EBR Systems, Inc.
For the period ended Mar 31, 2026. Filed May 11, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 11, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001214659-25-016334
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001214659-26-005938
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 116 previous paragraphs and 92 current paragraphs.
50 unchanged; 28 reworded; 12 added; 30 removed; 8 previous and 2 current paragraphs rearranged.
Tables are not compared: 54 previous and 35 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
Selling, General and Administrative Expenses
Current report
Revenue and cost of goods sold was $2.4 million and $2.2 million, respectively, during the three-month period ended March 31, 2026, resulting from the Company completing commercial implants at nineteen hospitals in the US. There was no revenue or cost of goods sold during the three-month period ended March 31, 2025, resulting from the FDA approval of our WiSE CRT System in April 2025.
Current report
Research and development expenses increased by $1.0 million, or 18.4% during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase was primarily due to a $0.4 million increase in contract manufacturing, materials and components as a result of higher expenses related to research and development projects. Clinical expenses increased by $0.2 million as a result of higher expenses related to WiSE CRT post-approval study. Facility-related expenses increased by $0.3 million in support of our continuing expansion of research and development activities.
Current report
Selling, General and Administrative Expenses
Current report
Going concern consideration
Current report
The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. For the three months ended March 31, 2026 and 2025, we incurred a net loss of $17.1 million and $10.6 million, respectively. During the three months ended March 31, 2026 and 2025, we had negative cash flows from operations of $20.3 million and $13.6 million, respectively. As of March 31, 2026, we had working capital of $42.0 million and accumulated deficit of $419.3 million. These factors raise substantial doubt about our ability to continue as a going concern. Until we are able to generate consistent and sufficient revenue from sales of our WiSE CRT System, our ability to continue as a going concern is dependent on our ability to raise additional capital through the issuance of additional common stock or borrowings from financial institutions. Our ability to obtain additional capital in the equity capital markets is subject to several factors, including market and economic conditions, our performance, and investor sentiment with respect to our company and our industry.
Current report
Future Funding Requirements
Current report
Despite recent FDA approval of WiSE CRT System, the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether our future development activities may succeed; or whether we will be able to effectively commercialize WiSE CRT System in the U.S., if at all. We may never recoup our investment in any WiSE CRT System development which would adversely affect our financial condition and our business and business prospects. In addition, our plans and timing expectations could be further delayed or interrupted by the effects of macroeconomic or other global conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues.
Current report
To date, we have not generated significant commercial product revenue. We will continue to require additional capital to successfully commercialize WiSE CRT System and fund operations for the foreseeable future. Our primary uses of cash are to fund our operations, which consist primarily of research and development expenses, manufacturing automation and scaleup, and selling, general and administrative expenses. We expect our expenses to continue to increase in connection with our ongoing activities as we continue to commercialize WiSE CRT System.
Current report
We may seek to raise capital through equity offerings or debt financings, collaboration agreements, or other arrangements with other companies, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our consolidated financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including:
Current report
If we raise additional capital through debt financing, we may be subject to covenants that restrict our operations including limitations on our ability to incur liens or additional debt, pay dividends, make certain investments, and engage in certain merger, consolidation, or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us. If we raise funds through collaborations, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials or delay investments in our manufacturing scale-up and automation. In addition, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets. Furthermore, this Quarterly Report on Form 10-Q contains statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.
Current report
Net cash provided by financing activities during the three months ended March 31, 2026, was $0.1 million, compared to $0.2 million during the three months ended March 31, 2025, representing a decrease in cash provided of $0.1 million, which was primarily attributable to the proceeds from exercise of stock options.
Removed paragraphs (30)
Previous report
We have implemented a Limited Market Release (“LMR”), with the following objectives:
Previous report
LMR objective 1: Initial Target Accounts
Previous report
LMR objective 2: Expansion and Optimization
Previous report
LMR objective 3: Increase Implants Per Site
Previous report
As of September 30, 2025, we have seven active LMR hospitals or medical facilities.
Previous report
Full Market Release
Previous report
Our full market release strategy includes the following objectives:
Previous report
Our OUS commercial activities will not commence until we obtain regulatory approvals and certification in select, target markets. These initial target markets include Australia, the United Kingdom, and the European Union. The timing of launch in each of these OUS markets thus depends on meeting additional regulatory requirements, as well as on securing the appropriate payment coverage for WiSE in each market.
