ENvue Medical, Inc.

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.

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.

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.

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.