ENvue Medical, Inc 10-Q for FY2026 Q1
ENvue Medical, Inc. (FEED)
About this 10-Q
ENvue Medical, Inc filed this 10-Q on May 18, 2026, covering the quarter ended March 31, 2026 (FY2026 Q1).
Headline figures
Quarter ended March 31, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $653K
- down 36.3% from $1.03M a year earlier
- Net loss
- $3.82M
- compared with a net loss of $1.87M a year earlier
- Diluted EPS
- -$6.88
- compared with -$29.90 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
OR
For the transition period from to
Commission
File Number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification Number) | |
| (Address of principal executive office) | (Zip Code) |
Registrant’s
telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
Securities registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares outstanding of the registrant’s common stock as of May 18, 2026, was shares.
ENVUE MEDICAL, INC.
Quarter Ended March 31, 2026
TABLE OF CONTENTS
| i |
PART I - FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Balance Sheets
(Amounts in thousands except share and per share data)
| March 31, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Trade receivables | ||||||||
| Prepaid expenses and other accounts receivable | ||||||||
| Inventory | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Property and equipment, net | ||||||||
| Severance pay fund | ||||||||
| Operating lease right-of-use assets | ||||||||
| Long-term trade receivables | ||||||||
| Intangible assets, net | ||||||||
| Goodwill | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||||||||
| Current liabilities: | ||||||||
| Trade payables | $ | $ | ||||||
| Arbitration liability | ||||||||
| Other accounts payable and accrued expenses | ||||||||
| Loan | ||||||||
| Deferred revenue | ||||||||
| Operating lease liabilities - current | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities: | ||||||||
| Warrant liability | ||||||||
| Accrued severance pay | ||||||||
| Operating lease liabilities, non-current | ||||||||
| Total liabilities | $ | $ | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity [*]: | ||||||||
| Series G Preferred stock of $ par value - Authorized: shares at March 31, 2026, and December 31, 2025; Issued and outstanding: $ shares at March 31, 2026 and December 31, 2025 | [*] | |||||||
| Series X Preferred stock of $ par value - Authorized: shares at March 31, 2026, and December 31, 2025; Issued and outstanding: and shares at March 31, 2026 and December 31, 2025, respectively | [*] | |||||||
| Series H Preferred stock of $ par value - Authorized: shares at March 31, 2026, and December 31, 2025; Issued and outstanding: and shares at March 31, 2026 and December 31, 2025, respectively | [*] | |||||||
| Common stock of $ par value - Authorized: shares at March 31, 2026, and December 31, 2025; Issued and outstanding: and shares at March 31, 2026 and December 31, 2025, respectively | [*] | |||||||
| Additional paid in capital | [*] | |||||||
| Accumulated other comprehensive income | [*] | ( | ) | ( | ) | |||
| Accumulated deficit | [*] | ( | ) | ( | ) | |||
| Total stockholders’ equity | [*] | |||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
| [*] |
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 1 |
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(Amounts in thousands except share and per share data)
| For the Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Revenues | $ | $ | ||||||
| Cost of revenues | ||||||||
| Gross profit (loss) | ( | ) | ||||||
| Operating expenses: | ||||||||
| Research and development | ||||||||
| Selling and marketing | ||||||||
| General and administrative | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Interest expense | ( | ) | ( | ) | ||||
| Financial income (expense), net | ( | ) | ||||||
| Loss before taxes on income | ( | ) | ( | ) | ||||
| Income tax expense | ( | ) | ( | ) | ||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Preferred Stock dividends | ||||||||
| Dividend on Series X Preferred Stock | ( | ) | ||||||
| Dividend on Series H Preferred Stock | ( | ) | ||||||
| Deemed dividend for down round on Series H Preferred Stock | ( | ) | ||||||
| Deemed contribution on extinguishment of Series X Preferred Stock | ||||||||
| Deemed dividend on modification of Series H Preferred Stock | ( | ) | ||||||
| Net loss available to common stockholders | ( | ) | ( | ) | ||||
| Basic and diluted net loss available for holders of common stock [*] | $ | ) | $ | ) | ||||
| Weighted average common shares outstanding: | ||||||||
| Basic and diluted [*] | ||||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Change in foreign currency translation adjustments | ( | ) | ||||||
| Total Comprehensive loss | $ | ( | ) | $ | ( | ) | ||
| [*] |
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 2 |
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statement of Stockholders’ Equity (Unaudited)
(Amounts in thousands except share and per share data)
| Series G Preferred Stock | Series X Preferred Stock | Series H Preferred Stock | Common Stock | Additional Paid-in- | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount |
Capital | Income | Deficit | Equity | |||||||||||||||||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| ENvue Merger | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Exercise of pre-funded warrants | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Warrant exchange agreement | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Rounding-up of fractional shares due to reverse stock split | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Currency translation adjustment | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statement of Stockholders’ Equity (Unaudited)
(Amounts in thousands except share and per share data)
| Series G Preferred Stock | Series X Preferred Stock | Series H Preferred Stock | Common Stock | Additional Paid-in- | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount |
Capital | Income | Deficit | Equity | |||||||||||||||||||||||||||||||||||||
| Balance, December 31, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| Issuance of Series H Preferred Stock | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series H Preferred Stock and accrued dividends into Common Stock | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Repurchase of Series X Preferred Stock | - | ( | ) | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||
| Dividend on Convertible Preferred Series X | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Dividend on Convertible Preferred Series H | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Deemed dividend for down round feature on Series H Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Balance, March 31, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 3 |
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statements of Cash Flows (Unaudited)
(Amounts in thousands except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Noncash interest expense | ||||||||
| Change in fair value of warrant liability | ||||||||
| Change in fair value of note payable | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Trade receivable | ( | ) | ( | ) | ||||
| Prepaid expenses and other accounts receivable | ( | ) | ( | ) | ||||
| Inventory | ||||||||
| Trade payables | ( | ) | ( | ) | ||||
| Other accounts payable and accrued expenses | ||||||||
| Deferred revenue | ( | ) | ( | ) | ||||
| Operating right-of-use asset | ||||||||
| Operating lease liabilities | ( | ) | ||||||
| Accrued severance pay, net | ( | ) | ||||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Cash acquired in ENvue Merger | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash (used in) provided by investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from the issuance of common stock, preferred stock and warrants, net | ||||||||
| Repurchase of Series X Preferred Stock | ( | ) | ||||||
| Proceeds from issuance of notes payable to related party | ||||||||
| Net cash provided by financing activities | ||||||||
| Effects of currency translation on cash and cash equivalents | ( | ) | ||||||
| Net decrease in cash, cash equivalents and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents and restricted cash at beginning of period | ||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | $ | ||||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
| Cash and cash equivalents | ||||||||
| Restricted cash at end of period | ||||||||
| Total cash, cash equivalents and restricted cash | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | $ | ||||||
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 4 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
NOTE 1 - DESCRIPTION OF BUSINESS
ENvue Medical, Inc. (formerly known as NanoVibronix, Inc.) (the “Company”) was incorporated as a Delaware corporation in October 2003. The Company is a medical device company focusing on non-invasive biological response-activating devices that target wound healing and pain therapy and can be administered at home without the assistance of medical professionals, utilizing its proprietary low-intensity ultrasound (acoustic) technology. The Company’s principal research and development activities are conducted in Israel through its wholly-owned subsidiary, NanoVibronix Ltd., a company registered in Israel, which commenced operations in October 2003.