Previous report
As a result of its breakthrough device designation (“BDD”), our WiSE CRT technology is eligible for incremental payment coverage in the U.S. for up to three years following FDA approval. The Centers for Medicare & Medicaid Services (“CMS”) has approved of the New Technology Add-On Payment (“NTAP”) for WiSE, commencing October 1, 2025. The NTAP is designed to bridge the financial gap between the costs of innovative technologies and the standard Medicare severity Diagnosis Related Groups (“MS-DRG” or “DRG”) payment structure in place, while encouraging early adoption of the breakthrough medical advancements used in the inpatient setting for Medicare patients. NTAP secures the maximum reimbursement rate of 65% of the cost of WiSE. This is in addition to the DRG payments, which are intended to cover the procedure and the remaining device cost. In June 2025, we received preliminary approval for Transitional Pass-Through (“TPT”) reimbursement scheme of WiSE. Preliminary approval for the TPT reimbursement scheme, will commence October 1, 2025, and is effective for three years. TPT provides hospitals with Medicare reimbursement when treating patients in an outpatient setting. In combination, these reimbursements are intended to fully cover the cost of WiSE in a hospital or outpatient setting.
Previous report
In May 2025, we completed an institutional placement of 55,900,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $33,467,662, net of $2,498,398 of related issuance costs. In June 2025, we completed a non-underwritten rights offering to existing stockholders, or Securities Purchase Plan, and issued an additional 20,000,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $12,751,318, net of $110,682 of related issuance costs.
Previous report
Other Income (Expenses), net
Previous report
Other income
Previous report
Other income includes reimbursements of clinical trial expenses as well as refundable tax incentives from the Australian Taxation Office.
Previous report
Revenue Recognition
Previous report
In accordance with Accounting Standards Codification 606Revenue from Contracts with Customers (“ASC 606”), we recognize revenue when control is transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for the goods or services. To recognize revenue, we apply the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied.
Previous report
We recognize all of our revenue from contracts with customers at a point in time. As the majority of revenue consists of sales of WiSE CRT System and battery replacements, where our sales representative provides assistance at the point of implantation at hospitals or medical facilities, we recognize revenue upon completion of the procedure. We also generate a small portion of our revenue from the sale of surgical tool kits that are ordered in advance of a procedure. As the performance obligation is the delivery of the product, we recognize revenue for surgical tool kits upon shipment to the customers. For all performance obligations, the standalone selling price is directly observable as these goods are sold separately by us. Sales prices are specified in the executed customer contract and purchase order prior to the transfer of control to the customer. Our standard payment terms are generally net 30 days.
Previous report
Revenue and cost of goods sold increased to $0.5 million and $0.3 million, respectively, or 100%, during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, resulting from the FDA approval of our WiSE CRT System in April 2025. During the three months ended September 30, 2025, we had commercial implants at four incrementally new hospitals in the US.
Previous report
Research and development expenses decreased by $0.1 million, or 0.9%, during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The decrease was primarily due to a $0.5 million decrease in contract manufacturing, materials and components, resulting from a decrease in professional services related to the development testing of WiSE, as well as capitalization of inventory. Facility-related expenses decreased by $0.3 million, as we capitalized certain overhead costs to inventory during the three months ended September 30, 2025. These decreases were partially offset by a $0.5 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits, resulting from workforce expansion, and a $0.2 million increase in clinical trial expenses.
Previous report
Comparison of the Nine Months Ended September 30, 2025, to the Nine Months Ended September 30, 2024
Previous report
Revenue and cost of goods sold increased to $0.7 million and $0.4 million, respectively, or 100%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, resulting from the FDA approval of our WiSE CRT System in April 2025. During the nine months ended September 30, 2025, we had commercial implants at seven hospitals in the US.
Previous report
Gross Profit, and Gross Margin
Previous report
Operating Expenses
Previous report
Research and Development
Previous report
Research and development expenses decreased by $2.6 million, or 12.7%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The decrease was primarily due to a $2.9 million decrease in contract manufacturing, materials and components, resulting from a decrease in professional services related to the development testing of the WiSE CRT System, as well as capitalization of inventory. Facility-related expenses decreased by $1.1 million, as we capitalized certain overhead costs to inventory during the nine months ended September 30, 2025. These decreases were partially offset by a $1.0 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits, resulting from the normal annual salary increases and workforce expansion, and a $0.3 million increase in clinical expenses.
Previous report
Other (expense) income, net
Previous report
Other (expense) income, net decreased by $0.3 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. Other income increased by $0.3 million, primarily resulting from an increase in refundable tax incentives, and interest expense decreased by $0.3 million. These changes were partially offset by a $0.3 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities.
