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SIBN on Nasdaq

SI-Bone (United States)

Logo: si-bone.com4

In its 2026 annual report the company says: “We are a leader in developing innovative procedural solutions for compromised bone, grounded in expertise in biomechanical design and anatomy-specific innovation.”7 It was founded in 2008.1 It is headquartered in San Jose.1 Its shares trade on Nasdaq under the symbol SIBN.1

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Last updated Oct 21, 2026.

Overview

2008Founded1

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  • TickerSIBN on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersSan Jose1
  • Websitesi-bone.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address471 El Camino Real, Suite 101, Santa Clara, Ca 950505
  • Filer categoryLarge accelerated filer5
  • LEI549300J8JGYVJJHV9C313
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 45206683

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SI-Bone (United States) image from its website
Image: si-bone.com4

We are a leader in developing innovative procedural solutions for compromised bone, grounded in expertise in biomechanical design and anatomy-specific innovation. As pioneers of minimally invasive treatment for sacroiliac joint dysfunction and degeneration, we have developed a deep competency in addressing the challenges of low-density bone in the sacrum. With our additive manufacturing, or 3D-printing, experience developed in sacroiliac fusion, we have established a technology platform that now extends to meet critical unmet needs in thoracolumbar fixation and fusion and pelvic trauma.7 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

79.6%Gross margin8
-11.1%Operating margin8
-9.4%Net margin8
20.2%Revenue growth, 20258
-10.6%Return on equity8
0.20×Debt to equity8
-$9.1MFree cash flow8

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 95% of the revenue SI-Bone (United States) broke down this way in fiscal 2025.

  1. United States$191.1M895%up 21% from 2024
  2. Outside the United States$9.8M85%up 12% from 2024
Regions by year
Regions202320242025
United States$130.6M$158.4M$191.1M
Outside the United States$8.3M$8.8M$9.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue20¢$41.0M
  • Research and development9¢$17.4M
  • Other costs71¢$142.4M

Out of $200.9M in revenue.8 The company lost money this year.

Financial statements

Revenue91011128$200.9M in 2025+199% since 2019
0$100.0M$200.0M$300.0M2019: $67.3M$67.3M20192020: $73.4M$73.4M2020+9%2021: $90.2M$90.2M2021+23%2022: $106.4M$106.4M2022+18%2023: $138.9M$138.9M2023+31%2024: $167.2M$167.2M2024+20%2025: $200.9M$200.9M2025+20%
Gross profit91011128$159.9M in 2025+164% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $60.5M$60.5M20192020: $64.5M$64.5M2020+7%2021: $79.7M$79.7M2021+24%2022: $90.7M$90.7M2022+14%2023: $109.4M$109.4M2023+21%2024: $132.1M$132.1M2024+21%2025: $159.9M$159.9M2025+21%
Operating income91011128-$22.3M in 2025−38% since 2019
-$60.0M-$40.0M-$20.0M02019: -$36.0M-$36.0M20192020: -$38.6M-$38.6M2020+7%2021: -$51.7M-$51.7M2021+34%2022: -$59.6M-$59.6M2022+15%2023: -$46.9M-$46.9M2023−21%2024: -$35.2M-$35.2M2024−25%2025: -$22.3M-$22.3M2025−37%
Net income91011128-$18.9M in 2025−51% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$38.4M-$38.4M20192020: -$43.7M-$43.7M2020+14%2021: -$56.6M-$56.6M2021+29%2022: -$61.3M-$61.3M2022+8%2023: -$43.3M-$43.3M2023−29%2024: -$30.9M-$30.9M2024−29%2025: -$18.9M-$18.9M2025−39%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Revenue$200.9M$167.2M$138.9M
Cost of goods sold$41.0M$35.1M$29.5M
Gross profit$159.9M$132.1M$109.4M
Sales and marketing$124.2M$117.1M$110.3M
Research and development$17.4M$16.6M$15.0M
General and administrative$40.5M$33.8M$31.1M
Total operating expenses$182.2M$167.4M$156.4M
Loss from operations-$22.3M-$35.2M-$46.9M
Interest income$6.1M$7.8M$6.9M
Interest expense-$2.6M-$3.4M-$3.5M
Other income (expense), net-$20.0K-$73.0K$141.0K
Net loss-$18.9M-$30.9M-$43.3M
Unrealized gain (loss) of marketable securities$13.0K$26.0K$166.0K
Changes in foreign currency translation$559.0K-$117.0K-$63.0K
Comprehensive loss-$18.3M-$31.0M-$43.2M
Net loss per share, basic (in dollars per share)-$0.44-$0.75-$1.13
Net loss per share, diluted (in dollars per share)-$0.44-$0.75-$1.13
Weighted-average number of common shares used to compute basic net loss per share (in shares)43.0M shares41.5M shares38.4M shares
Weighted-average number of common shares used to compute diluted net loss per share (in shares)43.0M shares41.5M shares38.4M shares

