secwatch.observer — SEC 8-K summary
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Issuer:     enVVeno Medical Corp (NVNO)
CIK:        0001661053
Form:       8-K
Filed at:   2024-03-06T23:59:59+00:00
Accession:  0001493152-24-008950
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enVVeno Medical Reports Positive VenoValve Pivotal Trial Data; 97% of Patients Show Clinical Improvement at Six Months
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- 97% of VenoValve study patients showed clinical improvement at six months measured by revised Venous Clinical Severity Score (rVCSS).
- 74% of patients achieved clinically meaningful benefit (rVCSS improvement of 3 or more points).
- Average rVCSS improvement per patient was 8 points, over 2.5 times the threshold for clinically meaningful benefit.
- Company on track to file VenoValve FDA approval application (PMA) in Q4 2024.
- Data presented at 2024 American Venous Forum Annual Meeting in Tampa, Florida on March 6, 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1661053/000149315224008950/0001493152-24-008950-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1661053/000149315224008950/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-008950

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