Overview
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- TickerTNON on Nasdaq1
- IndustrySurgical & Medical Instruments & Apparatus1
- HeadquartersLos Gatos, California1
- Incorporated inDE2
- Business address104 Cooper Ct., Los Gatos, Ca 950322
- Filer category, Emerging growth company2
- Legal formCorporation
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Market under the symbol “TNON.” We are currently evaluating our options for regaining compliance with the Bid Price Rule.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
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue40¢$1.6M
- Research and development54¢$2.1M
- Other costs5¢$209.0K
Out of $3.9M 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 |
|---|---|---|
| Revenue | $3.9M | $3.3M |
| Cost of sales | $1.6M | $1.6M |
| Gross Profit | $2.4M | $1.7M |
| General and administrative | $7.0M | $7.8M |
| Sales and marketing | $6.0M | $5.1M |
| Research and development | $2.1M | $2.6M |
| Total Operating Expenses | $15.2M | $15.5M |
| Loss from Operations | -$12.8M | -$13.8M |
| Gain on investments | $236.0K | $183.0K |
| Interest expense | -$34.0K | |
| Other expense, net | -$56.0K | |
| Total Other Income, net | $236.0K | $93.0K |
| Net Loss | -$12.6M | -$13.7M |
| Basic (in Dollars per share) | -$1.70 | -$11.26 |
| Diluted (in Dollars per share) | -$1.70 | -$11.26 |
| Basic (in Shares) | 7.4K shares | 1.2K shares |
| Diluted (in Shares) | 7.4K shares | 1.2K shares |
| Foreign currency translation adjustment | $46.0K | |
| Total Comprehensive Loss | -$12.6M | -$13.6M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 5 quarters (quarterly), latest first.4
| Period ending | 2026-02-28 | 2025-12-31 | 2025-10-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $3.8M | $6.5M | |||
| Accounts receivable, net | $1.7M | $863.0K | |||
| Inventory | $1.1M | $606.0K | |||
| Prepaid expenses and other current assets | $260.0K | $206.0K | |||
| Total current assets | $6.8M | $8.2M | |||
| Property and equipment, net | $918.0K | $752.0K | |||
| Deposits | $51.0K | $51.0K | |||
| Operating lease right-of-use asset | $131.0K | $399.0K | |||
| Deferred offering costs | $431.0K | ||||
| Intangible assets, net (Notes 3 and 6) | $485.0K | ||||
| Goodwill (Note 3) | $2.4M | ||||
| TOTAL ASSETS | $10.8M | $9.8M | |||
| Accounts payable | $845.0K | $369.0K | |||
| Accrued expenses | $1.6M | $910.0K | |||
| Current portion of accrued commissions | $590.0K | $303.0K | |||
| Current portion of operating lease liability | $141.0K | $287.0K | |||
| Total current liabilities | $3.2M | $1.9M | |||
| Accrued commissions, net of current portion | $1.5M | $1.9M | |||
| Operating lease liability, net of current portion | $141.0K | ||||
| Contingent consideration (Note 3) | $993.0K | ||||
| Total liabilities | $5.7M | $3.9M | |||
| Common stock, $0.001 par value; 130,000,000 shares authorized at December 31, 2025 and 2024; 10,851,273 and 3,138,804 shares issued and outstanding at December 31, 2025 and 2024, respectively | $11.0K | $3.0K | |||
| Additional paid-in capital | $83.3M | $71.0M | |||
| Accumulated deficit | -$81.3M | -$68.7M | |||
| Total stockholders equity | $5.0M | $6.0M | $778.0K | ||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $10.8M | $9.8M | |||
| Common stock, per share | $1.00 | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 130.0M shares | 130.0M shares | |||
| Common stock, shares outstanding | 10.9M shares | 3.1M shares | |||
| Common stock, shares issued | 10.9M shares | 3.1M shares |
| Period ending | 2026-02-28 | 2025-12-31 | 2025-10-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $3.8M | $6.5M | |||
| Accounts receivable, net | $1.7M | $863.0K | |||
| Inventory | $1.1M | $606.0K | |||
| Prepaid expenses and other current assets | $260.0K | $206.0K | |||
