Business Context and Reporting Period
Company: Envue Medical, Inc. (formerly NanoVibronix, Inc.)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Reporting Date: April 15, 2026
Envue Medical operates through two primary segments: NanoVibronix (ultrasound-based pain therapy and biofilm prevention devices) and ENvue (electromagnetic navigation systems for enteral feeding tube placement). On February 14, 2025, the Company completed a merger with ENvue Medical Holdings LLC, acquiring its enteral feeding technology. The Company is a smaller reporting company listed on the Nasdaq Capital Market under the symbol "FEED."
Key Financial Metrics
| Metric | 2025 (in thousands) | 2024 (in thousands) |
|---|---|---|
| Revenues | $2,553 | $2,558 |
| Gross Profit | $153 | $1,508 |
| Gross Margin | 6% | 59% |
| Net Loss | $(18,185) | $(3,705) |
| Cash and Cash Equivalents (Year End) | $4,224 | $752 |
| Operating Cash Flow | $(9,372) | $(2,516) |
| Goodwill | $29,082 | $0 |
| Accumulated Deficit | $(90,481) | $(69,801) |
Material Changes vs. Prior Period
- Revenue Stability: Revenue remained flat at approximately $2.55 million, driven by a shift in product mix. NanoVibronix revenue (PainShield/UroShield) declined due to the removal of PainShield Ultra, partially offset by new revenue from the ENvue System.
- Gross Margin Compression: Gross margin collapsed from 59% to 6%. This was primarily due to inventory write-downs related to PainShield Ultra and significant amortization of intangible assets recognized from the ENvue merger recorded within Cost of Goods Sold.
- Impairment Charges: The Company recorded a non-cash impairment charge of $11.15 million ($10.5 million goodwill, $0.65 million intangible assets) related to the ENvue reporting unit, reflecting a decline in estimated fair value.
- Expense Increases:
- R&D: Increased 94% to $1.76 million due to patent activities and regulatory audits for the ENvue system.
- Selling & Marketing: Increased 246% to $2.49 million, driven by amortization of acquired intangibles and commercialization costs.
- G&A: Increased 121% to $7.63 million due to merger-related legal fees, litigation costs, and executive severance.
- Capital Structure: The Company raised approximately $19.1 million in net proceeds through various equity financings (Series G, Series H, and common stock offerings) during 2025 to fund operations and the merger.
Guidance, Outlook, and Risks
- Going Concern: Management has expressed substantial doubt about the Company's ability to continue as a going concern. With a cash balance of ~$4.2 million and negative operating cash flow of $9.4 million, the Company lacks sufficient resources to fund operations for the next 12 months without additional financing.
- Outlook: Future success depends on the commercial adoption of the ENvue System in U.S. hospitals and securing reimbursement for NanoVibronix products (PainShield/UroShield). The Company plans to fund operations through equity financings or strategic alliances.
- Key Risks:
- Liquidity: Immediate need for capital raises; failure to secure funding could force a reduction or cessation of operations.
- Legal Contingency: A confirmed arbitration award of approximately $2.25 million (including interest) is owed to Protrade Systems, Inc., following a court decision in March 2026 affirming the award.
- Geopolitical: Operations in Israel are subject to risks from regional conflicts, which could disrupt manufacturing and supply chains.
- Regulatory: PainShield reimbursement by CMS was denied in 2022; UroShield lacks FDA clearance in the U.S. The ENvue System requires continued market education and adoption.
- Internal Controls: The Company identified material weaknesses in internal controls over financial reporting, specifically regarding management review procedures and IT general controls.
Investor Verification Checklist
- Cash Runway: Verify the timeline and terms of any new financing agreements announced after the filing date to assess the ability to fund operations beyond the next 12 months.
- Protrade Liability: Confirm the status of the $2.25 million arbitration liability payment and any potential appeals or settlement discussions.
- ENvue Adoption: Monitor quarterly revenue reports for growth in the ENvue segment to validate the commercialization strategy and offset the decline in NanoVibronix revenue.
- Reimbursement Status: Track updates on CMS reimbursement applications for PainShield and FDA clearance progress for UroShield.
- Internal Controls: Review subsequent filings (10-Q) for progress in remediating the identified material weaknesses in internal controls over financial reporting.