Previous report
To the extent that current and anticipated future sources of liquidity are insufficient to fund our future business activities and cash and other requirements, we may be required to seek additional equity or debt financing. The sale of additional equity would result in additional dilution to our stockholders. The incurrence of additional debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. In the event that additional financing is required from outside sources, there is a possibility we may not be able to raise it on terms acceptable to us or at all. Further, the current macroeconomic environment may make it difficult for us to raise capital on terms favorable to us or at all. If we are unable to raise additional capital when desired, our business, operating results, and financial condition could be adversely affected.
Previous report
Recent Financings
Previous report
In May 2025, we completed an institutional placement of 55,900,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $33,467,662, net of $2,498,398 of related issuance costs. In June 2025, we completed a non-underwritten rights offering to existing stockholders, or Securities Purchase Plan, and issued an additional 20,000,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $12,751,318, net of $110,682 of related issuance costs.
Previous report
Net cash provided by financing activities during the nine months ended September 30, 2025 was $46.8 million, compared to $29.8 million during the nine months ended September 30, 2024, representing an increase of $17.0 million. This increase was primarily attributed to the $16.7 million increase in proceeds from a capital raise, net of issuance cost, during the nine months ended September 30, 2025, as well as by a $0.4 million increase in proceeds from exercise of stock options. These increases were partially offset by $0.1 million decrease in proceeds from borrowings on notes payable during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.
Reworded paragraphs (28)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes and other information included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2024. In addition to historical data, this discussion contains forward-looking statements about our business, ability to successfully commercialize our WiSE CRT System, results of operations, cash flows, financial condition and prospects based on current expectations that involve risks, uncertainties, assumptions, and other important factors. Our actual results could differ materially from such forward-looking statements. Factors that could cause or contribute to those differences include, but are not limited to, those identified below and those discussed in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K. Additionally, our historical results are not necessarily indicative of the results that may be expected for any period in the future. We use words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "seek," "should," "will," "would," and similar expressions to identify forward-looking statements.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes and other information included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2025. In addition to historical data, this discussion contains forward-looking statements about our business, ability to continue as a going concern, ability to successfully commercialize our WiSE CRT System, results of operations, cash flows, financial condition and prospects based on current expectations that involve risks, uncertainties, assumptions, and other important factors. Our actual results could differ materially from such forward-looking statements. Factors that could cause or contribute to those differences include, but are not limited to, those identified below and those discussed in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K. Additionally, our historical results are not necessarily indicative of the results that may be expected for any period in the future. We use words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "seek," "should," "will," "would," and similar expressions to identify forward-looking statements.
Previous wording
We have launched WiSE with the focus on driving adoption of WiSE at key, high-volume, hospitals or medical facilities within the U.S. to be followed by select, high-volume hospitals or medical facilities in markets outside the U.S. (“OUS”) that we would target after evaluating regulatory and reimbursement considerations.
Current wording
We have launched WiSE with the focus on driving adoption of WiSE at key, high-volume, hospitals or medical facilities within the U.S. to be followed by select, high-volume hospitals or medical facilities in markets outside the U.S. (“OUS”) that we would target after evaluating regulatory and reimbursement considerations. The growth of our business depends on our ability to successfully commercialize WiSE and gain wide acceptance of WiSE by continuing to make physicians and other hospital staff aware of the benefits of WiSE to generate increased demand and frequency of use and thus increase sales to our hospital customers. Our ability to grow our business will also depend on our ability to expand our customer base in existing or new target markets. The rate at which we grow our sales force and the speed at which newly hired salespeople become effective can impact our revenue growth or our costs incurred in anticipation of such growth. We intend to make significant investments in our sales and marketing organization by increasing the number of U.S. sales representatives and expanding our international marketing programs to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our products to new hospital accounts.
Previous wording
Our WiSE CRT System received approval from the FDA for commercial distribution in April 2025, and we began commercializing WiSE during the second quarter of 2025. The commercial potential of and our ability to successfully commercialize WiSE is unproven and will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations. Based on our current operating plans and assumptions we believe that our existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenue from the U.S of the WiSE CRT System will be sufficient to fund our projected operating requirements for at least the next 12 months from the date of this filing.
