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EBR Systems (United States)

Logo: ebrsystemsinc.com3

EBR Systems (United States) is an American surgical and medical instruments and apparatus company.1 It was founded in 2003.1 It is headquartered in Sunnyvale.1 Its shares trade on OTC under the symbol NONE-.1

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Last updated Oct 21, 2026.

Overview

2003Founded1

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  • TickerNONE- on OTC1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersSunnyvale1
  • Websiteebrsystemsinc.com
  • Incorporated inDE4
  • Business address480 Oakmead Parkway, Sunnyvale, Ca 940854
  • Filer category, Emerging growth company4

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EBR Systems (United States) image from its website
Image: ebrsystemsinc.com5

WiSE CRT introduces a novel approach to cardiac pacing, with the potential to transform CRT delivery.6 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

30.3%Gross margin7
-2850.2%Operating margin7
-3015.3%Net margin7
-190.6%Return on equity7
1.63×Debt to equity7
-$56.9MFree cash flow7

What sells

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

Products and services

WiSE CRT System brought in 96% of the revenue EBR Systems (United States) broke down this way in fiscal 2025.

  1. WiSE CRT System$1.5M796%
  2. Battery replacements$54.0K73%
  3. Surgical tool kits$15.0K71%
Products and services by year
Products and services2025
WiSE CRT System$1.5M
Battery replacements$54.0K
Surgical tool kits$15.0K

Regions

United States brought in 99% of the revenue EBR Systems (United States) broke down this way in fiscal 2025.

  1. United States$1.6M799%
  2. International$24.0K71%
Regions by year
Regions2025
United States$1.6M
International$24.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue4¢$1.1M
  • Research and development78¢$23.9M
  • Interest18¢$5.6M
  • Income tax0¢$2.0K

Out of $1.6M in revenue.7 The company lost money this year.

Financial statements

Operating income87-$46.1M in 2025+33% since 2023
-$60.0M-$40.0M-$20.0M02023: -$34.5M-$34.5M20232024: -$38.3M-$38.3M2024+11%2025: -$46.1M-$46.1M2025+20%
Net income87-$48.8M in 2025+39% since 2023
-$60.0M-$40.0M-$20.0M02023: -$35.0M-$35.0M20232024: -$40.8M-$40.8M2024+16%2025: -$48.8M-$48.8M2025+20%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Revenue$1.6M
Cost of goods sold$1.1M
Gross profit$490.0K
Research and development$23.9M$27.1M
Selling, general and administrative$22.6M$11.3M
Total operating expenses$46.6M$38.3M
Loss from operations-$46.1M-$38.3M
Interest expense-$5.6M-$6.0M
Interest income$2.7M$3.2M
Other income$304.0K$361.0K
(Loss) gain on foreign currency-$36.0K$10.0K
Total other (expense), net-$2.7M-$2.5M
Loss before income taxes-$48.8M-$40.8M
Income tax expense-$2.0K-$2.0K
Net loss-$48.8M-$40.8M
Net loss per share attributable to common stockholders, basic-$0.12-$0.13
Net loss per share attributable to common stockholders, diluted-$0.12-$0.13
Weighted-average number of common shares outstanding, basic417.3M shares325.0M shares
Weighted-average number of common shares outstanding, diluted417.3M shares325.0M shares

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Corporate structure

EBR Systems (United States) 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 EBR Systems (United States)