On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger, dated as of February 14, 2025 (the “Merger Agreement”), by and among the Company, NVEH Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub”), NVEH Merger Sub II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Second Merger Sub”), and ENvue Medical Holdings, Corp. (“Predecessor ENvue”), the Company and Predecessor ENvue effected (i) a merger of First Merger Sub with and into Predecessor ENvue, with First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned subsidiary of the Company, and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together with the First Merger, the “ENvue Merger”), with Second Merger Sub being the surviving entity (the “Surviving Entity”). At the effective time of the Second Merger, the certificate of formation of the Surviving Entity was amended and restated to, among other things, change the name of the Surviving Entity to “ENvue Medical Holdings LLC.”
ENvue Medical Holdings LLC (formerly ENvue Medical Holding, Corp.) (“ENvue”), a wholly-owned subsidiary of the Company, is a Delaware limited liability company incorporated on June 5, 2024. ENvue has two wholly-owned subsidiaries: ENvue Medical (USA) Inc. and ENvue Medical Ltd. (formerly ENvue Medical Israel Ltd.). ENvue is engaged in the research, development, marketing, and sale of medical devices in the field of enteral feeding and is in the initial stage of commercializing its products.
NOTE 2 - LIQUIDITY AND PLAN OF OPERATIONS
As
of March 31, 2026, the Company has incurred recurring losses and negative cash flows from operations and has an accumulated deficit of
$
The Company expects to incur future net losses and its transition to profitability is dependent upon, among other things, the achievement of a level of revenues adequate to support the cost structure. Until the Company achieves profitability or generates positive cash flows, it will continue to be dependent on raising additional funds to fund its operations. The Company intends to fund its future operations through cash on hand, additional private and/or public offerings of debt or equity securities or a combination of the foregoing. There are no assurances, however, that the Company will be able to obtain an adequate level of financial resources that are required to fund its operation.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for twelve months from the date of issuance of these interim condensed consolidated financial statements. The accompanying interim condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation and principles of consolidation
The unaudited interim consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to state fairly the financial position and results of operations of the Company. These interim condensed consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2025, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2026.
The balance sheet for December 31, 2025, was derived from the Company’s audited financial statements for the year ended December 31, 2025. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire fiscal year. Certain information and footnote disclosures normally included in the consolidated financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim reporting.
The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, including ENvue as of the date of the ENvue Merger. Intercompany accounts and transactions have been eliminated upon consolidation.
| 5 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
Use of estimates
The preparation of the interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions. The Company believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Concentration of credit risk
Financial
instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents, trade
receivables, and other accounts receivable. The Company holds cash and cash equivalents in various banking institutions. The
majority of the Company’s cash and cash equivalents and short-term bank deposits are invested with banks in United States.
Such investments are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $
The trade receivables of the Company are mainly derived from sales to a diverse set of customers located primarily in the United States. The Company performs ongoing credit evaluations of its customers and, to date, has not experienced any significant losses.
Trade receivables
The
Company’s trade receivable balance consists of amounts due from its customers. Trade Receivables are recorded when the right to
consideration becomes unconditional. The Current Expected Credit Losses (“CECL”) impairment model requires an estimate of
expected credit losses, measured over the contractual life of an instrument, which considers forecasts of future economic conditions
in addition to information about past events and current conditions. Based on this model, the Company considers many factors, including
the age of the balance, collection history, and current economic trends. Credit losses are written off after all collection efforts have
ceased. Allowances for credit losses are recorded as a direct reduction from an asset’s amortized cost basis. Credit losses and
recoveries are recorded in selling, general and administrative expenses in the consolidated statements of operations. Recoveries of financial
assets previously written off are recorded when received. As of March 31, 2026 and December 31, 2025, the credit losses allowance was
$
The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to common stockholders for the period to be allocated between shares of Common Stock, par value $ per share (the “Common Stock”) and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company’s Series X Preferred Shares and Series H Preferred Shares would be entitled to dividends that would be distributed to the holders of Common Stock of the Company, based on the conversion ratio, assuming conversion of all Series X Preferred Shares and Series H Preferred Shares into shares of Common Stock. The Company does not allocate losses to these participating securities as they do not share in the Company’s losses.
| 6 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The Company’s basic net loss per share is calculated by dividing net loss attributable to common and preferred stockholders by the weighted-average number of shares, which include prefunded warrants, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method based on the nature of such securities. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive shares of Common Stock are anti-dilutive.
Goodwill
Goodwill has been recorded as a result of the acquisition. Goodwill represents the excess of the purchase price in a business combination over the fair value of identifiable tangible and intangible assets acquired. Goodwill is not amortized but rather is subject to an impairment test.
ASC No. 350, “Intangibles - Goodwill and other” (“ASC No. 350”) requires goodwill to be tested for impairment at the reporting unit level at least annually or between annual tests in certain circumstances and written down when impaired.
ASC No. 350 allows an entity to first assess qualitative factors to determine whether it is necessary to perform the quantitative goodwill impairment test. If the qualitative assessment does not result in a more likely than not indication of impairment, no further impairment testing is required. If it does result in a more likely than not indication of impairment, the quantitative goodwill impairment test is performed. Alternatively, ASC No. 350 permits an entity to bypass the qualitative assessment for any reporting unit and proceed directly to perform the quantitative goodwill impairment test. The Company performs the quantitative goodwill impairment test during the fourth quarter of each fiscal year, or more frequently if impairment indicators are present and compares the fair value of the reporting unit with its carrying value.
During
the three months ended March 31, 2026 and 2025,
Intangible Assets
Purchased
intangible assets with finite lives are carried at cost, less accumulated amortization. Amortization is computed over the estimated useful
lives of the respective assets, which range from
For the three months ended March 31, 2026 and 2025, amortization expense amounted to $
The estimated useful lives of the Company’s intangible assets are as follows:
SCHEDULE OF INTANGIBLE ASSETS ESTIMATED USEFUL LIVES
| Intangible Assets | Years | |||
| Tradename and trademarks | ||||
| Technology | ||||
| Customer list | ||||
| 7 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
Leases
The Company may sell its insertion systems to customers through bundled lease arrangements which typically include insertion systems and nasoenteral tubes. Revenues under these bundled lease arrangements are allocated considering the relative standalone selling prices of the lease and non-lease components included in the bundled arrangement. The primary accounting provision the Company uses to classify transactions as sales-type or operating leases is whether the lease transfers ownership of the underlying asset to the lessee by the end of the lease term. Systems included in arrangements meeting this condition are accounted for as sales-type leases and revenue is recognized at lease commencement. When leases are determined to be operating leases, revenue is recognized over the term of the lease. For the three months ended March 31, 2026, there were no operating leases in which the Company is the lessor.
Revenue from sales-type leases is presented on a gross basis when the Company enters into a lease to realize value from a product that it would otherwise sell in its ordinary course of business. Interest income for the three months ended March 31, 2026 and 2025 was immaterial.