| Total current assets | $6.8M | $8.2M | |||
| Property and equipment, net | $918.0K | $752.0K | |||
| Deposits | $51.0K | $51.0K | |||
| Operating lease right-of-use asset | $131.0K | $399.0K | |||
| Deferred offering costs | $431.0K | ||||
| Intangible assets, net (Notes 3 and 6) | $485.0K | ||||
| Goodwill (Note 3) | $2.4M | ||||
| TOTAL ASSETS | $10.8M | $9.8M | |||
| Accounts payable | $845.0K | $369.0K | |||
| Accrued expenses | $1.6M | $910.0K | |||
| Current portion of accrued commissions | $590.0K | $303.0K | |||
| Current portion of operating lease liability | $141.0K | $287.0K | |||
| Total current liabilities | $3.2M | $1.9M | |||
| Accrued commissions, net of current portion | $1.5M | $1.9M | |||
| Operating lease liability, net of current portion | $141.0K | ||||
| Contingent consideration (Note 3) | $993.0K | ||||
| Total liabilities | $5.7M | $3.9M | |||
| Common stock, $0.001 par value; 130,000,000 shares authorized at December 31, 2025 and 2024; 10,851,273 and 3,138,804 shares issued and outstanding at December 31, 2025 and 2024, respectively | $11.0K | $3.0K | |||
| Additional paid-in capital | $83.3M | $71.0M | |||
| Accumulated deficit | -$81.3M | -$68.7M | |||
| Total stockholders equity | $5.0M | $6.0M | $778.0K | ||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $10.8M | $9.8M | |||
| Common stock, per share | $1.00 | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 130.0M shares | 130.0M shares | |||
| Common stock, shares outstanding | 10.9M shares | 3.1M shares | |||
| Common stock, shares issued | 10.9M shares | 3.1M 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.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$12.6M | -$13.7M |
| Stock-based compensation expense | $1.7M | $3.8M |
| Depreciation and amortization | $262.0K | $408.0K |
| Provision for losses on accounts receivable | $16.0K | $41.0K |
| Amortization of operating right-of-use asset | $268.0K | $247.0K |
| Accounts receivable | -$851.0K | -$386.0K |
| Inventory | -$387.0K | -$52.0K |
| Prepaid expenses and other assets | -$35.0K | $183.0K |
| Accounts payable | $486.0K | -$64.0K |
| Accrued expenses | $648.0K | -$171.0K |
| Operating lease liability | -$287.0K | -$256.0K |
| Net cash used in operating activities | -$10.7M | -$9.9M |
| Purchase of assets from SiVantage, Inc. | -$750.0K | |
| Purchases of property and equipment | -$273.0K | -$186.0K |
| Net cash used in investing activities | -$1.0M | -$186.0K |
| Gross proceeds from issuance of common stock, prefunded warrants, and warrants | $4.0M | $4.5M |
| Gross proceeds from exercise of warrants under inducement agreement | $3.1M | $4.6M |
| Gross proceeds from issuance of common stock and warrants | $2.9M | |
| Gross proceeds from issuance of Series A convertible preferred stock | $2.6M | |
| Gross proceeds from issuance of Series B convertible preferred stock | $550.0K | |
| Gross proceeds from issuance of common stock | $2.1M | |
| Gross proceeds from exercise of warrants | $812.0K | |
| Offering costs | -$928.0K | -$1.1M |
| Net cash provided by financing activities | $9.0M | $14.1M |
| Effect of foreign currency translation on cash flow | $46.0K | |
| Net (Decrease) Increase in Cash and Cash Equivalents | -$2.8M | $4.1M |
| Warrant modification costs | $5.1M | $992.0K |
| Preferred stock issued upon conversion of debt and accrued interest | $1.2M | |
| Reclassification of deferred offering costs to additional paid-in capital | $421.0K | $367.0K |
| Common stock issued upon conversion of Series A preferred stock | $678.0K | |
| Common stock issued for purchase of assets from SiVantage, Inc. | $1.4M | |
| Contingent consideration for purchase of assets from SiVantage, Inc. | $1.0M |
No quarter-by-quarter statement was filed.