  • EBR Systems (United States) Sunnyvale

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

What it owns

What EBR Systems (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$8.7M7 Dec 31, 2025$4.5M7 Dec 31, 2024+92.4%
Accumulated depreciation$3.2M7 Dec 31, 2025$3.7M7 Dec 31, 2024−13.5%
Property and equipment, net$5.5M7 Dec 31, 2025$795.0K7 Dec 31, 2024+588.9%
Operating-lease assets (leased space)$12.6M7 Dec 31, 2025$929.0K7 Dec 31, 2024+1257.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$5.8M7 Dec 31, 2025$6.9M7 Dec 31, 2024−16.2%
Marketable securities, current$47.4M7 Dec 31, 2025$53.7M7 Dec 31, 2024−11.8%
Marketable securities, non-current$1.0M7 Dec 31, 2025$5.3M7 Dec 31, 2024−80.9%
Debt securities available for sale$48.4M7 Dec 31, 2025$59.1M7 Dec 31, 2024−18.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$13.8M7 Dec 31, 2025$1.4M7 Dec 31, 2024+891.3%
Raw materials$2.0M7 Dec 31, 2025$2.8M7 Dec 31, 2024−29.0%
Work in process$9.2M7 Dec 31, 2025
Finished goods$4.5M7 Dec 31, 2025

Properties, in its own words

We lease office and laboratory facilities for our business and operations located in Sunnyvale, California, where we occupy approximately 15,237 square feet of office space under a lease until December 31, 2026. In January 2025, we entered into a new lease agreement to lease our new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California, where we will occupy approximately 51,136 square feet under a lease until December 31, 2036. We believe our new facility is adequate for our needs for the foreseeable future.

Item 2 of the 10-K filed Mar 18, 2026.6

Leadership

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

Chief executive

  1. John McCutcheon2024–now

President

  1. John McCutcheon2024–now

Chief financial officer

  1. Gary W. Doherty2024–now

Chief operating officer

  1. Michael Hendricksen2024–now
20052010201520202025
Board members and other officers (8)

Former names

  • EBR Systems IncDec 8, 2005 to Feb 10, 20114

Timeline

  1. Aug 24, 20268-K Executive or director change; Other events21
  2. Aug 20, 20268-K Shareholder vote22
  3. Jun 10, 20268-K Entered a material agreement; Unregistered sale of shares23
  4. May 7, 20268-K Shareholder vote24
  5. Apr 9, 20268-K Results of operations25
  6. Mar 26, 20268-K Bylaws or fiscal year changed26
  7. Mar 13, 20268-K Shareholder vote27
  8. Jan 13, 20268-K Results of operations28
  9. May 29, 20258-K Entered a material agreement; Unregistered sale of shares29
  10. May 23, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed; Shareholder vote30
  11. Apr 15, 20258-K Other events31
  12. Apr 14, 20258-K Other events32
  13. Sep 30, 2024New chief executive John McCutcheon becomes CEO11
  14. 2003Founded Founded1

Calendar

When it reported results

  1. Apr 9, 2026Reported quarterly or annual results25
  2. Jan 13, 2026Reported quarterly or annual results28

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

Filings

115 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 13 major events, 53 insider forms, 12 large holders, 29 other. The latest 20:

  1. Aug 25, 2026SCHEDULE 13G/A EDGAR
  2. Aug 25, 20264 EDGAR
  3. Aug 24, 2026S-8 EDGAR
  4. Aug 24, 20268-K EDGAR
  5. Aug 20, 20268-K EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 13, 2026SCHEDULE 13G/A EDGAR
  8. Aug 12, 2026SCHEDULE 13G/A EDGAR
  9. Aug 11, 202610-Q EDGAR
  10. Jul 28, 20264/A EDGAR
  11. Jul 28, 20264/A EDGAR
  12. Jul 28, 20264/A EDGAR
  13. Jul 28, 20264/A EDGAR
  14. Jul 28, 20264/A EDGAR
  15. Jul 28, 20264/A EDGAR
  16. Jul 28, 20264/A EDGAR
  17. Jul 9, 2026DEFA14A EDGAR
  18. Jul 9, 2026DEF 14A EDGAR
  19. Jul 8, 20263 PRIMARY DOCUMENT EDGAR
  20. Jul 7, 20264 EDGAR

The 115 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

1 open-market trades by officers, directors and large owners since October 2021: 1 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 21, 2026Host-Plus Pty Ltd as trustee for the HOSTPLUS Pooled Superannuation Trust10% ownerBuy7,700,119$2.70$20.8MForm 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.

