Overview
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- TickerCARL on Nasdaq2
- IndustrySurgical & Medical Instruments & Apparatus2
- HeadquartersDover, United States2
- Incorporated inDE3
- Business address1800 Aston Avenue, Suite 100, Carlsbad, Ca 920083
- Filer category, Emerging growth company3
- Legal formCorporation2
- LEI5299003NUOF1GRY8UX102
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o A REGISTERED AGENT, INC., 8 THE GREEN, STE A, 19901 Dover, United States2
- Registered withDivision of Corporations, Department of State, 69421932
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 revenue25¢$12.5M
- Research and development34¢$17.0M
- Other costs39¢$19.6M
- Interest3¢$1.4M
Out of $50.5M 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 | $50.5M | $27.2M |
| Cost of sales | $12.5M | $7.1M |
| Gross profit | $38.0M | $20.0M |
| Research and development | $17.0M | $14.3M |
| Sales and marketing | $35.0M | $21.5M |
| General and administrative | $16.6M | $8.4M |
| Total operating expenses | $68.6M | $44.2M |
| Loss from operations | -$30.6M | -$24.1M |
| Interest expense | -$1.4M | -$1.3M |
| Interest income | $2.7M | $1.3M |
| Change in fair value of warrant liabilities | -$328.0K | -$144.0K |
| Total other income (expense), net | $940.0K | -$135.0K |
| Net loss | -$29.6M | -$24.3M |
| Net loss and comprehensive loss | -$29.6M | -$24.3M |
| Deemed dividend to preferred stockholders | -$584.0K | -$592.0K |
| Net loss attributable to common stockholders | -$30.2M | -$24.8M |
| Net loss per share attributable to common stockholders, basic | -$2.12 | -$6.11 |
| Net loss per share attributable to common stockholders, diluted | -$2.12 | -$6.11 |
| Weighted-average number of common shares used to compute basic net loss per share | 14.2M shares | 4.1M shares |
| Weighted-average number of common shares used to compute diluted net loss per share | 14.2M shares | 4.1M 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 | $85.8M | $40.1M | $7.2M |
| Restricted cash | $100.0K | $100.0K | |
| Short-term investments | $24.0M | $0 | |
| Accounts receivable, net of allowances of $1,653 and $1,239, as of December 31, 2025 and December 31, 2024, respectively | $11.4M | $6.8M | |
| Inventory | $1.8M | $995.0K | |
| Prepaid expenses and other current assets | $3.6M | $1.4M | |
| Total current assets | $126.7M | $49.4M | |
| Property and equipment, net | $1.5M | $260.0K | |
| Operating lease right-of-use assets | $1.8M | $1.6M | |
| Other assets | $134.0K | $569.0K | |
| Total assets | $130.1M | $51.8M | |
| Accounts payable | $4.5M | $2.4M | |
| Accrued liabilities | $3.3M | $2.7M | |
| Accrued compensation | $5.8M | $3.3M | |
| Short-term operating lease liabilities | $752.0K | $449.0K | |
| Total current liabilities | $14.3M | $8.8M | |
| Long-term portion of term loan, net | $15.3M | $15.4M | |
| Long-term operating lease liabilities | $1.3M | $1.3M | |
| Warrant liabilities | $457.0K | ||
| Other long-term liabilities | $309.0K | $222.0K | |
| Total liabilities | $31.3M | $26.2M | |
| Preferred stock, $0.00001 par value; 10,000,000 shares authorized and zero shares issued and outstanding as of December 31, 2025; zero shares authorized, issued, and outstanding as of December 31, 2024 | $0 | $0 | |
| Common stock, $0.00001 par value; 600,000,000 shares authorized, 26,664,200 shares issued, and 26,604,462 shares outstanding as of December 31, 2025; 21,835,801 shares authorized, 4,234,798 shares issued, and 4,139,219 shares outstanding as of December 31, 2024 | $0 | $0 | |
| Additional paid-in capital | $199.7M | $541.0K | |
| Accumulated deficit | -$100.8M | -$71.2M | |
| Total stockholders' equity (deficit) | $98.9M | -$70.6M | -$46.1M |
| Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | $130.1M | $51.8M | |
