EBR Systems, Inc.
For the period ended Dec 31, 2025. Filed Mar 18, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 18, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-24.
0001214659-25-004709
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-18.
0001214659-26-003451
Item 7. 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 96 previous paragraphs and 110 current paragraphs.
57 unchanged; 21 reworded; 32 added; 17 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 40 previous and 40 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 (32)
Current report
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.
Current report
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".
Current report
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. (“OU”) that we would target after evaluating regulatory and reimbursement considerations.
Current report
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 year ended December 31, 2025, we had commercial implants at eleven hospitals in the US, and recognized revenue of $1.6 million. A total of 33 physicians were trained to implant the WiSE CRT System, and 21 purchase agreements were signed with target LMR sites during the year ended December 31, 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.
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 $33.5 million, net of $2.5 million 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 $12.8 million, net of $0.1 million 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 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 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 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.
Current report
Selling, General and Administrative Expenses
Current report
Other (expense) income
Current report
(Loss) gain on foreign currency
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 was $1.6 million and $1.1 million, respectively, during the year ended December 31, 2025, resulting from the FDA approval of our WiSE CRT System in April 2025. During the year ended December 31, 2025, we had commercial implants at eleven hospitals in the US. There was no revenue or cost of goods sold during the year ended December 31, 2024.
Current report
Gross Profit, and Gross Margin
Current report
Gross profit and gross margin was $0.5 million and 30.3%, respectively, during the year ended December 31, 2025, resulting from the FDA approval of our WiSE CRT System in April 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 26.8%. There was no gross profit and gross margin during the year ended December 31, 2024.
Current report
Selling, General and Administrative Expenses
Current report
Other expense, net increased by $0.2 million during the year ended December 31, 2025, as compared to the year ended December 31, 2024. Interest expense decreased by $0.4 million, and interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities has decreased by $0.5 million. Additionally, other income decreased by $0.1 million, primarily resulting from a decrease in refundable tax incentive.
Current report
Going Concern Consideration
Current report
The accompanying 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 years ended December 31, 2025 and 2024, we incurred a net loss of $48.8 million and $40.8 million, respectively. During the years ended December 31, 2025 and 2024, we had negative cash flows from operations of $53.2 million and $41.2 million, respectively. As of December 31, 2025, we had working capital of $59.1 million and accumulated deficit of $402.2 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; however, no assurance can be given as to whether additional needed financing will be available on terms acceptable to the Company, or at all.
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 $33.5 million, net of $2.5 million 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 $12.8 million, net of $0.1 million of related issuance costs.
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. and generate sufficient revenue. 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 Annual Report on Form 10-K 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
As of December 31, 2025, we had working capital of $59.1 million, comprised of current assets of $73.1 million and current liabilities of $14.0 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, increased by $8.6 million as of December 31, 2025, compared to December 31, 2024. The capitalization of inventory resulted in a $12.4 million increase in working capital, and an increase in accounts and other receivables, primarily due to the reimbursements for leasehold improvements, resulted in a $1.9 million increase in working capital as of December 31, 2025. Additionally, higher prepaid insurance costs resulted in a $0.8 million increase in prepaid expenses and increase in other current assets primarily due to deposits to vendors for the purchases of machinery and equipment for the new manufacturing facility resulted in a $1.0 million increase in working capital as of December 31, 2025. These increases in current assets were partially offset by a $7.5 million decrease in cash, cash equivalents and marketable securities which were used to support our working capital and capital expenditure requirements.
Current report
Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, and interest payable, increased by approximately $5.7 million as of December 31, 2025, compared to December 31, 2024. The increase primarily resulted from a $3.8 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. Accrued expenses increased by approximately $1.3 million as of December 31, 2025, compared to December 31, 2024. The increase primarily resulted from an increase in payroll-related accruals due to the expansion of our workforce, as well as an increase in deferred revenue from sales of our WiSE CRT System. Additionally, the execution of a new lease agreement in 2025 resulted in $0.7 million increase in operating lease liabilities, which contributed to the overall increase in current liabilities.