Compare SI-Bone (United States) with another company

Corporate structure

SI-Bone (United States) sits at the top of its group. 4 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of SI-Bone (United States)

  • SI-Bone (United States) San Jose, California, United States
    • SI-BONE Deutschland GmbH Subsidiary · Germany
    • SI-BONE S.R.L. Subsidiary · Italy
    • SI-BONE UK LTD Subsidiary · United Kingdom

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What SI-Bone (United States) 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$43.8M8 Dec 31, 2025$39.9M8 Dec 31, 2024+9.8%
Accumulated depreciation$22.5M8 Dec 31, 2025$19.5M8 Dec 31, 2024+15.4%
Property and equipment, net$21.3M8 Dec 31, 2025$20.4M8 Dec 31, 2024+4.5%
Operating-lease assets (leased space)$1.1M8 Dec 31, 2025$2.0M8 Dec 31, 2024−45.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$42.2M8 Dec 31, 2025$34.9M8 Dec 31, 2024+20.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$33.9M8 Dec 31, 2025$27.1M8 Dec 31, 2024+25.2%
Work in process$4.0M8 Dec 31, 2025$24.0M8 Dec 31, 2024−83.3%
Finished goods$29.9M8 Dec 31, 2025$3.1M8 Dec 31, 2024+864.5%

Properties, in its own words

Our leased headquarters in Santa Clara, California, comprises approximately 21,848 square feet, and the lease for this space will expire in July 2026. We also lease research and development and warehouse space in another building in Santa Clara, California under a lease that will expire in October 2026. In February 2026, we entered into a lease agreement for approximately 50,485 square feet of office and warehouse space in San Jose, California, which is expected to commence in October 2026. We intend to use the space for our new corporate headquarters, research and development, and warehouse space, after the current two leases in Santa Clara expire.

We also lease office spaces in Gallarate, Italy which will expire in August 2027 to accommodate our European sales and marketing team. We believe our facilities are adequate and suitable for our current needs but in the future we may need additional space.

Item 2 of the 10-K filed Feb 24, 2026.7

Leadership

Who has led SI-Bone (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Laura Francis2021–now

President

  1. Anthony J. Recupero2021–now

Chief financial officer

  1. Laura Francis2018–2021
  2. Anshul Maheshwari2021–now
2010201520202025
Board members and other officers (20)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • SI-BONE Deutschland GmbH Germany6
  • SI-BONE S.R.L. Italy6
  • SI-BONE UK LTD United Kingdom6

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • SI-Bone Inc.Mar 27, 2009 to Sep 30, 20115

Timeline

  1. Sep 11, 20268-K Entered a material agreement; New debt or obligation; Other events41
  2. Aug 3, 20268-K Results of operations42
  3. Jun 8, 20268-K Entered a material agreement; New debt or obligation; Shareholder vote43
  4. May 11, 20268-K Results of operations44
  5. Feb 23, 20268-K Entered a material agreement; Results of operations; Executive or director change45
  6. Jan 12, 20268-K Results of operations; Regulation FD disclosure46
  7. Nov 10, 20258-K Results of operations; Executive or director change47
  8. Aug 4, 20258-K Results of operations; Executive or director change48
  9. Jun 6, 20258-K Shareholder vote49
  10. May 5, 20258-K Results of operations50
  11. Feb 24, 20258-K Results of operations51
  12. Jan 13, 20258-K Results of operations52
  13. Aug 16, 2021New chief executive Laura Francis becomes CEO17
  14. 2008Founded Founded1