| Allowance for credit loss on accounts receivable | $1.7M | $1.2M | |
| Preferred stock, par value per share | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 0 shares | |
| Preferred stock, shares, issued | 0 shares | 0 shares | |
| Preferred stock, shares, outstanding | 0 shares | 0 shares | |
| Common stock, par value per share | $0.00 | $0.00 | |
| Common stock, shares authorized | 600.0M shares | 21.8M shares | |
| Common stock, shares, issued | 26.7M shares | 4.2M shares | |
| Common stock, shares, outstanding | 26.6M shares | 4.1M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $85.8M | $40.1M | $7.2M |
| Restricted cash | $100.0K | $100.0K | |
| Short-term investments | $24.0M | $0 | |
| Accounts receivable, net of allowances of $1,653 and $1,239, as of December 31, 2025 and December 31, 2024, respectively | $11.4M | $6.8M | |
| Inventory | $1.8M | $995.0K | |
| Prepaid expenses and other current assets | $3.6M | $1.4M | |
| Total current assets | $126.7M | $49.4M | |
| Property and equipment, net | $1.5M | $260.0K | |
| Operating lease right-of-use assets | $1.8M | $1.6M | |
| Other assets | $134.0K | $569.0K | |
| Total assets | $130.1M | $51.8M | |
| Accounts payable | $4.5M | $2.4M | |
| Accrued liabilities | $3.3M | $2.7M | |
| Accrued compensation | $5.8M | $3.3M | |
| Short-term operating lease liabilities | $752.0K | $449.0K | |
| Total current liabilities | $14.3M | $8.8M | |
| Long-term portion of term loan, net | $15.3M | $15.4M | |
| Long-term operating lease liabilities | $1.3M | $1.3M | |
| Warrant liabilities | $457.0K | ||
| Other long-term liabilities | $309.0K | $222.0K | |
| Total liabilities | $31.3M | $26.2M | |
| Preferred stock, $0.00001 par value; 10,000,000 shares authorized and zero shares issued and outstanding as of December 31, 2025; zero shares authorized, issued, and outstanding as of December 31, 2024 | $0 | $0 | |
| Common stock, $0.00001 par value; 600,000,000 shares authorized, 26,664,200 shares issued, and 26,604,462 shares outstanding as of December 31, 2025; 21,835,801 shares authorized, 4,234,798 shares issued, and 4,139,219 shares outstanding as of December 31, 2024 | $0 | $0 | |
| Additional paid-in capital | $199.7M | $541.0K | |
| Accumulated deficit | -$100.8M | -$71.2M | |
| Total stockholders' equity (deficit) | $98.9M | -$70.6M | -$46.1M |
| Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | $130.1M | $51.8M | |
| Allowance for credit loss on accounts receivable | $1.7M | $1.2M | |
| Preferred stock, par value per share | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 0 shares | |
| Preferred stock, shares, issued | 0 shares | 0 shares | |
| Preferred stock, shares, outstanding | 0 shares | 0 shares | |
| Common stock, par value per share | $0.00 | $0.00 | |
| Common stock, shares authorized | 600.0M shares | 21.8M shares | |
| Common stock, shares, issued | 26.7M shares | 4.2M shares | |
| Common stock, shares, outstanding | 26.6M shares | 4.1M 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 | -$29.6M | -$24.3M |
| Depreciation and amortization | $281.0K | $145.0K |
| Stock-based compensation | $1.9M | $253.0K |
| Non-cash interest | $206.0K | $206.0K |
| Loss on remeasurement of warrant liabilities | $328.0K | $144.0K |
| Non-cash lease expense | $536.0K | $375.0K |
| Provision for credit losses | $414.0K | $368.0K |
| Provision for excess and obsolete inventory | $1.8M | $1.4M |
| Other non-cash items | $17.0K | $0 |
| Accounts receivable, net | -$5.0M | -$4.0M |
| Inventory | -$2.7M | -$1.8M |
| Prepaid expenses and other assets | -$2.3M | -$720.0K |
| Accounts payable | $2.3M | $297.0K |
| Accrued liabilities | $627.0K | $1.2M |
| Accrued compensation | $2.5M | $1.2M |
| Lease liabilities | -$290.0K | -$310.0K |
