Highest-materiality recent filing
enVVeno receives FDA IDE approval for pivotal study of non-surgical venous valve; $25M cash
FDA grants first-ever IDE for a U.S. pivotal study of a non-surgical replacement venous valve (enVVe System).
enVVeno Medical regains Nasdaq minimum bid price compliance; reports $28M cash at year-end
Received formal Nasdaq notice confirming compliance with minimum bid price rule; closing bid ≥ $1.00 for 10 consecutive business days Jan 20 - Feb 2, 2026, matter closed.
enVVeno stockholders reject 2025 equity plan; authorize reverse stock split
Elected Jenusaitis (3.47M for, 1.80M withheld) and Berman (4.73M for, 0.54M withheld) as Class II directors.
enVVeno loses FDA appeal for VenoValve PMA; shifts focus to enVVe device
Unfavorable FDA appeal upheld not-approvable letter for VenoValve (received Aug 19, 2025).
enVVeno Medical enters ATM offering agreement for up to $50M of common stock
Agreement with Ladenburg Thalmann allows sale of up to $50M of common stock from time to time.
enVVeno Medical receives Nasdaq bid-price deficiency notice; cure period to April 2026
Nasdaq notified enVVeno on Oct 7, 2025 that bid price closed below $1.00 for 30 consecutive business days.
enVVeno receives FDA not-approvable letter for VenoValve PMA
FDA issued not-approvable letter for VenoValve PMA, citing insufficient benefit-risk profile.
On May 19, 2025, the Board of Directors (the “ Board ”) of enVVeno Medical Corporation (the “ Company ”) appointed Jennifer Bright as Chief Financial Officer of the Company.
On May 19, 2025, Craig Glynn resigned as Chief Financial Officer of the Company.
Max materiality 0.95 · Median 0.65 · Most common event regulatory