Calendar

Coming up

  1. Nov 2, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.11) a share, on Nov 10, 2025.53

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results42
  2. May 11, 2026Reported quarterly or annual results44
  3. Feb 23, 2026Reported quarterly or annual results45
  4. Jan 12, 2026Reported quarterly or annual results46
  5. Nov 10, 2025Reported quarterly or annual results47
  6. Aug 4, 2025Reported quarterly or annual results48
  7. May 5, 2025Reported quarterly or annual results50
  8. Feb 24, 2025Reported quarterly or annual results51

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

426 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 34 major events, 247 insider forms, 42 large holders, 83 other. The latest 20:

  1. Oct 14, 20264 PRIMARY DOCUMENT EDGAR
  2. Oct 13, 2026144 EDGAR
  3. Oct 6, 20264 PRIMARY DOCUMENT EDGAR
  4. Oct 6, 20264 PRIMARY DOCUMENT EDGAR
  5. Oct 5, 2026144 EDGAR
  6. Oct 5, 20264 PRIMARY DOCUMENT EDGAR
  7. Sep 11, 20268-K EDGAR
  8. Sep 3, 20264 PRIMARY DOCUMENT EDGAR
  9. Aug 26, 20264 PRIMARY DOCUMENT EDGAR
  10. Aug 26, 20264 PRIMARY DOCUMENT EDGAR
  11. Aug 24, 2026144 EDGAR
  12. Aug 24, 2026144 EDGAR
  13. Aug 21, 2026144 EDGAR
  14. Aug 21, 2026144 EDGAR
  15. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  16. Aug 21, 20264 PRIMARY DOCUMENT EDGAR
  17. Aug 20, 2026144 EDGAR
  18. Aug 19, 2026144 EDGAR
  19. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  20. Aug 18, 20264 PRIMARY DOCUMENT EDGAR

The 426 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

206 open-market trades by officers, directors and large owners since October 2021: 0 buys and 206 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026DUNN JEFFREY WDirectorSale20,000$18.91$378.2KForm 4
Aug 24, 2026Maheshwari AnshulChief Op & Financial OfficerSale11,636$20.11$234.0KForm 4
Aug 24, 2026FRANCIS LAURAChief Executive OfficerSale25,972$20.12$522.6KForm 4
Aug 21, 2026Maheshwari AnshulChief Op & Financial OfficerSale11,228$20.02$224.8KForm 4
Aug 21, 2026FRANCIS LAURAChief Executive OfficerSale3,923$20.02$78.5KForm 4
Aug 20, 2026FRANCIS LAURAChief Executive OfficerSale51,884$19.46$1.0MForm 4
Aug 19, 2026Maheshwari AnshulChief Op & Financial OfficerSale5,747$19.55$112.4KForm 4
Aug 17, 2026Maheshwari AnshulChief Op & Financial OfficerSale4,665$18.65$87.0KForm 4
Aug 17, 2026PISETSKY MICHAEL A.SVP, Ops & Adm/Chief Legal OfrSale3,725$18.64$69.4KForm 4
Aug 17, 2026FRANCIS LAURAChief Executive OfficerSale14,956$18.66$279.1KForm 4
Aug 3, 2026DUNN JEFFREY WDirectorSale20,000$18.46$369.2KForm 4
Jul 2, 2026Maheshwari AnshulChief Op & Financial OfficerSale3,317$16.77$55.6KForm 4
Jul 2, 2026PISETSKY MICHAEL A.SVP, Ops & Adm/Chief Legal OfrSale3,134$16.71$52.4KForm 4
Jun 5, 2026DUNN JEFFREY WDirectorSale3,575$15.25$54.5KForm 4
May 29, 2026Davis Timothy E JRDirectorSale3,500$14.14$49.5KForm 4
May 28, 2026Davis Timothy E JRDirectorSale3,780$14.47$54.7KForm 4
May 18, 2026Maheshwari AnshulChief Op & Financial OfficerSale4,666$14.68$68.5KForm 4
May 18, 2026PISETSKY MICHAEL A.SVP, Ops & Adm/Chief Legal OfrSale3,726$14.63$54.5KForm 4
May 18, 2026FRANCIS LAURAChief Executive OfficerSale14,957$14.71$220.0KForm 4
May 4, 2026DUNN JEFFREY WDirectorSale337$13.15$4.4KForm 4