| Net cash used in operating activities | -$29.0M | -$25.5M |
| Purchase of short-term investments | -$24.0M | $0 |
| Purchase of property and equipment | -$642.0K | -$180.0K |
| Capitalized software costs | -$715.0K | $0 |
| Payment of initial direct costs related to operating leases | -$126.0K | $0 |
| Net cash used in investing activities | -$25.5M | -$180.0K |
| Proceeds from initial public offering, net of underwriting discounts and commissions | $93.5M | $0 |
| Payments for deferred initial public offering costs | -$5.4M | $0 |
| Proceeds from issuance of Series C convertible preferred stock, net of issuance costs | $11.9M | $52.3M |
| Proceeds from term loan, net of issuance costs | $0 | $6.2M |
| Payment of issuance costs related to term loan modification | -$50.0K | $0 |
| Proceeds from exercises of stock options | $205.0K | $34.0K |
| Net cash provided by financing activities | $100.1M | $58.5M |
| Increase in cash, cash equivalents, and restricted cash | $45.7M | $32.9M |
| Cash paid for interest | $1.2M | $1.1M |
| Conversion of convertible preferred stock upon initial public offering | $108.7M | $0 |
| Reclassification of warrants from liability classified to equity classified | $760.0K | $0 |
| Vesting of early exercised common stock options | $42.0K | $56.0K |
| Right-of-use asset obtained in exchange for lease liability | $593.0K | $0 |
| Reclassification of financial commitment asset to debt discount | $69.0K | $0 |
| Unpaid purchases of property and equipment | $41.0K | $0 |
| Capitalized software included in accounts payable and accrued liabilities | $127.0K | $0 |
| Preferred stock warrants issued in connection with term loan modifications | $0 | $313.0K |
| Unpaid deferred offering costs | $0 | $423.0K |
No quarter-by-quarter statement was filed.
Corporate structure
CARLSMED, 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 CARLSMED, INC.
- B CAPITAL GROUP MANAGEMENT, L.P. Filed SCHEDULE 13G on CARLSMED, INC., latest Nov 14, 2025
- Presidio Management Group XII, L.L.C. Filed SCHEDULE 13G on CARLSMED, INC., latest Nov 13, 2025
- Michael Cordonnier Filed SCHEDULE 13G on CARLSMED, INC., latest Jul 24, 2025
- CARLSMED, INC. Dover, Delaware, 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 CARLSMED, 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 | $2.0M4 Dec 31, 2025 | $659.0K4 Dec 31, 2024 | +205.5% |
| Accumulated depreciation | $526.0K4 Dec 31, 2025 | $399.0K4 Dec 31, 2024 | +31.8% |
| Property and equipment, net | $1.5M4 Dec 31, 2025 | $260.0K4 Dec 31, 2024 | +471.9% |
| Operating-lease assets (leased space) | $1.8M4 Dec 31, 2025 | $1.6M4 Dec 31, 2024 | +11.1% |
Real estate and locations
| Item | Latest | A year before | Change |
|---|---|---|---|
| Area of real estate | 23,000 sq ft4 Dec 31, 2025 | 16,000 sq ft4 May 1, 2021 | +43.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $85.8M4 Dec 31, 2025 | $40.1M4 Dec 31, 2024 | +113.8% |
| Marketable securities, current | $24.0M4 Dec 31, 2025 | $04 Dec 31, 2024 |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $1.8M4 Dec 31, 2025 | $995.0K4 Dec 31, 2024 | +85.4% |
| Work in process | $57.0K4 Dec 31, 2025 | $400.0K4 Dec 31, 2024 | −85.8% |
| Finished goods | $1.8M4 Dec 31, 2025 | $595.0K4 Dec 31, 2024 | +200.5% |
Properties, in its own words
Our corporate headquarters is in Carlsbad, California, where we lease a facility totaling approximately 23,000 rentable square feet under a lease agreement that expires on June 30, 2028.
Our existing facility will continue to support our research and development, finance, marketing, and administrative teams. We believe that our existing facility is adequate for our current needs and that suitable additional or alternative space would be available for lease, if and when required, on commercially reasonable terms.
