secwatch.observer — SEC 8-K summary
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Issuer:     enVVeno Medical Corp (NVNO)
CIK:        0001661053
Form:       8-K
Filed at:   2023-11-16T23:59:59+00:00
Accession:  0001493152-23-041594
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enVVeno Medical reports positive preliminary safety data from VenoValve pivotal trial; 8% MAE rate, no deaths or PEs
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- Preliminary device-related MAE rate 8% for fully enrolled 75-patient SAVVE trial; no deaths or pulmonary embolisms.
- Six DVTs occurred; three adjudicated as device-related mild, three pending, expected similar results.
- Higher-than-expected procedure-related bleeding in contiguous sub-group, all moderate, attributed to anticoagulation.
- Company expects to present topline efficacy data in Q2 2024 and file PMA application in Q4 2024.
- enVVeno also developing enVVe transcatheter valve; pivotal trial expected to begin Q4 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1661053/000149315223041594/0001493152-23-041594-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1661053/000149315223041594/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-041594

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