Current wording
Our WiSE CRT System received approval from the FDA for commercial distribution in April 2025, and we began commercializing WiSE during the second quarter of 2025. During the three months ended March 31, 2026, we had 41 commercial implants at 19 hospitals in the US, and recognized revenue of $2.4 million. An additional 22 physicians were trained to implant the WiSE CRT System, and 16 additional purchase agreements were signed with target LMR sites during the three months ended March 31, 2026. The commercial potential of and our ability to successfully commercialize WiSE is unproven and will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations.
Previous wording
Since inception, we have incurred significant net losses and expect to continue to incur net losses for the foreseeable future. Since our inception, our operations have been financed primarily by net proceeds from the sale of our CDIs, common stock, convertible preferred stock, and indebtedness. As of September 30, 2025, we had $73.0 million in cash, cash equivalents, restricted cash, and marketable securities and an accumulated deficit of $388.2 million.
Current wording
Since inception, we have incurred significant net losses and expect to continue to incur net losses until we are able to generate sufficient revenue. Since our inception, our operations have been financed primarily by net proceeds from the sale of our CDIs, common stock, convertible preferred stock, and indebtedness. As of March 31, 2026, we had $30.9 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $419.3 million. For a more comprehensive discussion see “Liquidity and Capital Resources” and “Future Funding Requirements” below.
Previous wording
We derive most of our revenue from sales of WiSE to the hospital facilities that implant our WiSE CRT System. We recognize revenue upon the transfer of goods or services to a customer at an amount that reflects the expected consideration to be received in exchange for those goods or services. Specifically, revenue from the sale of WiSE is recognized at an amount that reflects the expected consideration upon notice that our products have been used in a surgical procedure. Our revenue fluctuates primarily based on the volume of procedures performed. Our revenue is expected to continue to fluctuate in the future from quarter-to-quarter due to a variety of factors, including the success of our sales force in expanding adoption of WiSE in new accounts and the number of physicians who are aware of and implant WiSE.
Current wording
We derive most of our revenue from sales of WiSE to the hospital facilities that implant our WiSE CRT System. We recognize revenue upon the transfer of goods or services to a customer at an amount that reflects the expected consideration to be received in exchange for those goods or services. Specifically, revenue from the sale of WiSE is recognized at an amount that reflects the expected consideration upon notice that our products have been used in a surgical procedure. Our revenue fluctuates primarily based on the volume of procedures performed. Our revenue is expected to continue to fluctuate in the future from quarter-to-quarter due to a variety of factors, including the success of our sales force in expanding adoption of WiSE in new hospitals and the number of physicians who are aware of and implant WiSE.
Previous wording
We calculate gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily by our manufacturing costs, pricing, and the use of inventory that was previously expensed during our clinical trial. Our gross margin is expected to decrease over the near term as we continue to utilize inventory that was previously expensed, but over the long term our gross margin may increase to the extent our production volume increases as our fixed manufacturing costs would be spread over a larger number of units, thereby reducing our per-unit manufacturing costs. We expect our gross margin will fluctuate from period to period, however, based upon the factors described above.
Current wording
We calculate gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily by our manufacturing costs, pricing, and the use of inventory that was previously expensed during our clinical trial. Our gross margin is expected to decrease over the near term as we continue to utilize inventory that was previously expensed as research and development costs, but over the long term our gross margin may increase to the extent our production volume increases as our fixed manufacturing costs would be spread over a larger number of units, thereby reducing our per-unit manufacturing costs. We expect our gross margin will fluctuate from period to period based upon the factors described above.
Previous wording
Research and development expenses primarily consist of personnel-related expenses, including salaries, bonuses, fringe benefits and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions. Research and development expenses also include costs of conducting our ongoing clinical studies, such as expenses associated with our clinical research organization, or CRO, who provided project management and other services related to our SOLVE-CRT study, outside service fees paid to third party consultants and contractors related to our product candidate engineering, quality assurance and regulatory approval, as well as contract manufacturing of our product candidate and allocated facility costs.
Current wording
Research and development expenses primarily consist of personnel-related expenses, including salaries, bonuses, fringe benefits and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions. Research and development expenses also include costs of conducting our post-approval study, such as expenses associated with our clinical research organization, or CRO, who provided project management, outside service fees paid to third party consultants and contractors related to WiSE engineering, quality assurance and regulatory approval, as well as contract manufacturing of WiSE and allocated facility costs.
Previous wording
We anticipate that our research and development expenses will increase in the future as we:
Current wording
We anticipate that our research and development expenses will increase significantly in the future as we:
Previous wording
Selling, general and administrative expenses primarily consist of personnel-related costs, including salaries, bonuses, fringe benefits and other compensation-related costs, including stock-based compensation expense, for our personnel and external contractors involved in our sales and marketing, executive, finance, legal and other administrative functions, as well as losses on the disposal of property and equipment. Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including costs associated with obtaining and maintaining our patent portfolio and professional fees for accounting, auditing, tax, legal services, and other consulting expenses.
Current wording
Selling, general and administrative expenses primarily consist of personnel-related costs, including salaries, bonuses, fringe benefits and other compensation-related costs, including stock-based compensation expense, for our personnel and external contractors involved in our sales and marketing, executive, finance, legal and other administrative functions. Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including costs associated with obtaining and maintaining our patent portfolio and professional fees for accounting, auditing, tax, legal services, and other consulting expenses.
Previous wording
Our critical accounting estimates are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no significant changes to our critical accounting estimates since December 31, 2024, except as discussed below.
Current wording
Our critical accounting estimates are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no significant changes to our critical accounting estimates since December 31, 2025.
Previous wording
See the section titled “Summary of Significant Accounting Policies—Recently issued accounting pronouncements” in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
See the sections titled “Recently adopted accounting pronouncements” and “Recently issued accounting pronouncements not yet adopted” in Note 3 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Previous wording
Adjusted earnings before interest, income taxes, depreciation and amortization (“Adjusted EBITDA”), a non-GAAP measure used by management to assess operating performance, is defined as net loss, excluding interest expense, net, depreciation and amortization, stock-based compensation, and expenses associated with our Form 10 filling. Adjusted EBITDA is intended as a supplemental measure of our performance and provides useful information to management and investors regarding our operating results.
Current wording
Adjusted earnings before interest, income taxes, depreciation and amortization (“Adjusted EBITDA”), a non-GAAP measure used by management to assess operating performance, is defined as net loss, excluding interest expense, net, depreciation and amortization, and stock-based compensation. Adjusted EBITDA is intended as a supplemental measure of our performance and provides useful information to management and investors regarding our operating results.
Previous wording
We recorded a net loss of $12.2 million in the three months ended September 30, 2025, an increase of $2.1 million, or 21.2%, from the three months ended September 30, 2024. The increased loss in 2025 was due to an increase in selling, general and administrative expenses in 2025, which was partially offset by a decrease in research and development expenses, as discussed below. Other (expense) income, net decreased in 2025 primarily due to an increase in refundable tax incentives, as discussed below.
Current wording
We recorded a net loss of $17.1 million in the three-month period ended March 31, 2026, an increase of $6.5 million, or 61.8%, from the three-month period ended March 31, 2025. The increased loss in 2026 was due to an increase in selling, general and administrative expenses, and research and development expenses, as discussed below. Other (expense), net also increased in 2026, primarily due to a decrease in interest income, as discussed below.
Previous wording
We derive the majority of our revenue from sales to customers in the United States. International revenue is attributable to the battery replacements for clinical trial patients in the UK. Revenue by geography is based on the billing address of the customer. The table below summarizes our revenue by geography:
Current wording
We derive the majority of our revenue from sales to customers in the United States. International revenue is attributable to the battery replacements for clinical trial patients in the UK. Revenue by geography is based on the billing address of the customer.
Previous wording
Gross profit increased to $0.2 million, or 100% for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, resulting from the FDA approval of our WiSE CRT System in April 2025. Gross margin was 43.8% for the three months ended September 30, 2025. Our gross margin was positively affected and will continue to be affected in the near future by the use of inventory that was previously expensed during our clinical trial. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 25.3%.
Current wording
Gross profit increased to $0.2 million, or 100% during the three-month period ended March 31, 2026, as compared to the three-month period ended March 31, 2025, resulting from the FDA approval of our WiSE CRT System in April 2025. Gross margin was 7.8% for the three-month period ended March 31, 2026. Our gross margin was positively affected and will continue to be affected in the near future by the use of inventory that was previously expensed during our clinical trial. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 25.4%.
Previous wording
Selling, General and administrative expenses increased by $7.2 million, or 86.1%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $5.2 million as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Facility-related and other expenses increased by $0.4 million, primarily resulting from the higher non-cash rent expense due to a new lease agreement entered in 2025. Travel-related expenses increased by $1.2 million due the expansion of our workforce to support our sales and marketing efforts. Corporate expenses increased by $0.4 million, primarily resulting from the higher expenses related to insurance premiums, investor relations, and computer software.
