARJane Elizabeth Keyser, Board member
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- 20SEC EDGAROther events
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- 22SEC EDGAROther events
- 23SEC EDGARShareholder vote
- 24SEC EDGAROther events
- 25SEC EDGARResults of operations
- 26SEC EDGAROther events
- 27SEC EDGARResults of operations
- 28SEC EDGAREntered a material agreement
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- 30SEC EDGARShareholder vote
- 31SEC EDGARRegulation FD disclosure
- 32NasdaqNasdaq calendar
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