Item 2 of the 10-K filed Feb 25, 2026.7
Leadership
Who has led CARLSMED, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerMichael Cordonnier Jul 22, 2025 to now8
- PresidentMichael Cordonnier Jul 22, 2025 to now8
- Chief financial officerRichard Heppenstall Sep 30, 2026 to now9
- Chief financial officerLeonard M. Greenstein Jul 22, 2025 to Sep 30, 202610
- Chief operating officerJeffrey Bertolini Sep 10, 2026 to now11
Board members and other officers (10)
- Chief IP Officer, SecretaryNiall Casey Jul 22, 2025 to now12
- Chief Commercial OfficerWilliam Scott Durall Jul 22, 2025 to now13
- Board memberJonathan D. Root Jul 22, 2025 to now14
- Board memberKevin C. Oboyle Jul 22, 2025 to now15
- Board memberKevin Sidow Jul 22, 2025 to now16
- Board memberMichael Cordonnier Jul 22, 2025 to now8
- Board memberNiall Casey Jul 22, 2025 to now12
- Board memberPhilip M. Young Jul 22, 2025 to now17
- Board memberRobert Mittendorff Jul 22, 2025 to now18
- General counselJennifer Kamocsay Sep 30, 2026 to now19
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Sep 30, 20268-K Executive or director change; Regulation FD disclosure22
- Sep 8, 20268-K Executive or director change; Regulation FD disclosure23
- Aug 5, 20268-K Results of operations24
- Jun 3, 20268-K Shareholder vote25
- May 5, 20268-K Results of operations26
- Feb 25, 20268-K Results of operations27
- Jan 12, 20268-K Results of operations28
- Nov 6, 20258-K Results of operations29
- Oct 30, 20258-K Entered a material agreement; New debt or obligation30
- Aug 28, 20258-K Results of operations31
- Jul 24, 20258-K Bylaws or fiscal year changed; Other events32
- Jul 22, 2025New chief executive Michael Cordonnier becomes CEO8
- Jun 4, 2018Founded CARLSMED, INC. is founded2
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.40) a share, on Nov 6, 2025.33
When it reported results
- Aug 5, 2026Reported quarterly or annual results24
- May 5, 2026Reported quarterly or annual results26
- Feb 25, 2026Reported quarterly or annual results27
- Jan 12, 2026Reported quarterly or annual results28
- Nov 6, 2025Reported quarterly or annual results29
- Aug 28, 2025Reported quarterly or annual results31
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
90 filings to the SEC since October 2021: 1 annual reports, 4 quarterly reports, 11 major events, 39 insider forms, 3 large holders, 3 private raises, 29 other. The latest 20:
- Oct 14, 2026144 EDGAR
- Oct 6, 20264 EDGAR
- Oct 5, 2026144 EDGAR
- Oct 1, 20264 EDGAR
- Oct 1, 2026S-8 EDGAR
- Sep 30, 2026144 EDGAR
- Sep 30, 20268-K EDGAR
- Sep 30, 20263 EDGAR
- Sep 30, 20264 EDGAR
- Sep 30, 20263 EDGAR
- Sep 15, 20264/A EDGAR
- Sep 10, 20264 EDGAR
- Sep 10, 20263 EDGAR
- Sep 8, 20268-K EDGAR
- Aug 21, 2026EFFECT EDGAR
- Aug 14, 2026S-3 EDGAR
- Aug 5, 202610-Q EDGAR
- Aug 5, 20268-K EDGAR
- Jun 22, 20264 EDGAR
- Jun 22, 20264 EDGAR
The 90 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
7 open-market trades by officers, directors and large owners since October 2021: 6 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Mar 2, 2026 | Cordonnier MichaelCEO, President | Sale | 197,855 | $13.29 | $2.6M | Form 4 |
| Jul 24, 2025 | Tansey Casey M10% owner | Buy | 200,000 | $15.00 | $3.0M | Form 4 |
| Jul 24, 2025 | B Capital Healthcare I, L.P.10% owner | Buy | 1,333,333 | $15.00 | $20.0M | Form 4 |
| Jul 24, 2025 | Sidow KevinDirector | Buy | 13,333 | $15.00 | $200.0K | Form 4 |
| Jul 24, 2025 | Mittendorff Robert IIDirector | Buy | 1,333,333 | $15.00 | $20.0M | Form 4 |
| Jul 24, 2025 | ROOT JONATHAN DDirector | Buy | 466,666 | $15.00 | $7.0M | Form 4 |
| Jul 24, 2025 | YOUNG PHILIP MDirector | Buy | 59,999 | $15.00 | $900.0K | 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.
