PLSE on Nasdaq

PULSE BIOSCIENCES, INC.

American surgical and medical instruments and apparatus company2

In its 2026 annual report the company says: “We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells.”5 It is headquartered in Hayward, United States.2 Its shares trade on Nasdaq under the symbol PLSE.2

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Last updated Oct 21, 2026.

Overview

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  • TickerPLSE on Nasdaq2
  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersHayward, United States2
  • Incorporated inDE3
  • Business address3957 Point Eden Way, Hayward, Ca 945453
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI529900NJUBI06118FM732
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 69362772

We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells. NPS technology, also referred to as Nanosecond Pulsed-Field Ablation (“nsPFA”) technology when used to ablate cellular tissue, can be used to treat a variety of medical conditions for which an optimal solution remains unfulfilled. We developed our proprietary nPulse System (formerly known as CellFX), a novel nsPFA delivery platform, and commercialized the initial application of its nsPFA technology to treat benign lesions of the skin. In parallel, we have designed a variety of applicators, or disposables, to explore the potential use of the nPulse platform to treat disorders in othe…5 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

-21982.6%Operating margin6
-20794.6%Net margin6
-90.2%Return on equity6
-$54.4MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$539.0K
  • Research and development58¢$44.7M
  • Selling, general and admin41¢$32.0M

Out of $350.0K in revenue.6 The company lost money this year.

Financial statements

Revenue7896$350.0K in 2025
0$500.0K$1.0M$1.5M2020: $0$020202021: $1.4M$1.4M20212022: $700.0K$700.0K2022−51%2023: $0$020232024: $0$020242025: $350.0K$350.0K2025
Operating income107896-$76.9M in 2025+60% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$48.0M-$48.0M20192020: -$50.0M-$50.0M2020+4%2021: -$63.0M-$63.0M2021+26%2022: -$58.1M-$58.1M2022−8%2023: -$43.6M-$43.6M2023−25%2024: -$56.3M-$56.3M2024+29%2025: -$76.9M-$76.9M2025+37%
Net income107896-$72.8M in 2025+55% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$47.0M-$47.0M20192020: -$49.9M-$49.9M2020+6%2021: -$63.7M-$63.7M2021+28%2022: -$58.5M-$58.5M2022−8%2023: -$42.2M-$42.2M2023−28%2024: -$53.6M-$53.6M2024+27%2025: -$72.8M-$72.8M2025+36%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Product revenue$350.0K$0
Cost of product revenue$539.0K$0
Research and development$44.7M$32.3M
Selling, general and administrative$32.0M$23.9M
Total cost and expenses$77.3M$56.3M
Loss from operations-$76.9M-$56.3M
Interest income$4.2M$2.7M
Other expense-$52.0K-$18.0K
Total other income$4.2M$2.7M
Net loss-$72.8M-$53.6M
Comprehensive loss-$72.8M-$53.6M
Net loss per share, basic and diluted (in dollars per share)-$1.08-$0.92
Weighted average common shares outstanding, basic and diluted (in shares)67.4M shares58.4M shares

Compare PULSE BIOSCIENCES, INC. with another company

Corporate structure

PULSE BIOSCIENCES, INC. sits at the top of its group. 4 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PULSE BIOSCIENCES, INC.

  • Robert W. Duggan Filed SCHEDULE 13D/A on PULSE BIOSCIENCES, INC., latest May 13, 2026 (7 filings since Jun 13, 2022)
  • PULSE BIOSCIENCES, INC. Hayward, California, United States
    • 2783162 Ontario Inc. Subsidiary · Ontario, Canada
    • BioElectroMed Corp., a California Corporation Subsidiary · California, United States
    • NanoBlate Corp., a Delaware Corporation Subsidiary · Delaware, United States

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 PULSE BIOSCIENCES, 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$5.4M6 Dec 31, 2025$5.1M6 Dec 31, 2024+5.8%
Accumulated depreciation$4.4M6 Dec 31, 2025$4.0M6 Dec 31, 2024+10.2%
Property and equipment, net$1.1M6 Dec 31, 2025$1.2M6 Dec 31, 2024−9.4%
Operating-lease assets (leased space)$6.0M6 Dec 31, 2025$7.2M6 Dec 31, 2024−16.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$80.7M6 Dec 31, 2025$118.0M6 Dec 31, 2024−31.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$2.8M6 Dec 31, 2025$2.8M6 Dec 31, 20240%
Accumulated amortization$7.4M6 Dec 31, 2025$6.8M6 Dec 31, 2024+9.8%
Finite-lived intangibles, net$575.0K6 Dec 31, 2025$1.2M6 Dec 31, 2024−52.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$136.0K6 Dec 31, 2025$06 Dec 31, 2024

Properties, in its own words

We currently lease approximately 50,300 square feet of premises located in Hayward, California, which is used for our principal operating facility. The term of the lease extends through October 2029.

