OM on Nasdaq

Outset Medical, Inc.

Outset Medical, Inc. is a medical technology company pioneering a first-of-its-kind technology.1 It is headquartered in San Jose, California.1

$4.07 up 0.23 (5.99%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerOM on Nasdaq1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersSan Jose, California1
  • Incorporated inDE3
  • Business address3052 Orchard Drive, San Jose, Ca 951343
  • Filer categoryAccelerated filer, Smaller reporting company3
  • Legal formCorporation

Outset is a medical technology company pioneering a first-of-its-kind technology to improve clinical outcomes in dialysis with less cost and complexity. We believe the Tablo® Hemodialysis System (Tablo) represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. We designed Tablo from the ground up to be a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by virtually anyone. Tablo is currently cleared by the U.S. Food and Drug Administration (FDA) for use in the hospital, clinic or home setting. Our technology is designed to elevate the dialysis experience for patients, and help providers overcome traditional care delivery challenges. Our focus on flexibility, ease of use, data analytics and user experience transla…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

39.1%Gross margin5
-55.8%Operating margin5
-68.3%Net margin5
5.1%Revenue growth, 20255
-64.3%Return on equity5
0.76×Debt to equity5
-$47.1MFree cash flow5

What sells

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

Products and services

Consumables Product brought in 45% of the revenue Outset Medical, Inc. broke down this way in fiscal 2025.

  1. Consumables Product$54.1M545%up 6% from 2024
  2. Service and Other Revenue$34.7M529%up 6% from 2024
  3. Consoles Product$30.7M526%up 3% from 2024
Products and services by year
Products and services202320242025
Consumables Product$42.2M$51.1M$54.1M
Service and Other Revenue$26.8M$32.7M$34.7M
Consoles Product$61.3M$29.8M$30.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue61¢$72.7M
  • Research and development18¢$21.2M
  • Other costs9¢$10.8M
  • Interest12¢$14.0M
  • Income tax1¢$718.0K

Out of $119.5M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$119.5M in 2025+692% since 2019
0$50.0M$100.0M$150.0M2019: $15.1M$15.1M20192020: $49.9M$49.9M2020+231%2021: $102.6M$102.6M2021+105%2022: $115.4M$115.4M2022+12%2023: $130.4M$130.4M2023+13%2024: $113.7M$113.7M2024−13%2025: $119.5M$119.5M2025+5%
Gross profit67895$46.8M in 2025
-$20.0M0$20.0M$40.0M$60.0M2019: -$17.8M-$17.8M20192020: -$13.0M-$13.0M2020−27%2021: $7.6M$7.6M20212022: $17.8M$17.8M2022+134%2023: $29.0M$29.0M2023+63%2024: $38.6M$38.6M2024+33%2025: $46.8M$46.8M2025+21%
Operating income67895-$66.7M in 2025−5% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$70.3M-$70.3M20192020: -$117.5M-$117.5M2020+67%2021: -$130.5M-$130.5M2021+11%2022: -$161.0M-$161.0M2022+23%2023: -$169.8M-$169.8M2023+5%2024: -$113.4M-$113.4M2024−33%2025: -$66.7M-$66.7M2025−41%
Net income67895-$81.7M in 2025+20% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$68.3M-$68.3M20192020: -$121.5M-$121.5M2020+78%2021: -$131.9M-$131.9M2021+9%2022: -$163.0M-$163.0M2022+24%2023: -$172.8M-$172.8M2023+6%2024: -$128.0M-$128.0M2024−26%2025: -$81.7M-$81.7M2025−36%

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$119.5M$113.7M$130.4M
Cost of revenue$72.7M$75.1M$101.4M
Gross profit$46.8M$38.6M$29.0M
Research and development$21.2M$38.4M$57.3M
Sales and marketing$54.4M$70.0M$96.2M
General and administrative$37.9M$43.5M$45.2M
Total operating expenses$113.5M$151.9M$198.8M
Loss from operations-$66.7M-$113.4M-$169.8M
Interest income and other income, net$7.4M$9.8M$10.2M
Interest expense-$14.0M-$23.9M-$12.7M
Loss on extinguishment of term loan-$7.7M$0$0
Loss before provision for income taxes-$80.9M-$127.5M-$172.3M
Provision for income taxes$718.0K$491.0K$523.0K
Net loss-$81.7M-$128.0M-$172.8M
Net loss per share, basic-$5.37-$36.96-$52.28
Net loss per share, diluted-$5.37-$36.96-$52.28
Shares used in computing net loss per share, basic15.2K shares3.5K shares3.3K shares
Shares used in computing net loss per share, diluted15.2K shares3.5K shares3.3K shares

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Corporate structure

Outset Medical, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Outset Medical, Inc.