Current wording
Selling, general and administrative expenses increased by $5.6 million, or 127.8%, during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $2.8 million as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $1.7 million due to increased travel to support our sales and marketing efforts. Professional fees increased by $0.4 million, primarily resulting from higher accounting and legal services fees. Facility-related and other expenses increased by $0.4 million, primarily resulting from the higher rent and common area maintenance costs for our new corporate headquarters and manufacturing facility. Corporate expenses increased by $0.2 million, primarily resulting from the higher expenses related to investor relations, and computer software licenses.
Previous wording
Other (expense) income, net decreased by $0.6 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. Other income has increased by $0.3 million, primarily resulting from an increase in refundable tax incentives. Interest expense decreased by $0.1 million, and interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities has increased by $0.2 million.
Current wording
Other (expense) income, net increased by $0.2 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This increase primarily resulted from a $0.2 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities.
Previous wording
We believe that our cash and cash equivalents, and marketable securities, and anticipated revenues from sales of our WiSE CRT System will be sufficient to fund our operations for at least the next 12 months from the date of this filing. We manage our cash and capital structure to maximize shareholder return, maintain its financial condition and maintain flexibility for future strategic initiatives. We continuously assess our working capital needs, debt and leverage levels, debt maturity schedule, capital expenditure requirements and future investments. As of September 30, 2025 and December 31, 2024, we had approximately $70.4 million and $66.0 million, respectively, in cash, cash equivalents, and marketable securities. In the long-term, our ability to support our working capital and capital expenditure requirements will depend on many factors, including:
Current wording
We manage our cash and capital structure to maximize shareholder return, maintain its financial condition and maintain flexibility for future strategic initiatives. We continuously assess our working capital needs, debt and leverage levels, debt maturity schedule, capital expenditure requirements and future investments. As of March 31, 2026 and December 31, 2025, we had approximately $30.9 million and $54.2 million, respectively, in cash, cash equivalents, and marketable securities. Based on our cash, cash equivalents, and marketable securities as of March 31, 2026, and our expectation to generate operating losses and negative operating cash flows in the foreseeable future, there exists substantial doubt regarding our ability to continue as a going concern for a period of at least twelve months from the date of this Form 10-Q.
Previous wording
On June 30, 2022, we entered into a loan and security agreement with Runway Growth Finance Corp. The debt is secured against substantially all of our assets, except for intellectual property, but includes all proceeds from the sale of intellectual property.
Current wording
On June 30, 2022, we entered into a loan and security agreement with Runway Growth Finance Corp. The debt is secured against substantially all of our assets, except for intellectual property, but includes all proceeds from the sale of intellectual property. The loan agreement provides three term loan tranches. We received the initial draw of $20.0 million in June 2022. We received positive interim analysis data, sufficient to proceed with the clinical trial and premarket approval submission to the U.S. Food and Drug Administration, which allowed us to draw the second tranche of $20.0 million in June 2023. The final tranche provided $10.0 million from the date of approval from the FDA for the WiSE CRT System and ended on June 30, 2024. We did not receive FDA approval by June 30, 2024, and therefore did not meet the draw requirements of the third and final tranche.
Previous wording
Interest on the term loan accrues on the principal amount outstanding at a floating per annum rate equal to the greater of the rate of interest noted in The Wall Street Journal Money Rates section, as the “Prime Rate” or 4.00% plus a margin of 4.9% and is payable monthly in arrears and shall be computed on the basis of a 360-day year for the actual number of days elapsed. We are required to make interest only payments from July 2022 to May 2027. The note payable has a maturity date of June 15, 2027, at which time any unpaid interest, outstanding principal balance, and a final payment of 4.5% of the original principal amount borrowed shall be due in full. If we repay the loan prior to maturity, we will be required to pay a prepayment fee of 0.5% - 1% of the outstanding principal balance. We are also required to pay a 3% success fee of the funded principal amount of the term loan at the time of a liquidity event, as defined in the loan and security agreement. The success fee is enforceable within 10 years from the execution date of the agreement.