We also currently lease approximately 2,000 square feet of premises located in Miami, Florida, which is used for our corporate headquarters. The term of the lease is 65 months and it commenced on November 8, 2024.

The rest of Item 2

We believe that our existing and expanded facilities will be sufficient to meet our needs for the foreseeable future.

Item 2 of the 10-K filed Feb 19, 2026.5

Leadership

Who has led PULSE BIOSCIENCES, INC., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (15)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • 2783162 Ontario Inc. Ontario4
  • BioElectroMed Corp., a California Corporation California4
  • NanoBlate Corp., a Delaware Corporation Delaware4
  • Pulse Biosciences BV Netherlands4

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

Former names

  • Electroblate, Inc.Nov 13, 2014 to Nov 13, 20143

Timeline

  1. Oct 14, 20268-K Other events34
  2. Oct 7, 20268-K Other events35
  3. Sep 15, 20268-K Other events36
  4. Sep 15, 20268-K Entered a material agreement; Ended a material agreement37
  5. Aug 6, 20268-K Results of operations38
  6. Aug 6, 20268-K Entered a material agreement39
  7. Jul 29, 20268-K Other events40
  8. Jun 12, 20268-K Shareholder vote41
  9. Jun 10, 20268-K Other events42
  10. May 6, 20268-K Other events43
  11. May 4, 20268-K Results of operations; Other events44
  12. Apr 27, 20268-K Regulation FD disclosure45
  13. Jan 13, 2025New chief executive Paul A. Laviolette becomes CEO14
  14. May 22, 2024New chief executive Burke Thomas Barrett becomes CEO15
  15. Sep 27, 2022New chief executive Kevin Patrick Danahy becomes CEO16
  16. May 13, 2016New chief executive Darrin Uecker becomes CEO17

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.29) a share, on Nov 5, 2025.46

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 4, 2026Reported quarterly or annual results44
  3. Feb 19, 2026Reported quarterly or annual results47
  4. Nov 5, 2025Reported quarterly or annual results48
  5. Aug 12, 2025Reported quarterly or annual results49
  6. May 8, 2025Reported quarterly or annual results50
  7. Mar 28, 2025Reported quarterly or annual results51
  8. Oct 30, 2024Reported quarterly or annual results52

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

Filings

325 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 106 major events, 120 insider forms, 7 large holders, 70 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 7, 20268-K EDGAR
  3. Sep 15, 20268-K EDGAR
  4. Sep 15, 2026424B5 EDGAR
  5. Sep 15, 20268-K EDGAR
  6. Sep 2, 20264 EDGAR
  7. Aug 28, 20264 EDGAR
  8. Aug 28, 20264 EDGAR
  9. Aug 28, 20263 EDGAR
  10. Aug 28, 20264 EDGAR
  11. Aug 28, 20263 EDGAR
  12. Aug 6, 20268-K EDGAR
  13. Aug 6, 2026424B5 EDGAR
  14. Aug 6, 202610-Q EDGAR
  15. Aug 6, 20268-K EDGAR
  16. Jul 29, 20268-K EDGAR
  17. Jun 15, 20264 EDGAR
  18. Jun 15, 20264 EDGAR
  19. Jun 15, 20264 EDGAR
  20. Jun 15, 20264 EDGAR

