PRCT on Nasdaq

PROCEPT BioRobotics Corp

In its 2026 annual report the company says: “We are a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH.”4 It is headquartered in San Jose, California.1 Its shares trade on Nasdaq under the symbol PRCT.1

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Last updated Oct 21, 2026.

Overview

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  • TickerPRCT on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersSan Jose, California1
  • Incorporated inDE2
  • Business address150 Baytech Drive, San Jose, Ca 951342
  • Filer categoryLarge accelerated filer2

We are a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. Each of our robotic systems employs a single-use disposable handpiece to deliver our proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. We designed our robotic systems to enable consistent and reproducible BPH surgery outcomes. We believe t…4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

63.7%Gross margin5
-33.7%Operating margin5
-31.0%Net margin5
37.2%Revenue growth, 20255
-26.1%Return on equity5
0.14×Debt to equity5
-$58.3MFree cash flow5

What sells

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

Regions

United States brought in 88% of the revenue PROCEPT BioRobotics Corp broke down this way in fiscal 2025.

  1. United States$270.4M588%up 35% from 2024
  2. Outside the United States$37.7M512%up 57% from 2024
Regions by year
Regions202320242025
United States$124.3M$200.5M$270.4M
Outside the United States$11.9M$24.0M$37.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue27¢$111.8M
  • Research and development17¢$71.3M
  • Selling, general and admin56¢$228.8M
  • Income tax0¢$190.0K

Out of $308.1M in revenue.5 The company lost money this year.

Financial statements

Revenue6785$308.1M in 2025+3892% since 2020
0$100.0M$200.0M$300.0M$400.0M2020: $7.7M$7.7M20202021: $34.5M$34.5M2021+347%2022: $75.0M$75.0M2022+118%2023: $136.2M$136.2M2023+82%2024: $224.5M$224.5M2024+65%2025: $308.1M$308.1M2025+37%
Gross profit6785$196.2M in 2025
-$50.0M0$50.0M$100.0M$150.0M$200.0M2020: -$1.3M-$1.3M20202021: $15.9M$15.9M20212022: $37.1M$37.1M2022+134%2023: $71.0M$71.0M2023+92%2024: $137.1M$137.1M2024+93%2025: $196.2M$196.2M2025+43%
Operating income6785-$103.9M in 2025+117% since 2020
-$150.0M-$100.0M-$50.0M02020: -$47.8M-$47.8M20202021: -$54.2M-$54.2M2021+13%2022: -$80.7M-$80.7M2022+49%2023: -$109.2M-$109.2M2023+35%2024: -$96.6M-$96.6M2024−12%2025: -$103.9M-$103.9M2025+7%
Net income6785-$95.6M in 2025+80% since 2020
-$150.0M-$100.0M-$50.0M02020: -$53.0M-$53.0M20202021: -$59.9M-$59.9M2021+13%2022: -$87.2M-$87.2M2022+46%2023: -$105.9M-$105.9M2023+22%2024: -$91.4M-$91.4M2024−14%2025: -$95.6M-$95.6M2025+5%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Revenue$308.1M$224.5M$136.2M
Cost of sales$111.8M$87.4M$65.1M
Gross profit$196.2M$137.1M$71.0M
Research and development$71.3M$62.3M$48.4M
Selling, general and administrative$228.8M$171.4M$131.8M
Total operating expenses$300.1M$233.7M$180.2M
Loss from operations-$103.9M-$96.6M-$109.2M
Interest expense-$3.6M-$4.2M-$4.0M
Interest and other income (expenses), net$12.1M$9.8M$7.3M
Loss before income taxes-$95.4M-$91.0M-$105.8M
Provision for income taxes$190.0K$368.0K$80.0K
Net loss-$95.6M-$91.4M-$105.9M
Net loss per share, basic (in dollars per share)-$1.72-$1.75-$2.24
Net loss per share, diluted (in dollars per share)-$1.72-$1.75-$2.24
Basic (in shares)55.5M shares52.1M shares47.3M shares
Diluted (in shares)55.5M shares52.1M shares47.3M shares
Foreign currency translation adjustment-$77.0K$0$0
Unrealized gain on cash equivalents$0$30.0K$90.0K
Comprehensive loss-$95.6M-$91.4M-$105.8M

Compare PROCEPT BioRobotics Corp with another company

Corporate structure

PROCEPT BioRobotics Corp sits at the top of its group. 3 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PROCEPT BioRobotics Corp

