EBR Systems Posts Rising Losses Despite Initial WiSE CRT Revenue

TL;DR

**EBR Systems is finally generating revenue from its FDA-approved device, but the widening losses mean it's still a cash-burning machine that needs to prove it can scale profitably.**

AI Summary

EBR Systems, Inc. reported revenue of $512,093 for the three months ended September 30, 2025, and $681,797 for the nine months ended September 30, 2025, a significant change from zero revenue in the prior year periods, following FDA approval of its WiSE CRT System on April 11, 2025. Despite this new revenue stream, the company posted a net loss of $12,188,854 for the quarter and $34,710,566 for the nine months, compared to losses of $10,055,917 and $30,700,608 in the respective 2024 periods. Operating expenses increased to $12,104,546 for the quarter and $33,102,595 for the nine months, driven by a substantial rise in selling, general and administrative expenses to $5,860,612 for the quarter and $15,488,421 for the nine months. Research and development expenses decreased slightly to $6,243,934 for the quarter and $17,614,174 for the nine months. The company's cash and cash equivalents increased to $12,641,581 as of September 30, 2025, from $6,917,546 at December 31, 2024, primarily due to $46,771,689 in net cash provided by financing activities, including $48,828,060 from common stock issuance. Total assets grew to $104,991,554 from $73,559,494, while total liabilities increased to $66,341,039 from $49,203,993 over the same period.

Why It Matters

EBR Systems' first revenue generation from its FDA-approved WiSE CRT System is a critical milestone, signaling the transition from pure R&D to commercialization. However, the escalating net losses and negative operating cash flow, despite significant capital raises, indicate substantial challenges in scaling operations and achieving profitability. For investors, this highlights the high-risk, high-reward nature of medical device startups; while market entry is positive, sustained losses could necessitate further dilution. Competitors in the cardiac rhythm management space will be watching EBR's market penetration and financial stability closely, as successful commercialization could disrupt existing lead-based CRT solutions. Employees and customers will be impacted by the company's ability to secure long-term funding and effectively execute its commercial strategy.

Risk Assessment

Risk Level: high — EBR Systems reported a net loss of $34,710,566 for the nine months ended September 30, 2025, and negative cash flows from operations of $38,181,204 for the same period. The accumulated deficit reached $388,168,246 as of September 30, 2025, indicating a history of significant losses and a continued reliance on external financing to sustain operations.

Analyst Insight

Investors should monitor EBR Systems' revenue growth trajectory and gross margin improvements in upcoming quarters to assess the commercial viability of the WiSE CRT System. Given the high burn rate and accumulated deficit, potential investors should exercise caution and evaluate the company's ability to achieve positive operating cash flow before considering a position.

Financial Highlights

debt To Equity

1.72

revenue

$681,797

operating Margin

-4823.5%

total Assets

$104,991,554

total Debt

$40,728,398

net Income

$(34,710,566)

eps

N/A

gross Margin

45.2%

cash Position

$12,641,581

revenue Growth

N/A

Revenue Breakdown

Key Numbers

• $681,797 — Total Revenue (Generated for the nine months ended September 30, 2025, up from $0 in the prior year, marking commercialization post-FDA approval.)
• $(34,710,566) — Net Loss (Increased from $(30,700,608) for the nine months ended September 30, 2024, indicating growing operational costs despite new revenue.)
• $(38,181,204) — Net Cash Used in Operating Activities (Increased from $(30,242,772) in the prior year, highlighting continued significant cash burn from operations.)
• $12,641,581 — Cash and Cash Equivalents (Increased from $6,917,546 at December 31, 2024, primarily due to financing activities.)
• $48,828,060 — Proceeds from Issuance of Common Stock (Key driver of cash provided by financing activities for the nine months ended September 30, 2025.)
• $388,168,246 — Accumulated Deficit (As of September 30, 2025, reflecting substantial historical losses.)
• $15,488,421 — Selling, General and Administrative Expenses (Increased significantly from $8,321,998 in the prior year, reflecting commercialization efforts.)
• 449,889,450 — Common Shares Outstanding (Increased from 371,076,200 at December 31, 2024, indicating dilution from stock issuances.)

