ENvue Medical, Inc.

Current report

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.

Current report

There were no unregistered sales of equity securities during the quarter ended March 31, 2026, other than as reported in our Current Reports on Form 8-K filed with the SEC.

Previous report

The following description of risk factors includes any material changes to, and supersedes the description of, the risk factors addressed below associated with our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC on March 31, 2025. Our business, financial condition, and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results, and stock price.

Previous report

Risks Related to our Series H Preferred Stock

Previous report

The Series H Certificate of Designations provides for the payment of cumulative dividends in shares of our common stock which will require us to have shares of common stock available to pay the dividends.

Previous report

Each share of the Series H Preferred Stock is entitled to receive cumulative dividends at the rate per share of 9% per annum (as a percentage of the Stated Value per share), payable on each conversion date (with respect to only the shares of Series H Preferred Stock being converted), in duly authorized, validly issued, fully paid and non-assessable shares of common stock at the conversion price then on effect in accordance with the terms of the Series H Certificate of Designations. As such, we may rely on having available shares of common stock to pay such dividends, which will result in dilution to our shareholders. If we do not have such available shares, we may not be able to satisfy our obligations as related to these dividends pursuant to the terms of the Series H Certificate of Designations.

Previous report

The Series H Certificate of Designations contains certain anti-dilution provisions, which may dilute the interests of our stockholders, depress the price of our common stock, and make it difficult for us to raise additional capital.

Previous report

Certain events, for example, a Dilutive Issuance (as defined in the Series H Certificate of Designations) may reduce the conversion price of the Series H Preferred Stock, which in turn may lead to further dilution to the holders of our common stock. In addition, the perceived risk of dilution may cause our shareholders to be more inclined to sell their common stock, which may in turn depress the price of common shares regardless of our business performance. We may also find it more difficult to raise additional equity capital while any of the shares of Series H Preferred Stock and the Series H Warrants remain outstanding.

Previous report

Under the Series H Purchase Agreement, we are subject to certain restrictive covenants that may make it difficult to procure additional financing.

Previous report

The Series H Purchase Agreement contains, among others, the following restrictive covenants: (A) from the date of the Series H Purchase Agreement until 90 days after the Stockholder Approval Date (as defined in the Series H Purchase Agreement), we shall not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or common stock equivalents or (ii) file any registration statement or any amendment or supplement thereto, in each case other than as contemplated pursuant to the Series H Purchase Agreement and (B) until the one year anniversary of the date of the Series H Initial Closing, we shall be prohibited from entering into any variable rate transactions, subject to certain exceptions.

Previous report

If we require additional funding while these restrictive covenants remain in effect, we may be unable to effect a financing transaction on terms acceptable to us, or at all, while also remaining in compliance with the terms of the Series H Purchase Agreement, or we may be forced to seek a waiver from the investor party to the Series H Purchase Agreement, which such investor is not obligated to grant to us.

Previous report

Additionally, the Series H Purchase Agreement requires us to hold a meeting of our stockholders at the earliest practicable date to seek the Stockholder Approval and to hold a meeting every four months thereafter to seek the Stockholder Approval if such approval is not obtained at the initial meeting until the earlier of the date the Stockholder Approval is obtained or the Series H Preferred Stock is no longer outstanding, which may be time consuming and costly.

Previous report

Risks Related to our Prior Independent Registered Public Accounting Firm

Previous report

We may incur material expenses or delays in financings or SEC filings due to the dismissal of our prior independent registered public accounting firm, Zwick CPA, PLLC, and our stock price and access to the capital markets may be affected.

Previous report

As a public company, we are required to file financial statements with the SEC that are audited or reviewed, as applicable, by an independent registered public accounting firm. In August 2025, following discussions with Zwick CPA, PLLC (“Zwick”) regarding potential proceedings that could be instituted against them, which may result in their suspension or bar from appearing or practicing before the SEC as an independent registered public accounting firm, we were notified by Zwick that they could no longer continue to serve as our independent registered public accounting firm for purposes of providing audited financial statements in compliance with SEC rules. Our access to the capital markets, and our ability to make timely SEC filings, has depended in the past and will continue to depend on having financial statements audited or reviewed by an independent registered public accounting firm.

Previous report

As of the date of this prospectus, no formal proceedings have been brought against Zwick. We understand that any such proceedings are not expected to question the services previously provided by Zwick to the company. However, if proceedings are initiated and actions are taken against Zwick, we anticipate that the PCAOB may determine that investors cannot rely on Zwick’s audit reports or the financial statements audited by Zwick for the years ended December 31, 2024, and 2023, or on Zwick to provide customary deliverables such as consents or comfort letters in connection with financings or other transactions. While a revocation of Zwick’s registration would not, in and of itself, affect the validity of Zwick’s previously issued audit reports, the absence of their consent could require us to have our financial statements for prior years re-audited by our current independent registered public accounting firm. This could result in significant delays, additional costs, and other complications in connection with financings or other transactions. Any delay in or inability to access the public capital markets could disrupt our operations and adversely affect the price and liquidity of our securities.

Previous report

In addition, any negative developments concerning potential proceedings against Zwick may adversely affect investor confidence in companies that were previously audited by Zwick. These factors could materially and adversely affect the market price of our common stock and our ability to access the capital markets.

Previous report

On October 30, 2025, the Second Closing of the July 2025 Private Placement was consummated. In the Second Closing, an aggregate of 2,222 shares of Series H Preferred Stock and warrants to purchase up to 116,960 shares of common stock at an exercise price of $22.50 per share were issued for aggregate gross proceeds of $2.2 million, prior to deducting fees and offering expenses payable by the Company.