EBR Systems, Inc.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
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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.
Jun 30, 2025 · Filed Aug 12, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001214659-25-007491
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001214659-25-011868
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 89 previous paragraphs and 115 current paragraphs.
47 unchanged; 32 reworded; 31 added; 10 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 45 previous and 54 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 (31)
Current report
Our full market release strategy includes the following objectives:
Current 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 $33,468,468, net of $2,497,592 of related issuance costs. In June 2025, we completed a non-underwritten rights offering to existing stockholders, or Security 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 $12,760,947, net of $101,053 of related issuance costs.
Current report
Revenue
Current report
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 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 report
Nearly all our revenue results from sales in the United States, but we also have limited sales of replacement batteries for our WiSE CRT System to hospital facilities with patients who have been or are currently enrolled in our clinical study in the United Kingdom (“UK”).
Current report
Cost of Goods Sold and Gross Margin
Current report
Cost of goods sold consists primarily of costs related to materials, components and subassemblies, personnel-related expenses for our manufacturing and quality assurance employees, manufacturing overhead and charges for excess, obsolete and non-sellable inventories. Overhead costs include the cost of quality assurance, testing, material procurement, inventory control, operations supervision and management personnel, an allocation of facilities and information technology expenses, including rent and utilities, and equipment depreciation. Cost of goods sold also includes certain indirect costs such as those incurred for shipping our WiSE CRT System. We record adjustments to our inventory valuation for estimated excess, obsolete and non-sellable inventories based on assumptions about future demand, past usage, changes to manufacturing processes and overall market conditions.
Current report
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 report
Revenue Recognition
Current 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.
Current 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 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 the 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.
Current report
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 report
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin:
Current report
Revenue and Cost of Goods Sold
Current report
Revenue and cost of goods sold increased to $0.2 million and $0.1 million, respectively, or 100%, during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, resulting from the recent FDA approval of our WiSE CRT System. During the three months ended June 30, 2025, we had commercial implants at three hospitals in the US.
Current report
Gross Profit, and Gross Margin
Current report
Gross profit increased to $0.1 million, or 100% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, resulting from the recent FDA approval of our WiSE CRT System. Gross margin was 50.0% for the three months ended June 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 51.2%.
Current report
Selling, General and administrative expenses increased by $2.0 million, or 61.0%, during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $1.6 million as a result of the expansion of our workforce to support our sales and marketing efforts after the FDA approval of WiSE. Facility-related expenses increased by $0.6 million, primarily resulting from higher non-cash rent expense due to a new lease agreement entered in 2025. Corporate expenses increased by $0.2 million, primarily resulting from the higher expenses related to insurance premiums, investor relations, and computer software licenses. These increases were offset by $0.4 million decrease in professional fees, as we did not incur any additional accounting and legal fees in connection with preparation for Form 10 filing in the current period, as we did during the three months ended June 30, 2024.
Current report
Comparison of the Six Months Ended June 30, 2025, to the Six Months Ended June 30, 2024
Current report
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 report
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin:
Current report
Revenue and Cost of Goods Sold
Current report
Revenue and cost of goods sold increased to $0.2 million and $0.1 million, respectively, or 100%, during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, resulting from the recent FDA approval of our WiSE CRT System. During the six months ended June 30, 2025, we had commercial implants three hospitals in the US.
Current report
Gross Profit, and Gross Margin
Current report
Gross profit increased to $0.1 million, or 100% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, resulting from the recent FDA approval of our WiSE CRT System. Gross margin was 50.0% for the six months ended June 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 51.2%.
Current report
Operating Expenses
Current report
Research and Development
Current report
Other (expense) income, net
Current 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.
Current report
Recent Financings
Current 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 $33,468,468, net of $2,497,592 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 $12,760,947, net of $101,053 of related issuance costs.
Removed paragraphs (10)
Previous report
The successful development of product candidates is subject to numerous risks and uncertainties. For a discussion of certain risks related to the development of product candidates and costs of clinical trials, see “Item 1A. Risk Factors” in our Form 10-K.
Previous report
General and Administrative Expenses
Previous report
General and Administrative Expenses
Previous report
Going concern consideration
Previous report
The accompanying 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, 2025 and 2024, we incurred a net loss of $10,554,271 and $9,150,003, respectively. During the three months ended March 31, 2025 and 2024, we had negative cash flows from operations of $13,563,695 and $10,059,772, respectively. As of March 31, 2025, we had working capital of $46,751,043 and accumulated deficit of $364,011,951. 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.
Previous report
Future Funding Requirements
Previous 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.
Previous report
To date, we have not generated any 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 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.
Previous 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:
Previous 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.
Reworded paragraphs (32)
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 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.