Key Players & Entities

• EBR Systems, Inc. (company) — Registrant and medical device company
• U.S. Food and Drug Administration (regulator) — Approved WiSE CRT System on April 11, 2025
• WiSE CRT System (company) — Implantable cardiac device developed by EBR Systems
• $512,093 (dollar_amount) — Revenue for the three months ended September 30, 2025
• $681,797 (dollar_amount) — Revenue for the nine months ended September 30, 2025
• $12,188,854 (dollar_amount) — Net loss for the three months ended September 30, 2025
• $34,710,566 (dollar_amount) — Net loss for the nine months ended September 30, 2025
• $38,181,204 (dollar_amount) — Negative cash flows from operations for the nine months ended September 30, 2025
• $388,168,246 (dollar_amount) — Accumulated deficit as of September 30, 2025
• $48,828,060 (dollar_amount) — Proceeds from issuance of common stock for the nine months ended September 30, 2025

FAQ

Risk Factors

• FDA Approval Dependency [high — regulatory]: The company's primary revenue stream is dependent on the FDA approval of its WiSE CRT System, which was received on April 11, 2025. Any future regulatory challenges or changes in approval status could significantly impact revenue and operations.
• Significant Cash Burn [high — financial]: The company incurred a net loss of $34,710,566 for the nine months ended September 30, 2025, and net cash used in operating activities was $38,181,204. This indicates a substantial ongoing cash burn that requires continuous financing.
• Reliance on Financing Activities [high — financial]: The increase in cash and cash equivalents to $12,641,581 as of September 30, 2025, was primarily driven by $46,771,689 in net cash provided by financing activities, including $48,828,060 from common stock issuance. This highlights a strong reliance on external funding.
• Increased Operating Expenses [medium — operational]: Total operating expenses rose to $33,102,595 for the nine months ended September 30, 2025, an increase from $28,493,304 in the prior year. This was largely due to a significant increase in SG&A expenses to $15,488,421, reflecting commercialization efforts.
• Accumulated Deficit [medium — financial]: The company has an accumulated deficit of $388,168,246 as of September 30, 2025. This substantial historical loss reflects the long development period and significant investment required before commercialization.
• Dilution from Stock Issuance [medium — financial]: The number of common shares outstanding increased from 371,076,200 at December 31, 2024, to 449,889,450 at September 30, 2025. This 21.25% increase indicates significant dilution for existing shareholders due to stock issuances to fund operations.
• Market Adoption of WiSE CRT System [medium — market]: The success of the company is now dependent on the market's adoption of the WiSE CRT System. Factors such as physician acceptance, reimbursement, and competition will influence revenue growth post-FDA approval.
• Inventory Growth [low — operational]: Inventory increased from $1,391,008 at December 31, 2024, to $9,689,369 for current inventory and $1,451,532 to $1,483,832 for noncurrent inventory as of September 30, 2025. This significant build-up suggests increased production in anticipation of commercial sales.

Industry Context

The cardiac rhythm management market is a segment of the broader medical device industry, characterized by high R&D investment, stringent regulatory oversight, and a focus on technological innovation. Companies compete on device efficacy, patient outcomes, and physician adoption. EBR Systems' WiSE CRT System offers a leadless solution, a potentially disruptive innovation in a market traditionally dominated by lead-based CRT devices.

Regulatory Implications

The company's primary regulatory hurdle, FDA approval for its WiSE CRT System, has been cleared. However, ongoing compliance with manufacturing standards, post-market surveillance requirements, and potential future regulatory changes remain critical. Any adverse regulatory actions could severely impact market access and revenue.

What Investors Should Do

1. Monitor revenue ramp-up and market adoption of the WiSE CRT System.
2. Analyze SG&A expense trends relative to revenue growth.
3. Evaluate the company's cash burn rate and future financing needs.
4. Assess the competitive landscape and physician acceptance of leadless CRT technology.
5. Review the impact of share dilution on existing shareholders.

