secwatch.observer — SEC 8-K summary
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Issuer:     Vivos Therapeutics, Inc. (VVOS)
CIK:        0001716166
Form:       8-K
Filed at:   2024-09-18T23:59:59+00:00
Accession:  0001493152-24-036942
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vivos Therapeutics receives first FDA 510(k) clearance for oral device to treat pediatric OSA
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- FDA cleared Vivos' DNA appliance to treat moderate to severe OSA and snoring in children aged 6–17.
- Up to 10.1 million U.S. children estimated to suffer from pediatric OSA; current standard is adenotonsillectomy.
- Clinical study (n=48) showed 62.7% improvement in AHI, 58% snoring reduction, no safety concerns.
- Company plans to leverage clearance via new marketing & distribution alliances with medical sleep providers.
- Believed to be first-ever FDA clearance of an oral medical device for pediatric OSA treatment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/0001493152-24-036942-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-036942

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