All 206 trades can be filtered by person here when JavaScript is on.

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.

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.

YearExecutiveAgeSalaryTotal pay
2025Laura A. FrancisChief Executive Officer59$685.0K$7.5M65
2025Anshul MaheshwariChief Operating Officer & Chief Financial Officer46$496.7K$2.8M65
2025Anthony J. RecuperoFormer President, Commercial Operations$500.6K$2.4M65
2025Michael A. PisetskyChief Business & Legal Affairs Officer48$493.4K$2.4M65
2024Laura A. FrancisChief Executive Officer59$652.0K$7.1M65
2024Anthony J. RecuperoFormer President, Commercial Operations$486.0K$2.6M65
2024Anshul MaheshwariChief Operating Officer & Chief Financial Officer46$464.2K$2.5M65
2023Laura A. FrancisChief Executive Officer59$622.1K$3.7M65
2023Anthony J. RecuperoFormer President, Commercial Operations$472.0K$2.1M65
2023Anshul MaheshwariChief Operating Officer & Chief Financial Officer46$439.0K$1.9M65

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
First Light Asset Management, LLC8,127,985$132.6M8.1%+2,774,795
BlackRock, Inc.3,676,259$60.0M0.0%+247,718
Cadian Capital Management, LP3,347,574$54.6M4.1%+1,460,102
American Century Companies Inc2,510,963$41.0M0.0%+1,898
Brown Advisory Inc2,077,134$33.9M0.1%−45,198
Granahan Investment Management, LLC1,931,182$31.5M1.1%+192,085
Vanguard Capital Management LLC1,838,499$30.0M0.0%+74,186
First Eagle Investment Management, LLC1,537,882$25.1M0.0%+898,941
Impax Asset Management Group plc1,425,010$23.3M0.2%No change
Gilder Gagnon Howe & Co LLC1,253,042$20.4M0.2%+204,526
Paradigm Capital Management Inc/ny1,233,200$20.1M0.5%+106,700
State Street Corp1,214,286$19.8M0.0%+84,471
Silvercrest Asset Management Group LLC1,158,576$18.9M0.1%−86,008
Geode Capital Management, LLC1,076,839$17.6M0.0%+125,111
Nuveen, LLC1,026,036$16.7M0.0%−259,475
Champlain Investment Partners, LLC896,462$14.6M0.4%+18,857
Point72 Asset Management, L.P.790,323$12.9M0.0%−50,023
Wellington Management Group Llp742,857$12.1M0.0%−29,755
Dimensional Fund Advisors LP708,319$11.6M0.0%+89,380
Marshall Wace, Llp690,288$11.3M0.0%+522,160
Next Century Growth Investors LLC585,289$9.6M0.5%+201,331
Vanguard Portfolio Management LLC548,287$8.9M0.0%+134,793
Goldman Sachs Group Inc441,912$7.2M0.0%−180,530
Northern Trust Corp439,161$7.2M0.0%+80,824
HighMark Wealth Management LLC425,049$6.9M2.3%+265,217