  • BlackRock Filed SCHEDULE 13G/A on PROCEPT BioRobotics Corp, latest Jul 29, 2026 (2 filings since Jan 26, 2024)
  • AllianceBernstein Filed SCHEDULE 13G/A on PROCEPT BioRobotics Corp, latest May 18, 2026 (2 filings since Nov 14, 2025)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on PROCEPT BioRobotics Corp, latest Apr 30, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on PROCEPT BioRobotics Corp, latest Mar 27, 2026 (5 filings since Feb 9, 2023)
  • FMR LLC Filed SCHEDULE 13G/A on PROCEPT BioRobotics Corp, latest Mar 6, 2026 (6 filings since Feb 9, 2022)
  • T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G on PROCEPT BioRobotics Corp, latest Feb 17, 2026 (4 filings since Feb 14, 2023)
  • BNP Paribas Asset Management Holding S.A. Filed SCHEDULE 13G on PROCEPT BioRobotics Corp, latest Feb 11, 2026
  • CPMG Inc Filed SC 13D/A on PROCEPT BioRobotics Corp, latest May 22, 2024 (6 filings since Sep 8, 2022)
  • VIKING GLOBAL INVESTORS LP Filed SC 13G/A on PROCEPT BioRobotics Corp, latest Feb 14, 2023 (3 filings since Feb 14, 2022)
  • PROCEPT BioRobotics Corp San Jose, California
    • PROCEPT BioRobotics K.K. Subsidiary · Japan
    • PROCEPT BioRobotics UK Ltd. Subsidiary · United Kingdom

Built from 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 PROCEPT BioRobotics Corp 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$43.2M5 Dec 31, 2025$34.5M5 Dec 31, 2024+24.9%
Accumulated depreciation$12.8M5 Dec 31, 2025$7.8M5 Dec 31, 2024+62.9%
Property and equipment, net$30.4M5 Dec 31, 2025$26.7M5 Dec 31, 2024+13.8%
Operating-lease assets (leased space)$17.5M5 Dec 31, 2025$18.9M5 Dec 31, 2024−7.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$286.5M5 Dec 31, 2025$333.7M5 Dec 31, 2024−14.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Accumulated amortization$1.8M5 Dec 31, 2025$1.6M5 Dec 31, 2024+12.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$70.7M5 Dec 31, 2025$56.2M5 Dec 31, 2024+25.9%
Raw materials$18.6M5 Dec 31, 2025$18.2M5 Dec 31, 2024+2.4%
Work in process$13.4M5 Dec 31, 2025$11.5M5 Dec 31, 2024+17.4%
Finished goods$38.6M5 Dec 31, 2025$26.5M5 Dec 31, 2024+45.6%

Properties, in its own words

Our principal office is located at 150 Baytech Drive, San Jose, California, where we lease approximately 158,221 square feet of office space. The principal office lease commenced in July 2022, and will continue for 122 months thereafter, with two five-year options to extend the term of the lease.

Item 2 of the 10-K filed Feb 26, 2026.4

Leadership

Who has led PROCEPT BioRobotics Corp, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (16)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • PROCEPT BioRobotics GmbH Germany3
  • PROCEPT BioRobotics K.K. Japan3
  • PROCEPT BioRobotics UK Ltd. United Kingdom3

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

Timeline

  1. Oct 2, 20268-K Executive or director change30
  2. Sep 24, 20268-K Entered a material agreement31
  3. Aug 4, 20268-K Results of operations32
  4. Jun 10, 20268-K Shareholder vote33
  5. Apr 29, 20268-K Results of operations34
  6. Mar 6, 20268-K Executive or director change35
  7. Feb 26, 20268-K Regulation FD disclosure36
  8. Feb 25, 20268-K Results of operations37
  9. Nov 4, 20258-K Results of operations38
  10. Sep 18, 20258-K Executive or director change39
  11. Sep 4, 2025New chief executive Larry L. Wood becomes CEO12
  12. Aug 6, 20258-K Results of operations40
  13. Jul 25, 20258-K Results of operations; Executive or director change; Regulation FD disclosure41
  14. Sep 14, 2021New chief executive Reza Zadno becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.38) a share, on Nov 4, 2025.42

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results32
  2. Apr 29, 2026Reported quarterly or annual results34
  3. Feb 25, 2026Reported quarterly or annual results37
  4. Nov 4, 2025Reported quarterly or annual results38
  5. Aug 6, 2025Reported quarterly or annual results40
  6. Jul 25, 2025Reported quarterly or annual results41
  7. Apr 24, 2025Reported quarterly or annual results43
  8. Feb 25, 2025Reported quarterly or annual results44

