CLPT on Nasdaq

ClearPoint Neuro, Inc.

In its 2026 annual report the company says: “We are a commercial-stage medical device company, incorporated in 1998 as a Delaware corporation, that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain.”4 It is headquartered in Solana Beach, California.1 Its shares trade on Nasdaq under the symbol CLPT.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCLPT on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersSolana Beach, California1
  • Incorporated inDE2
  • Business address120 S. Sierra Avenue, Suite 100, Solana Beach, Ca 920752
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

We are a commercial-stage medical device company, incorporated in 1998 as a Delaware corporation, that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain. From our inception in 1998, we have deployed significant resources to fund our efforts to develop the foundational capabilities for enabling magnetic resonance imaging (“MRI”) guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies we develop. In 2021, our efforts expanded beyond the MRI suite to encompass development and commercialization of neurosurgical device products for the operating room setting, as well as consulting services for pharmaceutical companies.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

61.4%Gross margin5
-65.4%Operating margin5
-69.1%Net margin5
17.8%Revenue growth, 20255
-91.1%Return on equity5
1.75×Debt to equity5
-$24.4MFree cash flow6

What sells

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

Products and services

Biologics And Drug Delivery - Services And License Fees brought in 43% of the revenue ClearPoint Neuro, Inc. broke down this way in fiscal 2025.

  1. Biologics And Drug Delivery - Services And License Fees$11.7M543%down 0% from 2024
  2. Biologics and Drug Delivery - Disposable Products$7.3M527%up 31% from 2024
  3. Capital Equipment and Software Revenue$3.1M511%down 18% from 2024
  4. Capital Equipment and Software-Related Service$2.1M58%down 9% from 2024
  5. Capital Equipment and Software - Systems and Software Products$1.7M56%down 38% from 2024
  6. Capital Equipment and Software - Services$1.4M55%up 33% from 2024
Products and services by year
Products and services20242025
Biologics And Drug Delivery - Services And License Fees$11.7M$11.7M
Biologics and Drug Delivery - Disposable Products$5.6M$7.3M
Capital Equipment and Software Revenue$3.8M$3.1M
Capital Equipment and Software-Related Service$2.3M$2.1M
Capital Equipment and Software - Systems and Software Products$2.7M$1.7M
Capital Equipment and Software - Services$1.1M$1.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue32¢$14.3M
  • Research and development31¢$13.9M
  • Selling, general and admin37¢$16.5M
  • Income tax0¢$55.0K

Out of $37.0M in revenue.5 The company lost money this year.

Financial statements

Revenue78910115$37.0M in 2025+230% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $11.2M$11.2M20192020: $12.8M$12.8M2020+14%2021: $16.3M$16.3M2021+27%2022: $20.6M$20.6M2022+26%2023: $24.0M$24.0M2023+17%2024: $31.4M$31.4M2024+31%2025: $37.0M$37.0M2025+18%
Gross profit8910115$22.7M in 2025+149% since 2020
0$10.0M$20.0M$30.0M2020: $9.1M$9.1M20202021: $11.1M$11.1M2021+22%2022: $13.5M$13.5M2022+22%2023: $13.6M$13.6M2023+1%2024: $19.1M$19.1M2024+40%2025: $22.7M$22.7M2025+19%
Operating income78910115-$24.2M in 2025+426% since 2019
-$30.0M-$20.0M-$10.0M02019: -$4.6M-$4.6M20192020: -$6.2M-$6.2M2020+35%2021: -$13.4M-$13.4M2021+115%2022: -$16.3M-$16.3M2022+22%2023: -$22.4M-$22.4M2023+37%2024: -$19.7M-$19.7M2024−12%2025: -$24.2M-$24.2M2025+22%
Net income78910115-$25.5M in 2025+361% since 2019
-$30.0M-$20.0M-$10.0M02019: -$5.5M-$5.5M20192020: -$6.8M-$6.8M2020+22%2021: -$14.4M-$14.4M2021+112%2022: -$16.4M-$16.4M2022+14%2023: -$22.1M-$22.1M2023+34%2024: -$18.9M-$18.9M2024−14%2025: -$25.5M-$25.5M2025+35%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenue$37.0M$31.4M
Cost of revenue$14.3M$12.3M
Gross profit$22.7M$19.1M
Research and development costs$13.9M$12.4M
Sales and marketing expenses$16.5M$14.5M
General and administrative expenses$16.5M$12.0M
Operating loss-$24.2M-$19.7M
Other expense, net-$146.0K-$40.0K
Interest income$1.2M$1.4M
Interest expense-$2.4M-$518.0K
Net loss before income taxes-$25.5M-$18.9M
Income tax expense$55.0K$12.0K
Net loss-$25.5M-$18.9M
Basic (in dollars per share)-$0.90-$0.70
Diluted (in dollars per share)-$0.90-$0.70
Basic (in shares)28.3M shares27.0M shares
Diluted (in shares)28.3M shares27.0M shares