Corporate structure
Tenon Medical, 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 Tenon Medical, Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G on Tenon Medical, Inc., latest Aug 14, 2026
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on Tenon Medical, Inc., latest Jul 6, 2026
- SiVantage Inc. Filed SCHEDULE 13D on Tenon Medical, Inc., latest Aug 8, 2025
- NorthCoast Asset Management LLC Filed SC 13G on Tenon Medical, Inc., latest Oct 4, 2024 (2 filings since Aug 8, 2024)
- TMD Wealth Management, LLC Filed SC 13G/A on Tenon Medical, Inc., latest Aug 8, 2024 (4 filings since Sep 13, 2023)
- Zuhlke Ventures AG Filed SC 13G on Tenon Medical, Inc., latest May 17, 2022
- Tenon Medical, Inc. Los Gatos, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Tenon Medical, 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 | $1.8M4 Dec 31, 2025 | $1.4M4 Dec 31, 2024 | +28.5% |
| Accumulated depreciation | $906.0K4 Dec 31, 2025 | $668.0K4 Dec 31, 2024 | +35.6% |
| Property and equipment, net | $918.0K4 Dec 31, 2025 | $752.0K4 Dec 31, 2024 | +22.1% |
| Operating-lease assets (leased space) | $131.0K4 Dec 31, 2025 | $399.0K4 Dec 31, 2024 | −67.2% |
Investments
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Goodwill | $2.4M4 Dec 31, 2025 | ||
| Intangible assets, net (excluding goodwill) | $485.0K4 Dec 31, 2025 | ||
| Finite-lived intangibles, gross | $509.0K4 Dec 31, 2025 | ||
| Accumulated amortization | $24.0K4 Dec 31, 2025 | ||
| Finite-lived intangibles, net | $485.0K4 Dec 31, 2025 |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $1.1M4 Dec 31, 2025 | $606.0K4 Dec 31, 2024 | +73.9% |
| Raw materials | $21.0K7 Dec 31, 2024 | $22.0K7 Dec 31, 2023 | −4.5% |
| Finished goods | $1.0M4 Dec 31, 2025 | $585.0K4 Dec 31, 2024 | +76.6% |
Properties, in its own words
We lease and maintain our primary offices at 104 Cooper Court, Los Gatos, CA 95032. We do not currently own any real estate.
Item 2 of the 10-K filed Mar 27, 2026.3
Leadership
Who has led Tenon Medical, Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
- Chief financial officerDick Steven M. Van Apr 26, 2022 to Feb 13, 202410
Board members and other officers (10)
- Chief Innovation OfficerWyatt D. Geist Aug 11, 2025 to now11
- Chief Commercial OfficerNathaniel A. Grawey Aug 13, 2025 to now12
- Chief Technology OfficerRichard Ginn Apr 26, 2022 to now13
- Board memberKristine M. Jacques Mar 29, 2024 to now14
- Board memberFrank M. Fischer Apr 26, 2022 to May 24, 202315
- Board memberIvan Howard Apr 26, 2022 to now16
- Board memberRichard Ginn Apr 26, 2022 to now13
- Board memberRichard M. Ferrari Apr 26, 2022 to now17
- Board memberRobert K. Weigle Apr 26, 2022 to now18
- Board memberStephen Hochschuler Apr 26, 2022 to now19
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Sep 16, 20268-K Entered a material agreement; Unregistered sale of shares; Other events22
- Sep 9, 20268-K Other events23
- Aug 31, 20268-K Entered a material agreement; Unregistered sale of shares; Other events24
- Aug 26, 20268-K Entered a material agreement; Unregistered sale of shares; Other events25
- Aug 24, 20268-K Other events26
- Aug 13, 20268-K Results of operations27
- Aug 10, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Regulation FD disclosure28
- Jul 24, 20268-K Shareholder vote29
- Jul 20, 20268-K Other events30
- Jul 10, 20268-K Other events31
- Jul 2, 20268-K Entered a material agreement; Other events32
- Jun 12, 20268-K Entered a material agreement; Executive or director change33
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/202634