The 325 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

50 open-market trades by officers, directors and large owners since October 2021: 32 buys and 18 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Teplitsky Liane RaeChief Operating OfficerBuy1,001$49.95$50.0KForm 4
Aug 31, 2026Teplitsky Liane RaeChief Operating OfficerBuy1,024$48.80$50.0KForm 4
Aug 28, 2026Teplitsky Liane RaeChief Operating OfficerBuy1,034$48.35$50.0KForm 4
Aug 26, 2026Teplitsky Liane RaeChief Operating OfficerBuy1,036$48.24$50.0KForm 4
May 11, 2026DUGGAN ROBERT WDirectorBuy660,233$19.69$13.0MForm 4
May 11, 2026LAVIOLETTE PAUL AChief Executive OfficerBuy15,000$19.69$295.4KForm 4
May 11, 2026LAVIOLETTE PAUL AChief Executive OfficerBuy15,000$19.69$295.4KForm 4
May 11, 2026DUGGAN ROBERT WDirectorBuy660,233$19.69$13.0MForm 4
Feb 18, 2026Danahy Kevin PatrickChief Commercial OfficerSale5,000$23.64$118.2KForm 4
Feb 17, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$23.63$472.6KForm 4
Feb 13, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$23.53$470.6KForm 4
Feb 12, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$23.37$467.4KForm 4
Feb 11, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$25.20$504.0KForm 4
Feb 10, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$23.52$470.4KForm 4
Feb 9, 2026Danahy Kevin PatrickChief Commercial OfficerSale20,000$21.45$429.0KForm 4
Oct 2, 2025Danahy Kevin PatrickChief Commercial OfficerSale4,600$18.53$85.2KForm 4
Sep 19, 2025Danahy Kevin PatrickChief Commercial OfficerSale400$18.48$7.4KForm 4
Sep 18, 2025Danahy Kevin PatrickChief Commercial OfficerSale20,000$18.49$369.8KForm 4
Sep 17, 2025UECKER DARRINChief Technology OfficerSale20,000$16.21$324.2KForm 4
Sep 16, 2025UECKER DARRINChief Technology OfficerSale25,000$16.28$407.0KForm 4

All 50 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
2025Paul A. LaViolette68$708.5K$7.4M54
2025Jon Skinner$366.7K$2.8M54
2025Darrin R. Uecker60$540.3K$869.9K54
2025Kevin P. Danahy$525.0K$854.6K54
2024Former ChiefExecutive Officer and Former Director$327.3K$9.1M54
2024Former Chief Commercial Officer$512.5K$1.9M54
2024Chief Technology Officer and Director$512.5K$616.4K54
2023Former Chief Commercial Officer$433.3K$6.2M54
2023Chief Technology Officer and Director$433.3K$5.4M54
2023Former Chief Strategy Officer and Former Director$369.6K$1.6M54
2022Former Chief Commercial Officer$350.0K$1.6M54
2022Chief Technology Officer and Director$485.9K$487.2K54
2022Former Chief Strategy Officer and Former Director$360.0K$361.3K54

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.1,466,702$40.7M0.0%+126,924
Bank Of America Corp /de/1,446,611$40.1M0.0%+580,550
Vanguard Capital Management LLC788,640$21.9M0.0%−27,212
Portolan Capital Management, LLC753,333$20.9M0.8%+19,961
Balyasny Asset Management L.P.718,103$19.9M0.0%+452,939
Citadel Advisors LLC626,514$17.4M0.0%+484,364
Geode Capital Management, LLC536,276$14.9M0.0%+44,330
State Street Corp529,624$14.7M0.0%+72,697
Massachusetts Financial Services Co /ma/462,734$12.8M0.0%−165
UBS Group AG275,669$7.6M0.0%+241,715
Griffin Asset Management, Inc.227,285$6.3M0.7%+2,108
Vanguard Portfolio Management LLC179,497$5.0M0.0%+14,296
Northern Trust Corp173,590$4.8M0.0%−13,682
Charles Schwab Investment Management Inc151,991$4.2M0.0%+4,223
Vanguard Fiduciary Trust Co131,253$3.6M0.0%+647
Point72 Asset Management, L.P.106,457$3.0M0.0%New
Norges Bank105,647$2.9M0.0%New
Nuveen, LLC101,683$2.8M0.0%+56,248
Panoramic Capital, LLC98,054$2.7M1.2%+40,000
D. E. Shaw & Co., Inc.81,818$2.3M0.0%+68,092
Westside Investment Management, Inc.77,768$2.2M0.3%+7,276
Wellington Management Group Llp74,716$2.1M0.0%−6,536
Sectoral Asset Management Inc67,895$1.9M1.3%New
Bank of New York Mellon Corp43,114$1.2M0.0%+4,637
Goldman Sachs Group Inc34,379$953.3K0.0%+5,668