Removed paragraphs (17)
Previous report
On September 25, 2024, we issued 55,856,325 shares of common stock, in connection with an institutional placementand the institutional component of a 1-for-20 pro-rata accelerated non-renounceable entitlement offer on the ASX, at a purchase price of $0.56 per share. We raised approximately $29.4 million, net of issuance costs of approximately $1.9 million. On October 16, 2024, we issued 5,075,733 shares of common stock, in connection with the retail component of a 1-for-20 pro-rata non-renounceable entitlement offer on the ASX, at a purchase price of $0.54 per share. We raised approximately $2.6 million, net of issuance costs of approximately $0.2 million.
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” herein.
Previous report
General and Administrative Expenses
Previous report
Other Income (Expenses), net
Previous report
Gain/ (loss) on foreign currency
Previous report
Pre-launch inventory
Previous report
We capitalized pre-launch inventory costs associated with its products prior to regulatory approval when, based on management judgement, future commercialization was considered probable and future economic benefit was expected to be realized. We assess the regulatory approval process and where the product stands in relation to that approval process including any known constraints or impediments to approval. Pre-launch inventory costs associated with products that have not yet received regulatory approval are capitalized if there is probable future commercial use and future economic benefit. If future commercial use and future economic benefit are not considered probable, then costs associated with pre-launch inventory that has not yet received regulatory approval are expensed as research and development expense during the period the costs are incurred. The determination to capitalize pre-launch inventory is based on the specific facts and circumstances relating to the product.
Previous report
Capitalization of pre-launch inventory began during the year ended December 31, 2024 when we determined that: (i) positive clinical trial results had been obtained, as evidenced by meeting both the primary efficacy and safety endpoints at the interim analysis, which supported our belief that regulatory approval is probable; (ii) uncertainties regarding regulatory approval had been significantly reduced, as evidenced by our submission of all modules of the pre-market approval application and ongoing communication with the regulatory bodies; and (iii) it is probable that these capitalized costs will provide future economic benefit, in excess of capitalized costs, as evidenced by the lack of alternative therapies for our target market and the anticipated average selling price of the WiSE CRT System.
Previous report
Once we capitalize pre-launch inventory for a product candidate that is not yet approved, we monitor, on a quarterly basis, the status of this candidate within the regulatory approval process. We could be required to expense previously capitalized costs related to pre-launch inventory upon a change in management’s judgment of future commercial use and net realizable value, due to a denial or delay of approval by regulatory bodies, a delay in the timeline for commercialization or other potential factors. On a quarterly basis, the Company evaluates all inventory, including capitalized pre-launch inventory for which regulatory approval has not yet been obtained, to determine if any lower of cost or net realizable value adjustment is required. As it relates to pre-launch inventory, we consider several factors including expected timing of FDA approval, projected sales volume and estimated selling price.
Previous report
Clinical trial accrual
Previous report
The clinical trial accrual involves identifying services that third parties, contracted by us, have performed and estimating the associated cost incurred for these services which remain uninvoiced as of the balance sheet date. In addition, the clinical trial accrual involves the measurement of milestone achievements achieved by the patients participating in the clinical trial and the associated costs which have not been invoiced as of the balance sheet date. Our objective is to reflect the appropriate clinical trial expenses in our consolidated financial statements by matching the appropriate expenses with the period in which services are provided. We account for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. Our clinical trial accrual is dependent, in part, upon the receipt of timely and accurate reporting from the third parties. We estimate our liability using our judgment based upon the facts and circumstances known at the time. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates.