SEC filer profile

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

  • Name on EDGAREBR Systems, Inc.2
  • CIK0001347123
  • Employer ID (EIN)51-11646696
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address480 Oakmead Parkway, Sunnyvale, CA 940852
  • Phone408 720-19062
  • Shares outstanding75,335,559 as of Aug 11, 202610
  • Public float$351.0M as of Jun 30, 20256
  • AuditorDeloitte & Touche LLP, Tempe, Arizona PCAOB ID 34; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceDec 8, 20052
  • Filings121 in all: 4 (30), 3 (13), 8-K (13), 4/A (8), SCHEDULE 13G/A (7), 10-Q (6), UPLOAD (6), D (5)2
    All 21 form types

    SC 13G (5), DEF 14A (4), DEFA14A (4), PRE 14A (4), 10-12G/A (3), 10-K (2), 3/A (2), ARS (2), CORRESP (2), S-8 (2), 10-12G (1), ARS/A (1), REGDEX (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Jul 9, 2026
    Latest 8-K (8-K) Aug 24, 2026

Risk factors and legal proceedings

The risks EBR Systems (United States) names in Item 1A of its 10-K filed Mar 18, 2026: 72 risks under these headings, as written.6

  • Risks Related to Our Business and the Development, Manufacturing and Commercialization of Our Products
  • Risks Related to Our Industry
  • Risks Related to Our Financial Position and Need for Additional Capital
  • Risks Related to Government Regulation
  • Risks Related to Our Intellectual Property
  • Risks Related to Our CDIs and Common Stock
  • The commercial success of WiSE will depend upon attaining significant market acceptance among hospitals, physicians, patients, and payors.
  • Adoption of our products depends upon appropriate physician training, and inadequate training may lead to negative patient outcomes, affect adoption of our products, and adversely affect our business.
  • We have limited sales and marketing resources. If we are unable to grow our marketing and sales capabilities to support our commercialization efforts, we may not be able to effectively market and sell our WiSE CRT System or generate product revenue.
  • We have limited experience manufacturing our products in commercial quantities, which could harm our business.
  • We depend upon third-party suppliers, including single-source suppliers, making us vulnerable to supply disruptions and price fluctuations.
  • We are subject to ongoing FDA post-marketing obligations concerning our WiSE CRT System, which may result in significant additional expense, and we may be subject to penalties or product withdrawal if we fail to comply with these regulatory requirements and commitments or if we experience unanticipated regulatory issues with WiSE CRT System.
The other 65 risks
  • We have limited data and experience regarding the safety and efficacy of its WiSE-CRT system.
  • The sizes of the markets for our current and future products may be smaller than our estimates.
  • We may not realize the benefits from continued research and development costs.
  • We have limited management resources and must attract and retain skilled staff.
  • Defects or failures associated with our products could lead to recalls, safety alerts, or litigation, as well as significant costs and negative publicity.
  • If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be adversely affected.
  • The continuing development of our products depends upon maintaining strong working relationships with physicians.
  • Cost-containment efforts of our potential customers, purchasing groups and governmental organizations could have a material adverse effect on future sales and profitability.
  • Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
  • Our ability to utilize our net operating loss carryforwards may be limited.
  • If our information technology systems or those third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • We may face difficulties encountered by many medical technology companies early in their commercialization.
  • Litigation and other legal proceedings may adversely affect our business.
  • Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.
  • New or competing technologies or products could emerge which may adversely affect future sales of our products and may cause our products to become obsolete.
  • We are subject to stringent privacy laws, rules, regulations, information security and privacy policies, contractual obligations, and other obligations governing the use, processing and cross-border transfer of personal information.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • Regulatory registrations or market approvals may be withdrawn, or regulatory requirements may change.
  • There is substantial doubt regarding our ability to continue as a going concern. If we are unable to raise additional capital when needed, we may be forced to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
  • Our existing indebtedness contains restrictions that limit our flexibility in operating our business. In addition, we may be required to make a prepayment or repay our outstanding indebtedness earlier than we expect.
  • We have a history of net losses, and we expect to continue to incur losses for at least the next several years. We may never generate significant revenue from commercial products or become profitable or, if we ever achieve profitability, we may not be able to sustain it.
  • In order to support our continued operations and the growth of our business, we may seek to raise additional capital, which may not be available to us on acceptable terms, or at all.
  • The issuance of additional shares of our common stock in connection with financings, acquisitions, investments, our share incentive plans or otherwise will dilute all other stockholders.
  • Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.
  • We are an emerging growth company, and a smaller reporting company under U.S. securities laws; should we choose to list on a US exchange, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors.
  • Our results may be impacted by changes in foreign currency exchange rates.
  • Regulatory compliance is expensive, complex, and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
  • Our operations are subject to pervasive and continuing FDA regulatory requirements.
  • 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 be subject to recalls which could divert managerial and financial resources, harm our reputation, and adversely affect our business.
  • If we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may be negatively affected.
  • Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws, including the FCPA, as well as export control laws, customs laws, sanctions laws and other laws governing our operations could result in civil or criminal penalties, other remedial measures, and legal expenses.
  • The impact of the E.U. Medical Device Regulation may be costly and disruptive to our business.
  • Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of our planned or future products and to manufacture, market and distribute our products after clearance or approval is obtained.
  • If we fail to comply with U.S. federal and state fraud and abuse and other healthcare laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties, and our business operations and financial condition could be adversely affected.
  • Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.
  • Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violation of these requirements could harm our business.
  • Modifications to our products may require new regulatory clearances, or other premarket approvals or may require us to recall or cease marketing our products and services until clearances or approvals are obtained.
  • If any of our products cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
  • Our employees, independent contractors, consultants, strategic partners, distributors, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Compliance with environmental laws and regulations could be expensive, and failure to comply with these laws and regulations could subject us to significant liability.
  • We could be adversely affected by violations of the FCPA and similar worldwide anti-bribery laws and any investigation.
  • If our facilities become damaged or inoperable, or if we are required to vacate a facility, we may be unable to manufacture our products or we may experience delays in production or an increase in costs, which could adversely affect our results of operations.
  • We are dependent on the protection and enforcement of our intellectual property rights.
  • We may be subject to future third party intellectual property rights disputes.
  • If we are unable to obtain and maintain patent protection or freedom to operate for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any products we may develop, and our technology, may be adversely affected.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell and market our products.
  • We may not be successful in obtaining necessary rights to any products we may develop through acquisitions and in-licenses.
  • If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims that we or our employees, consultants or contractors have wrongfully used, disclosed, or otherwise 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 or claims asserting an ownership interest in intellectual property we regard as our own.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • 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 trade names are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.
  • Our common stock may never be listed on a major U.S. stock exchange.
  • The issuance of additional securities in connection with financings, acquisitions, investments, our share incentive plans or otherwise may adversely affect the value of and rights associated with our common stock.
  • The market price of our CDIs and common stock may be volatile, which could cause the value of our common stock to decline.
  • The requirements of being an SEC registrant may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
  • The different characteristics of the capital markets in Australia and the United States may negatively affect the trading prices of our CDIs and common stock and may limit our ability to take certain actions typically performed by a U.S. company.
  • If securities and industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Our principal stockholders could collectively exert control over us and may not make decisions that are in the best interests of all stockholders.
  • Provisions of our Amended and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law could make an acquisition of us more difficult and may prevent attempts by stockholders to replace or remove current members of the Board.
  • The costs and management time involved in complying with Delaware laws, Australian laws and U.S. reporting requirements are likely to be significant.
  • Our Amended and Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America 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.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.6

Sources

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    SEC EDGAROther events
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    SEC EDGAROther events
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