Current wording
Interest on the term loan accrues on the principal amount outstanding at a floating per annum rate equal to the greater of the rate of interest noted in The Wall Street Journal Money Rates section, as the “Prime Rate” or 4.00% plus a margin of 4.9% and is payable monthly in arrears and shall be computed on the basis of a 360-day year for the actual number of days elapsed. We are required to make interest only payments from July 2022 to May 2027. The note payable has a maturity date of June 15, 2027, at which time any unpaid interest, outstanding principal balance, and a final payment of 4.5% of the original principal amount borrowed shall be due in full. If we repay the loan prior to maturity, we will be required to pay a prepayment fee of 0.5% of the outstanding principal balance. We are also required to pay a 3% success fee of the funded principal amount of the term loan at the time of a liquidity event, as defined in the loan and security agreement. The success fee is enforceable within 10 years from the execution date of the agreement.
Previous wording
As of September 30, 2025 and December 31, 2024, the outstanding principal balance was $41,800,000, which includes final payment of 4.5% of the principal borrowings to date.
Current wording
As of March 31, 2026 and December 31, 2025, the outstanding principal balance was $41.8 million, which included the principal borrowings under tranche one and tranche two, as well as the final payment of 4.5% of the principal borrowings to date.
Previous wording
As of September 30, 2025, we had $0.7 million in operating lease obligations for our corporate headquarters and laboratory space located in Sunnyvale, California. Additionally, in January 2025, we entered into a new lease agreement for our new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California, for which we had recorded $15.4 million in operating lease obligations as of September 30, 2025.
Current wording
As of March 31, 2026, we had $0.4 million in operating lease obligations for our corporate headquarters and laboratory space located in Sunnyvale, California. Additionally, in January 2025, we entered into a new lease agreement for our new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California, for which we had recorded $18.1 million in operating lease obligations as of March 31, 2026.
Previous wording
As of September 30, 2025, the outstanding principal balance under our loan and security agreement described above was $41,800,000, which includes the final payment of 4.5% of the principal borrowings to date.
Current wording
As of March 31, 2026, the outstanding principal balance under our loan and security agreement described above was $41.8 million, which included the principal borrowings under tranche one and tranche two, as well as the final payment of 4.5% of the principal borrowings to date.
Previous wording
In addition, we enter into contracts in the normal course of business with third-party contract organizations for clinical trials, manufacturing and other services and products for operating purposes. In certain instances, our purchase agreements allow us to cancel, reschedule, or adjust our purchase requirements based on our business needs prior to firm orders being placed. Consequently, only a portion of our purchase commitments are firm and non-cancelable. As of September 30, 2025, our obligations under non-cancelable arrangements were approximately $12.1 million.
Current wording
In addition, we have agreements with suppliers and other parties to purchase inventory. Product inventory obligations consist primarily of purchase order commitments for raw materials and sub-assemblies used in the production of the WiSE CRT System. In certain instances, our purchase agreements allow us to cancel, reschedule, or adjust our purchase requirements based on our business needs prior to firm orders being placed. As of March 31, 2026, our obligations under such arrangements were approximately $14.0 million.
Previous wording
As of September 30, 2025, we had working capital of $71.9 million, comprised of current assets of $82.2 million and current liabilities of $10.3 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, increased by $17.8 million as of September 30, 2025, compared to December 31, 2024. The sale of CDIs discussed above contributed to the overall increase in cash, cash equivalents and marketable securities, resulting in a $7.7 million increase in working capital as of September 30, 2025. Additionally, the capitalization of inventory resulted in a $8.3 million increase in working capital, and an increase in the accounts and other receivables primarily due to the reimbursements for leasehold improvements resulted in a $2.3 million increase in working capital as of September 30, 2025. Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, and interest payable, increased by approximately $2.0 million as of September 30, 2025, compared to December 31, 2024. The increase primarily resulted from a $1.3 million increase in accounts payable, which was mainly due to the activity related to construction of leasehold improvements at the new corporate headquarters, as well as the purchases of raw materials. The abovementioned construction of leasehold improvements also resulted in a $0.2 million increase in accrued expenses due to increase in retainage that will be payable upon the project completion. Additionally, the execution of a new lease agreement in 2025 resulted in $0.5 million increase in operating lease liabilities, which contributed to the overall increase in current liabilities.
Current wording
As of March 31, 2026, we had working capital of $42.0 million, comprised of current assets of $54.0 million and current liabilities of $12.0 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, decreased by $19.1 million as of March 31, 2026, compared to December 31, 2025. The capitalization of inventory resulted in a $1.7 million increase in working capital. An increase in accounts and other receivables, primarily due to the amounts outstanding from customers from sales of Company’s product, as well as the reimbursements for leasehold improvements, resulted in a $2.8 million increase in working capital as of March 31, 2026. Additionally, an increase in other current assets, primarily due to an increase in deferred costs of goods sold, which was offset by a decrease in deposits to vendors for the purchases of machinery and equipment for the new manufacturing facility, resulted in a $0.2 million increase in working capital as of March 31, 2026. These increases in current assets were offset by $0.5 million decrease in prepaid expenses, and a $23.3 million decrease in cash, cash equivalents and marketable securities which were used to support our working capital and capital expenditure requirements.