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How SI-Bone (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSI-BONE, Inc.2
  • CIK0001459839
  • Employer ID (EIN)26-22163517
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address471 El Camino Real, Suite 101, Santa Clara, CA 950502
  • Phone40820707002
  • Shares outstanding44,818,575 as of Jul 29, 202614
  • Public float$800.0M as of Jun 30, 20257
  • AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; it also attests to the company’s internal control over financial reporting7
  • On EDGAR sinceMar 27, 20092
  • Filings772 in all: 4 (450), 8-K (68), 144 (54), 3 (26), 10-Q (24), SC 13G/A (19), SC 13G (17), SCHEDULE 13G/A (13)2
    All 40 form types

    CORRESP (9), S-8 (9), UPLOAD (9), 10-K (8), DEF 14A (8), 424B5 (6), D (5), DEFA14A (5), SCHEDULE 13G (5), ARS (4), DRS (3), EFFECT (3), S-3 (3), S-3ASR (3), 4/A (2), DRS/A (2), RW (2), 10-Q/A (1), 144/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), DEFR14A (1), DRSLTR (1), PRE 14A (1), RW WD (1), S-1 (1), S-1/A (1), S-1MEF (1), SUPPL (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Sep 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareSIBNThe Nasdaq Global Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks SI-Bone (United States) names in Item 1A of its 10-K filed Feb 24, 2026: 59 risks under these headings, as written.7