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

Filings

339 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 47 major events, 173 insider forms, 30 large holders, 67 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 5, 20263 EDGAR
  3. Oct 2, 20268-K EDGAR
  4. Sep 24, 20268-K EDGAR
  5. Sep 10, 20264 EDGAR
  6. Sep 10, 20264 EDGAR
  7. Sep 10, 20264 EDGAR
  8. Sep 9, 2026144 EDGAR
  9. Sep 9, 2026144 EDGAR
  10. Sep 9, 2026144 EDGAR
  11. Aug 14, 20264 EDGAR
  12. Aug 14, 20264 EDGAR
  13. Aug 14, 20264 EDGAR
  14. Aug 14, 20264 EDGAR
  15. Aug 10, 20264 EDGAR
  16. Aug 5, 202610-Q EDGAR
  17. Aug 4, 20268-K EDGAR
  18. Jul 29, 2026SCHEDULE 13G/A EDGAR
  19. Jun 10, 20264 EDGAR
  20. Jun 10, 20264 EDGAR

The 339 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

97 open-market trades by officers, directors and large owners since October 2021: 6 buys and 91 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026Waters KevinEVP, CFOSale373$20.95$7.8KForm 4
Sep 9, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale297$20.95$6.2KForm 4
Sep 9, 2026Templin Barry LEVP, Chief Technology OfficerSale373$20.95$7.8KForm 4
Aug 7, 2026Wood Larry LPresident, CEOBuy23,900$20.85$498.3KForm 4
Jun 8, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale285$28.48$8.1KForm 4
Jun 8, 2026Waters KevinEVP, CFOSale357$28.48$10.2KForm 4
Jun 8, 2026Templin Barry LEVP, Chief Technology OfficerSale358$28.48$10.2KForm 4
Mar 19, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale5,363$25.96$139.2KForm 4
Mar 17, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale304$28.15$8.6KForm 4
Mar 17, 2026Waters KevinEVP, CFOSale706$28.15$19.9KForm 4
Mar 10, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale3,243$25.65$83.2KForm 4
Mar 9, 2026Desai Antal RohitDirectorBuy98,699$24.55$2.4MForm 4
Mar 6, 2026Nouri AlalehEVP, CLO, CORP. SEC.Sale6,892$23.70$163.3KForm 4
Mar 6, 2026Waters KevinEVP, CFOSale6,721$23.70$159.3KForm 4
Mar 6, 2026Desai Antal RohitDirectorBuy160,317$23.59$3.8MForm 4
Mar 5, 2026Desai Antal RohitDirectorBuy167,246$25.58$4.3MForm 4
Aug 13, 2025MOLL FREDERIC HDirectorBuy20,000$39.26$785.2KForm 4
Jun 12, 2025Desai Antal RohitDirectorSale25,000$61.49$1.5MForm 4
Jun 11, 2025Desai Antal RohitDirectorSale25,000$63.38$1.6MForm 4
Jun 10, 2025Desai Antal RohitDirectorSale25,000$63.91$1.6MForm 4

All 97 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
2025Larry L. WoodPresident & Chief Executive Officer60$304.8K$16.8M54
2025Reza Zadno, Ph.D.Former President & Chief Executive Officer$471.3K$6.8M54
2025Kevin WatersEVP, Chief Financial Officer48$502.2K$2.8M54
2025Alaleh NouriEVP, Chief Legal Officer & Corporate Secretary47$471.5K$2.3M54
2025Hisham ShiblaqFormer EVP, Chief Commercial Officer$336.0K$2.0M54
2024Reza Zadno, Ph.D.Former President & Chief Executive Officer$671.9K$6.5M54
2024Hisham ShiblaqFormer EVP, Chief Commercial Officer$477.5K$3.6M54
2024Alaleh NouriEVP, Chief Legal Officer & Corporate Secretary47$448.8K$2.7M54
2024Kevin WatersEVP, Chief Financial Officer48$482.5K$2.2M54
2023Reza Zadno, Ph.D.Former President & Chief Executive Officer$612.6K$6.1M54
2023Kevin WatersEVP, Chief Financial Officer48$448.8K$2.7M54
2023Hisham ShiblaqFormer EVP, Chief Commercial Officer$430.0K$2.6M54
2023Alaleh NouriEVP, Chief Legal Officer & Corporate Secretary47$410.8K$2.2M54