When it reported results
- Aug 13, 2026Reported quarterly or annual results27
- May 12, 2026Reported quarterly or annual results35
- Mar 19, 2026Reported quarterly or annual results36
- Feb 6, 2026Reported quarterly or annual results37
- Mar 14, 2024Reported quarterly or annual results38
- Jun 7, 2022Reported quarterly or annual results39
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
294 filings to the SEC since October 2021: 4 annual reports, 14 quarterly reports, 60 major events, 75 insider forms, 10 large holders, 11 private raises, 120 other. The latest 20:
- Oct 9, 2026EFFECT EDGAR
- Oct 9, 2026424B3 PROSPECTUS EDGAR
- Oct 9, 20263 EDGAR
- Oct 5, 2026S-3 REGISTRATION STATEMENT EDGAR
- Sep 21, 2026D EDGAR
- Sep 16, 20268-K CURRENT REPORT EDGAR
- Sep 11, 20264 PRIMARY DOCUMENT EDGAR
- Sep 10, 20264 EDGAR
- Sep 9, 20268-K CURRENT REPORT EDGAR
- Sep 8, 20264 PRIMARY DOCUMENT EDGAR
- Sep 8, 2026424B3 PROSPECTUS EDGAR
- Sep 4, 2026EFFECT EDGAR
- Sep 4, 2026D EDGAR
- Sep 3, 20264 PRIMARY DOCUMENT EDGAR
- Sep 2, 2026S-3/A AMENDMENT NO. 2 TO FORM S-3 EDGAR
- Sep 1, 20264 PRIMARY DOCUMENT EDGAR
- Aug 31, 20264 PRIMARY DOCUMENT EDGAR
- Aug 31, 20263 PRIMARY DOCUMENT EDGAR
- Aug 31, 20268-K CURRENT REPORT EDGAR
- Aug 26, 20268-K/A AMENDMENT NO. 1 TO FORM 8-K EDGAR
The 294 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: 10 buys and 9 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 10, 2026 | HRT FINANCIAL LP10% owner | Buy | 67,925 | $3.63 | $246.3K | Form 4 |
| Sep 10, 2026 | HRT FINANCIAL LP10% owner | Sale | 65,582 | $5.56 | $364.6K | Form 4 |
| Sep 9, 2026 | HRT FINANCIAL LP10% owner | Buy | 39,508 | $3.40 | $134.3K | Form 4 |
| Sep 9, 2026 | HRT FINANCIAL LP10% owner | Sale | 60,343 | $2.88 | $174.0K | Form 4 |
| Sep 8, 2026 | HRT FINANCIAL LP10% owner | Buy | 707 | $3.34 | $2.4K | Form 4 |
| Sep 4, 2026 | HRT FINANCIAL LP10% owner | Sale | 1,506 | $3.70 | $5.6K | Form 4 |
| Sep 3, 2026 | HRT FINANCIAL LP10% owner | Buy | 1,658 | $3.98 | $6.6K | Form 4 |
| Sep 2, 2026 | HRT FINANCIAL LP10% owner | Sale | 450 | $4.53 | $2.0K | Form 4 |
| Sep 1, 2026 | HRT FINANCIAL LP10% owner | Buy | 1,790 | $4.57 | $8.2K | Form 4 |
| Aug 31, 2026 | HRT FINANCIAL LP10% owner | Sale | 1,276 | $4.66 | $5.9K | Form 4 |
| Aug 28, 2026 | HRT FINANCIAL LP10% owner | Buy | 18,357 | $5.58 | $102.5K | Form 4 |
| Aug 28, 2026 | HRT FINANCIAL LP10% owner | Sale | 7,023 | $7.32 | $51.4K | Form 4 |
| Aug 27, 2026 | HRT FINANCIAL LP10% owner | Sale | 419 | $4.96 | $2.1K | Form 4 |
| Nov 14, 2025 | FOSTER STEVEN MCEO and President | Buy | 19,455 | Form 4 | ||
| Nov 14, 2025 | Geist Wyatt D.Chief Innovation Officer | Buy | 19,455 | Form 4 | ||
| Nov 14, 2025 | Grawey Nathaniel A.Chief Commercial Officer | Buy | 101,167 | Form 4 | ||
| Jun 14, 2023 | VAN DICK STEVEN MChief Financial Officer | Buy | 50,000 | $0.27 | $13.5K | Form 4 |
| May 23, 2023 | FOSTER STEVEN MCEO and President | Sale | 27,791 | $1.26 | $35.0K | Form 4 |
| May 23, 2023 | GINN RICHARDChief Technology Officer | Sale | 64,990 | $1.26 | $81.9K | 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.
- ARMISTICE CAPITAL, LLCSCHEDULE 13G, 1 filing Aug 14, 202640
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 1 filing Jul 6, 202641
- SiVantage Inc.SCHEDULE 13D, 1 filing Aug 8, 202542
- NorthCoast Asset Management LLCSC 13G, 2 filings Aug 8, 2024 to Oct 4, 202443
- TMD Wealth Management, LLCSC 13G/A, 4 filings Sep 13, 2023 to Aug 8, 202444
- Zuhlke Ventures AGSC 13G, 1 filing May 17, 202245
Money raised
Private offerings the company reported to the SEC on Form D.
