ENvue Medical, Inc 10-Q for FY2026 Q2
ENvue Medical, Inc. (FEED)
About this 10-Q
ENvue Medical, Inc filed this 10-Q on August 17, 2026, covering the quarter ended June 30, 2026 (FY2026 Q2).
Headline figures
Quarter ended June 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $239K
- down 51.6% from $494K a year earlier
- Net loss
- $4.9M
- compared with a net loss of $3.97M a year earlier
- Diluted EPS
- -$1.98
- compared with -$1.03 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 August 17, 2026, was shares.
ENVUE MEDICAL, INC.
Quarter Ended June 30, 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)
| June 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Trade receivables, net | ||||||||
| 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 June 30, 2026, and December 31, 2025; Issued and outstanding: shares at June 30, 2026 and December 31, 2025 | [*] | |||||||
| Series X Preferred Stock of $ par value - Authorized: shares at June 30, 2026, and December 31, 2025; Issued and outstanding: and shares at June 30, 2026 and December 31, 2025, respectively | [*] | |||||||
| Series H Preferred Stock of $ par value - Authorized: shares at June 30, 2026, and December 31, 2025; Issued and outstanding: and shares at June 30, 2026 and December 31, 2025, respectively | [*] | |||||||
| Preferred stock value | ||||||||
| Common stock of $ par value - Authorized: shares at June 30, 2026, and December 31, 2025; Issued and outstanding: and shares at June 30, 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)
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Cost of revenue | ||||||||||||||||
| Gross (loss) profit | ( | ) | ( | ) | ( | ) | ||||||||||
| Operating expense: | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Financial income, net | ||||||||||||||||
| Loss before taxes on income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income (tax expense) tax benefit | ( | ) | ( | ) | ( | ) | ||||||||||
| 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 per common stock [*] | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common stock outstanding [*] | ||||||||||||||||
| Basic and diluted [*] | ||||||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Changes in foreign currency translation adjustment | ( | ) | ( | ) | ||||||||||||
| Comprehensive loss available to common stockholders | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| [*] |
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)
| Shares | Amount | Shares | Amount | Shares | Amount [*] | Capital [*] | Income | Deficit | Equity | |||||||||||||||||||||||||||||||
| Series G Preferred Stock | Series X Preferred Stock | Common Stock[*] | Additional Paid-in- | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital [*] | Income | Deficit | Equity | |||||||||||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | | $ | ( | ) | $ | ( | ) | $ | | |||||||||||||||||||||||||||
| ENvue Merger | - | |||||||||||||||||||||||||||||||||||||||
| Dividend on Series X Preferred Stock | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Exercise of warrants | - | - | ||||||||||||||||||||||||||||||||||||||
| Exercise of pre-funded warrants | - | - | ||||||||||||||||||||||||||||||||||||||
| Warrant exchange agreement | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of Series G Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of Series G Preferred Stock into common stock | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Rounding-up of fractional shares due to reverse stock split | - | - | ||||||||||||||||||||||||||||||||||||||
| Currency translation adjustment | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| [*] |
| Shares | Amount | Shares | Amount | Shares | Amount [*] | Capital [*] | Income | Deficit | Equity | |||||||||||||||||||||||||||||||
| Series G Preferred Stock | Series X Preferred Stock | Common Stock[*] | Additional Paid-in- | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital [*] | Income | Deficit | Equity | |||||||||||||||||||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | $ | | $ | ( | ) | $ | ( | ) | $ | | |||||||||||||||||||||||||||
| ENvue Merger | - | - | ||||||||||||||||||||||||||||||||||||||
| Dividend on Series X Preferred Stock | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Exercise of warrants | - | - | ||||||||||||||||||||||||||||||||||||||
| Exercise of pre-funded warrants | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of Series G Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of Series G Preferred Stock into common stock | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Currency translation adjustment | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| [*] |
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 3 |
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statement of Stockholders’ Equity (Unaudited)
(Amounts in thousands except share and per share data)
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount |
Capital | Income | Deficit | Equity | |||||||||||||||||||||||||||||||||||||
| 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, March 31, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| Issuance of Series H Preferred Stock, net of issuance costs | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series H Preferred Stock into Common Stock | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Repurchase of Series X Preferred Stock | - | ( | ) | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||
| Issuance of Restricted Stock | ||||||||||||||||||||||||||||||||||||||||||||||||
| Dividend on Series X Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Dividend on Series H Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Deemed dividend for down round on Series H Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| 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 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
| Issuance of Series H Preferred Stock, net of issuance costs | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series H Preferred Stock into common stock | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Repurchase of Series X Preferred Stock | - | ( | ) | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||
| Issuance of Restricted Stock | ||||||||||||||||||||||||||||||||||||||||||||||||
| Dividend on Series X Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Dividend on Series H Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Deemed dividend for down round on Series H Preferred Stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 4 |
ENVUE MEDICAL, INC.