The
Company’s short-term net investment in a lease receivable as of March 31, 2026 and December 31, 2025 was $
Revenue recognition
Revenues from product and services are recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before revenue can be recognized: (1) Identifying the contract(s) with a customer that create(s) enforceable rights and obligations; (2) Identifying the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) Determining the transaction price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer; (4) Allocating the transaction price to the performance obligations in the contract, which requires the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of each distinct good or services promised in the contract; and (5) Recognizing revenue when (or as) the entity satisfies a performance obligation by transferring a promised good or service to a customer.
| 8 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The Company’s performance obligation is generally the sale and delivery of its products. Revenues from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from discounts, commissions as well as allowances for returns.
Revenue from NanoVibronix product sales are recognized at a point in time when control of the product is transferred, which is generally upon shipment to the customer.
Regarding its ENvue sales, the Company regularly sells its insertion systems and nasoenteral tubes on a stand-alone basis and therefore concludes these products are separate performance obligations. Revenue from product sales is recognized at a point in time when control of the product is transferred, which is generally upon delivery to the customer.
When a contract includes one performance obligation, the entire transaction price is allocated to that performance obligation. When a contract includes a combination of products and services, the transaction price is allocated to each performance obligation on a stand-alone selling price basis. The stand-alone selling prices are generally determined based on the prices at which the Company separately sells the products and services. The Company’s contracts with its ENvue customers generally do not include rights of return.
The Company extends credit to its customers in the ordinary course of business. Payment terms are typically between 30 and 60 days from the date of invoice for both NanoVibronix and ENvue customers.
The Company applied the practical expedient in ASC 606 and did not evaluate payment terms of one year or less for the existence of a significant financing component. The related revenue is recognized net of any taxes collected from customers which are subsequently remitted to governmental entities (e.g., sales tax and other indirect taxes). The Company elected to not disclose information about the remaining performance obligations that have original expected durations of one year or less.
In
some of its contracts, the Company provides assurance warranty services to its customers, in accordance with legal provisions or
industry standards to ensure the quality of the products. As such, the Company recognizes a provision for warranties in its
financial statements as applicable. As of March 31, 2026 and December 31, 2025, the Company’s provision for warranty amounted
to $
Deferred revenue
Deferred revenue includes payments received in advance of performance under the contract and are realized with the associated revenue recognized under the contract. The following table presents the changes in the deferred revenue for the three months ending March 31, 2026:
SCHEDULE OF DEFERRED REVENUE
| Balance as of December 31, 2025 | $ | |||
| Revenue recognized | ( | ) | ||
| Balance as of March 31, 2026 | $ |
| 9 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
Fair Value Measurements
Fair value is defined as the exchange price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company measures financial assets and liabilities at fair value at each reporting period using a fair value hierarchy which requires the Company to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument’s classification within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Three levels of inputs may be used to measure fair value:
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying value of cash equivalents, restricted cash, other accounts receivable, trade payables, and other accounts payable and accrued expenses approximate their fair value due to their short-term maturities.
The Company warrant liabilities are measured at fair value using Level 3 inputs.
Reclassification
Certain comparative figures have been reclassified to conform to the current period presentation.
Recently Adopted Accounting Standards
In July 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”). This amendment introduces a practical expedient for the application of the current expected credit loss model to current accounts receivable and contract assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025, and interim reporting periods within those annual reporting periods. Early adoption is permitted. The Company adopted this guidance on January 1, 2026 on a prospective basis. The Company has elected the practical expedient provided by ASU 2025-05. Under this expedient, the Company assumes that economic conditions as of the balance sheet date remain unchanged for the remaining life of all current accounts receivable and current contract assets arising from transactions under ASC 606. The adoption did not have a material impact on the consolidated financial statements.
Recently issued accounting standards
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosure (Subtopic 220-40), Disaggregation of Income Statement Expenses, which requires disclosure of disaggregated information about certain expense captions presented in the Interim Condensd Consolidated Statements of Operations and Comprehensive Loss as well as disclosure about selling expense. The guidance will be effective for the Company for annual periods beginning January 1, 2027, and interim periods beginning January 1, 2028, with early adoption permitted. It could be applied either prospectively or retrospectively. The Company is currently evaluating the impact on its financial statement disclosures.
In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity, which clarifies current guidance for determining the accounting acquirer for a transaction effected primarily by exchanging equity interests in which the legal acquiree is a variable interest entity that meets the definition of a business. ASU 2025-03 is effective for annual reporting periods beginning after December 15, 2026, including interim reporting periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, to modernize the accounting for costs related to internal-use software and better align it with current software development practices. The amended guidance removes references to project stages and clarifies when entities are required to begin capitalizing eligible costs. This guidance will be effective for the Company for annual periods beginning January 1, 2028, with early adoption permitted. The guidance may be applied prospectively, retrospectively, or using a modified prospective transition method. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.
In April 2026, the FASB issued ASU 2026-01, Equity (Topic 505): Initial Measurement of Paid-in-Kind Dividends on Equity-Classified Preferred Stock. The amendments in this update require entities to initially measure paid-in-kind (“PIK”) dividends on equity-classified preferred stock using the PIK dividend rate stated in the preferred stock agreement, rather than at fair value. The ASU is effective for annual periods beginning after December 15, 2026, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.
NOTE 4 – PREPAID EXPENSES AND OTHER ACCOUNTS RECEIVABLES
Prepaid expenses and other receivables consist of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER RECEIVABLES
| March 31, 2026 | December 31, 2025 | |||||||
| Prepaid expenses | $ | $ | ||||||
| Other receivables | ||||||||
| Total prepaid expenses and other accounts receivable | $ | $ | ||||||
| 10 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
NOTE 5 – INVENTORY
Inventory consists of the following components as of:
SCHEDULE OF INVENTORY
| March 31, 2026 | December 31, 2025 | |||||||
| Raw materials | $ | $ | ||||||
| Finished goods | ||||||||
| Inventory | $ | $ | ||||||
Inventory
write-down charged to the cost of sales amounted to $
NOTE 6 – OTHER ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Other accounts payable and accrued expenses consist of the following:
SCHEDULE OF OTHER ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| March 31, 2026 | December 31, 2025 | |||||||
| R&D accrued expenses | $ | $ | ||||||
| Credit allowance | ||||||||
| Compensation and payroll accrual | ||||||||
| Taxes payable | ||||||||
| Other accrued expenses | ||||||||
| Total | $ | $ | ||||||
NOTE 7 - STOCKHOLDERS’ EQUITY
Common Stock
The Common Stock confers upon the holders the right to receive notice to participate and vote in general meetings of the Company, and the right to receive dividends, if declared, and to participate in the distribution of the surplus assets and funds of the Company in the event of liquidation, dissolution or winding up of the Company.
Reverse stock splits
On
March 13, 2025, the Company effected a
As a result of the March 2025 Reverse Stock Split, every eleven () shares of issued and outstanding Common Stock were automatically combined into one (1) issued and outstanding share of Common Stock, without any change in the par value per share.
As a result of the August 2025 Reverse Stock Split, every ten () shares of issued and outstanding Common Stock were automatically combined into one (1) issued and outstanding share of Common Stock, without any change in the par value per share.