Compare ClearPoint Neuro, Inc. with another company

Corporate structure

ClearPoint Neuro, Inc. sits at the top of its group. 8 entities, 6 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ClearPoint Neuro, Inc.

  • MAK CAPITAL ONE LLC Filed SCHEDULE 13G/A on ClearPoint Neuro, Inc., latest Aug 12, 2026
  • BIGGER CAPITAL FUND L P Filed SCHEDULE 13G/A on ClearPoint Neuro, Inc., latest Aug 4, 2026 (9 filings since Jan 26, 2022)
  • BlackRock Filed SCHEDULE 13G/A on ClearPoint Neuro, Inc., latest Jul 27, 2026 (4 filings since Jan 29, 2024)
  • MAK Capital Fund LP Filed SCHEDULE 13G/A on ClearPoint Neuro, Inc., latest May 15, 2026 (2 filings since Mar 13, 2026)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on ClearPoint Neuro, Inc., latest Mar 26, 2026 (5 filings since Feb 13, 2024)
  • Bigger Capital, LLC Filed SC 13G/A on ClearPoint Neuro, Inc., latest Nov 8, 2024 (2 filings since Feb 6, 2024)
  • PTC Therapeutics Filed SC 13D/A on ClearPoint Neuro, Inc., latest Aug 27, 2024 (2 filings since Jun 15, 2023)
  • ClearPoint Neuro, Inc. Solana Beach, California
    • ClearPoint Holdings, LLC Subsidiary · Delaware, United States
    • ClearPoint Neuro (Canada) Inc. Subsidiary · Canada
    • ClearPoint Neuro Germany GmbH. Subsidiary · Germany
    • ClearPoint Neuro Italy, S.r.l. Subsidiary · Italy
    • ClearPoint Neuro UK Ltd Subsidiary · United Kingdom
    • IRRAS USA, Inc. Subsidiary · Delaware, United States
    • IRRAS, AB Subsidiary · Sweden

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 ClearPoint Neuro, 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.3M5 Dec 31, 2025$3.3M5 Dec 31, 2024+29.6%
Accumulated depreciation$1.7M5 Dec 31, 2025$1.3M5 Dec 31, 2024+27.8%
Property and equipment, net$2.6M5 Dec 31, 2025$2.0M5 Dec 31, 2024+30.7%
Operating-lease assets (leased space)$8.4M5 Dec 31, 2025$3.1M5 Dec 31, 2024+173.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$45.9M5 Dec 31, 2025$20.1M5 Dec 31, 2024+128.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$7.5M5 Dec 31, 2025$05 Dec 31, 2024
Intangible assets, net (excluding goodwill)$13.9M5 Dec 31, 2025$05 Dec 31, 2024
Finite-lived intangibles, gross$14.1M5 Dec 31, 2025
Accumulated amortization$168.0K5 Dec 31, 2025
Finite-lived intangibles, net$13.9M5 Dec 31, 2025

Inventory

ItemLatestA year beforeChange
Inventory, total$8.4M5 Dec 31, 2025$6.9M5 Dec 31, 2024+21.8%
Work in process$5.5M11 Dec 31, 2024$6.5M11 Dec 31, 2023−14.9%
Finished goods$4.8M5 Dec 31, 2025$3.6M5 Dec 31, 2024+33.0%

Properties, in its own words

We lease approximately 7,500 square feet of space in Solana Beach, California, which serves as our corporate headquarters and houses certain management and research-and-development personnel. We also lease an approximately 20,000 square-foot industrial building in Carlsbad, California to use as an office and manufacturing facility. In 2025, we entered into a lease of approximately 30,000 square feet of space within a life science building in San Diego, California to perform research and development services for our pharmaceutical and biotech customers. In connection with the IRRAS acquisition, we also assumed a lease for a facility located in San Diego, California, consisting of approximately 21,200 square feet used for manufacturing and office purposes. We believe that these facilities are sufficient to meet our current purposes, and that additional space can be obtained on commercially reasonable terms as needed.