Interim Condensed Consolidated Statements of Cash Flows (Unaudited)
(Amounts in thousands except share and per share data)
| 2026 | 2025 | |||||||
| Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Non-cash interest expense | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||
| Issuance cost allocated to warrant liability | ||||||||
| 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 | ||||||||
| Proceeds from issuance of convertible note payable from related party | ||||||||
| Payments of note payable to related party | ( | ) | ||||||
| Payments of short-term loans to related party | ( | ) | ||||||
| Proceeds from issuance of short-term loan payable | ||||||||
| Repurchase of Series X Preferred Stock | ( | ) | ||||||
| Proceeds from exercise of options and warrants | ||||||||
| Net cash provided by financing activities | ||||||||
| Effects of currency translation on cash and cash equivalents | ( | ) | ||||||
| Net increase (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 | $ | $ | ||||||
| Non-cash transactions: | ||||||||
| Right of use asset obtained in the exchange for operating lease liabilities | $ | $ | ||||||
The accompanying notes are an integral part of these interim condensed consolidated financial statements
| 5 |
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.
Following the ENvue Merger, the Company operates through two operating segments: NanoVibronix and ENvue.
NOTE 2 - LIQUIDITY AND PLAN OF OPERATIONS
As
of June 30, 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.
| 6 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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.
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 $250. Cash balances could exceed insured amounts at any given time.
Generally, these investments may be redeemed upon demand, and the Company believes that the financial institutions that hold the Company’s
cash deposits are financially sound and, accordingly, bear minimal risk. As of June 30, 2026 and December 31, 2025, the Company had cash
in excess of the FDIC insured amount totaling approximately $
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 June 30, 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.
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.
| 7 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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.
Accounting Standard Codification (“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 six months ended June 30, 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 six months ended June 30, 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 | ||||
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 six months ended June 30, 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 six months ended June 30, 2026 and 2025 was immaterial.
The
Company’s short-term net investment in a lease receivable as of June 30, 2026 and December 31, 2025 was $
| 8 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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.
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 June 30, 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 six months ending June 30, 2026:
SCHEDULE OF DEFERRED REVENUE
| Balance as of December 31, 2025 | $ | |||
| Revenue recognized | ( | ) | ||
| Balance as of June 30, 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 Condensed 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.
| 10 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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
| June 30, 2026 | December 31, 2025 | |||||||
| Prepaid expenses | $ | $ | ||||||
| Other receivables | ||||||||
| Total prepaid expenses and other accounts receivable | $ | $ | ||||||
NOTE 5 – INVENTORY
Inventory consists of the following components as of:
SCHEDULE OF INVENTORY
| June 30, 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
| June 30, 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.
| 11 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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.
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 June 30, 2026, there were outstanding shares of Series G Preferred Stock.
| 12 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 service provider of Predecessor ENvue, replacing its equity interest in ENvue, resulting in a total of shares of Series X Preferred Stock outstanding after the ENvue Merger.
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 had an initial 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.
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 $
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 six months ended June 30, 2026, the Company repurchased a total of shares of Series X Preferred Stock from Alpha for an aggregate
repurchase price of approximately $
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 certain
institutional investor (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
| 13 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 Exercises
During
the six months ended June 30, 2026, Alpha, as the holder of the Series H Preferred Stock, exercised the Additional Investment Right pursuant
to the July 2025 Purchase Agreement on six occasions, for an aggregate value of $
Series H Preferred Stock — Additional Investment Right Conversions
During
the six months ended June 30, 2026, Alpha converted an aggregate value of $
As of June 30, 2026, Alpha holds shares of Series H Preferred Stock.
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).
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 $
Down-round Feature
During
the six months ended June 30, 2026, the Company issued shares of Series H Preferred Stock to Alpha for aggregate gross proceeds
of $
| 14 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
The
deemed dividends consisted of $
All 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 $
Restricted Stock Issuance
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 into common stock (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 approval of the Board of Directors and 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. As the grant was fully vested on the grant date with no additional service required the Company recorded on the Initial Grant Date $ stock-based compensation expense related to the Besser Initial RSUs.
Options
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.
On December 4, 2025, the Company held its Annual Meeting, at which the Company’s stockholders approved the first amendment to the NanoVibronix, Inc. 2024 Long-Term Incentive Plan (the “First Amendment”). The First Amendment further increased the number of shares of Common Stock available for issuance pursuant to awards under the 2024 Plan by an additional shares of Common Stock, to a total of shares of Common Stock. As of March 31, 2026, there were shares of Common Stock available to be issued under the 2024 Plan.
During the six months ended June 30, 2026, employee options were granted, exercised or expired.