Previous report
General and Administrative Expenses
Previous report
Other expense, net increased by $2.0 million during the year ended December 31, 2024, as compared to the year ended December 31, 2023. The change was caused by increased interest expense, decreased interest income, and decreased refundable tax incentives in 2024 as compared to 2023. Interest expense increased by $1.5 million, which resulted from an additional $20.0 million in borrowings on June 30, 2023. Refundable tax incentives decreased by $0.4 million in 2024, compared to 2023, which included two years of refundable tax incentives due to the timing of tax filings. During the year ended December 31, 2024, we earned interest income, including the accretion of discounts, from investment in marketable securities of $3.2 million, a decrease of $0.1 million as compared to the year ended December 31, 2023.
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
On June 28, 2023, we issued 27,472,527 CDIs in connection with the first tranche of an institutional placement on the ASX, and on July 10, 2023, we issued 5,494,506 CDIs in connection with the second and final tranche of the institutional placement. On July 25, 2023, we issued 2,921,307 shares of common stock in connection with a Security Purchase Plan (“SPP”). We raised a total of approximately $20.6 million, net of issuance costs of approximately $1.0 million. Of this amount, $18.9 million were net cash proceeds from the institutional placement, and $1.7 million were cash proceeds from the SPP.
Previous report
On September 25, 2024, we issued 55,856,325 CDIs in connection with an institutional placement and the institutional component of a 1-for-20 pro-rata accelerated non-renounceable entitlement offer on the ASX. We raised approximately $29.4 million, net of issuance costs of approximately $1.9 million. On October 16, 2024, we issued 5,075,733 CDIs in connection with the retail component of a fully underwritten 1-for-20 pro-rata non-renounceable entitlement offer. We raised approximately $2.6 million, net of issuance costs of approximately $0.2 million.
Previous report
As of December 31, 2024, we had working capital of $56.1 million, comprised of current assets of $64.5 million and current liabilities of $8.3 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 $9.9 million as of December 31, 2024, compared to December 31, 2023. Current liabilities, consisting primarily of accounts payable, accrued liabilities, operating lease liability, the current portion of notes payable and interest payable, increased by approximately $1.9 million as of December 31, 2024, compared to December 31, 2023. The proceeds from borrowings under tranche 2 of the loan and security agreement, as well as the sale of common stock in 2023, contributed to the increase in cash, cash equivalents, and marketable securities during 2023, resulting in an increase in working capital as of December 31, 2023.
Reworded paragraphs (21)
Previous wording
EBR is a U.S. based medical device company that is developing the WiSE CRT System, an implantable cardiac pacing system able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of leads. That implantable investigational device is part of a cardiac CRT, potentially offering endocardial heart tissue stimulation without the complications associated with traditional lead-based systems. CRM systems use leads to conduct electricity from an IPG to electrodes that deliver therapeutic electric pulses to heart tissue. While leads are a critical part of most CRM systems, they have long been recognized as a primary shortcoming of these systems and are a leading cause of device failure.
Current wording
EBR is a U.S. based medical device company that developed the WiSE CRT System (“WiSE”), an implantable cardiac pacing system able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of leads. That implantable device is part of a cardiac resynchronization therapy (“CRT”), offering endocardial heart tissue stimulation without the complications associated with traditional lead-based systems. Cardiac rhythm management (“CRM”) systems use leads to conduct electricity from an implantable pulse generator (“IPG”) to electrodes that deliver therapeutic electric pulses to heart tissue. While leads are a critical part of most CRM systems, they have long been recognized as a primary shortcoming of these systems and are a leading cause of device failure.
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 December 31, 2024, we had $66.0 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $353.5 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 December 31, 2025, we had $54.2 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $402.2 million. For a more comprehensive discussion see “Liquidity and Capital Resources” and “Future Funding Requirements” below.
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 provides 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
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. 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
We use the Black-Scholes option pricing model, which incorporates assumptions and estimates, to measure the fair value of its option awards on the date of grant of each stock option award.
Current wording
We use the Black-Scholes option pricing model, which incorporates assumptions and estimates, to measure the fair value of its option awards on the date of grant of each stock option award. We determined the assumptions for the Black-Scholes option-pricing model as discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.