- B CAPITAL GROUP MANAGEMENT, L.P.SCHEDULE 13G, 1 filing Nov 14, 202534
- Presidio Management Group XII, L.L.C.SCHEDULE 13G, 1 filing Nov 13, 202535
- Michael CordonnierSCHEDULE 13G, 1 filing Jul 24, 202536
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.
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, the top 25 of 75. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How CARLSMED, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCARLSMED, INC.1
- CIK0001794546
- Employer ID (EIN)83-10818637
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company7
- Incorporated inDelaware7
- 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 address1800 Aston Avenue, Suite 100, Carlsbad, CA 920081
- Phone858-295-92901
- Shares outstanding27,302,743 as of Aug 3, 20266
- Public float$0 as of Jun 30, 20254
- AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting7
- On EDGAR sinceNov 19, 20191
- Filings93 in all: 4 (24), 3 (14), 8-K (11), CORRESP (5), 10-Q (4), 144 (4), D (4), S-8 (3)1
All 26 form types
SCHEDULE 13G (3), D/A (2), DRSLTR (2), EFFECT (2), UPLOAD (2), 10-K (1), 4/A (1), 424B4 (1), 8-A12B (1), ARS (1), CERT (1), DEF 14A (1), DEFA14A (1), DRS (1), DRS/A (1), S-1 (1), S-1/A (1), S-3 (1)
- Latest filingsAnnual report (10-K) Feb 25, 2026
Quarterly report (10-Q) Aug 5, 2026
Proxy statement (DEF 14A) Apr 22, 2026
Latest 8-K (8-K) Sep 30, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.00001 par value per share | CARL | Nasdaq |
From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).7
Risk factors and legal proceedings
The risks CARLSMED, INC. names in Item 1A of its 10-K filed Feb 25, 2026: 74 risks under these headings, as written.7
- We depend entirely on sales of aprevo interbody implants for our revenue. If we are unable to successfully achieve substantial market acceptance and adoption of the aprevo Technology Platform, or any of our future products, or if confidence in our products is diminished, our business, financial condition, results of operations, and prospects would be harmed.
- We have a limited operating history and have experienced periods of significant business changes in a short time, making it difficult for you to evaluate our business and future prospects. If we are unable to manage our business and any fluctuations in our business effectively, our business and growth prospects could be materially and adversely affected.
- We have a history of net losses, and we expect to incur additional substantial losses in the foreseeable future.
- Our business and growth strategy depend in part on our ability to broadly commercialize the aprevo Technology Platform for cervical spine fusion surgeries. If we are unable to do so, our future growth could be limited and our business could be harmed.
- Managing our on-demand, customized implant model to address evolving patterns of demand is expensive, time-consuming, and subject to significant uncertainties. If we are unable to manage our CMOs to consistently meet demand on a timely basis, customers and surgeons may choose to use our competitors’ products.
- We rely on a limited number of CMOs for the manufacture, treatment, sterilization, packaging, and distribution of our products. This reliance on third parties increases the risk that we will not have sufficient quantities of our products or such quantities at an acceptable cost, and reduces our control over the manufacturing process, which could delay, prevent, or impair our development or commercialization efforts, as well as our ability to timely deliver our aprevo interbody implants.
- If the third parties on which we rely to assist us with premarket development activities for future products do not perform as contractually required or expected, we may not obtain regulatory clearance or approval for our future products or be able to successfully commercialize our future products.
- We operate in a highly competitive industry, and competitive pressures or any new developments by competitors could make the aprevo Technology Platform non-competitive or obsolete and could have a material adverse effect on our business, financial condition, results of operations, and prospects.