During the six months ended June 30, 2026, and 2025, stock-based compensation expense related to these options were $ and , respectively.
| 15 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 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
June 30, 2026, was $
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 six months ended June 30, 2026:
SCHEDULE OF CHANGE IN WARRANT LIABILITY
| Balance as of December 31, 2025 | $ | |||
| Change in fair value | ( | ) | ||
| Balance as of June 30, 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 June 30, 2026, the loan balance was $
| 16 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 six months ended June 30, 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 June 30, 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 six months ended June 30, 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
| 2026 | 2025 | |||||||
| Three Months Ended June 30, | ||||||||
| 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 | ||||||||
| Net loss available to common stockholders | $ | ( | ) | $ | ( | ) | ||
| 2026 | 2025 | |||||||
| Six Months Ended June 30, | ||||||||
| 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 | $ | ( | ) | $ | ( | ) | ||
SUMMARY OF COMMON SHARE EQUIVALENTS BEEN EXCLUDED FROM DILUTIVE LOSS PER SHARE AS ANTI-DILUTIVE
| June 30, 2026 | June 30, 2025 | |||||||
| Stock options - employee and non-employee | $ | $ | ||||||
| Warrants | ||||||||
| Total | $ | $ | ||||||
The diluted loss per share equals basic loss per share for the six months ended June 30, 2026, and 2025 because the Company had a net loss and the impact of the assumed exercise of stock options and warrants would have been anti-dilutive.
| 17 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 June 30, 2026 | ||||||||||||||||
| Goodwill | $ | $ | $ | $ | ||||||||||||
| Assets | $ | $ | $ | $ | ||||||||||||
| Balance sheet at December 31, 2025 | ||||||||||||||||
| Goodwill | $ | $ | $ | $ | ||||||||||||
| Assets | $ | $ | $ | $ | ||||||||||||
Segment operating results
| Six Months Ended June 30, 2026: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Six Months Ended June 30, 2025: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Three Months Ended June 30, 2026: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
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ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
| Three Months Ended June 30, 2025: | NanoVibronix | ENvue | Corporate | Total | ||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Geographic Information and Major Customer Data
The following is a summary of revenues within geographic areas:
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| United States | $ | $ | $ | $ | ||||||||||||
| Europe | ||||||||||||||||
| Australia/New Zealand | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Major Customer Data as a Percentage of Total Revenues
The following is a summary of revenues:
SCHEDULE OF PERCENTAGE OF TOTAL REVENUES
| 2026 | 2025 | |||||||
| Three Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Customer F | % | % | ||||||
| Customer C | % | % | ||||||
| Customer D | % | % | ||||||
| Total | % | % | ||||||
| 2026 | 2025 | |||||||
| Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Customer A | % | % | ||||||
| Customer B | % | % | ||||||
| Customer C | % | % | ||||||
| Customer D | % | % | ||||||
| Total | % | % | ||||||
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ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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 six-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 six months ended June 30, 2026, and 2025.
The following table presents changes in Level 3 asset and liability measured at fair value for the six months ended June 30, 2026, and 2025:
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE
| Warrant Liability | ||||
| Balance December 31, 2025 | $ | |||
| Fair value adjustments – warrant liability | ( | ) | ||
| Balance, June 30, 2026 | $ | |||
| Warrant Liability | ||||
| Balance December 31, 2024 | $ | |||
| Issuance – warrant liability | ||||
| Fair value adjustments – warrant liability | ( | ) | ||
| Balance, June 30, 2025 | $ | |||
The Company measures certain financial liabilities at fair value on a recurring basis, including its warrant liability, using Level 3 valuation techniques such as the Black-Scholes option pricing model.
The
following are the inputs used in the Company’s valuation models:
SCHEDULE OF INPUTS USED IN LEVEL 3 VALUATION TECHNIQUES
| Warrant Liability June 30, 2026 | Warrant Liability December 31, 2025 | Warrant Liability June 30, 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
| Level I | Level II | Level III | Total | |||||||||||||
| Fair Value Measurements as of June 30, 2026 | ||||||||||||||||
| Level I | Level II | Level III | Total | |||||||||||||
| Warrant liability | ||||||||||||||||
| Level I | Level II | Level III | Total | |||||||||||||
| Fair Value Measurements as of June 30, 2025 | ||||||||||||||||
| Level I | Level II | Level III | Total | |||||||||||||
| Warrant liability | $ | |||||||||||||||
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ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
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.
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 June 30, 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.
Alpha Series X Redemptions and Series H Preferred Stock Additional Investment Right Exercises and Conversions
During the six months ended June 30, 2026, the Company repurchased
shares of Series X Preferred Stock from Alpha for an aggregate repurchase price of approximately $
| 21 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
Besser Initial RSUs
In addition, on April 4, 2026, the Board approved an award of 1,044,741 fully vested restricted stock units to Dr. Besser, for which the Company recorded $2,048 of stock-based compensation expense. See Note 7 for further details.
NOTE 15 - SUBSEQUENT EVENTS
Series H Preferred Stock — Additional Investment Right and Conversions
On
August 5, 2026, Alpha exercised $
During
July 2026, the Alpha also converted an aggregate of
Issuances of Common Stock
On August 7, 2026, the Company issued an aggregate of shares of Common Stock, consisting of shares to service providers of the Company as consideration for services rendered, and shares to an employee pursuant to the 2024 Plan.
Committed Equity Facility of up to $50 million
On
August 12, 2026, the Company entered into a Common Shares Purchase Agreement (the “Purchase Agreement”), with Alpha relating
to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, the Company has the right from time
to time at its option to sell to Alpha up to $
| 22 |
ENVUE MEDICAL, INC.