Previous wording
Adjusted earnings before interest, income taxes, depreciation and amortization (“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. Adjusted net loss per common share is defined as Adjusted EBITDA divided by the weighted-average number of shares outstanding.
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
A reconciliation between net loss and adjusted EBITDA, and net loss per common share and adjusted net loss per common share are presented below:
Current wording
A reconciliation between net loss and adjusted EBITDA is presented below:
Previous wording
(b)Represents nonrecurring expenses associated with our Form 10 filing in 2024.
Current wording
(b) Represents nonrecurring expenses associated with our Form 10 filing in 2024.
Previous wording
We recorded a net loss of $40.8 million in 2024, an increase of $5.8 million, or 16.4%, from 2023. The increased loss in 2024 was primarily due to an increase in general and administrative expenses and interest expense in 2024, as discussed below. We expect to continue reporting losses until such time as we obtain FDA approval, commercialize our WiSE CRT System, and are able to generate revenue and gross margin sufficient to offset our operating expenses.
Current wording
We recorded a net loss of $48.8 million in 2025, an increase of $8.0 million, or 19.5 % from 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.
Previous wording
Research and development expenses decreased by $0.1 million, or 0.3%, during the year ended December 31, 2024, as compared to the year ended December 31, 2023. 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 certain inventory purchases. Clinical trial related expenses decreased by $1.4 million, primarily due to completing enrollment in the SOLVE-CRT Study in July 2022. This decrease was offset by a $3.5 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits as a result of the expansion of our workforce to support the ongoing development of the WiSE CRT System.
Current wording
Research and development expenses decreased by $3.1 million, or 11.5%, during the year ended December 31, 2025, as compared to the year ended December 31, 2024. The decrease was primarily due to a $3.4 million decrease in contract manufacturing, materials and components, resulting from the capitalization of inventory, as well as a decrease in professional services related to the development testing of the WiSE CRT System. Facility-related expenses decreased by $1.4 million, as we capitalized certain overhead costs to inventory during the year ended December 31, 2025. These decreases were partially offset by a $1.2 million increase in personnel-related expenses, including salaries, bonuses, and certain fringe benefits, resulting from the normal annual salary increases and a workforce expansion, and a $0.3 million increase in clinical expenses to support the WiSE CRT post-approval study.
Previous wording
General and administrative expenses increased by $3.9 million, or 52.0%, during the year ended December 31, 2024, as compared to the year ended December 31, 2023. Professional fees increased by $2.4 million, primarily resulting from higher audit, legal, regulatory, and tax-related services in connection with preparation for our filing of a registration statement on Form 10. Personnel-related expenses, including salaries, bonuses and certain fringe benefits increased by $1.1 million as a result of the expansion of our workforce to support our business needs. Corporate expenses increased by $0.4 million, which resulted from an increase in expenses related to investor relations, insurance premiums, and computer supplies and software as a result of the expansion of our workforce.
Current wording
Selling, general and administrative expenses increased by $11.4 million, or 101.1%, during the year ended December 31, 2025, as compared to the year ended December 31, 2024. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $8.1 million as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $2.1 million due to the expansion of our workforce to support our sales and marketing efforts. Facility-related and other expenses increased by $0.5 million, primarily resulting from the higher non-cash rent expense due to a new lease agreement entered in 2025 for our new corporate headquarters and manufacturing facility. Corporate expenses increased by $0.7 million, primarily resulting from the higher expenses related to insurance premiums, and computer hardware and software.
Previous wording
We believe that we maintain a level of liquidity sufficient to allow us to meet our financial obligations as they become due for the next twelve months. We manage our cash and capital structure to maximize shareholder return, maintain our 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 December 31, 2024 and 2023, we had approximately $66.0 million and $73.4 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 December 31, 2025 and 2024, we had approximately $54.2 million and $66.0 million, respectively, in cash, cash equivalents, and marketable securities. Based on our cash, cash equivalents, and marketable securities as of December 31, 2025, and our expectation to generate operating losses and negative operating cash flows in the foreseeable future, substantial doubt exists regarding our ability to continue as a going concern for a period of at least twelve months from the date of this Form 10-K.