- If we are unable to meet customer demands for new technology, or if the technologies we introduce are viewed less favorably than our competitors’ products, our results of operations and future prospects may be negatively affected.
- Our business and growth strategy depend on our ability to maintain and expand our aprevo Personalized Spine Provider program. If we are unable to do so, our future growth would be limited, and our business would be harmed.
- Any future sales in international markets will subject us to additional costs and risks that may have a material adverse effect on our business, financial condition, results of operations, and prospects.
- If we fail to attract and retain senior management and other key personnel, our business may be materially and adversely affected.
The other 62 risks
- We rely on our independent sales agents to generate revenue, which subjects us to various risks.
- If we are unable to successfully develop new products and effectively manage their introduction or improve our existing products, our business may be adversely affected.
- We spend significant amounts on marketing and brand-building initiatives to acquire and retain customers, which may not be successful or cost effective.
- We may be subject to product and other liability claims that could require us to pay substantial sums.
- The off-label use of aprevo interbody implants may harm our reputation in the marketplace or result in injuries that lead to fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, either of which could have a material adverse effect on our business, financial condition, and results of operations.
- A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
- Any of our products and technologies may have unforeseen adverse events or undesirable side effects, which may require our products to be taken off the market, require our products to include safety warnings, or otherwise limit sales of our products.
- The size and expected growth of our total addressable market has not been established with precision and may be smaller than we estimate.
- Discovery of alternative technologies or other personalized spinal implant technologies could materially adversely affect our business, financial condition, results of operations, and prospects.
- Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.
- Macroeconomic conditions could materially adversely affect our business, financial condition, results of operations, and prospects.
- Cybersecurity risks could materially affect our business, operations, or financial condition.
- Risk Related to Regulatory Matters
- The continued commercialization of the aprevo Technology Platform depends in part on the extent to which third-party payors provide coverage and adequate reimbursement levels. Failure to obtain and maintain coverage and adequate reimbursement for aprevo interbody implants could limit our ability to market them and decrease our ability to generate revenue.
- We are subject to certain federal and state fraud and abuse laws and transparency laws, and any failure to comply could subject us to substantial penalties or other adverse consequences. In addition, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
- Our employees, independent sales agents, consultants, and other commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- We may be subject to damages resulting from claims that we or our employees or our independent sales agents have wrongfully used or disclosed alleged trade secrets or proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
- Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could have a material adverse effect on our business, financial condition, results of operations, and prospects.
- Our products and operations are subject to extensive government regulation and oversight in the United States, and our failure to comply with applicable requirements could harm our business.
- Failure to maintain marketing authorizations for our products, or to timely obtain necessary marketing authorizations for our future products, may have a material adverse effect on our business, financial condition, results of operations, and prospects.
- Interim, “top-line,” or preliminary data from clinical studies or trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- We are subject to ongoing regulatory review and scrutiny. Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
- Our products must be manufactured in accordance with applicable laws and regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.
- aprevo interbody implants may cause or contribute to adverse medical events that we may be required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, results of operations, and prospects. In addition, the discovery of serious safety issues with aprevo interbody implants, or a recall of them either voluntarily or at the direction of the FDA, could have a negative impact on us.
- Legislative or regulatory reforms in the United States may make it more difficult and costly for us to manufacture, market, or distribute our products, or to obtain marketing authorizations for any future products.
- Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel and prevent new or modified products from being developed, reviewed, approved, or commercialized in a timely manner, or at all, which could negatively impact our business.
- We face risks related to obtaining necessary foreign marketing authorizations.
- Failure to comply with the Foreign Corrupt Practices Act (the “FCPA”), economic and trade sanctions regulations, and similar laws could subject us to penalties and other adverse consequences.
- Data Privacy Risk Factors
- Actual or perceived failures to comply with applicable data privacy and security laws, regulations, standards, and other requirements could adversely affect our business, financial condition, results of operations, and prospects.
- We may face risks associated with our use and development of AI models.
- Our business and operations may suffer in the event of information technology system failures, cyberattacks, or deficiencies in our cybersecurity.
- Risks Related to Our Intellectual Property
- Our success will depend on our ability to obtain, maintain, enforce, and protect our intellectual property rights.