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(Amounts in thousands except share and per share data)
Sales of the Common Stock to Alpha under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time in its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Common Stock and determinations by the Company regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at which the Common Stock is sold to Alpha. The Company is required to use 40% of the net proceeds from any sales under the Purchase Agreement to redeem outstanding shares of its Series X Preferred Stock, par value $ per share (the “Series X Preferred Stock”), until no such shares of Series X Preferred Stock remain outstanding, with the remainder of any net proceeds to be used for working capital and general corporate purposes.
Upon the initial satisfaction of the conditions to Alpha’s obligation to purchase Common Stock set forth in the Purchase Agreement (the “Commencement”), including, but not limited to, that a registration statement registering the resale by Alpha of the Common Shares under the Securities Act of 1933, as amended (the “Securities Act”), that may be sold to it by the Company under the Purchase Agreement (the “Initial Resale Registration Statement”), is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC, the Company will have the right, but not the obligation, from time to time at its sole discretion until the first day of the month next following the 36-month period from and after Commencement, to direct Alpha to purchase up to a specified maximum amount of Common Stock as set forth in the Purchase Agreement by delivering written notice to Alpha prior to the commencement of trading on any trading day. The purchase price of the Common Stock that the Company elects to sell to Alpha pursuant to the Purchase Agreement will be 90% of the lowest volume weighted average price of the Common Stock during the three (3) trading days immediately preceding the applicable purchase date on which the Company has timely delivered written notice to Alpha directing it to purchase Common Stock under the Purchase Agreement.
The Purchase Agreement contains customary registration rights, representations, warranties, conditions and indemnification obligations by each party. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of the Purchase Agreement and as of specific dates, were solely for the benefit of the parties to such agreement and are subject to certain important limitations.
The Company has the right to terminate the Purchase Agreement at any time after Commencement, at no cost or penalty, upon five (5) trading days’ prior written notice. No termination of the Purchase Agreement will affect the registration rights provisions contained within the Purchase Agreement, which will survive any termination of the Purchase Agreement.
July 2025 Purchase Agreement Amendment
The Company entered into a Securities Purchase Agreement, dated as of July 18, 2025, as amended on January 30, 2026 (the “Series H Purchase Agreement”), by and between the Company and Alpha, pursuant to which the Company agreed to issue and sell to Alpha newly designated shares of its Series H Convertible Preferred Stock, par value $ per share (the “Series H Preferred Stock”).
On
August 12, 2026, the Company entered into that certain Second Amendment Agreement to the Series H Purchase Agreement (the “Second
Amendment Agreement”) with Alpha. Pursuant to the terms of the Second Amendment Agreement, the Company and Alpha agreed, among
other things, subject to the receipt of Shareholder Approval (as defined in the Second Amendment), to amend the Series H Purchase Agreement
to increase the total Additional Investment Rights (as defined in the Series H Purchase Agreement) to a total aggregate amount of up
to $
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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 June 30, 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 is the initial stage of commercializing its products.
Following the ENvue Merger, the Company has progressively consolidated certain functions and resources across the combined organization in order to reduce duplication and improve operating efficiency. This has included the sharing of personnel and technical resources across the Company’s two product platforms based on their respective development, regulatory, manufacturing and commercial requirements. Accordingly, changes in the level of expenses attributed to either operating segment from period to period may reflect the timing and requirements of particular activities and the deployment of shared Company resources and should be considered together with the operating circumstances affecting each business during the applicable period.
Results of Operations
Three Months Ended June 30, 2026, Compared to Three Months Ended June 30, 2025
Revenues. For the three months ended June 30, 2026, and 2025, our revenues were approximately $239 and $494, respectively, a decrease of approximately 51.6%, or $255, between the periods. The decrease was primarily attributable to a halt in production of our PainShield/UroShield products resulting from the war in Israel and the relocation of our PainShield/Uroshield manufacturing operations to the United States. Notwithstanding the temporary disruption to NanoVibronix production during the period, NanoVibronix products continued to represent approximately 18% of the Company’s consolidated revenues for the three months ended June 30, 2026. The Company completed the transition of its NanoVibronix manufacturing operations to the United States in August 2026, and production has been re-established.
This decline was partially offset by growth in ENvue revenues, which increased by approximately 275%, from approximately $49 to approximately $184, driven by continued expansion of our installed hospital base and adoption of the ENvue Navigation Platform. We also continued to generate revenues through certain sales representatives and our largest direct medical equipment distributor. The decline in NanoVibronix revenues during the period was primarily attributable to the temporary production disruption and manufacturing relocation described above and expect PainShield/UroShield revenues to resume now that production has been re-established, although we can provide no assurance as to the timing or extent of any such recovery.
For the three months ended June 30, 2026, the percentage of revenues attributable to our products was: 16% for PainShield and monthly kits, 2% for UroShield and monthly kits, 77% for ENvue systems and tubes and 5% for other products. For the three months ended June 30, 2025, the percentage of revenues attributable to our products was: 87% for PainShield and monthly kits, 10% ENvue systems and tubes; and 3% for other products.