No fractional shares were issued as a result of the Reverse Stock Splits. Any fractional shares that would otherwise have resulted from the Reverse Stock Splits were rounded up to the next whole number. In connection with the August 2025 Reverse Stock Split, the Company issued an aggregate of additional shares to round up fractional shares to whole shares.
The number of authorized shares of Common Stock under the Company’s Amended and Restated Certificate of Incorporation, as amended, remained unchanged at shares.
All references in these consolidated financial statements to the number of shares, price per share and weighted average number of shares of Common Stock outstanding prior to the Reverse Stock Splits have been adjusted to reflect the Reverse Stock Splits on a retroactive basis, unless otherwise noted.
Underwritten Public Offering, Series G Convertible Preferred Stock
On
May 15, 2025, the Company announced the closing of an underwritten public offering (the “2025 Underwritten Offering”) of shares
of the Company’s Series G Convertible Preferred Stock (“Series G Preferred Stock”), with a par value $ per
share and stated value of $per share, and liability classified warrants to purchase up to
On May 15, 2025, prior to the closing of the 2025 Underwritten Offering, the Company filed the Certificate of Preferences, Rights and Limitations of the Series G Convertible Preferred Stock (the “Series G Certificate of Designations”) with the Secretary of State of the State of Delaware, which became effective upon filing. Pursuant to the terms of the Series G Certificate of Designations, the holders of the Series G Preferred Stock are entitled to receive cumulative dividends at the rate per share of % per annum of the stated value per share until the fifth anniversary of the date of issuance of the Series G Preferred Stock, which such dividends may be paid, at the Company’s option, shares of Common Stock. In addition, in accordance with the Series G Certificate of Designations, accrued and unpaid dividends are payable upon the conversion of the Series G Preferred Stock prior to the fifth anniversary of issuance, upon any liquidation, dissolution, or winding up of the Company, and in connection with certain fundamental transactions. The five year % per annum dividend upon conversion of the Series G Preferred Stock irrespective of the timing of conversion such that upon conversion, the conversion price will incorporate the five-year 9% dividend.
| 11 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The
aggregate net proceeds of the 2025 Underwritten Offering were approximately $
Conversion of Series G Convertible Preferred Stock
Between May 16, 2025, and July 1, 2025, a majority of the Series G Preferred holders exercised their conversion right, converting shares of Series G Preferred Stock into shares of Common Stock. As of March 31, 2026, there were outstanding shares of Series G Preferred Stock.
Series X Non-Voting Convertible Preferred Stock
On
February 14, 2025, in connection with the ENvue Merger, the Company issued
shares of Series X Non-Voting Convertible Preferred Stock (the “Series X Preferred Stock”) to the certain investors of Predecessor
ENvue. In addition, the Company issued
shares of Series X Preferred Stock to a to a service provider of Predecessor ENvue, replacing its equity interest in ENvue, resulting in a total of
The ENvue Merger was consummated and completed on February 14, 2025.
After
giving effect to the ENvue Merger, pursuant to the terms and conditions of the Merger Agreement:
Each share of Series X Preferred Stock has a stated value of $ per share and ranks senior to the Company’s Common Stock with respect to dividend rights and rights upon liquidation, dissolution or winding up. The Series X Preferred Stock is not subject to mandatory redemption and may not be redeemed at the option of the Company or the holder.
Holders shall be entitled to receive, and the Company shall pay, dividends on shares of Series X Preferred Stock, based on the stated value, at a rate of eight percent (8%) per annum, commencing on the three (3) month anniversary of the Original Issue Date (as defined in the Series X Certificate of Designations) until the date the Company obtains the Stockholder Approval. Such dividends can be paid in the form of cash or additional issuances of shares of Series X Preferred Stock based on the stated value, with such type of payment determined in the sole discretion of the Company, and accrued and compounded daily on the basis of a 360-day year and twelve (12) 30-day months and shall be paid the earlier of: (i) promptly after conversion of the Series X Preferred Stock or (ii) quarterly starting on the six (6) month anniversary of the Original Issue Date.
On
May 12, 2025, the Company filed an amendment to the Series X Certificate of Designations (the “Series X Certificate of Amendment”) with the Secretary of State of the State of Delaware, thereby amending
the Series X Certificate of Designations. The Series X Certificate of Amendment became effective with the Secretary of State of the State
of Delaware upon filing. The amendment decreased the Series X Preferred Stock conversion price from $
The
Company concluded that the modification of the Series X Preferred Stock should be accounted for as an extinguishment. As such, the difference
between the fair value of the modified Series X Preferred Stock and their carrying amount was accounted for as a deemed contribution
in the amount of $
| 12 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
On
July 22, 2025, the Company repurchased
then outstanding shares of its Series X Preferred Stock from Alpha Capital Anstalt (“Alpha”) in accordance with the
terms of the Certificate of Designations of the Series X Preferred Stock for $
During the three months ended March
31, 2026, the Company repurchased a total of
Private Placement, Series H Convertible Preferred Stock
On
July 18, 2025, the Company entered into a Securities Purchase Agreement (the “July 2025 Purchase Agreement”) with a
Alpha (the “July 2025 Investor”), pursuant to which it agreed to sell to the July 2025 Investor
(i) an aggregate of
shares of the Company’s newly-designated Series H Convertible Preferred Stock (“Series H Preferred Stock”), and
(ii) warrants to acquire up to an aggregate of
Pursuant
to the terms of the July 2025 Purchase Agreement, the Company also agreed to issue
shares of Series H Preferred Stock and warrants to purchase up to
The Initial Closing occurred on July
22, 2025, and the Second Closing occurred on October 30, 2025. The aggregate net proceeds from the July 2025 Private Placement were
approximately $
Holders
of the Series H Preferred Stock shall be entitled to receive cumulative dividends at the rate per share (as a percentage of the stated
value per share) of
Series H Preferred Stock — Additional Investment Right and Conversions
In
January 2026, the July 2025 Investor exercised $
On
March 24, 2026, the holder also exercised an additional $
In
aggregate, during the three months ended March 31, 2026, the holder exercised a total of $
During
the month of January 2026, the holder of the Series H Preferred Stock also converted an aggregate of $
Certificate of Amendment to Series H Preferred Stock
On
January 30, 2026, the Company entered into an amendment agreement (the “Series H Amendment Agreement”) with the Required
Holders (as defined in the Series H Amendment Agreement). Pursuant to the Series H Amendment Agreement, the Required Holders agreed
to amend the Series H Certificate of Designations by filing the Series H Certificate of Amendment to the Series H Certificate of
Designations with the Secretary of State of the State of Delaware to remove the Floor Price (as defined in the Series H Certificate
of Designations) in consideration of the holders of the Series H Preferred Stock exercising $
The Company concluded that the modification of the Series H Preferred Stock should be accounted for as an extinguishment.
As such, the difference between the fair value of the modified Series H Preferred Stock and their carrying amount was accounted for as
a deemed dividend in the amount of $
| 13 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
Down-round Feature
During
the three months ended March 31, 2026, the Company issued shares of Series H Preferred Stock to Alpha for aggregate gross proceeds
of $
The
deemed dividends consisted of $
Both amounts were recorded as an increase to additional paid-in capital with a corresponding charge to accumulated deficit, resulting in no net impact to total stockholders’ equity, and are reflected as an increase to net loss attributable to common stockholders for purposes of calculating net loss per share.
