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.
enVVeno Medical closes $15M public offering of common stock and pre-funded warrants
Gross proceeds of ~$15M from sale of 4,206,106 common shares and 79,609 pre-funded warrants at $3.50/$3.4999.
72% of SAVVE trial patients achieved ≥3-point rVCSS improvement at a weighted average of 11 months post-surgery.
97% of VenoValve study patients showed clinical improvement at six months measured by revised Venous Clinical Severity Score (rVCSS).
Preliminary device-related MAE rate 8% for fully enrolled 75-patient SAVVE trial; no deaths or pulmonary embolisms.
enVVeno raises $28M in PIPE financing with milestone-based warrants
Gross proceeds of $28M from sale of 3,844,704 shares, pre-funded warrants for 977,900 shares, and two tranches of warrants.
enVVeno expects 9 SAVVE trial sites active; shareholders approve director elections, plan amendments
Elected Dr. Francis Duhay and Dr. Sanjay Shrivastava as Class I directors for terms ending at 2024 annual meeting.
Hancock Jaffe to rename enVVeno Medical, focus on venous disease; VenoValve trial to start
Name change to enVVeno Medical Corporation, tickers NVNO/NVNW effective Oct 1, 2021.
Hancock Jaffe raises $20M in registered direct offering with Perceptive Advisors
Gross proceeds of $20M from sale of 781,615 shares at $7.872/share and pre-funded warrants for 1,759,035 shares at $0.0001 exercise.
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 0.60 · Most common event other_material