Item 2 of the 10-K filed Mar 17, 2026.4

Leadership

Who has led ClearPoint Neuro, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (25)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorMatthew B. Klein named Feb 5, 202645

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ClearPoint Holdings, LLC Delaware3
  • ClearPoint Neuro (Canada) Inc. Canada (New Brunswick)3
  • ClearPoint Neuro Germany GmbH. Germany3
  • ClearPoint Neuro Italy, S.r.l. Italy3
  • ClearPoint Neuro UK Ltd United Kingdom3
  • IRRAS USA, Inc. Delaware3
  • IRRAS, AB Sweden3

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

Former names

  • MRI INTERVENTIONS, INC.Jul 15, 2011 to Feb 11, 20202
  • SURGIVISION INCNov 6, 2009 to Oct 22, 20102
  • SURGI VISION INCMar 30, 2004 to May 2, 20072

Timeline

  1. Aug 3, 20268-K Results of operations; Regulation FD disclosure46
  2. May 21, 20268-K Executive or director change; Shareholder vote47
  3. May 13, 20268-K Results of operations; Regulation FD disclosure48
  4. Mar 17, 20268-K Results of operations; Regulation FD disclosure49
  5. Feb 5, 20268-K Financial statements and exhibits50
  6. Jan 12, 20268-K Results of operations51
  7. Jan 5, 20268-K Entered a material agreement; New debt or obligation52
  8. Nov 20, 20258-K Entered a material agreement; Completed an acquisition or sale; Unregistered sale of shares53
  9. Nov 6, 20258-K Entered a material agreement; Regulation FD disclosure54
  10. Nov 6, 20258-K Results of operations; Regulation FD disclosure55
  11. Aug 12, 20258-K Results of operations; Regulation FD disclosure56
  12. Jun 17, 20258-K Entered a material agreement57
  13. Nov 7, 2017New chief executive Joseph Michael Burnett becomes CEO14
  14. Aug 17, 2015New chief executive Francis P. Grillo becomes CEO15
  15. Feb 27, 2012New chief executive Kimble L. Jenkins becomes CEO16

Calendar

Coming up

  1. Oct 28, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.21) a share, on Nov 6, 2025.58

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results46
  2. May 13, 2026Reported quarterly or annual results48
  3. Mar 17, 2026Reported quarterly or annual results49
  4. Jan 12, 2026Reported quarterly or annual results51
  5. Nov 6, 2025Reported quarterly or annual results55
  6. Aug 12, 2025Reported quarterly or annual results56
  7. May 13, 2025Reported quarterly or annual results59
  8. Feb 26, 2025Reported quarterly or annual results60

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

Filings

396 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 51 major events, 254 insider forms, 25 large holders, 1 private raises, 45 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Sep 3, 20264 EDGAR
  4. Aug 12, 2026SCHEDULE 13G/A EDGAR
  5. Aug 4, 2026SCHEDULE 13G/A EDGAR
  6. Aug 3, 202610-Q EDGAR
  7. Aug 3, 20268-K EDGAR
  8. Jul 27, 2026SCHEDULE 13G/A EDGAR
  9. Jul 6, 20264 EDGAR
  10. Jul 6, 20264 EDGAR
  11. Jul 2, 20264 EDGAR
  12. Jul 2, 20264 EDGAR
  13. Jul 2, 20264 EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jun 29, 2026144 EDGAR
  16. Jun 22, 20264 EDGAR
  17. Jun 17, 2026144 EDGAR
  18. Jun 17, 2026144 EDGAR
  19. Jun 8, 20264 EDGAR
  20. Jun 2, 20264 EDGAR

The 396 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

14 open-market trades by officers, directors and large owners since October 2021: 0 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 29, 2026BURNETT JOSEPHCEO and PresidentSale20,000$19.38$387.6KForm 4
Jun 17, 2026BURNETT JOSEPHCEO and PresidentSale61,843$17.79$1.1MForm 4
Jun 1, 2026Richards Timothy T.DirectorSale5,415$12.17$65.9KForm 4
May 21, 2026Klein Matthew B.DirectorSale16,000$11.59$185.4KForm 4
May 20, 2026FALLON LYNNETTE CDirectorSale5,091$11.14$56.7KForm 4
Feb 25, 2026BURNETT JOSEPHCEO and PresidentSale19,951$15.17$302.7KForm 4
Jan 26, 2026BURNETT JOSEPHCEO and PresidentSale2,943$15.57$45.8KForm 4
Jan 9, 2026BURNETT JOSEPHCEO and PresidentSale20,000$16.12$322.4KForm 4
Oct 10, 2025BURNETT JOSEPHCEO and PresidentSale26,463$26.98$714.0KForm 4
Jun 10, 2025Richards Timothy T.DirectorSale10,000$13.28$132.8KForm 4
Jun 9, 2025BURNETT JOSEPHCEO and PresidentSale21,247$13.29$282.4KForm 4
Jun 3, 2025FALLON LYNNETTE CDirectorSale10,200$12.57$128.2KForm 4
Aug 15, 2022BURNETT JOSEPH MICHAELCEO and PresidentSale18,867$16.07$303.2KForm 4
Nov 11, 2021BURNETT JOSEPH MICHAELCEO and PresidentSale10,000$16.88$168.8KForm 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.

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
2025Joseph M. Burnett$584.2K$2.8M68
2025Danilo D’Alessandro$385.8K$1.3M68
2025Jeremy L. Stigall$365.4K$1.1M68
2024Chief Executive Officer$537.7K$2.5M68
2024Chief Financial Officer$351.8K$1.2M68
2024Chief Business Officer$326.5K$1.1M68

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Nov 20, 2025Raised $17.9 million in a private offering of equity Form D: 46 investors so far 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.2,379,804$42.5M0.0%+297,054
Mak Capital One LLC2,375,861$42.4M5.9%+474,372
Vanguard Capital Management LLC1,232,807$22.0M0.0%−10,808
State Street Corp816,547$14.6M0.0%+136,728
Geode Capital Management, LLC749,932$13.4M0.0%+44,212
Lane Generational LLC444,831$7.9M7.0%−42,018
UBS Group AG428,632$7.6M0.0%−3,728
Millennium Management LLC357,676$6.4M0.0%+125,702
Brown Advisory Inc325,906$5.8M0.0%No change
Compass Financial Management LLC295,680$5.3M0.6%New
Susquehanna International Group, Llp240,282$4.3M0.0%+103,998
Northern Trust Corp230,986$4.1M0.0%+21,560
Pier Capital, LLC222,761$4.0M0.5%New
Vanguard Fiduciary Trust Co213,246$3.8M0.0%+7,491
Vanguard Portfolio Management LLC194,584$3.5M0.0%−90,225
Tudor Investment Corp Et Al173,759$3.1M0.0%+16,788
Morgan Stanley165,786$3.0M0.0%+35,914
Two Sigma Investments, LP154,851$2.8M0.0%−55,929
Bank of New York Mellon Corp151,767$2.7M0.0%+8,020
Parsons Capital Management Inc/ri148,976$2.7M0.1%−194
Pekin Hardy Strauss, Inc.143,375$2.6M0.2%+3,000
Goldman Sachs Group Inc138,911$2.5M0.0%−324,706
Taylor Frigon Capital Management LLC132,009$2.4M1.1%+108
CM Management, LLC125,000$2.2M1.4%−25,000
Diametric Capital, LP123,293$2.2M0.2%New

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

SEC filer profile

How ClearPoint Neuro, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARClearPoint Neuro, Inc.1
  • CIK0001285550
  • Employer ID (EIN)58-23946284
  • Filer statusNon-accelerated filer not an emerging growth company; 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 address120 S. Sierra Avenue, Suite 100, Solana Beach, CA 920751
  • Phone94990068331
  • Shares outstanding30,504,227 as of Jul 27, 20266
  • Public float$328.0M as of Jun 30, 20254
  • AuditorCherry Bekaert LLP, Tampa, Florida PCAOB ID 677; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceMar 30, 20041
  • Filings1,289 in all: 4 (650), 8-K (203), 424B3 (74), 10-Q (44), 3 (33), EFFECT (22), S-1/A (20), CORRESP (17)1
    All 46 form types