Gross Profit (Loss). For the three months ended June 30, 2026, and 2025, gross loss was approximately $266 and $35, respectively, an increase in gross loss of approximately 660%, or $231. The increase in gross loss, as well as the decline in the underlying gross margin percentage, was mainly due to $140 of amortization of technology and trademark intangible assets recognized in connection with the ENvue Merger, the sale of ENvue systems at discounted prices as part of our commercialization strategy of expanding the installed base in order to drive recurring sales of our tubes, lower UroShield sales, and the write-down of $41 of inventory.
Gross profit as a percentage of revenues was approximately negative 111% and negative 7% for the three months ended June 30, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
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Research and Development Expenses. For the three months ended June 30, 2026, and 2025, research and development expenses were approximately $510 and $1,016, respectively, a decrease of approximately 50%, or $506, between the periods. The decrease reflects changes in development plans, including the temporary suspension of certain research and development projects, as well as changes in the timing and level of research and development activity across the Company’s product operating segments that vary throughout the year.
Additionally, the research and development expense decrease is attributed to the relocation of the NanoVibronix manufacturing and research and development testing operations from Israel to the United States, a phased transition that began in 2025 and continued through the first half of 2026 following disruption from regional conflict, together with the deployment of shared Company research and development resources across the two product operating segments.
Our research and development expenses consist mainly of expenses related to subcontracted research and development, 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 June 30, 2026, and 2025, selling and marketing expenses were approximately $1,198 and $673, respectively, an increase of approximately 78%, or $525 between the periods. The increase was primarily attributable to commercialization efforts for the ENvue Systems and the expansion of UroShield into the United Kingdom, including the hiring of sales employees during the second quarter of 2026, participation in a trade exhibition, and increased social media and other product-awareness marketing activity.
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 June 30, 2026, and 2025, general and administrative expenses were approximately $3,500 and $2,252, respectively, an increase of 55.4%, or $1,248 between the periods. The increase was primarily attributable to stock-based compensation costs associated with a share issuance, partially offset by a decrease in professional and consulting fees as compared to the prior year.
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.
Interest expense. For the three months ended June 30, 2026, and 2025, our interest expense was approximately $30 and $144, respectively. This primarily pertains to the interest on the Company’s loan acquired in the business combination, which was fully recognized during 2025.
Financial income, net. For the three months ended June 30, 2026, and 2025, financial income, net, was approximately $603 and $211, respectively. This primarily pertains to the Company’s change in fair value of warrant liability.
Income tax expense. For the three months ended June 30, 2026, we recorded an income tax benefit of approximately $2 as compared to income tax expense of approximately $62 in the three months ended June 30, 2025.
Net Loss. Our net loss for the three months ended June 30, 2026, increased by approximately $928, or 23%, reaching approximately $4,899, compared to a net loss of approximately $3,971 for the same period in 2025. This increase in net loss was primarily due to the factors described above.
Six Months Ended June 30, 2026, Compared to Six Months Ended June 30, 2025
Revenues. For the six months ended June 30, 2026 and 2025, our revenues were approximately $892 and $1,519 respectively, a decrease of approximately 41.3%, or $627 between the periods. The decrease was primarily attributable to a halt in production of our PainShield/UroShield products resulting from the war in Israel and the relocation of our PainShield/UroShield manufacturing operations to the United States. Notwithstanding the temporary disruption to NanoVibronix production during the period, NanoVibronix products continued to represent approximately 66% of the Company’s consolidated revenues for the six months ended June 30, 2026. The Company completed the transition of NanoVibronix manufacturing operations to the United States in August 2026, and production has been re-established.
Additionally, the decline was partially offset by growth in ENvue revenues, which increased by approximately 100%, from approximately $152 to approximately $303, reflecting continued expansion of our installed hospital base and adoption of the ENvue Navigation Platform. This growth was further supported by three-year purchasing agreement renewals with two group purchasing organizations representing over 100 U.S. hospitals, as well as a network-wide standardization agreement with a 12-hospital health system in Virginia and North Carolina. In support of continued clinical adoption and commercial traction, an independent, peer-reviewed study published in Critical Care Nurse (June 2026) documented zero pulmonary misplacements across 531 procedures using the ENvue Navigation Platform, along with a 67% reduction in ventilator-associated pneumonia, supporting continued clinical and commercial adoption. Our revenues may vary from period to period, as new customers are added and existing distributors or consumers may make significant purchases in one quarter and no purchases in the following quarter. Accordingly, revenue trends should not be expected to follow a linear or consistent pattern.
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For the six months ended June 30, 2026, the percentage of revenues attributable to our products was: 45% for PainShield and monthly kits, 19% for UroShield and monthly kits, 34% for ENvue systems and tubes and 2% for other products. For the six months ended June 30, 2025, the percentage of revenues attributable to our products was: 84% for PainShield and monthly kits, 10% for ENvue systems and tubes, and 6% for other products.
Gross Profit (Loss). For the six months ended June 30, 2026 and 2025, gross loss was approximately $321 compared to gross profit of approximately $334, respectively, a decrease of approximately 196%, or $655. The decrease was mainly due to $280 of amortization of technology and trademark intangible assets recognized in connection with the ENvue Merger, the sale of ENvue systems at discounted prices as part of our commercialization strategy to increase our installed base and recurring sales of our tubes, lower UroShield sales, and the write-down of $163 of inventory.