  • BML Investment Partners, L.P. Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Oct 6, 2026 (5 filings since Jan 14, 2026)
  • AQR CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Outset Medical, Inc., latest Aug 12, 2026
  • Bank of America Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Aug 12, 2026 (2 filings since Feb 11, 2026)
  • BlackRock Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Jul 29, 2026 (8 filings since Oct 8, 2021)
  • Alyeska Investment Group, L.P. Filed SCHEDULE 13G/A on Outset Medical, Inc., latest May 15, 2026 (2 filings since May 15, 2025)
  • Woodline Partners LP Filed SCHEDULE 13G/A on Outset Medical, Inc., latest May 15, 2026 (2 filings since May 15, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Mar 27, 2026 (8 filings since Feb 10, 2022)
  • Durable Capital Partners LP Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Feb 17, 2026 (3 filings since Jan 10, 2025)
  • PFM Health Sciences, LP Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Feb 17, 2026 (4 filings since Feb 14, 2022)
  • T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Nov 14, 2025 (4 filings since Feb 14, 2023)
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Outset Medical, Inc., latest May 15, 2025 (3 filings since Feb 15, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on Outset Medical, Inc., latest Apr 7, 2025 (6 filings since Feb 9, 2022)
  • Outset Medical, Inc. San Jose, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Outset Medical, 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$29.6M5 Dec 31, 2025$29.2M5 Dec 31, 2024+1.4%
Accumulated depreciation$24.9M5 Dec 31, 2025$21.0M5 Dec 31, 2024+18.4%
Property and equipment, net$4.7M5 Dec 31, 2025$8.1M5 Dec 31, 2024−42.6%
Operating-lease assets (leased space)$4.8M5 Dec 31, 2025$3.9M5 Dec 31, 2024+21.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.0M5 Dec 31, 2025$124.0M5 Dec 31, 2024−71.8%
Marketable securities, current$133.9M5 Dec 31, 2025$34.7M5 Dec 31, 2024+286.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$47.6M5 Dec 31, 2025$59.4M5 Dec 31, 2024−19.8%
Raw materials$27.2M5 Dec 31, 2025$25.7M5 Dec 31, 2024+5.8%
Work in process$7.3M5 Dec 31, 2025$10.0M5 Dec 31, 2024−26.6%
Finished goods$13.1M5 Dec 31, 2025$23.7M5 Dec 31, 2024−44.7%

Properties, in its own words

We currently lease 40,413 square feet of office space for our corporate headquarters located in San Jose, California under a lease agreement that terminates in 2027. This facility supports research and development and general and administrative activities. In Tijuana, Mexico, we also lease 87,187 square feet of space for our manufacturing facility under a lease agreement that will expire in 2026 (or 2031 if and when our renewal option is exercised and mutually agreed) and 7,739 square feet of office space for certain research and development and general and administrative activities under a lease agreement that will expire in 2028.

We believe that these facilities are suitable and sufficient to meet our current and anticipated needs in the near term and that additional space can be obtained on commercially reasonable terms as needed.

Item 2 of the 10-K filed Feb 13, 2026.4

Leadership

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

Board members and other officers (22)

Former names

  • Home Dialysis Plus, Ltd.Feb 26, 2010 to Feb 25, 20113

Timeline

  1. Aug 28, 20268-K Executive or director change38
  2. Aug 6, 20268-K Results of operations39
  3. Jun 17, 20268-K Entered a material agreement; Results of operations40
  4. Jun 5, 20268-K Shareholder vote41
  5. May 29, 20268-K Executive or director change42
  6. May 7, 20268-K Results of operations43
  7. Feb 11, 20268-K Results of operations44
  8. Jan 27, 20268-K Other events45
  9. Jan 12, 20268-K Results of operations; Executive or director change; Regulation FD disclosure46
  10. Nov 10, 20258-K Results of operations47
  11. Aug 6, 20258-K Results of operations48
  12. Jun 3, 20258-K Executive or director change; Shareholder vote; Regulation FD disclosure49
  13. Sep 14, 2020New chief executive Leslie Trigg becomes CEO13

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.98) a share, on Nov 10, 2025.50

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results39
  2. Jun 17, 2026Reported quarterly or annual results40
  3. May 7, 2026Reported quarterly or annual results43
  4. Feb 11, 2026Reported quarterly or annual results44
  5. Jan 12, 2026Reported quarterly or annual results46
  6. Nov 10, 2025Reported quarterly or annual results47
  7. Aug 6, 2025Reported quarterly or annual results48
  8. May 7, 2025Reported quarterly or annual results51