    144 (16), DEF 14A (15), 10-K (14), D (14), UPLOAD (14), SC 13G/A (13), POS AM (11), S-8 (11), SCHEDULE 13G/A (11), S-1 (9), SC 13G (9), CT ORDER (7), SC 13D (7), REGDEX (6), SC 13D/A (6), 424B5 (5), 10-12G/A (4), 10-Q/A (4), 8-A12B (4), ARS (4), DEFA14A (4), PRE 14A (4), RW (4), S-3 (4), 4/A (3), CERTNAS (3), REGDEX/A (3), SCHEDULE 13G (3), 10-K/A (2), 5 (2), CERT (2), D/A (2), 10-12G (1), 144/A (1), 25 (1), 424B2 (1), 8-K/A (1), AW (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 3, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Aug 3, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par value per shareCLPTNasdaq

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks ClearPoint Neuro, Inc. names in Item 1A of its 10-K filed Mar 17, 2026: 57 risks under these headings, as written.4

  • example only and are not intended to be a complete listing or a representation as to whether or not the factors,events or contingencies discussed below have occurred in the past or their likelihood of occurring in the future.
  • Risks Related to Our Business and Industry
  • Our business, financial condition, and results of operations may be adversely affected by general economic and financial market conditions and current and future social and geopolitical instability.
  • We may fail to realize the anticipated benefits of our acquisition of IRRAS, and the combined company may not perform as we or the market expect, which could adversely affect our business, results of operations, and the price of our common stock.
  • If we cannot maintain our current relationships or programs, or enter into new relationships or programs, with drug delivery customers, our revenue prospects could be meaningfully reduced.
  • The sizes of the markets for our products and services and any future products and services may be smaller than we estimate and may decline.
  • Our ClearPoint system and our IRRAflow system may not achieve broad market adoption.
  • Our future business growth is dependent on our ability to market and sell both the ClearPoint system and the IRRAflow system, and on our ability to integrate and effectively manage a combined commercial team that must support two distinct product platforms; our limited experience selling the ClearPoint system in the operating room may further increase these challenges.
  • Our long-term growth depends on our ability to compete effectively in the neurosurgery and neurocritical care markets by developing and commercializing new products and services through our research and development efforts, independently and through third-party collaborations, including key development work required to support broader adoption of the IRRAflow system.
  • Limitations in the existing clinical evidence for the IRRAflow system may affect clinical and commercial adoption.
  • If coverage and reimbursement from third-party payors for procedures utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability will suffer.
  • We currently have significant customer concentration, so economic difficulties or changes in the purchasing policies or patterns of our key customers could have a significant impact on our business and operating results.
The other 46 risks
  • We rely on single facilities for manufacturing and performance of services, which exposes us to significant risk of disruption.
  • Our reliance on single-source suppliers for components, finished products and services could harm our ability to meet demand for our products or services in a timely manner or within budget.
  • Our use of hazardous materials in manufacturing and in the conduct of services may exposes us to significant health, safety, environmental, and regulatory risks.
  • To the extent we seek a new indication for use of, or new claims for, our products, the FDA may not grant 510(k) clearance or PMA approval of such new use or claims, which may affect our ability to grow our business.
  • If we fail to obtain the necessary clearances, certifications or approvals for our new products, our ability to grow our business globally could be harmed.
  • Our role as a collaborator, funder, and sponsor of current and future clinical studies in connection with the IRRAflow system requires significant resources, and in some cases, may limit our ability to control the conduct and outcomes of these studies. Negative or unfavorable results from these clinical studies could adversely impact adoption of our IRRAflow products.
  • The markets for medical devices are highly competitive, and we may not be able to compete effectively against the larger, well-established companies in our markets or emerging and small innovative companies that may seek to obtain or increase their share of the market.
  • We sell our products outside of the U.S., and we are subject to various economic, political, regulatory, and other risks relating to international operations, which could harm our revenue and profitability.
  • Disruptions of critical information systems or material breaches in the security of our systems could harm our business, customer relations and financial condition.
  • Our acquisition activities, including our recent acquisition of IRRAS, may expose us to heightened cybersecurity risks that could adversely affect our business, financial condition, and results of operations.
  • We may acquire other businesses, form joint ventures, or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt, or cause us to incur significant expense.
  • We need to hire and retain additional qualified personnel to grow and manage our business. If we are unable to attract and retain qualified personnel, including our senior management team, our sales, clinical support and marketing team and our engineering team, our business and growth could be seriously harmed.
  • Risks Related to Our Financial Position
  • We have incurred losses since our inception, and we may continue to incur losses. If we fail to generate significant revenue from sales of our products and services, we may never achieve or sustain profitability.