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 December 31, 2024 and 2023, 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 December 31, 2025 and 2024, the outstanding principal balance was $41.8 million, which includes the final payment of 4.5% of the principal borrowings to date.
Previous wording
As of December 31, 2024, we had $1.1 million in operating lease liabilities for our corporate headquarters and laboratory space, located in Sunnyvale, California. In January 2025, we entered into a new lease agreement to lease our new corporate headquarters. See Note 6, “Leases”, in the notes to consolidated financial statements for additional information regarding leased properties.
Current wording
As of December 31, 2025, we had $0.6 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 $17.1 million in operating lease obligations as of December 31, 2025.
Previous wording
As of December 31, 2024, 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 December 31, 2025, 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 have entered into an equipment purchase agreement for the purchase of certain software. As of December 31, 2024, the outstanding principal balance was $37,286. 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 December 31, 2024, our obligation under such arrangements was approximately $14.4 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 December 31, 2025, our obligations under such arrangements were approximately $7.8 million.
Previous wording
Net cash used in operating activities during the year ended December 31, 2024, was $41.2 million, compared to $32.7 million during the year ended December 31, 2023, representing an increase in use of $8.5 million. This increase was primarily attributed to an increase in net loss of $5.8 million, a decrease in cash from changes in working capital of $2.8 million, offset by a $0.1 increase in non-cash adjustments.
Current wording
Net cash used in operating activities during the year ended December 31, 2025, was $53.2 million, compared to $41.2 million during the year ended December 31, 2024, representing an increase in use of $12.0 million. This increase was primarily attributed to an increase in net loss of $8.0 million, a decrease in cash from changes in working capital of $6.7 million, offset by a $2.7 million increase in non-cash adjustments.
Previous wording
Net cash provided by investing activities during the year ended December 31, 2024, was $1.1 million, compared to $8.6 million used in investing activities during the year ended December 31, 2023, representing a decrease in cash used of $9.7 million. The decrease was attributable to a $11.9 million decrease in the purchase of marketable securities and a $0.1 million decrease in the purchase of property and equipment. These decreases were offset by a $2.3 million increase in the maturities and sales of marketable securities during the year ended December 31, 2024, as compared to the year ended December 31, 2023.
Current wording
Net cash provided by investing activities during the year ended December 31, 2025, was $7.8 million, compared to $1.1 million provided in investing activities during the year ended December 31, 2024, representing an increase in cash provided of $6.7 million. The increase was mainly attributable to a $10.8 million decrease in the purchase of marketable securities during the year ended December 31, 2025, as compared to the year ended December 31, 2024. This change was partially offset by a $3.4 million increase in purchase of property and equipment, and a $0.7 million decrease in cash provided from sales and maturities of marketable securities during the year ended December 31, 2025, as compared to the year ended December 31, 2024.
Previous wording
Net cash provided by financing activities during the year ended December 31, 2024, was $32.5 million, compared to $40.5 million during the year ended December 31, 2023, representing a decrease of $8.0 million. This decrease is primarily attributed to the $19.7 million borrowing, net of issuance cost, under tranche 2 of the loan and security that took place during the year ended December 31, 2023. This decrease was partially offset by a $11.3 million increase in proceeds from a capital raise, net of issuance cost, during the year ended December 31, 2024, as well as by a $0.4 million increase in proceeds from exercise of stock options.
Current wording
Net cash provided by financing activities during the year ended December 31, 2025, was $46.8 million, compared to $32.5 million during the year ended December 31, 2024, representing an increase of $14.3 million. This increase was primarily attributed to the $14.3 million increase in proceeds from a capital raise, net of issuance cost, during the year ended December 31, 2025 as compared to the year ended December 31, 2024.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We determined the assumptions for the Black-Scholes option-pricing model as discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.