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

Filings

576 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 52 major events, 290 insider forms, 68 large holders, 1 private raises, 145 other. The latest 20:

  1. Oct 6, 2026SCHEDULE 13G/A EDGAR
  2. Oct 5, 20264 EDGAR
  3. Aug 28, 20268-K EDGAR
  4. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  5. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  6. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  7. Aug 14, 2026144 EDGAR
  8. Aug 14, 2026144 EDGAR
  9. Aug 14, 2026144 EDGAR
  10. Aug 12, 2026SCHEDULE 13G EDGAR
  11. Aug 12, 2026SCHEDULE 13G/A EDGAR
  12. Aug 6, 202610-Q EDGAR
  13. Aug 6, 20268-K EDGAR
  14. Jul 29, 2026SCHEDULE 13G/A EDGAR
  15. Jun 29, 20264 PRIMARY DOCUMENT EDGAR
  16. Jun 29, 20264 PRIMARY DOCUMENT EDGAR
  17. Jun 29, 20264 PRIMARY DOCUMENT EDGAR
  18. Jun 17, 20268-K EDGAR
  19. Jun 5, 20264 PRIMARY DOCUMENT EDGAR
  20. Jun 5, 20264 PRIMARY DOCUMENT EDGAR

The 576 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

213 open-market trades by officers, directors and large owners since October 2021: 1 buys and 212 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 17, 2026Trigg LeslieChair and CEOSale3,437$4.39$15.1KForm 4
Aug 17, 2026Brottem John L.General CounselSale2,632$4.39$11.6KForm 4
Aug 17, 2026Gaeta ReneeChief Financial OfficerSale4,543$4.39$19.9KForm 4
Jun 3, 2026Gaeta ReneeChief Financial OfficerSale17,672$4.94$87.3KForm 4
May 15, 2026Trigg LeslieChair and CEOSale3,445$3.70$12.7KForm 4
May 15, 2026Nash MarcEVP Operations R&D & ServiceSale1,582$3.70$5.9KForm 4
May 15, 2026Brottem John L.General CounselSale2,638$3.70$9.8KForm 4
Feb 17, 2026Nash MarcEVP Operations R&D & ServiceSale1,817$3.35$6.1KForm 4
Feb 17, 2026Brottem John L.General CounselSale2,842$3.35$9.5KForm 4
Feb 17, 2026Trigg LeslieChair and CEOSale3,361$3.35$11.3KForm 4
Jan 21, 2026Nash MarcEVP Operations R&D & ServiceSale980$4.98$4.9KForm 4
Jan 21, 2026Brottem John L.General CounselSale1,180$5.01$5.9KForm 4
Jan 21, 2026Trigg LeslieChair and CEOSale2,120$5.05$10.7KForm 4
Jan 20, 2026Nash MarcEVP Operations R&D & ServiceSale5,375$5.12$27.5KForm 4
Jan 20, 2026Brottem John L.General CounselSale9,314$5.12$47.7KForm 4
Jan 20, 2026Trigg LeslieChair and CEOSale11,794$5.12$60.4KForm 4
Jan 7, 2026Nash MarcEVP Operations R&D & ServiceSale108$4.27$461Form 4
Jan 7, 2026Brottem John L.General CounselSale224$4.27$956Form 4
Jan 7, 2026Trigg LeslieChair and CEOSale1,795$4.27$7.7KForm 4
Dec 1, 2025Drexler KarenDirectorSale1,548$4.37$6.8KForm 4

All 213 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
2025Renee Gaeta$276.9K$3.4M73
2025Leslie Trigg$755.2K$3.3M73
2025John Brottem$466.6K$1.4M73
2025Marc Nash$432.6K$1.3M73
2025Nabeel Ahmed$212.8K$610.1K73
2024PresidentCEO & Board Chair$725.0K$4.0M73
2024Former Chief Financial Officer$460.1K$1.8M73
2024General Counsel & Secretary$415.8K$1.5M73
2024EVPR&D, Operations & Service$398.9K$1.5M73
2023PresidentCEO & Board Chair$723.1K$6.5M73
2023Former Chief Financial Officer$459.5K$2.3M73
2023General Counsel & Secretary$415.2K$1.7M73
2023EVPR&D, Operations & Service$335.5K$1.0M73

