ENvue Medical, Inc.
For the period ended Dec 31, 2025. Filed Apr 15, 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 Apr 15, 2026
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Item 8. Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of ENvue Medical, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of ENvue Medical, Inc. (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
The Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered recurring losses and negative cash flows from operations, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
| Business Combination | |
|---|---|
| Description of the matter | As described in Note 4 to the consolidated financial statements, during 2025 the Company completed the acquisition of ENvue Medical Holding LLC (“ENvue”) for a total consideration of $42,452 thousands, which included a combination of the Company’s ordinary shares, Series X Preferred Stock and Pre-Funded Warrants. The transaction was accounted for as a business combination. Auditing the Company’s accounting for its acquisition of ENvue was complex due to the significant estimation uncertainty required by management in determining the fair value of the identified intangible assets, which principally consisted of technology intangible asset in the amount of $3,500 thousands and Customer relationships intangible asset in the amount of $1,820 thousands. The significant assumptions used to estimate the fair value of the technology and customer relationships intangible assets included, among others, discount rate and projected revenue growth rates. These significant assumptions are forward-looking and could be affected by future economic and market conditions. |
| How we addressed the matter in our audit | To test the estimated fair value of the technology and customer relationships intangible assets, we performed audit procedures that included, among others, evaluating the methods and significant assumptions used by the Company, and evaluating the completeness and accuracy of the underlying data supporting the significant assumptions and estimates. We involved our valuation specialists to assist in evaluation of the methodology used by the Company and certain assumptions included in the fair value estimates. Our valuation specialists’ procedures included, among others, developing a range of independent estimates for the discount rates used in the valuation models and comparing those to the discount rates selected by management. In addition, we evaluated the appropriateness of the related disclosures in relation to the acquisition. |
| Impairment of Goodwill and long-lived assets | |
| Description of the matter | As described in Note 21 to the consolidated financial statements, during 2025 the Company recorded an impairment loss on goodwill and certain long-lived assets related to the ENvue reporting unit. The Company evaluated the ENvue long-lived assets and goodwill for recoverability and determined that certain assets were not recoverable. As a result, the Company recognized a $645 thousands impairment loss related to ENvue long-lived assets, and a $10,509 thousands impairment of goodwill. This represented the amount by which the carrying value exceeded the estimated fair value of these assets. Auditing the Company’s goodwill and long-lived assets impairment assessments involved significant auditor judgment due to the significant estimation uncertainty in determining the fair value of the reporting unit. The significant estimation uncertainty was primarily due to the sensitivity of the fair values to the significant underlying assumptions. Significant assumptions used in the Company’s fair value estimate included discount rates, royalty rates, and certain assumptions that form the basis of the forecasted results (e.g., revenue growth rates). These significant assumptions are especially challenging to audit as they are forward looking and could be affected by future economic and market conditions. |
| How we addressed the matter in our audit | Our audit procedures included, among others, testing the key inputs and significant assumptions discussed above. We involved our valuation specialists to assist with our evaluation of discount rates and royalty rates. Additionally, we evaluated the significant assumptions used by the Company, and validated the completeness and accuracy of the underlying data supporting the significant assumptions and estimates. We also performed a sensitivity analysis of the significant assumptions to evaluate the change in the fair values that would result from changes in the assumptions. |
/s/KOST FORER GABBAY & KASIERER
A Member of EY Global
We have served as the Company’s auditor since 2025.
Tel-Aviv, Israel
April 15, 2026
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