Key Dates

• 2025-04-11: FDA Approval of WiSE CRT System — Marks the critical regulatory milestone enabling commercialization and revenue generation for the company's leadless cardiac pacing technology.
• 2025-09-30: End of Q3 2025 — Reporting period for the 10-Q, showing initial revenue post-FDA approval and increased operating expenses.
• 2024-12-31: End of Fiscal Year 2024 — Baseline for comparison of financial position, showing zero revenue and lower cash reserves prior to commercialization.
• 2021-11-24: IPO on ASX — Initial public offering date, establishing the company's public trading presence.

Glossary

WiSE CRT System

An implantable cardiac device developed by EBR Systems that provides left-ventricle endocardial pacing for cardiac resynchronization therapy without the use of wires or leads. (This is the company's flagship product, the sole source of current revenue following FDA approval.)

PMA

Premarket Approval application, a process required by the FDA for certain medical devices to demonstrate safety and effectiveness before marketing. (The successful completion of the PMA process led to the FDA approval of the WiSE CRT System.)

Cardiac Resynchronization Therapy (CRT)

A type of pacemaker therapy that uses a special device to help the lower chambers of the heart (ventricles) contract in a more synchronized way. (The WiSE CRT System is designed to provide this therapy, addressing a specific medical need.)

Endocardial

Relating to or situated within the heart. (Describes the location where the WiSE device provides stimulation, differentiating it from epicardial or transvenous approaches.)

CDIs

CHESS Depositary Interests, a type of security that allows investors to trade shares of a foreign company on a local exchange (in this case, ASX). (EBR Systems trades on the ASX using CDIs.)

Accumulated Deficit

The total cumulative net losses of a company since its inception, minus any cumulative net income. (Indicates the company's historical unprofitability, a common characteristic of early-stage medical device companies.)

SG&A

Selling, General, and Administrative expenses, which include costs associated with marketing, sales, and general corporate operations. (A significant driver of increased operating expenses as the company moves into commercialization.)

Operating Lease Liability

The financial obligation to make lease payments for assets used in operations over the lease term. (Represents a significant liability on the balance sheet, particularly for right-of-use assets related to facilities or equipment.)

Year-Over-Year Comparison

Compared to the prior year's periods (ended September 30, 2024), EBR Systems has transitioned from zero revenue to generating $681,797 in the nine months ended September 30, 2025, driven by FDA approval of its WiSE CRT System. However, this revenue growth is accompanied by a substantial increase in net loss from $(30,700,608)$ to $(34,710,566)$ and a significant rise in operating expenses, particularly SG&A, from $8,321,998$ to $15,488,421$. While cash reserves have increased due to financing activities, the overall financial picture shows a company in a critical commercialization phase with high cash burn.

Key Financial Figures

• $0.0001 — ,658 shares of common stock, par value $0.0001 per share, including shares underlying
• $5,000 — nsation, with a maximum annual match of $5,000 per employee. Matching contributions ve

Filing Documents

• ebr11725010q.htm (10-Q) — 1346KB
• ex31_1.htm (EX-31.1) — 7KB
• ex31_2.htm (EX-31.2) — 7KB
• ex32_1.htm (EX-32.1) — 6KB
• 0001214659-25-016334.txt ( ) — 7199KB
• cik0001347123-20250930.xsd (EX-101.SCH) — 53KB
• cik0001347123-20250930_cal.xml (EX-101.CAL) — 81KB
• cik0001347123-20250930_def.xml (EX-101.DEF) — 184KB
• cik0001347123-20250930_lab.xml (EX-101.LAB) — 375KB
• cik0001347123-20250930_pre.xml (EX-101.PRE) — 336KB
• ebr11725010q_htm.xml (XML) — 1319KB

— Financial Information

Part I — Financial Information 3

Condensed Consolidated Financial Statements (Unaudited)