Gross profit as a percentage of revenues was approximately negative 36% and positive 22% for the six months ended June 30, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
Research and Development Expenses. For the six months ended June 30, 2026, and 2025, research and development expenses were approximately $1,024 and $1,567, respectively, a decrease of approximately 35%, or $543, between the periods. The decrease is mainly attributed to changes in development plans, including the temporary suspension of certain research and development projects related to the voluntary 510(k) withdrawal of our PainShield MD Plus product. The decrease was also attributed to the timing and level of research and development activity across our product operating segments, whose development efforts are currently focused on product enhancements and regulatory compliance.
Additionally, changes in research and development expense attributed to our operating segments also reflect the relocation of the NanoVibronix manufacturing and research and development testing operations from Israel to the United States, a phased transition that began in 2025 and continued through the first half of 2026 following disruption from regional conflict, together with the deployment of our shared research and development resources across the two product operating segments.
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 six months ended June 30, 2026, and 2025, selling and marketing expenses were approximately $1,924 and $1,001, respectively, an increase of approximately 92.2%, or $923 between the periods. The increase was primarily attributable to commercialization activities across the Company’s product portfolio, including commercialization efforts for the ENvue Systems and expansion of UroShield into the United Kingdom, as well as the hiring of sales employees during the second quarter of 2026, participation in a trade exhibition during the quarter, along with increased social media and other product-awareness marketing activity.
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 six months ended June 30, 2026, and 2025, general and administrative expenses were approximately $5,916 and $3,594, respectively, an increase of approximately 64.6%, or $2,322 between the periods. The increase was primarily attributable to a full six 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 June 30, 2025 in the prior year, as well as stock-based compensation costs associated with share issuances, higher legal fees and payroll costs, and severance and termination costs associated with former executive management and board members, partially offset by a decrease in professional and consulting fees as compared to the prior year.
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.
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Interest expense. For the six months ended June 30, 2026, and 2025, our interest expense was approximately $66 and $197, respectively. This primarily pertains to the interest on the Company’s loan acquired in the business combination, which was fully recognized during 2025.
Financial income, net. For the six months ended June 30, 2026, and 2025, financial income, net, was approximately $561 and $259, respectively. This primarily pertains to the Company’s change in fair value of warrant liability.
Income tax expense. For the six months ended June 30, 2026, our income tax expense was approximately $31 as compared to $77 in the six months ended June 30, 2025.
Net Loss. Our net loss for the six months ended June 30, 2026, increased by approximately $2,878, or 49%, reaching approximately $8,721, compared to a net loss of approximately $5,843 for the same period in 2025. This increase in net loss was primarily due to the factors described above.
Liquidity and Capital Resources
Going Concern
We have incurred net losses of approximately $8,721 during the six months ended June 30, 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 $7,003 for the six months ended June 30, 2026. Although we had cash and cash equivalents of approximately $1,084 as of June 30, 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 operations 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 our 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.
During the six months ended June 30, 2026, we met our short-term liquidity requirements from proceeds of the exercise of additional investment rights by our existing investor 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 June 30, 2026, and we are not aware of any material trends in capital resources that would impact our business.
As of June 30, 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 Exercises
During the six months ended June 30, 2026, Alpha, as the holder of the Series H Preferred Stock, exercised the Additional Investment Right pursuant to the July 2025 Purchase Agreement on six occasions, for an aggregate value of $7,600, resulting in the issuance of 7,600 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousands), all of which remained outstanding as of June 30, 2026.
Series H Preferred Stock — Additional Investment Right Conversions
During the six months ended June 30, 2026, Alpha converted an aggregate value of $7,719 of Series H Preferred Stock and $602 of accrued dividends, into 6,049,233 shares of Common Stock. This consisted of $4,802 of stated value and $451 of accrued dividends converted during the first quarter of 2026 into 2,600,495 shares of Common Stock, and $2,917 of stated value and $151 of accrued dividends converted during the second quarter of 2026 into 3,448,738 of Common Stock.
Purchase Agreement Facility
On August 12, 2026, we entered into a Common Shares Purchase Agreement (the “Purchase Agreement”), with Alpha Capital Anstalt (“Alpha”) relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, we have the right from time to time at our option to sell to the Investor up to $50.0 million of our Common Stock, subject to certain conditions and limitations set forth in the Purchase Agreement.
Sales of the Common Stock to Alpha under the Purchase Agreement, and the timing of any sales, will be determined by us from time to time in its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Common Stock and determinations by us regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at which the Common Stock is sold to Alpha. The Company is required to use 40% of the net proceeds from any sales under the Purchase Agreement to redeem outstanding shares of its Series X Preferred Stock, until no such shares of Series X Preferred Stock remain outstanding, with the remainder of any net proceeds to be used for working capital and general corporate purposes.