Dividend Accrual
The
Series H Preferred Stock accrues dividends at a rate of
The
Series X Preferred Stock accrues dividends at a rate of
September 2025 Registered Direct Offering
On
September 16, 2025, the Company entered into a securities purchase agreement with Alpha, pursuant to which
the Company issued and sold (i) shares of Common Stock and (ii) prefunded warrants to purchase up to shares of Common Stock (the “September 2025 Pre-Funded Warrants”) pursuant to an effective shelf registration statement on Form S-3 (the “September
2025 Offering”). The offering price was $ per share of Common Stock and $ per September 2025 Pre-Funded Warrant, was the price of each share of Common Stock sold in the September 2025 Offering, minus the $
Share-based Compensation
On December 19, 2024, stockholders approved the NanoVibronix, Inc. 2024 Long-Term Incentive Plan (the “2024 Plan”), as a successor to the Nanovibronix 2014 Long-Term Incentive Plan, which was adopted by the Board on November 6, 2023. As of December 31, 2024, under the 2024 Plan, shares of the Company’s Common Stock were reserved for issuance. The Company effected the 2025 Reverse Stock Splits that consequently, reduced the number of shares of Common Stock of the Company reserved for issuance pursuant to awards under the 2024 Plan to shares. As of March 31, 2026, there were shares of Common Stock available to be issued under the plan, See Note 16.
| 14 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
During the three months ended March 31, 2026, and 2025, employee options were exercised, options were granted.
During the three months ended March 31, 2026, and 2025, stock-based compensation expense related to these options were $.
SCHEDULE OF OPTIONS ACTIVITY
| Shares Under Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Life (Years) | ||||||||||
| Outstanding – December 31, 2025 | ||||||||||||
| Granted | - | |||||||||||
| Exercised | - | |||||||||||
| Expired | - | |||||||||||
| Outstanding – March 31, 2026 | ||||||||||||
Warrant Exchange Agreement
On
January 7, 2025, the Company entered into a securities exchange agreement (the “Exchange Agreement”) with a certain institutional
investor pursuant to which the Company agreed to issue an aggregate of (i) shares
of Common Stock (the “January 2025 Exchange Shares”), (ii) a warrant to purchase up to
NOTE 8– WARRANT LIABILITY
The May 2025 Warrants (see Note 3) do not meet all the equity classification criteria and therefore were determined to be classified as liabilities measured at fair value through earnings. The Company utilized the Black Scholes Model to calculate the value of the May 2025 Warrants.
The
aggregate fair value of the May 2025 Warrants as of March 31, 2026, was
$
| 15 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The
Company recognized changes in the fair value of the warrant liability of $
Changes in the warrant liability balance
Below is the change in the warrant liability balance for the three months ended March 31, 2026:
SCHEDULE OF CHANGE IN WARRANT LIABILITY
| Balance as of December 31, 2025 | $ | |||
| Change in fair value | ||||
| Balance as of March 31, 2026 | $ |
See Note 12 for assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy.
NOTE 9 – LOANS
ENvue Consolidated Secured Note
On
January 17, 2025, ENvue issued a Consolidated Secured Note (as amended, the “Alpha Note”) in the aggregate principal amount
of $
On
March 25, 2026, the Company and Alpha entered into an amendment to a loan to modify the maturity date and to extend it to December
31, 2026. All other terms of the loan remain unchanged. As of March 31, 2026, the loan balance was $
Convertible Debenture
On
February 13, 2025, the Company entered into a Securities Purchase Agreement with Alpha, pursuant to which the Company issued a senior
convertible debenture (the “Debenture”) with an initial principal amount of $
For
the three months ended March 31, 2025, the Company recorded a gain of $
On May 19, 2025, the Company repaid the A&R Debenture in full. There was no balance outstanding as of March 31, 2026.
Basic net loss per common share (“Basic EPS”) is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. All outstanding stock options and warrants for the three months ended March 31, 2026, and 2025 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for all periods presented.
SCHEDULE OF NET LOSS PER SHARE
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Numerator: | $ | $ | ||||||
| Net loss | ( | ) | ( | ) | ||||
| Dividend on Series X Preferred Stock | ( | ) | ||||||
| Dividend on Series H Preferred Stock | ( | ) | ||||||
| Deemed dividend for down round on Series H Preferred Stock (See note 7) | ( | ) | ||||||
| Deemed contribution on extinguishment of Series X Preferred Stock | ||||||||
| Deemed dividend on modification of Series H Preferred Stock (See note 7) | ( | ) | ||||||
| Net loss available to common stockholders | $ | ( | ) | $ | ( | ) | ||
| 16 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE
| March 31, 2026 | March 31, 2025 | |||||||
| Stock options - employee and non-employee | $ | $ | ||||||
| Warrants | ||||||||
| Total | $ | $ | ||||||
The diluted loss per share equals basic loss per share for the three months ended March 31, 2026, and 2025 because the Company had a net loss and the impact of the assumed exercise of stock options and the vesting of restricted stock would have been anti-dilutive.
NOTE 11 – SEGMENT INFORMATION
Operating
segments are defined as components of an entity for which separate financial information is available and that is regularly provided
to the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in
assessing performance. The Company conducted the business through
The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information presented by operating segment in making operating decisions, allocating resources, and evaluating financial performance. The CODM allocates resources to and assesses the performance of each operating segment using information about the operating segment’s loss from operations.
SCHEDULE OF SEGMENT INFORMATION
Goodwill and Assets
| NanoVibronix | ENvue | Corporate | Total | |||||||||||||
| Balance sheet at March 31, 2026 | ||||||||||||||||
| Goodwill | $ | $ | $ | $ | ||||||||||||
| Assets | $ | $ | $ | $ | ||||||||||||
| Balance sheet at December 31, 2025 | ||||||||||||||||
| Goodwill | $ | $ | $ | $ | ||||||||||||
| Assets | $ | $ | $ | $ | ||||||||||||
Segment operating results
| Three Months Ended 31, 2026: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Impairment expense | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Three Months Ended 31, 2025: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 17 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
Geographic Information and Major Customer Data
The following is a summary of revenues within geographic areas:
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS
Three Months Ended March 31 | ||||||||
| 2026 | 2025 | |||||||
| United States | $ | $ | ||||||
| Europe | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
Major Customer Data as a Percentage of Total Revenues
The following is a summary of revenues:
SCHEDULE OF PERCENTAGE OF TOTAL REVENUES
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Customer A | % | % | ||||||
| Customer B | % | % | ||||||
| Customer C | % | % | ||||||
| Total | % | % | ||||||
NOTE 12 – FAIR VALUE
Financial Liabilities Measured at Fair Value on a Recurring Basis
The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:
| ● | Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; |
| ● | Level 2 inputs: Inputs, other than quoted prices included in Level 1, that are observable either directly or indirectly; and |
| ● | Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. |
There were no transfers between Level 3 during the three months ended March 31, 2026, and 2025.