Item 1. Condensed Consolidated Financial Statements (Unaudited) 3 Condensed Consolidated Balance Sheets (Unaudited) 3 Condensed Consolidated Statements of Operations (Unaudited) 4 Condensed Consolidated Statements of Comprehensive Loss (Unaudited) 5 Condensed Consolidated Statements of Stockholders' Equity (Unaudited) 6 Condensed Consolidated Statements of Cash Flows (Unaudited) 7 Notes to the Condensed Consolidated Financial Statements (Unaudited) 8

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 26

Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk 38

Controls and Procedures

Item 4. Controls and Procedures 38

— Other Information

Part II — Other Information 39

Legal Proceedings

Item 1. Legal Proceedings 39

Risk Factors

Item 1A. Risk Factors 39

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 40

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities 40

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 40

Other Information

Item 5. Other Information 41

Exhibits

Item 6. Exhibits 42

Signatures

Signatures 43 Table of Contents

— FINANCIAL INFORMATION

PART I — FINANCIAL INFORMATION ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS EBR SYSTEMS, INC. Condensed Consolidated Balance Sheets (Unaudited) September 30, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 12,641,581 $ 6,917,546 Marketable securities 55,721,860 53,746,411 Accounts and other receivables, net 2,709,473 441,439 Inventory 9,689,369 1,391,008 Prepaid expenses 1,297,645 1,693,560 Other current assets 171,221 276,419 Total current assets 82,231,149 64,466,383 Restricted cash, noncurrent 2,603,568 - Property and equipment, net 3,185,903 794,959 Right of use operating lease asset 12,898,019 929,243 Marketable securities 2,032,239 5,303,950 Inventory, noncurrent 1,483,832 1,451,532 Other assets 556,844 613,427 TOTAL ASSETS $ 104,991,554 $ 73,559,494 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,590,136 $ 3,247,453 Accrued expenses and other liabilities 4,541,009 4,295,841 Interest payable 206,667 224,889 Operating lease liability 1,012,971 522,525 Current portion of notes payable - 37,286 Total current liabilities 10,350,783 8,327,994 Other liabilities 204,815 37,617 Operating lease liability 15,057,043 574,777 Notes payable, net 40,728,398 40,263,605 Total liabilities 66,341,039 49,203,993 Commitments and contingencies (Note 15) STOCKHOLDERS' EQUITY Common stock, $ 0.0001 par value; 600,000,000 shares authorized, 449,889,450 and 371,076,200 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 44,989 37,108 Additional paid-in capital 425,830,332 376,902,576 Accumulated deficit ( 388,168,246 ) ( 353,457,680 ) Accumulated other comprehensive income 943,440 873,497 Total stockholders' equity 38,650,515 24,355,501 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 104,991,554 $ 73,559,494 These financial statements should be

Financial Statements

Financial Statements Note 1 - Business and organization

Business

Business overview EBR Systems, Inc. and subsidiaries (collectively, "EBR", "we", "our" or the "Company") is a United States based medical device company that developed the WiSE CRT System ("WiSE"), an implantable cardiac device able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of leads. This implantable device delivers left-ventricle endocardial pacing for cardiac resynchronization therapy ("CRT"), without the use of wires or leads going into the heart. On April 11, 2025, the Company received notification that the U.S. Food and Drug Administration ("FDA") has completed its review of the premarket approval application ("PMA") and approved WiSE for commercial distribution in the United States. The Company completed its initial public offering of CDIs ("CHESS Depositary Interests") and began trading on the Australian Securities Exchange ("ASX") on November 24, 2021, under the symbol "EBR". The Company operates wholly owned foreign subsidiary entities in Australia, EBR Systems (AUST) Pty Ltd ("EBR-AU"), and the United Kingdom, EBR Systems (UK) Limited ("EBR-UK"), which establish clinical trials in Australia and the United Kingdom, respectively, and work on intellectual property development. EBR-AU was incorporated on February 23, 2017, and EBR-UK was incorporated on July 31, 2015. Note 2 - Summary of significant accounting policies Basis of presentation These unaudited condensed consolidated financial statements as of September 30, 2025, and for the three and nine months ended September 30, 2025 and 2024, have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP"). Certain information and note disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited condensed consolidated financial statements should be read in

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