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Upon the initial satisfaction of the conditions to Alpha’s obligation to purchase Common Stock set forth in the Purchase Agreement (the “Commencement”), including, but not limited to, that a registration statement registering the resale by Alpha of the Common Stock under the Securities Act of 1933, as amended (the “Securities Act”), that may be sold to it by the Company under the Purchase Agreement (the “Initial Resale Registration Statement”), is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion until the first day of the month next following the 36-month period from and after Commencement, to direct Alpha to purchase up to a specified maximum amount of Common Stock as set forth in the Purchase Agreement by delivering written notice to the Investor prior to the commencement of trading on any trading day. The purchase price of the Common Stock that we elect to sell to Alpha pursuant to the Purchase Agreement will be 90% of the lowest volume weighted average price of the Common Stock during the three (3) trading days immediately preceding the applicable purchase date on which we have timely delivered written notice to Alpha directing it to purchase Common Stock under the Purchase Agreement.
Summary of Cash Flow
General. As of June 30, 2026, we had cash and cash equivalents of approximately $1,084, compared to approximately $4,030 as of June 30, 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 $7,003 and was approximately $4,726 for the same period in 2025.
Cash used in our investing activities was approximately $44 for the six months ended June 30, 2026, and cash provided by investing activities was $139 for the six months ended June 30, 2025, respectively. Cash used in the six months ended June 30, 2026, was primarily for the purchase of plant and equipment.
Cash provided by financing activities during the six months ended June 30, 2026, was approximately $3,934, consisting of net proceeds of $6,974 from the issuance of common stock, preferred stock and warrants, partially offset by $3,040 used to repurchase shares of Series X 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 during the six months ended June 30, 2025, was approximately $7,900, primarily resulting from net proceeds of $8,215 from the sale of Series G Preferred Stock, $1,300 in proceeds from issuance of notes payable to a related party, $360 from the issuance of a short-term loan payable, and $102 in proceeds from exercise of options, partially offset by payments of $1,300 on a related party note payable and $777 on a short-term loan to a related party. The Company’s future capital requirements and the adequacy of available funds will depend on a variety of factors, including the successful commercialization of its products, the development of future product offerings, and the impact of technological advancements and competitive market dynamics.
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 customer demand for our products.
Known Trends, Events and Uncertainties
Following a review, we 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 medical device industry, including but not limited to, risks associated with completing studies and clinical trials, receiving regulatory approvals for product, development by competitors of new medical device 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.
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ITEM 3. QUANTITATIVE 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 June 30, 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 year ended December 31, 2025, filed with the SEC on April 15, 2026.
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 year 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.
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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.
If we fail to comply with the continued listing requirements of Nasdaq, our Common Stock may be delisted and the price of our Common Stock and our ability to access the capital markets could be negatively impacted.
Our Common Stock is currently listed for trading on Nasdaq. We must satisfy Nasdaq’s continued listing requirements, including, among other things, a minimum stockholders’ equity of $2.5 million and a minimum closing bid price of $1.00 per share or risk delisting, which would have a material adverse effect on our business. A delisting of our Common Stock from Nasdaq could materially reduce the liquidity of our Common Stock and result in a corresponding material reduction in the price of our Common Stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.
On July 10, 2026, we received a letter (the “Staff Determination Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the Staff has determined that the closing bid price of our Common Stock has been below $1.00 per share for the previous 30 consecutive business days (from May 26, 2026 through July 8, 2026) and, as a result, we were not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). Ordinarily, a company that fails to meet the Minimum Bid Price Requirement would be afforded a 180-calendar day compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A) to regain compliance. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Staff has determined that we were not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A), because we previously effected a reverse stock split over the prior one-year period. As previously disclosed, we effected a 1-for-10 reverse stock split of the Common Stock on August 12, 2025. We timely requested a hearing before the Panel to appeal the Staff’s determination, in accordance with the procedures set forth in the Nasdaq Listing Rule 5800 Series, and as a result, the hearing stayed any suspension or delisting action pending the Panel’s decision. There can be no assurance that the Company’s request for continued listing will be granted or that the Company will be able to regain and maintain compliance with the Minimum Bid Price Requirement or all other applicable requirements for continued listing on The Nasdaq Capital Market.
On April 10, 2024, we received the Letter from the Staff of Nasdaq indicating that, based upon the closing bid price of our Common Stock for the 30 consecutive business days between February 27, 2024 and April 9, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to the Bid Price Rule. The Letter also indicated that we were provided with a compliance period of 180 calendar days, or until October 7, 2024, in which to regain compliance with the Bid Price Rule pursuant to Nasdaq Listing Rule 5810(c)(3)(A). We did not regain compliance with the Bid Price Rule by October 7, 2024, and on October 8, 2024, Nasdaq notified us that our securities were subject to delisting from Nasdaq unless we timely requested a hearing before the Panel. We subsequently and timely requested a hearing before the Panel, which was held on December 5, 2024.
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On November 19, 2024, we received an additional deficiency notice from the Staff indicating that we no longer satisfied the $2.5 million stockholders’ equity requirement set forth in the Equity Rule for continued listing on Nasdaq. The Staff indicated that our non-compliance with the Equity Rule would be considered by the Panel at the Hearing and could serve as an additional basis for delisting of our securities from Nasdaq.