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, 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.
Previous wording
We initially developed the WiSE CRT System for use in conjunction with another implanted pacemaker to provide CRT to patients who are unable to receive CRT from a traditional lead-based system or are at high risk of complications from an upgrade procedure. WiSE CRT technology is engineered to benefit patients who have not seen success with conventional CRT or face high complication risks. By eliminating lead requirements for left ventricular pacing, WiSE CRT introduces a novel approach to cardiac pacing, with the potential to transform CRT delivery.
Current wording
We initially developed WiSE for use in conjunction with another implanted pacemaker to provide CRT to patients who are unable to receive CRT from a traditional lead-based system or are at high risk of complications from an upgrade procedure. WiSE CRT technology is engineered to benefit patients who have not seen success with conventional CRT or face high complication risks. By eliminating lead requirements for left ventricular pacing, WiSE CRT introduces a novel approach to cardiac pacing, with the potential to transform CRT delivery.
Previous wording
On April 11, 2025, we received notification that the Center for Devices and Radiological Health (“CDRH”) of the Food and Drug Administration (“FDA”) had completed its review of our premarket approval application (“PMA”) for the WiSE CRT System and approved the WiSE CRT System for commercial distribution in the U.S. for adult patients who are at least 22 years of age, are indicated for CRT, have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories: patients in whom previous coronary sinus (“CS”) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable"; or patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators (“ICDs”) in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high risk upgrades".
Current wording
On April 11, 2025, we received notification that the Center for Devices and Radiological Health (“CDRH”) of the Food and Drug Administration (“FDA”) had completed its review of our premarket approval application (“PMA”) for WiSE and approved WiSE for commercial distribution in the U.S. for adult patients who are at least 22 years of age, are indicated for CRT, have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories: 1) patients in whom previous coronary sinus (“CS”) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable"; or 2) patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators (“ICDs”) in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high risk upgrades".
Previous wording
We intend to commercially launch WiSE with the focus on driving adoption of WiSE at key, high-volume, luminary sites within the U.S. to be followed by select, high-volume sites 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, sites within the U.S. to be followed by select, high-volume sites in markets outside the U.S. (“OUS”) that we would target after evaluating regulatory and reimbursement considerations.
Previous wording
We plan to implement a phased Limited Market Release (“LMR”), with the following phases:
Current wording
We have implemented a Limited Market Release (“LMR”), with the following objectives:
Previous wording
LMR Phase 1: Initial Target Accounts
Current wording
LMR objective 1: Initial Target Accounts
Previous wording
LMR Phase 2: Expansion and Optimization
Current wording
LMR objective 2: Expansion and Optimization
Previous wording
LMR Phase 3: Increase Implants Per Site
Current wording
LMR objective 3: Increase Implants Per Site
Previous wording
As a result of its breakthrough device designation (“BDD”), our WiSE CRT technology is expected to be 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 proposed approval of the New Technology Add-On Payment (“NTAP”) for our WiSE CRT System for fiscal year 2026, subject to final approval before October 1, 2025. CMS has recommended WiSE receive the maximum add on payment of 65% of the device cost, which is in additional to the normal Medicare Severity Diagnosis Related Group (“MS-DRG”) payment. In combination, if approved, these reimbursements are intended to fully cover the cost of the WiSE CRT System.
Current wording
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, which is expected to commence in October 2025 and if approved will be effective for three years, is expected to provide hospitals with Medicare reimbursement when treating patients in an outpatient setting. In combination, if approved, these reimbursements are intended to fully cover the cost of WiSE in a hospital setting.
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 March 31, 2025, we had $50.2 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $364.0 million.
Current 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 June 30, 2025, we had $87.2 million in cash, cash equivalents, restricted cash, and marketable securities and an accumulated deficit of $376.0 million.
Previous wording
Our WiSE CRT System has been approved by the FDA for commercial distribution in April 2025, and we will begin 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 U.S. sales of WiSE will be sufficient to fund our projected operating requirements into the first quarter of 2026.
Current wording
Our WiSE CRT System has been approved by 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 into the first quarter of 2027.
Previous wording
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 executive, finance, legal and other administrative functions as well as our commercial function, who is involved in market access related activities. 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, 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.
Previous wording
We anticipate that our general and administrative expenses will increase significantly in the future as we:
Current wording
We anticipate that our selling, general and administrative expenses will increase significantly in the future as we:
Previous wording
Other income includes reimbursements of clinical trial expenses as well as refundable tax incentives from the Australian Taxation Office.
Current wording
Other income includes reimbursements of clinical trial 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.
Current 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.
Previous wording
See the sections titled “Summary of Significant Accounting Policies—Recently issued accounting pronouncements” in Note 3 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current 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.