  • Risks Related to Our Business and Our Industry
  • 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 adversely affected.
  • We have incurred significant operating losses since inception, we may continue to incur operating losses in the future, and we may not be able to achieve or sustain future profitability.
  • If hospitals, physicians, and other healthcare providers are unable to obtain and maintain adequate or any coverage and reimbursement from third-party payors for procedures performed using our products, further adoption of our products may be delayed, and it is unlikely that they will gain further acceptance, and the prices paid for our implants may decline.
  • Uncertainty in the coverage and reimbursement environment may decrease demand for our products and adversely affect our business.
  • Healthcare reforms may have a material adverse effect on our operations.
  • Pricing pressure from our competitors, healthcare provider consolidation, the presence of physician-owned distributorships, and payor consolidation may impact our ability to sell our product at prices necessary to support our current business strategies.
  • Practice trends, market dynamics, and other factors, have caused, and may continue to cause, procedures to shift from the hospital environment to ambulatory surgical centers ("ASCs") or office-based labs ("OBLs") where pressure on the prices of our products is generally more acute.
  • We have historically been highly dependent on revenue from the sales of similar products focused on procedures, the goal of which is to stabilize and fuse the sacroiliac joint. Continued reliance on sales of similar products could negatively affect our results of operations and financial condition.
  • We are dependent on a limited number of third-party suppliers, some of them single-source and some of them in single locations, for most of our products and components, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials in a timely and cost-effective manner, could materially adversely affect our business.
  • Prolonged inflation and supply chain disruptions could result in delayed product launches, lost revenue, higher costs and decreased profit margins.
  • Disruptions in the supply of the materials and components used in manufacturing our products or the sterilization of our products by third-party suppliers could adversely affect our business, financial condition and results of operations.
The other 48 risks
  • Physicians and payors may not find the clinical evidence supporting our more recent products to be compelling, which could limit our sales and revenue, and on-going and future research may prove our products to be less safe and effective than currently thought.
  • We may not be able to demonstrate to physicians that our products are attractive alternatives to our competitors’ products and that our procedures are attractive alternatives to existing surgical and non-surgical treatments for their respective indications.
  • If clinical experience with our implants or instruments does not result in positive outcomes for patients, or if clinical studies involving our implant systems fail to show meaningful patient benefit, sales of our products could be adversely impacted.
  • If we are unable to maintain our network of direct sales representatives, third-party sales agents, and resellers, we may not be able to generate anticipated sales.
  • Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel.
  • If use of our products results in adverse events, this may require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
  • Various factors outside our direct control may adversely affect manufacturing, sterilization, and distribution of our products.
  • If we are not able to manage growth successfully, it could adversely affect our business, financial condition, and results of operations.
  • Unfavorable media reports or other negative publicity concerning both alleged improper methods of tissue recovery from donors and disease transmission from donated tissue could limit widespread acceptance of some of the products we market.
  • Natural disasters and man-made business disruptions such as war and terrorism could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • We may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results.
  • If we do not enhance and broaden our product offerings through our research and development efforts, we may be unable to compete effectively.
  • We are required to maintain adequate levels of inventory, the failure of which could consume our resources and reduce our cash flows.
  • The size and future growth in the market for minimally invasive sacroiliac fusion performed with a lateral approach, such as the iFuse procedure, has not been established with precision and may be smaller than we estimate, possibly materially. In addition, we estimate cost savings to the economy and healthcare system as a result of the iFuse procedure based on our market research. If our estimates and projections overestimate the size of this market or these benefits and cost savings, our sales growth may be adversely affected.
  • Our results of operations could suffer if we are unable to manage our international business effectively.
  • In the future our products may become obsolete, which would negatively affect operations and financial condition.
  • If our information technology systems or those third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business, impairment of our results of operations, reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • We have incorporated and continue to work to further incorporate artificial intelligence into our operations. Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our business.
  • 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.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the market price of our common shares.
  • Epidemic diseases, or the perception of their effects, may continue to adversely affect our business, financial condition, results of operations, or cash flows.
  • Risks Related to Our Legal and Regulatory Environment
  • We, our suppliers, and our third-party 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 sales representatives must comply with U.S. federal and state fraud and abuse laws, including those relating to healthcare provider kickbacks and false claims for reimbursement, and other applicable federal and state healthcare laws, as well as equivalent foreign laws, and failure to comply could negatively affect our business.
  • We are subject to risks associated with our non-U.S. operations.
  • Even if our products are approved by regulatory authorities or CE marked, if we, our contractors, or our suppliers fail to comply with ongoing FDA or other foreign regulatory 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, manufacturers, and third-party sales agents and resellers 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 products.
  • 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 another regulatory authority, including foreign regulatory authorities, or the discovery of serious safety issues or malfunctions with our products, can result in voluntary corrective actions or regulatory enforcement actions, which could have a significant adverse impact on us.
  • Modifications to our products may require new 510(k) clearances or premarket approvals and new conformity assessment by our Notified Body, or may require us to cease marketing or recall the modified products until clearances, approvals, or CE Certificates of Conformity are obtained.
  • There is no guarantee that the FDA will grant 510(k) clearance or premarket approval of our future products or that our Notified Body will issue the required CE Certificate of Conformity, and failure to obtain necessary clearances or approvals for our future products would adversely affect our business prospects.
  • We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.
  • The results of our clinical trials may not support our product candidate claims or may result in the occurrence of adverse events.
  • 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.
  • Certain of the products we market are derived from human tissue and are or could be subject to additional regulations and requirements.
  • Risks Related to Our Intellectual Property
  • If we or our licensors fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our ability to successfully commercialize our products may be impaired.
  • We may be subject to damages resulting from claims that we, our employees, or our third-party sales agents or resellers 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.
  • Risks Related to Ownership of Our Common Stock
  • The price of our common stock may be volatile, and the value of an investment in our common stock could decline.
  • Our sales volumes and our operating results may fluctuate over the course of the year, which could affect the price of our common stock.
  • We may be unable to utilize our federal and state net operating loss carryforwards to reduce our income taxes.
  • Our charter documents and Delaware law could discourage takeover attempts and lead to management entrenchment.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the U.S. federal district courts are the exclusive forums for substantially all disputes between us and our stockholders, which restricts our stockholders’ ability to bring a lawsuit against us or our directors, officers, or employees in jurisdictions other than Delaware and federal district courts.
  • Adverse developments affecting the banking industry or the broader financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity.
  • Our loan and security agreement contains covenants that may restrict our business and financing activities.
  • Our ability to access credit on favorable terms, if necessary, for the funding of our operations and capital projects may be limited due to changes in credit markets.

Legal proceedings

We may be subject to legal proceedings and claims in the ordinary course of business. We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and attention as well as the financial costs related to resolving such disputes.

The opening of Item 3, Legal Proceedings.7

Sources

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