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$3.9M 2025–2025
Money received by yearMoney received by year, 2025–2025: $3.9M in all. Private raises (Form D) $3.9M.$0$1M$2M$3M$4M2025 · Private raises (Form D): $3.9M2025
Figures by year
YearPrivate raises (Form D)Total
2025$3.9M$3.9M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jan 3, 2025Raised $3.9 million in a private offering of equity74 Form D: 13 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 92. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC2,742,887$11.8M0.0%+1,214
BML Capital Management, LLC2,519,701$10.9M6.2%+617,500
Aqr Capital Management LLC998,961$4.3M0.0%+190,676
Perceptive Advisors LLC833,333$3.6M0.1%No change
Vanguard Capital Management LLC780,134$3.4M0.0%+16,312
Assenagon Asset Management S.A.678,876$2.9M0.0%+174,783
Bank Of America Corp /de/665,847$2.9M0.0%−283,550
PFM Health Sciences, LP582,122$2.5M0.2%−12,508
Ensign Peak Advisors, Inc434,341$1.9M0.0%−92,244
BlackRock, Inc.418,211$1.8M0.0%−845,008
Peapod Lane Capital LLC331,951$1.4M1.0%New
Marshall Wace, Llp211,993$915.8K0.0%New
Geode Capital Management, LLC204,652$884.5K0.0%−216,721
Stratos Wealth Partners, LTD.200,546$866.4K0.0%No change
UBS Group AG190,289$822.0K0.0%−62,210
Morgan Stanley181,983$786.2K0.0%+12,540
Millennium Management LLC181,794$785.4K0.0%New
Goldman Sachs Group Inc173,460$749.3K0.0%+80,100
Jane Street Group, LLC139,197$601.3K0.0%+74,387
XTX Topco Ltd124,690$538.7K0.0%−17,760
Catalio Capital Management, LP118,279$511.0K0.1%No change
Vanguard Fiduciary Trust Co114,912$496.4K0.0%+3,273
GMT Capital Corp98,108$423.8K0.0%+55,687
Dimensional Fund Advisors LP90,698$391.8K0.0%−22,667
Pura Vida Investments, LLC83,333$360.0K1.0%No change

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

SEC filer profile

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

  • Name on EDGAROutset Medical, Inc.1
  • CIK0001484612
  • Employer ID (EIN)20-05143924
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address3052 Orchard Drive, San Jose, CA 951341
  • Phone669-231-82001
  • Shares outstanding18,797,164 as of Aug 4, 202611
  • Public float$334.7M as of Jun 30, 20254
  • AuditorKPMG LLP, San Francisco, California PCAOB ID 185; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceFeb 26, 20101
  • Filings741 in all: 4 (346), 144 (115), 8-K (66), SC 13G/A (33), 3 (27), SCHEDULE 13G/A (19), 10-Q (18), SC 13G (17)1
    All 34 form types

    CORRESP (10), SCHEDULE 13G (10), DEFA14A (9), D (7), DEF 14A (7), S-8 (7), 10-K (6), UPLOAD (6), 4/A (4), EFFECT (4), SD (4), 424B4 (3), DRS (3), DRSLTR (3), S-1 (3), 3/A (2), DRS/A (2), S-1MEF (2), 424B3 (1), 8-A12B (1), CERT (1), D/A (1), PRE 14A (1), S-1/A (1), S-3 (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Feb 13, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 28, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareOMThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 13, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Outset Medical, Inc. names in Item 1A of its 10-K filed Feb 13, 2026: 72 risks under these headings, as written.4