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, 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.
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, 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.
Previous wording
We recorded a net loss of $10.6 million in the three-month period ended March 31, 2025, an increase of $1.4 million, or 15.4%, from the three-month period ended March 31, 2024. The increased loss in 2025 was due to an increase in general and administrative expenses, which was partially offset by a decrease in research and development expenses, as discussed below. Other (expense), net also increased in 2025, primarily due to a decrease in interest income, as discussed below.
Current wording
We recorded a net loss of $12.0 million in the three months ended June 30, 2025, an increase of $0.5 million, or 4.1%, from the three months ended June 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 increased in 2025 primarily due to a decrease in interest income, as discussed below.
Previous wording
Other (expense) income, net increased by $0.2 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. This increase primarily resulted from a $0.3 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities, which was partially offset by a $0.1 million decrease in interest expense.
Current wording
Other (expense) income, net increased by $0.1 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. 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, which was partially offset by a $0.1 million decrease in interest expense.
Previous wording
Research and development expenses decreased by $1.0 million, or 15.3% during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. The decrease was primarily due to a $1.0 million decrease in contract manufacturing, materials and components, resulting from a decrease in professional services related to the development testing of WiSE CRT System, as well as capitalization of pre-launch inventory. Facility-related expenses decreased by $0.4 million, as we began to capitalize certain overhead costs during the three months ended March 31, 2025. These decreases were partially offset by a $0.3 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits, resulting from an expansion in our workforce to support the ongoing development efforts of the WiSE CRT System; and a $0.1 million increase in clinical expenses, primarily resulting from higher travel expenses, including lodging, air travel and ground transportation due to patient follow-up visits for the SOLVE-CRT Study.
Current wording
Research and development expenses decreased by $2.5 million, or 18.0%, during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The decrease was primarily due to a $2.5 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 $0.8 million, as we capitalized certain overhead costs to inventory during the six months ended June 30, 2025. These decreases were partially offset by a $0.6 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 $0.1 million increase in clinical expenses, primarily resulting from higher travel expenses, including lodging, air travel and ground transportation due to patient follow-up visits for the SOLVE-CRT Study.
Previous wording
General and administrative expenses increased by $2.2 million, or 100.8%, during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $1.2 million as a result of the expansion of our workforce to support our commercialization effort in anticipation of FDA approval of the WiSE CRT System. Professional fees increased by $0.6 million, primarily resulting from higher accounting and legal related services associated with being a public filer in the US. Travel expenses increased by $0.3 million, which included higher lodging, air travel and ground transportation expenses resulting from travel required for training of the commercial team. Corporate expenses increased by $0.1 million, primarily resulting from the higher expenses related to insurance premiums.
Current wording
Selling, General and administrative expenses increased by $4.2 million, or 76.9%, during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. 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. Facility-related expenses increased by $0.9 million, primarily resulting from the higher rent expense due to a new lease agreement entered in 2025. Corporate expenses increased by $0.3 million, primarily resulting from the higher expenses related to insurance premiums, investor relations, and computer software. Professional fees increased by $0.2 million, primarily resulting from higher accounting and legal related services associated with being a public reporting company in the US.
Previous 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, 2025 and December 31, 2024, we had approximately $50.2 million and $66.0 million, respectively, in cash, cash equivalents, and marketable securities. Based on our cash, cash equivalents, and marketable securities as of March 31, 2025, 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.
Current 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 June 30, 2025 and December 31, 2024, we had approximately $84.6 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:
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. The loan agreement provides three term loan tranches. We received the initial draw of $20,000,000 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 $20,000,000 in June 2023. The final tranche provided $10,000,000 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.
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.
Previous wording
As of March 31, 2025 and December 31, 2024, the outstanding principal balance was $41,800,000, 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.
Current wording
As of June 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.
Previous wording
As of March 31, 2025, we had $1.0 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 $13.3 million in operating lease obligations as of March 31, 2025.
Current wording
As of June 30, 2025, we had $0.8 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 $14.8 million in operating lease obligations as of June 30, 2025.
Previous wording
As of March 31, 2025, the outstanding principal balance under our loan and security agreement described above was $41,800,000, 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.
Current wording
As of June 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.
Previous wording
In addition, we have entered into an equipment purchase agreement for the purchase of certain software. As of March 31, 2025, the outstanding principal balance was$14,914. Additionally, 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 noncancelable. As of March 31, 2025, our obligations under such arrangements were approximately $16.2 million.
Current 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 noncancelable. As of June 30, 2025, our obligations under such arrangements were approximately $13.5 million.