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

SEC filer profile

How PULSE BIOSCIENCES, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARPULSE BIOSCIENCES, INC.1
  • CIK0001625101
  • Employer ID (EIN)46-56965975
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • 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 address3957 Point Eden Way, Hayward, CA 945451
  • Phone510-906-46001
  • Shares outstanding71,322,607 as of Jul 31, 202612
  • Public float$266.2M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceNov 13, 20141
  • Filings639 in all: 4 (196), 8-K (171), 10-Q (32), 3 (27), CORRESP (27), UPLOAD (22), SC 13D/A (17), EFFECT (13)1
    All 43 form types

    S-8 (13), DEF 14A (12), S-3 (11), 10-K (10), S-3/A (10), SD (7), 144 (6), 424B5 (6), 4/A (5), D (4), DEFA14A (4), SC 13G (4), 10-K/A (3), 424B3 (3), 424B4 (3), FWP (3), PRE 14A (3), S-1/A (3), SC 13G/A (3), 10-Q/A (2), 3/A (2), 8-K/A (2), SC 13D (2), SCHEDULE 13D/A (2), 424B2 (1), 5 (1), 8-A12B (1), 8-K12B (1), CERTNAS (1), CT ORDER (1), NT 10-Q (1), POS AM (1), S-1 (1), S-3MEF (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) May 11, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per sharePLSENasdaq

From the cover page of the 10-K filed Feb 19, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks PULSE BIOSCIENCES, INC. names in Item 1A of its 10-K filed Feb 19, 2026: 61 risks under these headings, as written.5