  • We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the applicable debt agreements may cause repayment obligations to accelerate. These agreements also contain certain covenants that restrict our operational and financial flexibility.
  • We expect to need additional funding for our combined business following the acquisition of IRRAS, and we may not be able to raise capital when needed or on terms that are acceptable to us. If we fail to obtain necessary financing, we may be forced to delay, reduce, or eliminate commercialization efforts, product development activities, integration initiatives, or other aspects of our operations.
  • Raising additional funds may cause dilution to existing stockholders, restrict our operations, or require us to relinquish proprietary rights.
  • Our cash, cash equivalents and short-term marketable securities are subject to economic risk.
  • We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), and the loss of such assets could have a negative effect on our operations and liquidity.
  • Risks Related to Our Intellectual Property
  • If we, or the third parties from whom we license intellectual property, are unable to secure and maintain patent or other intellectual property protection for the intellectual property covering our marketed products or our product candidates, our ability to compete will be harmed.
  • Others may assert that our products infringe their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our marketed products.
  • If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to successfully commercialize our marketed products and product candidates will be harmed, and we may not be able to operate our business profitably.
  • We rely on patent rights and licenses from third parties which are subject to termination or expiration.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we lose access to third-party software that is integrated into our products, our costs could increase and new installations of our products could be delayed, potentially hurting our competitive position.
  • Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others.
  • Risks Related to Legal and Regulatory Compliance
  • We operate in a highly-regulated industry and any failure to comply with the extensive government regulations may subject us to fines, injunctions and other penalties that could harm our business.
  • Federal legislation and other payment and policy changes may have a material adverse effect on our business.
  • The success of our biologics and drug delivery business is dependent on timely regulatory approval and commercialization of cell and gene therapies.
  • A government shutdown or prolonged lapse in federal appropriations could materially delay or disrupt FDA review and approval processes critical to our business, which could have a material adverse effect on our financial condition and results of operations.
  • Our products may be subject to product recalls that could harm our reputation, business operating results and financial condition. Likewise, products that are manufactured and sold by third parties and that are needed for procedures in which physicians use our products also may be subject to recalls, which could adversely impact our business, operating results and financial condition.
  • If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
  • We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the U.S. or elsewhere.
  • If we or our third-party suppliers fail to comply with the FDA’s QMSR or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.
  • We are subject to various laws protecting the confidentiality and security of certain personal information, and our failure to comply could result in penalties and reputational damage.
  • Risks Related to Our Common Stock
  • The market price of our common stock may be volatile, and a stockholder may not be able to resell their shares at or above the price at which the shares were purchased.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
  • We have not paid dividends in the past and do not expect to pay dividends in the future.
  • Anti-takeover provisions in our certificate of incorporation, bylaws and Delaware law could prevent or delay a change in control.
  • Our Fourth Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the U.S. will be the exclusive forums for substantially all 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.
  • We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price.
  • Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports. This may have a negative impact on the market price of our common stock.
  • General Risk Factors
  • Damage to our reputation could harm our businesses, including our competitive position and business prospects.
  • We have been, and could in the future become, subject to product liability or professional liability claims that could be expensive, divert management’s attention and harm our business.
  • Our operations are vulnerable to interruption or loss due to natural disasters, power loss and other events beyond our control, which would adversely affect our business.
  • The requirements of being a public company may strain our resources and distract management.

Legal proceedings

In the ordinary course of our business, we may be subject to various claims, pending and potential legal actions for damages, investigations relating to governmental laws and regulations and other matters arising out of the normal conduct of our business. Regardless of outcome, litigation and other legal proceedings can have an adverse impact on us because of defense and settlement costs, diversions of management resources and other factors. As of the date of filing this Annual Report, there is no material pending legal proceeding to which we are a party or to which any of our property is subject.

The opening of Item 3, Legal Proceedings.4

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