  • Risks Related to Our Business and Industry
  • Risks Related to Government Regulation
  • Risks Related to Our Intellectual Property
  • Risks Related to Ownership of Our Common Stock
  • General Risks
  • Risks Related to our Business and Industry
  • We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it.
  • Our ability to achieve sustainable gross margins depends on the success of our various initiatives designed to expand gross margin.
  • The commercial success of Tablo will depend upon attaining significant market acceptance among providers and patients.
  • We currently derive substantially all of our revenue from the sale of Tablo and associated consumables and are therefore highly dependent on Tablo for our success.
  • Our customers may face financial pressures including, but not limited to, capital budget constraints, staffing shortages and increased costs arising from macroeconomic conditions, evolving policy changes or other factors, that have had, and may continue to have, a negative impact on our financial condition or results of operations.
  • Our financial condition or results of operations, including our ability to generate revenue from home-based and post-acute dialysis, is subject to certain risks and uncertainties, including around the use of Tablo in the home and post-acute settings.
The other 66 risks
  • With a significant portion of our manufacturing operations, as well as key software development and certain IT personnel, located outside of the United States, we may experience operational disruptions, and be subject to additional risks associated with international manufacturing operations, including uncertain or changing regulatory and/or labor requirements.
  • We depend upon third-party suppliers, including a contract manufacturer and single source suppliers, making us vulnerable to supply problems and price fluctuations.
  • If we fail to expand the adoption of Tablo as we focus more heavily on enterprise selling, we may not be able to generate revenue growth.
  • If we fail to provide strong product performance, customer dissatisfaction could adversely affect our reputation and results of operations.
  • If we are unable to continue to innovate and improve Tablo, we could lose customers or market share.
  • We face competition from many sources, including larger companies and new entrants, and we may be unable to compete successfully.
  • We may face additional costs, loss of revenue, significant liabilities, harm to our brand, decreased use of our platform and business disruption if there are any security or data privacy breaches or other unauthorized or improper access.
  • We may encounter difficulties in managing our growth, which could disrupt our operations.
  • The home hemodialysis market may not expand sufficiently to support our growth prospects.
  • We traditionally have had significant customer concentration.
  • Any failure to offer high-quality product support for Tablo may adversely affect our relationships with providers and negatively impact our reputation among patients and providers, which may adversely affect our business, financial condition, and results of operations.
  • Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, Tablo and manage our inventory.
  • A pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide such as the COVID-19 pandemic could adversely affect our business.
  • Natural or man-made disasters and other similar events may significantly disrupt our business, and negatively impact our business, financial condition and results of operations.
  • Inadequate training of, and improper use of Tablo by, nurses, dialysis technicians, care partners and patients may lead to negative patient outcomes, affect use of Tablo and adversely affect our business.
  • 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 or any guidance we may provide.
  • The sizes of the markets for Tablo in the acute and home settings have not been established with precision and may be smaller than we estimate and may decline.
  • We use Amazon Web Services to support Tablo’s cloud connectivity and any disruption of service could interrupt or delay our ability to receive and deliver certain treatment and reporting information from and to providers and patients.
  • If we experience significant disruptions in our information technology systems, our business may be adversely affected.
  • 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 Tablo. The expense and potential unavailability of insurance coverage for liabilities resulting from Tablo could harm us and our ability to sell Tablo.
  • Any failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our commercialization, sales and marketing efforts, product development programs or other operations.
  • The terms of our credit agreement require us to meet certain operating and financial covenants, place restrictions on our operating and financial flexibility and subject us to interest rate risk, and our ability to access additional borrowings is subject to us achieving certain revenue milestone and obtaining lenders’ credit approval.
  • Performance issues, service interruptions or price increases by our shipping carriers and warehousing providers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
  • We bear the risk of warranty claims on Tablo.
  • Cost-containment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales and profitability.
  • Litigation and other legal proceedings may adversely affect our business.
  • 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.
  • To the extent we enter into foreign markets, we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Our ability to utilize our net operating loss carryforwards and research and development credit may be limited.
  • Risks Related to Governmental Regulation
  • As we continue to modify Tablo from time to time, such modifications may require new clearances or approvals from the FDA, which we may not be able to obtain on a timely basis or at all.
  • Changes to the reimbursement rates for dialysis treatments and measures to reduce healthcare costs may adversely impact our business.
  • Healthcare reform measures could hinder or prevent the commercial success of Tablo.
  • We must comply with anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations.
  • Tablo and our operations are subject to extensive government regulation and oversight in the United States. If we fail to obtain or maintain necessary regulatory approvals for Tablo and related products, or if approvals or clearances for future 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.
  • If we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal 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, such as Tablo, 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 Tablo.
  • Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products or product enhancements 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.
  • The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.
  • The medical device industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Our use, disclosure, and other processing of personally identifiable information, including health information, is subject to HIPAA and other federal, state, and data privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm and, in turn, a material adverse effect on our client base, member base and revenue.
  • 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 protect our intellectual property.
  • 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 Tablo.
  • 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.
  • 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 involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell Tablo and subject us to possible litigation.
  • Intellectual property rights do not necessarily address all potential threats.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • The market price of our common stock has been and may continue to be volatile and 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 may not be able to maintain the listing of our common stock on Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock.
  • 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.
  • If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the trading price or trading volume of our common stock could decline.
  • Our principal stockholders and management own a significant percentage of our stock and are able to exercise significant influence over matters subject to stockholder approval.
  • 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.
  • Our amended and restated certificate of incorporation designates a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers or employees.

Legal proceedings

The information set forth under “Litigation” in Note 6, Commitments and Contingencies, of the notes accompanying our audited financial statements in this Annual Report is incorporated herein by reference.

From time to time, we may become involved in legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition or cash flows.

The opening of Item 3, Legal Proceedings.4

Sources

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