The following table presents changes in Level 3 asset and liability measured at fair value for the three months ended March 31, 2026, and 2025:
| Convertible Debenture | ||||
| Balance, December 31, 2024 | $ | |||
| Convertible Debenture issued | ||||
| Change in fair value of Convertible Debenture | ( | ) | ||
| Balance, March 31, 2025 | $ | |||
| Warrants Liability | ||||
| Balance – December 31, 2025 | $ | |||
| Fair value adjustment of warrant liability | ||||
| Balance – March 31, 2026 | $ |
| 18 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The Company measures certain financial liabilities at fair value on a recurring basis, including its warrant liability and previously its convertible debenture, using Level 3 valuation techniques such as the Black-Scholes option pricing model and Monte Carlo simulation.
The following are the inputs used in the Company’s valuation models:
| Warrant Liability March 31, 2026 | Warranty Liability December 31, 2025 | Convertible Debenture March 31, 2025 | ||||||||||
| Stock price | $ | $ | ||||||||||
| Expected volatility | % | % | % | |||||||||
| Risk-free interest rate | % | % | % | |||||||||
| Expected term (in years) | ||||||||||||
The following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy:
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| Fair Value Measurements as of March 31, 2026 | ||||||||||||||||
| Level I | Level II | Level III | Total | |||||||||||||
| Warrant liability | $ | $ | $ | $ | ||||||||||||
| Fair Value Measurements as of March 31, 2025 | ||||||||||||||||
| Level I | Level II | Level III | Total | |||||||||||||
| Convertible Debenture | $ | $ | $ | $ | ||||||||||||
NOTE 13 - COMMITMENTS AND CONTINGENCIES
Pending and settled litigation
On
February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the
International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach
of an Exclusive Distribution Agreement dated March 7, 2019 (the “Exclusive Distribution Agreement”) between Protrade and
the Company. Protrade alleges, in part, that the Company has breached the Exclusive Distribution Agreement by discontinuing the manufacture
of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $
On
March 15, 2022, the arbitrator issued a final award which determined that (i) the Company had the right to terminate the Exclusive Distribution
Agreement; (ii) the Company did not breach the duty of good faith and fair dealing with regard to the Exclusive Distribution Agreement;
and (iii) the Company did not breach any confidentiality obligations to Protrade. Nevertheless, the arbitrator determined that the Company
did not comply with the obligation to supply Protrade with a year’s supply of patches, and awarded Protrade $
On July 22, 2022, the Company filed a cross-motion seeking to vacate arbitration award on the grounds that the arbitrator exceeded her authority, that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law. In particular, the Company averred in its motion that Protrade’s witness made false statements in arbitration, and that the arbitrator resolved a claim that was never raised by Protrade and that has no factual basis.
On October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion.
On November 9, 2022, the Company filed a motion to re-argue and renew its cross-motion to vacate the arbitration decision based on newer information that was not available during the initial hearing. On the same day, the Company also filed a notice of appeal with the Appellate Division, Second Department. On March 21, 2023, the court denied the motion to re-argue and renew.
On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed. In February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring with oral arguments to start by the end of May 2025.
| 19 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
On March 30, 2026, the Appellate Division of the Second Department issued a decision and order which affirmed the judgment of the Supreme Court, Nassau County in its entirety and dismissed the appeal, stating inter alia that “Nanovibronix failed to establish that the arbitration award violated a strong public policy, was irrational, procured by fraud, or clearly exceeded a specifically enumerated limitation of the arbitrator’s power”. It further held that Nanovibronix had not demonstrated that it had shown sufficient new facts to the court on the motion to renew. The decision was conclusory and did not analyze the facts as argued by the Company nor did it distinguish them specifically. The Company is reviewing the decision and considering its available alternatives.
As
of March 31, 2026, the Company accrued the amount of the arbitration award to Protrade of approximately $
NOTE 14 – RELATED PARTY TRANSACTION
ENvue Consolidated Secured Note
On
January 17, 2025, ENvue issued a Consolidated Secured Note (as amended, the “Alpha Note”) in the aggregate principal
amount of $
Prior to the Envue Merger, Alpha was the principal shareholder of Predecessor ENvue, and following the completion of the ENvue Merger, Alpha continues to be a significant shareholder of the Company, subject to a 4.99% beneficial ownership limitation.
Equity Financings
As of March 31, 2026, Alpha holds Series X Preferred Stock acquired in connection with the ENvue Merger.
Series H Preferred Stock — Additional Investment Right and Conversions
In January 2026, Alpha, as the holder of the Series H Preferred Stock, exercised $
On
March 24, 2026, the Alpha exercised an additional $
In
aggregate, during the three months ended March 31, 2026, Alpha exercised a total of $
In January 2026, Alpha converted an aggregate of $
As of March 31, 2026, Alpha holds Series H Preferred Stock (see Note 7).
NOTE 15 – AN IMMATERIAL ERROR IN PRIOR-PERIOD FINANCIAL STATEMENTS
In
preparing the interim condensed consolidated financial statements for the three and six months ended June 30, 2025, the Company
identified an error in the accounting for a warrant modification originally reported in the interim condensed consolidated financial
statements for the three months ended March 31, 2025. The Company had incorrectly recorded $
| 20 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (unaudited)
(Amounts in thousands except share and per share data)
The Company evaluated the materiality of the error and concluded that the correction would not be material to the financial position or results of operations for the three months ended March 31, 2025.
The impact of the error on the Company’s interim condensed consolidated financial statements for the three months
ended March 31, 2025 was as follows:
NOTE 16 - SUBSEQUENT EVENTS
Besser Initial Restricted Stock Units
On April 4, 2026, in connection with, and pursuant to the terms of that certain Amended and Restated Employment Agreement with Doron Besser, dated as of December 17, 2025, as amended on February 2, 2026, the Board approved, as recommended by the Compensation Committee (i) an award of fully vested restricted stock units (the “Besser Initial RSUs”) with a date of grant as of April 4, 2026 (the “Initial Grant Date”), subject to the terms and conditions of the 2024 Plan; and (ii) on each quarterly anniversary of the Initial Grant Date, subject to the authorized share limit under the 2024 Plan, an additional gross-up award, if necessary, in order for Dr. Besser to maintain 9.0% of the Company’s issued and outstanding Common Stock, determined on a fully diluted basis as of the grant date of such applicable quarterly gross-up award. Following Board approval, the Besser Initial RSUs were granted to Dr. Besser on the Initial Grant Date.
Series H Preferred Stock — Additional Investment Right and Conversions
On
April 23, 2026, the Alpha exercised $
During
the months of April and May 2026, the Alpha also converted an aggregate of
shares of Series H Preferred Stock into
shares of Common Stock and aggregate of $
| 21 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of the results of operations and financial condition of ENvue Medical, Inc. and its subsidiaries (collectively, the “Company”) as of March 31, 2026, should be read in conjunction with our financial statements and the notes to those financial statements that are included elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”). This discussion contains forward-looking statements that involve risks and uncertainties. Any or all of our forward-looking statements in this Quarterly Report may turn out to be incorrect. These forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Factors which could cause actual results to differ materially include those set forth in Part II — Item 1A — “Risk Factors” in this Quarterly Report and Part I — Item 1A — “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as well as those discussed elsewhere in this Quarterly Report. See “Forward-Looking Statements.” This discussion and analysis should be read in conjunction with the Company’s audited financial statements and related disclosures as of December 31, 2025, and for the year then ended, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2026. There have been no material changes to our critical accounting policies and estimates from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. References in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us,” “we,” “our,” and similar terms refer to the Company and its subsidiaries.
