---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-025735"
form_type: "8-K"
ticker: "RDGL"
cik: "0001449349"
company_name: "VIVOS INC"
filed_at: "2024-07-01T23:59:59+00:00"
generated_at: "2026-05-31T23:58:28.589866+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Vivos files IDE amendment with FDA to initiate human trials of Radiogel therapy

## Summary
- Filed IDE amendment with FDA for Radiogel™ Precision Radionuclide Therapy, addressing 63 prior FDA comments.
- Submission includes genotoxicity and retention study reports; builds on FDA Breakthrough Device Designation.
- Plans to submit to Mayo Clinic IRB for first-in-human trial targeting solid metastatic tumors in papillary thyroid cancer.
- Previous IDE (Q211938/S001) commented by 12 FDA reviewers; company prepared to address further questions promptly.

## SEC filing metadata
- accession: 0001493152-24-025735
- form_type: 8-K
- ticker: RDGL
- cik: 0001449349
- company_name: VIVOS INC
- filed_at: 2024-07-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1449349/000149315224025735/0001493152-24-025735-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1449349/000149315224025735/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-025735
- JSON: https://secwatch.observer/filing/0001493152-24-025735.json
- Plain text: https://secwatch.observer/filing/0001493152-24-025735.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.