Business Context and Reporting Period
This Form 8-K filing by Vivos Therapeutics, Inc. (VVOS) covers the period ending February 19, 2021, reporting on a material event that occurred on February 12, 2021. The Company, an emerging growth company incorporated in Delaware, operates in the healthcare sector focusing on sleep disordered breathing solutions.
Key Financial Metrics
This filing is a Current Report regarding a material definitive agreement and does not contain financial statements. Consequently, specific values for revenue, profit, cash flow, margins, debt, and liquidity are not provided in this document.
Material Changes and Agreements
On February 12, 2021, Vivos Therapeutics entered into a Licensing, Distribution, and Marketing Agreement with MyCardio, LLC. Key terms include:
- Product and Service: Vivos will distribute MyCardio's ring recorder devices and market the SleepImage System under the white-labeled brand "VivoScore TM, powered by SleepImage."
- Technology: The system utilizes FDA-cleared cardiopulmonary coupling (CPC) technology to diagnose and manage sleep disordered breathing (SDB) and obstructive sleep apnea (OSA).
- Exclusivity: The agreement is exclusive to Vivos for white-labeling in the Sleep Dentistry Market within the United States and Canada, subject to minimum performance requirements.
- Non-Exclusive Rights: Vivos may distribute products and market services to practitioners outside the Sleep Dentistry Market on a non-exclusive basis.
- Term: The initial term is two years with automatic one-year extensions, subject to termination rights for breach, bankruptcy, or change of control.
Outlook, Risks, and Management Commentary
Management intends to market the SleepImage System to licensed healthcare practitioners, including Vivos Integrated Practices (VIPs), and offer training for a fee. Independent dentists may eventually enroll as VIPs. MyCardio has agreed to refer practitioners in the Sleep Dentistry Market seeking training to Vivos. The filing notes that white-labeled use must clearly disclose the "Powered by SleepImage" branding and is subject to regulatory clearances in the territories.
Investor Verification Checklist
- Verify the specific minimum performance requirements attached to the exclusive rights in the Sleep Dentistry Market.
- Confirm the financial terms of the product purchase and training fees, which are not detailed in this filing.
- Review the press release filed as Exhibit 99.1 for additional strategic context.
- Monitor future filings for the impact of this agreement on revenue recognition and operating expenses.