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
BlackRock, Inc.4,869,828$110.0M0.0%+507,826
BNP PARIBAS ASSET MANAGEMENT Holding S.A.2,823,849$63.8M0.1%−265,529
Vanguard Portfolio Management LLC2,526,802$57.1M0.0%+105,440
Vanguard Capital Management LLC2,460,802$55.6M0.0%+61,735
Chicago Capital, LLC2,073,237$46.8M1.1%−87,350
State Street Corp1,617,475$36.5M0.0%+87,844
Geode Capital Management, LLC1,484,163$33.5M0.0%+120,663
Fmr LLC1,444,878$32.6M0.0%−17,026
Wellington Management Group Llp1,274,004$28.8M0.0%+412,399
Federated Hermes, Inc.1,253,420$28.3M0.0%+1,078,984
Jupiter Topco LLC1,103,404$24.9M0.0%New
Frontier Capital Management Co LLC1,091,528$24.6M0.2%+481,671
Soleus Capital Management, L.P.1,003,000$22.6M0.8%+843,000
Champlain Investment Partners, LLC981,381$22.2M0.6%−154,941
Baillie Gifford & Co911,751$20.6M0.0%−61,751
Fiera Capital Corp774,569$17.5M0.1%−193,026
LMR Partners LLP721,608$16.3M0.1%New
William Blair Investment Management, LLC709,484$16.0M0.0%+285,175
Artisan Partners Limited Partnership682,588$15.4M0.0%−504,761
Millennium Management LLC624,312$14.1M0.0%−381,146
Morgan Stanley605,407$13.7M0.0%−372,000
Northern Trust Corp597,549$13.5M0.0%+45,531
Blair William & Co/il531,724$12.0M0.0%+207,789
New York State Common Retirement Fund524,358$11.8M0.0%+84,302
Bank Of America Corp /de/516,198$11.7M0.0%−114,491

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

SEC filer profile

How PROCEPT BioRobotics Corp is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARPROCEPT BioRobotics Corp1
  • CIK0001588978
  • Employer ID (EIN)26-01991804
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • 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 address150 Baytech Drive, San Jose, CA 951341
  • Phone65023298321
  • Shares outstanding57,273,659 as of Jul 31, 202610
  • Public float$3.2B as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceOct 15, 20131
  • Filings394 in all: 4 (178), 8-K (48), 144 (44), 3 (16), 10-Q (15), SC 13G/A (10), D (7), S-8 (6)1
    All 36 form types

    SC 13D/A (6), SC 13G (6), 10-K (5), CORRESP (5), DEF 14A (5), DEFA14A (5), SCHEDULE 13G/A (5), 424B5 (4), SCHEDULE 13G (4), 4/A (3), SD (3), UPLOAD (3), 10-K/A (1), 10-Q/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), DRS/A (1), DRSLTR (1), EFFECT (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Oct 2, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.00001 par value per sharePRCTNasdaq Global Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks PROCEPT BioRobotics Corp names in Item 1A of its 10-K filed Feb 26, 2026: 74 risks under these headings, as written.4