- If we fail to identify our patentable inventions or adequately protect our patent rights, the commercial value of our products, services, or technologies may be adversely affected, and our competitive position may be harmed.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in U.S. or foreign patent laws or their interpretations could diminish the value of our patents in general, thereby impairing our ability to protect our current and future products, services, or technologies, and could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our current or future patents.
- We may not be able to protect our intellectual property rights throughout the world.
- If we cannot successfully enforce our intellectual property rights, the commercial value of our products, services, or technologies may be adversely affected, and our competitive position may be harmed.
- We may become a party to intellectual property litigation or administrative proceedings that could be expensive, time consuming, and unsuccessful, and could interfere with our ability to develop, manufacture, commercialize, import, or otherwise use our products, services, or technologies.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property rights.
- We depend on certain intellectual property rights that are licensed to us. We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture, commercialize, import, or use our current and/or future products, services, or technologies.
- If we are unable to protect the disclosure and use of our confidential information and trade secrets, the value of our products, services, and technologies and our business and competitive position could be harmed.
- If our trademarks and trade names are not adequately protected, we may not be able to build brand name recognition in our markets of interest, and our competitive position may be harmed.
- Our products contain third-party open-source software components, and failure to comply with the terms of the underlying open-source software licenses could restrict our ability to sell our products, affect our ability to protect our proprietary information, and subject us to possible litigation.
- Risks Relating to Financial and Accounting Matters
- Our ability to use our net operating loss carryforwards and other tax attributes may be limited due to certain provisions of the Internal Revenue Code of 1986, as amended, or state tax law.
- Our effective tax rate may vary significantly from period to period.
- Changes in tax laws or tax rulings could adversely affect our effective tax rates, results of operations, and financial condition.
- Our tax burden could increase as a result of ongoing or future tax audits.
- The terms of the Customers Loan Agreement require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility.
- Our cash deposits with financial institutions exceed insured limits.
- Risks Relating to Ownership of Our Common Stock
- We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
- We incur increased costs and are subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business.
- If we are unable to design, implement, and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock may decline.
- We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.
- If our operating and financial performance in any given period does not meet the guidance provided to the public or to the expectations of investment analysts, the market price of our common stock may decline.
- Future sales and issuances of our securities, including to support business growth or pursuant to our equity incentive plans, may cause dilution to our stockholders or decrease our stock price.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Claims for indemnification by our directors, officers, and other employees or agents may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
- The market price of our common stock may be volatile, which could cause the value of your investment to decline.
- If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
- General Risk Factors
- If we engage in acquisitions or strategic partnerships, it may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
- We or the third parties we depend on may be adversely affected by natural disasters and other catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious natural disaster or other catastrophic event. Any interruption in our operations or the operations of our CMOs may have a material adverse effect on our business, financial condition, results of operations, and prospects.
Legal proceedings
For discussion regarding legal proceedings, please refer to “Note 9 – Commitments and Contingencies” in the accompanying notes to our Financial Statements included elsewhere in this Annual Report.
The opening of Item 3, Legal Proceedings.7
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARCARLSMED, INC. filings on SEC EDGAR
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- 3SEC EDGARCARLSMED, INC. filings on SEC EDGAR
- 4SEC EDGARCARLSMED, INC. 10-K for fiscal 2025
- 5SEC EDGARCARLSMED, INC. 10-Q for fiscal 2026
- 6SEC EDGARCARLSMED, INC. 10-Q for fiscal 2026
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- 14SEC EDGARJonathan D. Root, Board member
- 15SEC EDGARKevin C. Oboyle, Board member
- 16SEC EDGARKevin Sidow, Board member
- 17SEC EDGARPhilip M. Young, Board member
- 18SEC EDGARRobert Mittendorff, Board member
- 19SEC EDGARJennifer Kamocsay, General counsel
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- 21
- 22
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- 24SEC EDGARResults of operations
- 25SEC EDGARShareholder vote
- 26SEC EDGARResults of operations
- 27SEC EDGARResults of operations
- 28SEC EDGARResults of operations
- 29SEC EDGARResults of operations
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- 31SEC EDGARResults of operations
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- 33NasdaqNasdaq calendar
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