ADDED
1 ITEM 1: BUSINESS 1 ITEM 1A: RISK FACTORS 41 ITEM 1B: UNRESOLVED STAFF COMMENTS 75 ITEM 1C: CYBERSECURITY 75 ITEM 2: PROPERTIES 76 ITEM 3: LEGAL PROCEEDINGS 77 ITEM 4: MINE SAFETY DISCLOSURES 78 PART II.
91 ITEM 10: DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 91 ITEM 11: EXECUTIVE COMPENSATION 97 ITEM 12: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 111 ITEM 13: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 112 ITEM 14: PRINCIPAL ACCOUNTANT FEES AND SERVICES 113 PART IV.
(the Company ), formerly known as NanoVibronix, Inc., was incorporated as a Delaware corporation in October 2003.
In December 2025, the Company changed its name from NanoVibronix, Inc.
Prior to such a name change, on February 14, 2025, the Company consummated and completed its merger (the Merger ) pursuant to the Agreement and Plan of Merger, dated as of February 14, 2025 (the Merger Agreement ), as further described herein.
Following the consummation of the Merger, the Company conducts its operations through two wholly-owned subsidiaries: (i) NanoVibronix Ltd.
( Nano OpCo ), a private company incorporated under the laws of the State of Israel, which focuses on non-invasive, biological response-activating medical devices targeting biofilm prevention and pain therapy, designed for home use without the need for medical professional assistance; and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company, which is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral feeding, currently in the initial growth stage of commercialization.
Further descriptions of each business division, their respective products, and business models are set forth below.
The Merger Agreement On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger (as amended, restated, amended and restated, supplemented or modified from time to time, the Merger Agreement ), dated as of February 14, 2025, by and among us, 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 or ENvue ), the Company and Predecessor ENvue effected (i) a merger of First Merger Sub with and into Predecessor ENvue, with the First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned subsidiary the Company (the First Merger , and effective time of such First Merger, the First Effective Time ) and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the Second Merger and, together with the First Merger, the Merger ), with Second Merger Sub being the surviving entity of the Second Merger ( Surviving Entity ).
REMOVED
1 ITEM 1: BUSINESS 1 ITEM 1A: RISK FACTORS 62 ITEM 1B: UNRESOLVED STAFF COMMENTS 108 ITEM 1C: CYBERSECURITY 108 ITEM 2: PROPERTIES 109 ITEM 3: LEGAL PROCEEDINGS 110 ITEM 4: MINE SAFETY DISCLOSURES 110 PART II.
125 ITEM 10: DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 125 ITEM 11: EXECUTIVE COMPENSATION 133 ITEM 12: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 148 ITEM 13: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 149 ITEM 14: PRINCIPAL ACCOUNTANT FEES AND SERVICES 150 PART IV.
(the Company ) NVEH Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of NVEH Merger Sub I, Inc.
Except as otherwise expressly provided herein, the information in this Annual Report on Form 10-K does not reflect the consummation of the Merger which, as discussed above, occurred subsequent to the period covered hereunder.
BUSINESS Overview We were organized as a Delaware corporation in October 2003.
On February 14, 2025, we consummated and completed the Merger pursuant to the Merger Agreement, as further described below.
Following the consummation of the Merger, NanoVibronix will conduct 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, Predecesor ENvue ).
Nano OpCo focuses on non-invasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals.
ENvue is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral feeding and are in the initial stage of commercializing our products.
The descriptions of the two business divisions, their corresponding products, and business models are detailed below.