secwatch.observer — SEC 8-K summary
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Issuer:     VIVOS INC (RDGL)
CIK:        0001449349
Form:       8-K
Filed at:   2024-07-01T23:59:59+00:00
Accession:  0001493152-24-025735
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1449349/000149315224025735/0001493152-24-025735-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1449349/000149315224025735/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-025735

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