  • Risks Related to Our Business
  • We have a history of significant net losses, we expect to continue to incur operating losses for the foreseeable future and we may not be able to achieve or sustain profitability.
  • Our revenue is primarily generated from sales of our robotic systems and the accompanying single-use disposable handpieces, and we are therefore highly dependent on the success of those products.
  • Our quarterly and annual operating results may fluctuate significantly and may not fully reflect the underlying performance of our business. This makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • The terms of our loan and security agreement require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • We may need additional funding to finance our planned operations, and may not be able to raise capital when needed, which could force us to delay, reduce or eliminate one or more of our product development programs and future commercialization efforts.
  • The commercial success of our products will depend upon the degree of market acceptance of our products among hospitals, surgeons and patients.
  • We have limited experience in training and marketing and selling our products and we may provide inadequate training, fail to increase our sales and marketing capabilities or fail to develop and maintain broad brand awareness in a cost-effective manner.
  • We rely on third-party distributors to effectively distribute our products in certain markets.
  • We may not be able to maintain adequate levels of third-party coverage and reimbursement, and third parties may rescind or modify their coverage or delay payments related to our products.
  • We face competition from many sources, including larger companies, and we may be unable to compete successfully.
  • If we are unable to continue to innovate and improve our products, we could lose customers or market share.
The other 63 risks
  • We have limited experience manufacturing our products in large-scale commercial quantities, and we face a number of manufacturing risks that may adversely affect our manufacturing abilities which could delay, prevent or impair our growth.
  • We depend upon third-party suppliers, including contract manufacturers and single source suppliers, making us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.
  • If we receive a significant number of warranty claims or our products require significant amounts of service after sale, our operating expenses may substantially increase, and our business and financial results will be adversely affected.
  • We need to ensure strong product performance and reliability to maintain and grow our business.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our products.
  • We may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our products and manage our inventory.
  • Our information technology systems, or those used by third party service providers, partners, our contractors or consultants, may fail or suffer security breaches, and such failure could negatively affect our business, financial condition and results of operations.
  • The use of artificial intelligence in our business, including in our products and internally by our employees or business partners, may expose us to additional legal, regulatory and other risks that could adversely affect our business.
  • Actual or perceived failure to comply with data protection, privacy and security laws, regulations, standards and other requirements could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • Natural or man-made disasters and other similar catastrophic events outside of our control may significantly disrupt our business, and negatively impact our business, financial condition and results of operations.
  • The sizes of the addressable markets for our products have not been established with precision and our potential market opportunity may be smaller than we estimate and may decline.
  • Until we are able to achieve broader market acceptance of our products, we may face risks associated with a more concentrated customer base.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our products. The expense and potential unavailability of insurance coverage for liabilities resulting from our products could harm us and our ability to sell our products.
  • Cost-containment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales and profitability.
  • We may seek strategic alliances, joint ventures or collaborations, or enter into licensing or partnership arrangements in the future and may not be successful in doing so, and even if we are, we may not realize the benefits or costs of such relationships.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Changes in United States trade policy, including the imposition of tariffs and the resulting consequences, may have a material adverse impact on our business and results of operations.
  • We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
  • We could be adversely affected by violations of the FCPA and similar worldwide anti-bribery laws, as well as violations of export or import controls or economic sanctions laws and regulations. Any investigation, and the outcome of any investigation, by government agencies of possible violations by us of such laws and regulations could have a material adverse effect on our business.
  • Our ability to utilize our net operating loss carryforwards and research and development credit may be limited.
  • We may acquire other businesses which could require significant management attention, disrupt our business, dilute stockholder value and adversely affect our results of operations.
  • Risks Related to Governmental Regulation
  • Changes to the reimbursement rates for our products and procedures utilizing our products, as well as measures to reduce healthcare costs may adversely impact our business.
  • Healthcare reform measures could hinder or prevent the commercial success of our products.
  • We must comply with anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations.
  • Our robotic systems and our operations are subject to extensive government regulation and oversight in the United States. If we fail to maintain necessary marketing authorizations for our robotic systems, or if approvals or clearances for future products or modifications to existing products are delayed or not issued, it will negatively affect our business, financial condition and results of operations.
  • Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products that will be accepted by the market in a timely manner. There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our future products on a timely basis, if at all, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
  • Modifications to our marketed products may require new 510(k) clearances, or may require us to cease marketing or recall the modified products until clearances or approvals are obtained.
  • Even though we have obtained marketing authorization for our products, 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 may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are 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 and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.
  • Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.
  • We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our products.
  • Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute our products after clearance or approval is obtained.
  • Clinical trials may be necessary to support future product submissions to the FDA. The clinical trial process is lengthy and expensive with uncertain outcomes, and often requires the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new products and will adversely affect our business, operating results and prospects.
  • If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as required or expected, we may not be able to obtain regulatory clearance or approval for or commercialize our products.
  • Changes in funding or disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, collaborators, independent contractors and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We must comply with environmental and occupational safety laws.
  • Risks Related to Our Intellectual Property
  • We have to obtain, maintain and protect our intellectual property and failure to do so may adversely impact our competitive position.
  • 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.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful, and if unsuccessful, the commercial value of our products and services will be adversely affected and our competitive position may be harmed.
  • We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture and/or commercialize our current and/or future products or services.
  • We may be subject to claims challenging the ownership or inventorship of our patents and other intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization of our current and future products.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • We may be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products or services, 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.
  • If our trademarks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.
  • We may become a party to intellectual property litigation or administrative proceedings that could be expensive, time-consuming, unsuccessful, and could interfere with our ability to sell and market our products or services.
  • Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell our current or future products and services, and subject us to possible litigation.
  • Intellectual property rights do not necessarily address all potential threats.
  • Patents covering our products could be found invalid or unenforceable if challenged in court or before administrative bodies globally.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We heavily depend on intellectual property licensed from third parties and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated, or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock may be volatile or may decline steeply or suddenly regardless of our operating performance, which could result in substantial losses for holders of our common stock, and we may not be able to meet investor or analyst expectations.
  • We do not intend to pay dividends for the foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • Future securities issuances could result in significant dilution to our stockholders and impair the market price of our common stock.
  • Delaware law and provisions in our amended and restated certificate of incorporation and bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
  • Risks Related to Being a Public Company
  • If we are not able to maintain adequate internal control over financial reporting, or if we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating results and the trading price of our common stock could decline.
  • If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information.
  • The requirements of being a public company may strain our resources, result in more litigation, and divert management’s attention.
  • General Risks
  • Litigation and other legal proceedings may adversely affect our business.
  • General economic and financial market conditions may exacerbate our business risks.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputation harm, and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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