  • Risks Relating to Our Business, Industry and Financial Condition
  • Because we have had a limited operating history and no significant revenue stream, it is difficult to evaluate the future of our business.
  • We have not generated significant revenue, and we may never become profitable.
  • We can give no assurance that our internal and external sources of liquidity will be sufficient for our cash requirements.
  • If we are unable to obtain sufficient funding, we may be unable to execute our business plan and fund operations. We may not be able to obtain additional financing on commercially reasonable terms, or at all.
  • Because our business is not profitable, from time to time, we may undergo a reduction in force to reduce our operating expenses. However, any corporate restructuring or headcount reduction may not result in anticipated savings, could result in total costs and expenses and attrition that are greater than expected and could disrupt our business.
  • Our revenue and future profitability are entirely dependent upon one family of products, the nPulse System, and one platform technology, Nano-pulse Stimulation.
  • We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause our stock price to decline.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations; our product revenues are limited and our profit margins are uncertain.
  • Because we operate in highly competitive markets, we can expect to face competition from large well-established manufacturers of medical technologies, devices and similar products; we may not be able to compete effectively against companies with significantly more resources.
  • We may rely on third parties for our sales, marketing, manufacturing, and/or distribution activities, and these third parties may not perform satisfactorily.
  • If we lose key management personnel, our ability to identify, develop and commercialize new or next generation product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
The other 50 risks
  • There is a limited talent pool of experienced professionals in our industry. If we are not able to retain and recruit personnel with the requisite technical skills, we may be unable to successfully execute our business strategy.
  • We have had limited experience selling the nPulse System.
  • Rapidly changing technology in life sciences could make the products we are developing obsolete.
  • If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.
  • We must successfully educate and train surgeons and their staff on the proper use of the nPulse System; if our customers do not adopt our technology into their medical practices, or adopt our technology slower than expected, our business could suffer.
  • We may encounter manufacturing problems or delays that could result in lost revenue or slower than anticipated product development. Additionally, we currently rely on third-party suppliers for critical components needed to manufacture the nPulse System and related applicators. Any problems experienced by these suppliers could result in a delay or interruption of their supply to us and, as a result, we may face delays in the development and commercialization of products.
  • We may not become commercially viable if our ultimate commercialized products or related treatments fail to obtain an adequate level of reimbursement by Medicare and other third-party payers.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • We have a substantial amount of goodwill and intangible assets which over time may have to be written down as we make the required periodic assessments as to their value as reflected in our financial statements.
  • Risks Related to Product Development and Product-Related Risks
  • Our nPulse System and any future product candidates may cause serious adverse side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial desirability or result in significant negative consequences.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
  • Our long-term growth depends on our ability to develop marketable products to treat AF, tumors and nodules through our research and development efforts, and if we fail to do so we may be unable to compete effectively or we may decide to scale back or eliminate some or all of our activities or otherwise curtail, suspend or discontinue our operations entirely.
  • Interim “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If we fail to maintain necessary regulatory clearance for our products, or if clearances or approvals for future devices and indications are delayed or not issued, the commercial prospects for our nPulse System and other NPS technologies would be harmed.
  • The mechanism of action of our NPS technology platform has not been fully determined or validated.
  • We may find it difficult to enroll patients in our clinical trials. If we cannot enroll a sufficient number of eligible patients to participate in our clinical trials, we may not be able to initiate or continue them, which could delay or prevent development of our product candidates.
  • Laboratory conditions differ from commercial conditions and field conditions, and the safety and effectiveness of our product candidates may depend on the technique of the user.
  • Issues with our firmware and software may negatively affect the function of our devices.
  • Risks Related to Intellectual Property, Cybersecurity, Data Privacy, & Litigation
  • If we are unable to protect our intellectual property, then our financial condition, results of operations and the value of our technology and products could be adversely affected.
  • Litigation or third-party claims of intellectual property infringement or challenges to the validity of our patents would require us to use resources to protect our technology and may prevent or delay our development, regulatory approval or commercialization of our product candidates.
  • Our intellectual property rights will not necessarily provide us with competitive advantages.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
  • If we are unable to protect the intellectual property used in our products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If our information technology systems or data, or those of third parties upon whom we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations and actions; litigation (including class claims); fines and penalties; a disruption of our business operations such as our clinical trials; reputational harm; loss of revenue and profits; and other adverse consequences.
  • Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our products or any future products that we may develop.
  • Risks Related to Government Regulation
  • We are subject to stringent domestic and foreign regulation. Any unfavorable regulatory action or adverse change in law may materially and adversely affect our future financial condition and business operations and prospects.
  • Disruptions in 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 product candidates and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • All our product development depends upon maintaining strong working relationships with physicians.
  • We are subject to healthcare and other laws and regulations relating to our business and could face substantial penalties if we are determined not to have fully complied with such laws, which could have an adverse impact on our business.
  • To obtain the necessary device approvals or clearances from regulatory authorities for our future product candidates, we will have to conduct various preclinical and clinical tests, which may be costly and time consuming, and may not provide results that will allow us to seek regulatory approval or clearance.
  • Even if a potential device or product ultimately is cleared or approved by regulatory authorities, it may be cleared or approved only for narrow indications which may render it commercially less viable.
  • We will be subject to ongoing requirements and inspections that could lead to the restriction, suspension or revocation of our clearance.
  • Our employees, collaborators and other personnel may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • We are subject to environmental regulations and any failure to comply with applicable laws could subject us to significant liabilities and harm our business.
  • Risks Related to Owning Our Common Stock
  • The price of our common stock has been, and we expect it to continue to be, highly volatile, and you may be unable to sell your shares at or above the price you paid to acquire them.
  • Sales or purchases of shares of our common stock may adversely affect the market for our common stock.
  • We do not know whether an active, liquid and orderly trading market will exist for our common stock and as a result it may be difficult for you to sell your common stock.
  • Concentration of ownership by our principal stockholder limits the ability of others to influence the outcome of director elections and other transactions requiring stockholder approval, or create the potential for conflicts of interest.
  • Robert W. Duggan’s controlling ownership position may impact our stock price and may deter or prevent efforts by others to acquire us, which could prevent our stockholders from realizing a control premium.
  • We have incurred and will continue to incur costs as a result of operating as a public company and our management has been and will be required to devote substantial time to public company compliance initiatives.
  • We are a “smaller reporting company”; we cannot be certain if the applicable reduced disclosure requirements will make our common stock less attractive to investors.
  • We have not paid dividends in the past and have no plans to pay dividends.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
  • General Risk Factors
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • If the interpretations, estimates or judgments we use to prepare our financial statements prove to be incorrect, investors and others may lose confidence in our financial data, which could cause our stock price to decline.
  • We may become involved in litigation that may materially adversely affect us.
  • Our facilities in California are located near known earthquake faults, and the occurrence of an earthquake or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.

Legal proceedings

From time to time, we may be involved in various legal proceedings arising in the ordinary course of business. We are not presently a party to any legal proceedings that, in the opinion of management, could have a material adverse effect on our results of operations or financial condition. Regardless of outcome, however, any litigation could have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm, and other factors.

The opening of Item 3, Legal Proceedings.5

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