On December 26, 2024, we received a letter (the “Decision Letter”) from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect a reverse stock split of our Common Stock; (ii) on or before March 31, 2025, we shall have effected a reverse stock split and, thereafter, maintain a $1.00 closing bid price of our Common Stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq. On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the March 2025 Reverse Stock Split, among others, and on March 13, 2025, the March 2025 Reverse Stock Split became effective.
On April 9, 2025, we received a letter (the “April Letter”) from the Staff notifying us that we had demonstrated compliance with the Bid Price Rule and the Equity Rule as required by the Panel pursuant to the Decision Letter.
There is no assurance that we will maintain compliance with such minimum listing requirements if we regain compliance with all applicable requirements for continued listing on Nasdaq. If our Common Stock were delisted from Nasdaq, trading of our Common Stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our Common Stock on an over-the-counter market, and many investors would likely not buy or sell our Common Stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our Common Stock would be subject to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our Common Stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our Common Stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.
If Nasdaq deems the transactions relating to the Merger Agreement with EnVue Medical Holdings dated February 14, 2025 to be a “Change of Control” in violation of Listing Rule 5110(a), our Common Stock may be subject to delisting.
The Staff of Nasdaq have had discussions with the Company with respect to the Company’s Agreement and Plan of Merger (the “Merger Agreement”) with EnVue Medical Holdings, Corp (“EnVue”), dated February 14, 2025. Pursuant to the terms of the Merger Agreement, the Company issued 1,734,995 shares of Common Stock and 57,720 shares of Series X Non-Voting Convertible Preferred Stock with provisions for the preferred shares to convert into 57,720,000 shares of Common Stock subject to shareholder approval.
On April 4, 2025, Staff determined that the Company’s transition with EnVue, a non-Nasdaq entity, constitutes a business combination that will result in a “Change of Control” upon shareholder approval to convert the Series X Non-Voting Convertible Preferred Stock. Pursuant to Listing Rule 5110(a) (the “Rule”), the post-transaction entity will be required to satisfy all of Nasdaq’s initial listing criteria and to complete Nasdaq’s initial listing process, including the payment of all applicable fees, prior to the shareholder vote to approve the conversion of the Preferred Shares discussed below, or other material changes triggering a change of control.
The Company previously updated the Staff with respect to the Company’s operations following the closing of the Merger Agreement to clarify that the Company’s legacy NanoVibronix, Inc. business continued to operate in the same manner as prior to closing. Recently, the Staff has inquired again with respect to the Company’s operations, namely those of the legacy NanoVibronix, Inc. business, particularly in light of the Company’s financial results and operations, as well as changes in management and the members of the Board of Directors since the closing of the transactions contemplated by the Merger Agreement. As part of this inquiry, the Staff noted that it believed the Company’s transaction with EnVue constituted a “Change of Control” requiring the Company to meet the initial listing requirements of Nasdaq, with respect to which the Company has never satisfied since the closing of that transaction. The Staff, however, has provided the Company with the opportunity to rebut this determination. If the Staff conclusively determines that the transactions contemplated by the Merger Agreement constituted a “Change of Control” that otherwise violates the Rule, Nasdaq could immediately delist the Company’s Common Stock. If such a delisting determination were to occur, the Company’s Common Stock would be immediately suspended from trading on Nasdaq.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the six months ended June 30, 2026, the Company issued an aggregate of 7,600 shares of Series H Preferred Stock to Alpha upon exercises of the Additional Investment Right under the July 2025 Purchase Agreement, on January 5, 2026, January 31, 2026, March 24, 2026, April 28, 2026, May 28, 2026 and June 29, 2026, for aggregate gross proceeds of $7,600, of which 3,700 shares for gross proceeds of $3,700 were issued during the three months ended June 30, 2026. During the same period, Alpha converted $7,719 of stated value of Series H Preferred Stock, together with $602 of accrued dividends, into 6,049,233 shares of Common Stock, of which $2,917 of stated value and $151 of accrued dividends converted into 3,448,738 shares of Common Stock during the three months ended June 30, 2026. The shares of Series H Preferred Stock were issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder, and the shares of Common Stock issued upon conversion were issued in reliance on the exemption provided by Section 3(a)(9) of the Securities Act. Except as set forth above, there were no unregistered sales of equity securities during the quarter ended June 30, 2026 that were not previously 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
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Item 6. Exhibits
EXHIBIT INDEX
| * | Filed herewith. |
| ** | Furnished herewith. |
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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: August 17, 2026 | By: | /s/ Doron Besser |
| Name: | Doron Besser | |
| Title: | Chief Executive Officer | |
| Date: August 17, 2026 | /s/ Nicole Fernandez-McGovern | |
| Name: | Nicole Fernandez-McGovern | |
| Title: | Chief Financial Officer |
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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: August 17, 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: August 17, 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 June 30, 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: August 17, 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 June 30, 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: August 17, 2026 | ||
| By: | /s/ Nicole Fernandez-McGovern | |
| Nicole Fernandez-McGovern | ||
| Chief Financial Officer | ||
| (Principal Financial Officer) | ||