Overview
We were organized as a Delaware corporation in October 2003. On February 14, 2025, we completed the ENvue Merger pursuant to the Merger Agreement, as further described below. Following the consummation of the ENvue Merger, the Company conducts its operations through its two wholly-owned subsidiaries: (i) NanoVibronix Ltd., a private company incorporated under the laws of the State of Israel (“Nano OpCo”) and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company (together with its respective subsidiaries, “ENvue”). Nano OpCo focuses on non-invasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals. ENvue is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral feeding and are in the initial stage of commercializing our products.
Results of Operations
Three Months Ended March 31, 2026, Compared to Three Months Ended March 31, 2025
Revenues. For the three months ended March 31, 2026, and 2025, our revenues were approximately $653 and $1,025, respectively, a decrease of approximately 36%, or $372, between the periods. The decrease was primarily attributable to the removal of PainShield Ultra from the market, partially offset by revenues generated from the ENvue Systems, as well as continued revenues from sales through certain sales representatives and our largest direct medical equipment distributor. Revenues may fluctuate as new customers are added or when existing distributors or customers place large orders in one period and not in another, as experienced during the three months ended March 31, 2025.
For the three months ended March 31, 2026, the percentage of revenues attributable to our products was: 82% for PainShield and monthly kits and 18% for ENvue system and tubes. For the three months ended March 31, 2025, the percentage of revenues attributable to our products was: 85 % for PainShield and monthly kits: 11% for ENvue systems and tubes; and 4% for ancillary products. For the three months ended March 31, 2026, and 2025, the portion of our revenues that was derived from our largest direct medical equipment distributor, Ultra Pain Products LLC, were 27% and 49%, respectively.
Gross Profit (Loss). For the three months ended March 31, 2026, and 2025, gross profit (loss) was approximately ($55) and $369, respectively, a decrease of approximately 115% or $424. Gross margin was also significantly impacted, declining primarily due to the removal of PainShield Ultra from the market, which historically generated higher margins, as well as inventory write-downs associated with PainShield Ultra and ENvue products. In addition, amortization expense related to intangible assets recognized in connection with the ENvue Merger, which is recorded within cost of goods sold, further contributed to the decline in gross margin.
Gross profit as a percentage of revenues were approximately (11%) and 36% for the three months ended March 31, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
| 22 |
Research and Development Expenses. For the three months ended March 31, 2026, and 2025, research and development expenses were approximately $468 and $530, respectively, a decrease of approximately 12%, or $62 between the periods. The decrease in research and development expenses is primarily attributable to changes in development plans, including the temporary suspension of certain projects.
Research and development expenses as a percentage of total revenues were approximately 72% and 52% for the three months ended March 31, 2026, and 2025, respectively.
Our research and development expenses consist mainly of expenses related to subcontracting research and development and clinical trial activities, as well as payroll expenses to employees, and the associated facilities’ costs, who are involved with research and development activities.
Selling and Marketing Expenses. For the three months ended March 31, 2026, and 2025, selling and marketing expenses were approximately $772 and $349, respectively, an increase of approximately 121%, or $423 between the periods. The increase was primarily attributable to a full three months of ENvue operating expenses in the current period compared to only the period from February 14, 2025 (the date of the ENvue Merger) through March 31, 2025 in the prior year, including amortization expense related to intangible assets recognized in connection with the purchase price allocation, as well as higher consulting fees and travel costs associated with system reactivation, new installations, commercialization activities, and rebranding efforts for the ENvue Systems.
Selling and marketing expenses as a percentage of total revenues were approximately 118% and 34% for the three months ended March 31, 2026, and 2025, respectively.
Selling and marketing expenses consist mainly of payroll expenses to direct sales and marketing employees, travel expenses, conventions, advertising and marketing expenses, rent and facilities expenses associated with and allocated to selling and marketing activities.
General and Administrative Expenses. For the three months ended March 31, 2026, and 2025, general and administrative expenses were approximately $2,416 and $1,342, respectively, an increase of approximately 80%, or $1,072 between the periods. The increase was primarily attributable to a full three months of ENvue operating expenses in the current period compared to only the period from February 14, 2025 (the date of the ENvue Merger) through March 31, 2025 in the prior year, as well as higher legal fees, accounting and professional consulting fees, payroll costs, and severance and termination costs associated with former executive management and board members.
Our general and administrative expenses consist mainly of payroll expenses for management and administrative employees, accounting, legal and facilities expenses associated with general and administrative activities and costs associated with being a publicly traded company.
General and administrative expenses as a percentage of total revenues were approximately 370% and 131% for the three months ended March 31, 2026, and 2025, respectively.
Interest expense. For the three months ended March 31, 2026, and 2025, our interest expenses were $36 and $53, respectively. This primarily pertains to the interest on the Company’s loan.
Income tax expense. For the three months ended March 31, 2026, our income tax expense was approximately $8 as compared to $15 in the three months ended March 31, 2025.
Net Loss. Our net loss increased by approximately $1,950 or 104%, to approximately $3,822 for the three months ended March 31, 2026, from approximately $1,872 during the same period in 2025. The increase in net loss resulted primarily from the factors described above.
Liquidity and Capital Resources
Going Concern
We have incurred net losses of approximately $3,822 during the three months ended March 31, 2026, which primarily consisted of decreased revenues and decreased gross margins offset by our operating expenses. We also had negative cash flow from operating activities of $4,312 for the three months ended March 31, 2026. Although we had a cash and cash equivalents of just over $2,235 as of March 31, 2026, we expect to continue to incur losses and negative cash flows from operating activities, and therefore, we do not have sufficient resources to fund our operation for the next twelve months from the date of this filing causing us to have substantial doubt of our ability to continue as a going concern. We will need to continue to raise additional capital to finance its losses and negative cash flows from operations beyond the next years and may continue to be dependent on additional capital raising as long as our products do not reach commercial profitability.
| 23 |
During the three months ended March 31, 2026, we met our short-term liquidity requirements from proceeds of the exercise of additional investment rights and from our existing cash reserves. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments as well as our ability to overcome obstacles that may be presented due to macroeconomic and geopolitical developments, including the ongoing conflict in the Middle East and the war between Russia and Ukraine. We expect to continue to incur losses and negative cash flows from operations. We intend to use the proceeds generated from equity financings, or strategic alliances with third parties, either alone or in combination with equity financing to meet our short-term liquidity requirements as well as to advance our long-term plans. There are no assurances that we will be able to raise additional capital, as required, on terms favorable to us.
We do not have any material commitments to capital expenditures as of March 31, 2026, and we are not aware of any material trends in capital resources that would impact our business.
As of March 31, 2026, we have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Series H Preferred Stock — Additional Investment Right and Conversions
During the month of January 2026, the holder of the Series H Preferred Stock exercised $3,500 of the Additional Investment Right pursuant to the July 2025 Purchase Agreement resulting in the issuance of 3,500 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousand).
On March 24, 2026, the holder also exercised an additional $400 of the Additional Investment Right, resulting in the issuance of 400 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousand).
In aggregate, during the three months ended March 31, 2026, the holder exercised a total of $3,900 of the Additional Investment Right resulting in the issuance of 3,900 new shares of Series H Preferred Stock, which remained outstanding as of March 31, 2026.