- Sep 11, 2026Raised $4.3 million in a private offering of securities Form D: 1 investor so far Form D
- Aug 27, 2026Raised $3 million in a private offering of equity Form D: 1 investor so far Form D
- Mar 11, 2026Raised $4.3 million in a private offering of debt Form D: 6 investors so far Form D
- Nov 10, 2025Raised $2.9 million in a private offering of equity Form D: 29 investors so far Form D
- Mar 25, 2025Raised $1.5 million in a private offering of securities Form D: 1 investor so far Form D
- Mar 25, 2025Raised $2.5 million in a private offering of securities Form D: 1 investor so far Form D
- Mar 12, 2025Raised $4.6 million in a private offering of securities Form D: 1 investor so far Form D
- Feb 20, 2024Raised $2.6 million in a private offering of equity Form D: $6 million offered in all Form D
- Nov 21, 2023Raised $1.2 million in a private offering of debt Form D: 2 investors so far Form D
- Jul 24, 2023Raised $286,835 in a private offering of equity Form D: 1 investor so far Form D
SEC filer profile
How Tenon Medical, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARTenon Medical, Inc.1
- CIK0001560293
- Employer ID (EIN)45-55747183
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address104 Cooper Ct., Los Gatos, CA 950321
- Phone(408) 649-57601
- Shares outstanding667,047 as of Aug 13, 20269
- Public float$7.3M as of Jun 30, 20253
- AuditorHaskell & White LLP, Irvine, California PCAOB ID 200; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceOct 16, 20121
- Filings298 in all: 4 (57), 8-K (54), 3 (15), 10-Q (14), EFFECT (14), CORRESP (12), D (12), S-1/A (11)1
All 39 form types
UPLOAD (11), 424B3 (9), S-1 (9), 8-K/A (6), DEF 14A (5), PRE 14A (5), 10-K (4), 424B4 (4), 424B5 (4), DEFR14A (4), DRS (4), POS AM (4), S-3 (4), S-3/A (4), S-8 (4), SC 13G (4), 5 (3), SC 13G/A (3), 8-A12B (2), CERT (2), DRS/A (2), DRSLTR (2), SCHEDULE 13G (2), ARS (1), D/A (1), DEL AM (1), RW (1), S-1MEF (1), SC TO-I (1), SC TO-I/A (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Mar 27, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Jun 23, 2026
Latest 8-K (8-K) Sep 16, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, par value $0.001 per share | TNON | Nasdaq |
| Warrants to purchase shares of Common Stock, par value $0.001 per share | TNONW | Nasdaq |
From the cover page of the 10-K filed Mar 27, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Tenon Medical, Inc. names in Item 1A of its 10-K filed Mar 27, 2026: 61 risks under these headings, as written.3
- Risks Related to Our Business and Operations
- We have incurred losses in the past, our financial statements have been prepared on a going concern basis and we may be unable to achieve or sustain profitability in the future.
- If hospitals, clinicians, and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our products, adoption of our products may be delayed, and it is unlikely that they will gain further acceptance.
- If the reimbursement provided by third-party payors to hospitals, clinicians, and other healthcare providers for procedures performed using our products is insufficient, adoption and use of our products and the prices paid for our implants may decline.
- We may not be able to convince physicians that The Catamaran System and The SImmetry+ System are attractive alternatives to our competitors’ products and that our procedures are an attractive alternative to existing surgical and non-surgical treatments of the SI Joint.
- Clinicians and payors may not find our clinical evidence to be compelling, which could limit our sales, and on-going and future research may prove our products to be less safe and effective than initially anticipated.
- Pricing pressure from our competitors, changes in third-party coverage and reimbursement, healthcare provider consolidation, payor consolidation and the proliferation of “physician-owned distributorships” may impact our ability to sell our products at prices necessary to support our current business strategies.
- We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected and we may not grow.
- We currently manufacture (through third parties) and sell products used in a single procedure, which could negatively affect our operations and financial condition.
- We have a limited operating history and may face difficulties encountered by early-stage companies in new and rapidly evolving markets.
- Our sales volumes and our operating results may fluctuate over the course of the year.
- If we do not successfully implement our business strategy, our business and results of operations will be adversely affected.
The other 50 risks
- Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel.
- Various factors outside our direct control may adversely affect manufacturing and distribution of our product.
- We are dependent on a limited number of contract manufacturers, some of them single-source and some of them in single locations, for our products, and the loss of any of these contract manufacturers, or their inability to provide us with an adequate supply of products in a timely and cost-effective manner, could materially adversely affect our business.
- As our sales grow, our contract manufacturers may encounter problems or delays in the manufacturing of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results.
- In the future our products may become obsolete, which would negatively affect operations and financial condition.
- If we experience significant disruptions in our information technology systems, our business, results of operations, and financial condition could be adversely affected.
