NanoVibronix Reports $3.7 Million Net Loss and 12% Revenue Growth for Fiscal Year 2024

NanoVibronix, Inc. (NAOV) reported a net loss of approximately $3.7 million for the fiscal year ended December 31, 2024, compared to a net loss of $3.7 million in 2023. Revenue increased by approximately 12% to $2.5 million in 2024 from $2.3 million in 2023, driven by increased sales to Veteran Administration facilities and through workers' compensation programs. However, gross profit decreased by 2% to $1.5 million, primarily due to a reduction in the wholesale sales price for certain customer segments. The company's accumulated deficit stood at approximately $70 million as of December 31, 2024.

Significant changes during the period included a 1-for-11 reverse stock split effective March 13, 2025, and a merger with ENvue Medical Holdings, Corp. completed on February 14, 2025. The merger resulted in the issuance of 1,734,995 shares of common stock and 57,720 shares of Series X Non-Voting Convertible Preferred Stock to ENvue stockholders. Post-merger, ENvue stockholders own approximately 85% of the combined company's outstanding equity (assuming conversion of Series X Preferred Stock), while NanoVibronix stockholders own approximately 15%. The company also completed a debenture financing, raising $1.3 million.

Operational developments included the launch of a month-to-month rental program for PainShield in March 2023 and the termination of a licensing agreement with Sanuwave Health, Inc. for WoundShield in September 2024. NanoVibronix has 15 full-time employees, while ENvue has 16. The company's largest customer in 2024 was Ultra Pain Products Inc., accounting for approximately 31% of total revenue. Distribution agreements are in place in the United States, United Kingdom, Europe, Australia, New Zealand, and Malta. The company is pursuing FDA approval for several products, including UroShield and PainShield Relief (an over-the-counter version of PainShield).

The company's financial statements were prepared on a going concern basis, but management expressed substantial doubt about its ability to continue as a going concern due to insufficient resources to fund operations for the next twelve months. Key risks identified in the filing include the company's history of losses, dependence on additional capital raising, potential product liability claims, the uncertain success of clinical trials, and the impact of healthcare reform and geopolitical instability. The company's outlook is contingent upon successful product commercialization, securing adequate reimbursement, and obtaining necessary regulatory approvals. The ongoing appeal of an arbitration award to Protrade Systems, Inc. for $1.5 million remains unresolved.