Summary of Cash Flow
General. As of March 31, 2026, we had cash and cash equivalents of approximately $2,235, compared to approximately $571 as of March 31, 2025. We have historically met our cash needs through a combination of issuance of equity, borrowing activities and sales. Our cash requirements are generally for product development, research and development costs, marketing and sales activities, general and administrative costs, capital expenditures and general working capital.
Cash used in our operating activities was approximately $4,312 for the three months ended March 31, 2026, and was approximately $1,343 for the same period in 2025.
Cash used in our investing activities was approximately $17 and cash provided by investing activities was $143 for the three months ended March 31, 2026, and 2025, respectively. Cash used in the three months ended March 31, 2026, was primarily for the purchase of plant and equipment.
Cash provided by financing activities during the three months ended March 31, 2026, was approximately $2,340, which was primarily composed of the net proceeds from issuance of common stock and preferred stock. Our future capital requirements and the adequacy of available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments. Cash provided by financing activities for the three months ended March 31, 2025, was approximately $1,050 which resulted from the issuance of note payable from a related party.
Factors That May Affect Future Operations
We believe that our future operating results will continue to be subject to quarterly variability based on a number of factors, including the ordering patterns of our distributors, the timing of regulatory approvals, the progress and implementation of clinical trials, and manufacturing efficiencies associated with the adoption of new materials and equipment.
Our operating results may also be impacted by geopolitical developments, including hostilities in Israel and the broader Middle East, which could disrupt trade, impact our ability to ship products, or affect our operations and those of our partners. In addition, fluctuations in foreign currency exchange rates, including a weakening of the Euro or strengthening of the New Israeli Shekel against the U.S. dollar, may adversely affect our results of operations.
More broadly, macroeconomic conditions, including changes in reimbursement policies and healthcare spending in the markets in which we operate, may impact on customer demand for our products.
| 24 |
Known Trends, Events and Uncertainties
Following a review, we have identified certain inaccuracies in our 510(k) application for the PainShield MD Plus product, and have submitted a request to FDA to withdraw the clearance. The company is unaware of any safety issue related to PainShield MD Plus, but intends to halt future sales of the product. The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict in the Middle East, conflicts between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. For a further discussion of factors that may affect future operating results see the section entitled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 15, 2026. Other than as discussed above and elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.
ITEM 3. AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this Item 3.
Item 4. Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures as of March 31, 2026, the end of the period covered by this Quarterly Report. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by the company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures are also designed to provide reasonable assurance that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Based on their evaluation, as of the end of the period covered by this Quarterly Report, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were not effective because of the material weaknesses in our internal control over financial reporting as described in Item 9A in our Annual Report on Form 10-K for the fiscal ended December 31, 2024, filed with the SEC on March 31, 2025.
Remediation Efforts to Address Material Weakness
With the oversight of senior management and audit committee of the Board of Directors, we have taken the steps below and we plan to take additional measures to remediate the underlying causes of the material weakness in our internal control over financial reporting as described in Item 9A in our Annual Report on Form 10-K for the fiscal ended December 31, 2025, filed with the SEC on April 15, 2026:
| ● | With assistance from a current finance and accounting third-party service provider, the Company was able to formalize our risk assessment process, policies and procedures, implementing revised control activities, controls documentation, and ongoing monitoring activities related to the internal controls over financial reporting including testing documentation to provide evidence that our system of internal controls over financial reporting meets the requirements of the COSO 2013 framework, and provide a foundation for the Company to communicate internal control deficiencies in a timely manner to those parties responsible for taking corrective action. |
| ● | Expanded consultations with third party specialists on complex accounting matters, financial reporting and regulatory filings, and create enhanced documentation to support a more precise review process, as well as enhanced monitoring of the review process, and effective enhanced monitoring of the review process, and an effective system of training of use and review of our inventory recording systems. |
In addition, under the direction of the audit committee of the Board of Directors, management will continue to review and make necessary changes to the overall design of the Company’s internal control environment, as well as to refine policies and procedures to improve the overall effectiveness of internal control over financial reporting of the Company. After all the remediation efforts, not all material weaknesses may be remediated and others may arise in future periods.
Changes in Internal Control over Financial Reporting
Other than described above in Item 4, there has been no change in our internal control over financial reporting that occurred during the last fiscal quarter to which this Quarterly Report relates that has materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 25 |
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome.
The information set forth in Note 13 – Commitments and Contingencies of the Notes to Interim Condensed Consolidated Financial Statements of this Quarterly Report is incorporated by reference herein.
There are no other material proceedings in which any of our directors, officers, affiliates, any registered or beneficial stockholder of more than 5% of our common stock, or any associate of any of the foregoing is an adverse party or has a material interest adverse to our interest.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in Part I, Item 1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, in addition to the other information included in this Quarterly Report on Form 10-Q before making an investment decision regarding our common stock. If any of these risks actually occur, our business, financial condition, or operating results would likely suffer, possibly materially, the trading price of our common stock could decline, and you could lose part or all of your investment.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
There were no unregistered sales of equity securities during the quarter ended March 31, 2026, other than as reported in our Current Reports on Form 8-K filed with the SEC.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
None of the Company’s officers or directors
| 26 |
Item 6. Exhibits
EXHIBIT INDEX
| * | Filed herewith. |
| ** | Furnished herewith. |
| 27 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Date: May 18, 2026 | By: | /s/ Doron Besser |
| Name: | Doron Besser | |
| Title: | Chief Executive Officer | |
| Date: May 18, 2026 | By: | /s/ Nicole Fernandez-McGovern |
| Name: | Nicole Fernandez-McGovern | |
| Title: | Chief Financial Officer |
| 28 |
Exhibit 31.1
CERTIFICATIONS UNDER SECTION 302
I, Doron Besser, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of ENvue Medical, Inc. (the “registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: May 18, 2026 | |
| /s/ Doron Besser | |
| Doron Besser | |
| Chief Executive Officer | |
| (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATIONS UNDER SECTION 302
I, Nicole Fernandez-McGovern, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of ENvue Medical, Inc. (the “registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: May 18, 2026 | |
| /s/ Nicole Fernandez-McGovern | |
| Nicole Fernandez-McGovern | |
| Chief Financial Officer | |
| (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION FURNISHED PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly Report on Form 10-Q (the “Form 10-Q”) for the quarter ended March 31, 2026, of ENvue Medical, Inc. (the “Company”). I, Doron Besser, the Chief Executive Officer of the Company, certify that, based on my knowledge:
(1) The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.
| Date: May 18, 2026 | ||
| By: | /s/ Doron Besser | |
| Doron Besser | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
Exhibit 32.2
CERTIFICATION FURNISHED PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly Report on Form 10-Q (the “Form 10-Q”) for the quarter ended March 31, 2026, of ENvue Medical, Inc. (the “Company”). I, Nicole Fernandez-McGovern, the Chief Financial Officer of the Company, certify that, based on my knowledge:
(1) The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.
| Date: May 18, 2026 | ||
| By: | /s/ Nicole Fernandez-McGovern | |
| Nicole Fernandez-McGovern | ||
| Chief Financial Officer | ||
| (Principal Financial Officer) | ||