- We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
- We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships with third-parties that may not result in the development of commercially viable products or the generation of significant future revenue.
- We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
- Geopolitical conditions, including trade disputes and direct or indirect acts of war or terrorism, could have an adverse effect on our operations and financial results.
- Inflation may adversely affect our operations and financial results.
- Risks Related to Our Legal and Regulatory Environment
- We and our contract manufacturers are subject to extensive governmental regulation both in the United States and abroad, and failure to comply with applicable requirements could cause our business to suffer.
- We and our independent sales representatives must comply with U.S. federal and state fraud and abuse laws, including those relating to physician kickbacks and false claims for reimbursement.
- Significant developments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition can have an adverse effect on our business and financial statements.
- Our failure to adequately protect personal information in compliance with evolving legal requirements could harm our business.
- Even though our products are approved by regulatory authorities, if our contract manufacturers fail to comply with ongoing FDA requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
- Our employees, independent contractors, consultants, contract manufacturers, and our independent sales representatives may engage in misconduct or other improper activities, relating to regulatory standards and requirements.
- We may be subject to enforcement action, including fines, penalties or injunctions, if we are determined to be engaging in the off-label promotion of our product.
- We are required to report certain malfunctions, deaths, and serious injuries associated with our products, which can result in voluntary corrective actions or agency enforcement actions.
- A recall of our products, either voluntarily or at the direction of the FDA or the discovery of serious safety issues or malfunctions with our products, can result in voluntary corrective actions or agency enforcement actions, which could have a significant adverse impact on us.
- Modifications to our products may require new 510(k) clearances or premarket approvals may require us to cease marketing or recall the products until clearances are received.
- The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.
- We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.
- We are subject to environmental laws and regulations that can impose significant costs and expose us to potential financial liabilities.
- U.S. tax legislation may materially affect our financial condition, results of operations and cash flows.
- Risks Related to Our Intellectual Property
- Our ability to protect our intellectual property and proprietary technology is uncertain.
- We may be subject to damages resulting from claims that we, our employees, or independent distributors along with their independent sales representatives have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
- The medical device industry is characterized by patent litigation, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from developing or marketing our existing or future products.
- Patent terms are limited, and we may not be able to effectively protect our products and business.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product.
- We may not be able to protect our intellectual property rights throughout the world.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
- Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
- Risks Related to the Ownership of our Common Stock and Warrants
- An active trading market for our shares may not be sustained.
- Future sales of substantial amounts of our common stock could adversely affect the market price of our common stock.
- We are currently listed on The Nasdaq Capital Market. Failure to maintain our compliance with Nasdaq’s continued listing standards or other requirements could result in our common stock being delisted from Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock and decrease or eliminate your investment.
- The trading price of our common stock has been and is likely to continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control.
- Our Series A Preferred Stock and Series B Preferred Stock rank senior to our common stock.
- Conversion of Series A Preferred Stock, Series B Preferred Stock or the Convertible Promissory Notes or the exercise of the Offering Warrants, Note Warrants, Series A Warrants, Series B Warrants, Series C Warrants, Series D Warrants (as defined below), Series E Warrants (as defined below) or PIPE Warrants may cause significant dilution to our stockholders.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
- The price of our common stock may be volatile, and you may be unable to resell your shares at or above the price paid.
- Our failure to maintain effective internal control over financial reporting could have an adverse impact on us.
- Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm our stock price.
- We must implement additional and expensive procedures and controls in order to grow our business and organization and to satisfy reporting requirements, which will increase our costs and require additional management resources.
- We may be subject to securities litigation, which is expensive and could divert our management’s attention.
- We are an “emerging growth company” under the JOBS Act of 2012 and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.
- Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.
- We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.
- The elimination of personal liability against our directors and officers under Delaware law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses.
- Our Certificate of Incorporation designates the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
Sources
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- 14SEC EDGARKristine M. Jacques, Board member
- 15SEC EDGARFrank M. Fischer, Board member
- 16SEC EDGARIvan Howard, Board member
- 17SEC EDGARRichard M. Ferrari, Board member
- 18SEC EDGARRobert K. Weigle, Board member
- 19SEC EDGARStephen Hochschuler, Board member
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- 23SEC EDGAROther events
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- 26SEC EDGAROther events
- 27SEC EDGARResults of operations
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- 29SEC EDGARShareholder vote
- 30SEC EDGAROther events
- 31SEC EDGAROther events
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- 34NasdaqNasdaq calendar
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