DEFA14A: Vivos Therapeutics Seeks Stockholder Support After Securing FDA Clearances and Capital

Vivos Therapeutics urges stockholders to vote in favor of proposals at the upcoming annual meeting after a year of regulatory approvals, revenue enhancement efforts, and balance sheet improvements.

Summary

• Vivos Therapeutics is seeking stockholder support at its 2024 Annual Meeting.
• The company highlights progress in regulatory approvals, revenue prospects, and balance sheet strength.
• A provider alliance marketing and distribution model in Colorado shows promising patient conversion rates, expected to boost revenues.
• Vivos received FDA clearances for its CARE oral medical devices, including the first for severe OSA in adults and another for snoring and moderate to severe OSA in children.
• Certain Vivos CARE devices are now Medicare eligible, and new CPT medical codes from the American Medical Association will be effective January 1, 2025.
• The company secured $11.8 million in new investor capital, extending its cash runway.
• Vivos has achieved eight consecutive quarters of operating cost reductions.
• Stockholders are urged to vote FOR the election of directors, approval of the 2024 Omnibus Equity Incentive Plan, and ratification of auditors.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to the FDA clearances, capital raise, cost reductions, and promising results from the provider alliance model. The focus on stockholder value and future growth contributes to the optimistic outlook.

Positives

• The provider alliance model in Colorado is showing positive results with patient conversion rates meeting forecasts.
• FDA clearances for CARE devices expand the company's market reach and treatment capabilities.
• Medicare eligibility and new CPT codes enhance reimbursement opportunities for Vivos CARE devices.
• The $11.8 million in new capital strengthens the balance sheet and extends the cash runway.
• Consistent operating cost reductions demonstrate improved financial discipline.

Future Outlook

Vivos expects the Colorado provider alliance model to significantly impact revenues over the next year as it expands to additional locations and seeks to fulfill its mission and drive value for investors.

Management Comments

• R. Kirk Huntsman, Chairman and CEO: 'I am pleased to report the progress we have made over the past 12 months to expand our regulatory approvals, enhance our prospects for top line revenue, and bolster our balance sheet.'
• R. Kirk Huntsman, Chairman and CEO: 'We believe more than ever that Vivos has the right vision to address the national crisis of sleep apnea and related conditions arising from certain dentofacial abnormalities.'
• R. Kirk Huntsman, Chairman and CEO: 'I wish to thank all of our stockholders for your continued support and look forward to the remainder of 2024 and beyond as we seek to fulfill our mission and drive value for our investors.'

Industry Context

The announcement highlights Vivos Therapeutics' efforts to address the sleep apnea market, a growing concern, with innovative oral medical devices and strategic partnerships. The company's focus on regulatory approvals and reimbursement pathways aligns with industry trends towards value-based healthcare.

Stakeholder Impact

• Shareholders: The company aims to drive value for investors through its strategic initiatives.
• Patients: FDA-cleared devices offer new treatment options for sleep apnea and related conditions.
• Providers: The provider alliance model creates opportunities for collaboration and revenue generation.

Next Steps

• Stockholders are urged to vote on the proposals outlined in the proxy statement.
• Vivos plans to extend the provider alliance model to two additional locations.
• The company will continue to push toward becoming cash flow positive.
• Vivos will seek to fulfill its mission and drive value for its investors.

Key Dates

Keywords

Vivos Therapeutics, Annual Meeting, Proxy Statement, FDA Clearance, OSA, Equity Incentive Plan, Medicare, CPT Codes, Capital Raise, Operating Costs