Previous wording
As of March 31, 2025, we had working capital of $46.8 million, comprised of current assets of $53.5 million and current liabilities of $6.7 million. Current assets, consisting of cash and cash equivalents, marketable securities, pre-launch inventory, prepaid expenses, non-trade receivables and other current assets, decreased by $11.2 million as of March 31, 2025, compared to December 31, 2024. The decrease was primarily caused by a decrease in cash, cash equivalents and marketable securities as a result of cash used in operating activities for the three months ended March 31, 2025. Refer to the cash flows discussion below for further details. Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, the current portion of notes payable and interest payable, decreased by approximately $1.8 million as of March 31, 2025, compared to December 31, 2024. The decrease primarily resulted from the payout of annual bonuses in January 2025, and a reduction in accounts payable from December 31, 2024 to March 31, 2025.
Current wording
As of June 30, 2025, we had working capital of $80.7 million, comprised of current assets of $90.3 million and current liabilities of $9.7 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, increased by $25.9 million as of June 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 $21.0 million increase in working capital as of June 30, 2025. Additionally, the capitalization of inventory resulted in a $3.7 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 $1.7 million increase in working capital as of June 30, 2025. Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, and interest payable, increased by approximately $1.4 million as of June 30, 2025, compared to December 31, 2024. The increase primarily resulted from an increase in accounts payable from December 31, 2024 to June 30, 2025, which was mainly due to the activity related to construction of leasehold improvements at the new corporate headquarters.
Previous wording
The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:
Current wording
The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:
Previous wording
Net cash used in operating activities during the three months ended March 31, 2025, was $13.6 million, compared to $10.1 million during the three months ended March 31, 2024, representing an increase in use of $3.5 million. This increase is primarily attributed to an increase in net loss of $1.4 million, a decrease in cash from changes in working capital of $2.8 million, which were partially offset by an increase in non-cash adjustments of $0.7 million.
Current wording
Net cash used in operating activities during the six months ended June 30, 2025, was $25.0 million, compared to $20.4 million during the six months ended June 30, 2024, representing an increase in use of $4.6 million. This increase is primarily attributed to an increase in net loss of $1.9 million and an increase in use of cash from changes in working capital of $4.2 million, which were partially offset by an increase in non-cash adjustments of $1.5 million.
Previous wording
Net cash provided by investing activities during the three months ended March 31, 2025, was $17.9 million, compared to $3.0 million during the three months ended March 31, 2024, representing an increase in cash provided of $14.9 million. The increase was attributable to a $8.9 million decrease in the purchase of marketable securities, as well as a $6.0 million increase in cash from the maturities and sales of marketable securities during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024.
Current wording
Net cash provided by investing activities during the six months ended June 30, 2025, was $18.8 million, compared to $14.0 million the six months ended June 30, 2024, representing an increase in cash provided of $4.8 million. The increase was attributable to a $10.6 million decrease in the purchase of marketable securities, as well as a $5.0 million net increase in cash from the maturities and sales of marketable securities during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. These increases in cash provided from investing activities were partially offset by $0.8 million increase in cash used for purchases of property and equipment during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.
Previous wording
Net cash provided by financing activities during both three months ended March 31, 2025 and 2024, was $0.2 million. The cash provided by financing activities during the three months ended March 31, 2025, was primarily attributable to the proceeds from exercise of stock options. Cash provided by financing activities during the three months ended March 31, 2024, was comprised from $0.1 million in proceeds from exercise of stock options and $0.1 million in proceeds from note payable related to the software purchase agreement.
Current wording
Net cash provided by financing activities during the six months ended June 30, 2025 was $46.9 million, compared to $0.2 million during the six months ended June 30, 2024, representing an increase of $46.7 million. This increase was primarily attributed to the $46.5 million in proceeds from a capital raise, net of issuance cost, during the six months ended June 30, 2025, as well as by a $0.3 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 six months ended June 30, 2025, as compared to the six months ended June 30, 2024.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Research and development expenses decreased by $1.5 million, or 20.4%, during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The decrease was primarily due to a $1.5 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 June 30, 2025. These decreases were partially offset by a $0.2 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits, resulting from workforce expansion.
Current report — wording carried from elsewhere
We recorded a net loss of $22.5 million in the six months ended June 30, 2025, an increase of $1.9 million, or 9.1%, from the six months ended June 30, 2024. The increased loss in 2025 was due to an increase in 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 increased in 2025 primarily due to a decrease in interest income, as discussed below.
Current report — wording carried from elsewhere
The following table summarizes our operating results for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table presents our total research and development expenses by category:
Current report — wording carried from elsewhere
Other (expense) income, net increased by $0.3 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. This increase primarily resulted from a $0.5 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities, which was partially offset by a $0.2 million decrease in interest expense.