Previous wording
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:
Current wording
The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:
Previous wording
Net cash used in operating activities during the nine months ended September 30, 2025, was $38.1 million, compared to $30.2 million during the nine months ended September 30, 2024, representing an increase in use of $7.9 million. This increase is primarily attributed to an increase in net loss of $4.0 million and an increase in use of cash from changes in working capital of $6.0 million, which were partially offset by an increase in non-cash adjustments of $2.1 million.
Current wording
Net cash used in operating activities during the three months ended March 31, 2026, was $20.3 million, compared to $13.6 million during the three months ended March 31, 2025, representing an increase in use of $6.7 million. This increase is primarily attributed to an increase in net loss of $6.5 million, a decrease in cash from changes in working capital of $0.8 million, which were partially offset by an increase in non-cash adjustments of $0.6 million.
Previous wording
Net cash used in investing activities during the nine months ended September 30, 2025, was $0.3 million, compared to $22.3 million net cash provided during the nine months ended September 30,2024, representing an increase in cash used of $22.6 million. The increase was attributable to a $18.2 million increase in the purchase of marketable securities, a $2.0 million increase in cash used for purchases of property and equipment, and a $2.4 million net decrease in cash provided from the maturities and sales of marketable securities during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.
Current wording
Net cash provided by investing activities during the three months ended March 31, 2026, was $20.9 million, compared to $17.9 million during the three months ended March 31, 2025, representing an increase in cash provided of $3.0 million. The increase was attributable to a $6.2 million increase in cash from the maturities and sales of marketable securities during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This change was partially offset by a $3.2 million increase in purchase of property and equipment during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
The table below summarizes our revenue by geography:
Current report — wording carried from elsewhere
Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, and interest payable, decreased by approximately $2.0 million as of March 31, 2026, compared to December 31, 2025. The decrease primarily resulted from a $1.3 million decrease in accounts payable, which was mainly due to the activity related to construction of leasehold improvements at the new corporate headquarters, as well as the purchases of raw materials. Accrued expenses decreased by approximately $0.6 million as of March 31, 2026, compared to December 31, 2025. The decrease primarily resulted from the payout of annual bonuses, which was partially offset by an increase in deferred revenue from sales of our WiSE CRT System. Additionally, operating lease liabilities decreased by approximately $0.1 million, which contributed to the overall decrease in current liabilities.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
Selling, General and administrative expenses increased by $3.0 million, or 103.6%, during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $2.3 million as a result of the expansion of our workforce to support our sales and marketing efforts after the FDA approval of WiSE. Travel-related expenses increased by $0.6 million due the expansion of our workforce to support our sales and marketing efforts. Facility-related expenses increased by $0.1 million, primarily resulting from the higher non-cash rent expense due to a new lease agreement entered in 2025.
Previous report — wording carried elsewhere
We recorded a net loss of $34.7 million in the nine months ended September 30, 2025, an increase of $4.0 million, or 13.1%, from the nine months ended September 30, 2024. The increased loss in 2025 was due to an increase in selling, general and administrative expenses in 2025, which was partially offset by a decrease in research and development expenses, as discussed below. Other (expense) income, net also decreased in 2025 primarily due to an increase in refundable tax incentives and decrease in interest expense, as discussed below.
Previous report — wording carried elsewhere
The following table summarizes our operating results for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
We derive the majority of our revenue from sales to customers in the United States. International revenue is attributable to the battery replacements for clinical trial patients in the UK. Revenue by geography is based on the billing address of the customer. The table below summarizes our revenue by geography:
Previous report — wording carried elsewhere
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin:
Previous report — wording carried elsewhere
Revenue and Cost of Goods Sold
Previous report — wording carried elsewhere
Gross profit increased to $0.3 million, or 100% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, resulting from the FDA approval of our WiSE CRT System in April 2025. Gross margin was 45.2% for the nine months ended September 30, 2025. Our gross margin was positively affected and will continue to be affected in the near future by the use of inventory that was previously expensed during our clinical trials. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 31.9%.
Previous report — wording carried elsewhere
The following table presents our total research and development expenses by category: