secwatch.observer — SEC 8-K summary
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Issuer:     VIVOS INC (RDGL)
CIK:        0001449349
Form:       8-K
Filed at:   2025-02-10T23:59:59+00:00
Accession:  0001493152-25-005623
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vivos reports positive initial RadioGel clinical trial results; plans expansion to 50 patients
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- First 5 patients showed safety; Y-90 remained at injection site with no adverse events.
- One patient (cancerous node near trachea) showed over 80% reduction in tumor size and metastatic activity.
- Lead investigator to request Ethics Committee approval to expand trial from 30 to 50 patients.
- New deep-injection CT-guided device targets deeper tumors (lung, pancreatic); initial trial by June 30, expanded by year-end.
- Data to be published and shared with FDA to support IDE submission for expanded U.S. indications.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1449349/000149315225005623/0001493152-25-005623-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1449349/000149315225005623/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-005623

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer