secwatch.observer — SEC 8-K summary
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Issuer:     enVVeno Medical Corp (NVNO)
CIK:        0001661053
Form:       8-K
Filed at:   2024-04-24T23:59:59+00:00
Accession:  0001493152-24-015752
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enVVeno: 72% of VenoValve patients show clinically meaningful benefit; FDA filing on track for Q4 2024
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- 72% of SAVVE trial patients achieved ≥3-point rVCSS improvement at a weighted average of 11 months post-surgery.
- Overall average rVCSS improvement of 8.46 points for meaningful-benefit cohort; 9.29 points at two-year milestone.
- 94% of patients showed clinical improvement (≥1 point rVCSS) at a weighted average of 11 months post-implant.
- Company expects to complete one-year data collection by September 2024 and file PMA for FDA approval in Q4 2024.
- Cash and investments of $46.4M at Dec 31, 2023 expected to fund operations through FDA decision and end of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/0001493152-24-015752-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-015752

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