StockTitan

@stocktitan.net

1 week ago

No replacement vein valves are approved. enVVeno is pushing one toward a 2026 trial $28.2M in cash and investments gives enVVeno runway into mid-2027 as it completes FDA trial planning for a device aimed at 3.5M U.S. patients.

#NVNO enVVeno Medical Reports Full Year 2025 Financial Results and Highlights Strategic Advancement of enVVe(R) System

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StockTitan

@stocktitan.net

2 months ago

enVVeno Medical Announces Reverse Stock Split enVVeno Medical (NASDAQ:NVNO) announced a reverse stock split at a 1-for-35 ratio, effective 12:01 a.m. ET on January 20, 2026. Post-split trading on The Nasdaq Capital Market under the existing symbol NVNO will begin on January 20, 2026, and the company will use a new CUSIP 29415J205.Shareholders approved the Reverse Stock Split at the annual meeting on December 11, 2025. The split will combine every 35 pre-split shares into one post-split share, reducing outstanding common stock from approximately 22.9 million to approximately 655 thousand. No fractional shares will be issued; cash will be paid in lieu of fractions. Equity awards and warrants will be adjusted accordingly.

#NVNO enVVeno Medical Announces Reverse Stock Split

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StockTitan

@stocktitan.net

4 months ago

#NVNO enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve

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StockTitan

@stocktitan.net

5 months ago

enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update - Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study- Cash burn of $4.2 million in Q3 remains in line with projected quarterly range- Ongoing engagement with FDA for supervisory appeal of the VenoValve

#NVNO enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

@stocktitan.net

6 months ago

Novel Venous Valve Device for 3.5M CVI Patients: enVVeno Challenges FDA Decision on VenoValve Medical device maker enVVeno to appeal FDA's not-approvable letter for VenoValve, a first-in-class treatment for severe chronic venous insufficiency affecting 2.5-3.5M US patients. Decision expected by 2025 end.

#NVNO enVVeno Medical Updates Regulatory Status of VenoValve(R)

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Small Cap Strategist

@smcapstrategist.bsky.social

6 months ago

Small-cap stock registering bullish MACD crossovers, Wed Sept 10th - #GLXG #SEER #QTTB #OBLG #NVNO #MAXN #LMFA #STRF #MIMI #HUHU #JUNS #AISP #BTBT #CAN - More: crystalequityresearch.com/trade-alerts... - #smallcap

Small Cap Strategist

@smcapstrategist.bsky.social

7 months ago

Small-cap stocks with declining money flow, Wed Aug 20th - #UPLD #TACO #SAVA #OSPN #NVNO #MCRI #LNSR #KIDS #JAMF #IRBT #RELI #ZSPC #VLN #WBH #YEXT #AXGN #BXFD #CRIS #DYAI #EXFY #FCEL #GGR #UMA #TFIN #SSTK - More: crystalequityresearch.com/leading-indi... - #smallcap

Market Wire News

@marketwirenews.com

7 months ago

News; ( NASDAQ: #NVNO ) PRISM Mid-Day Movers: FDA Setbacks and Convertible Note Pressure

StockTitan

@stocktitan.net

7 months ago

FDA Rejects First-Ever Surgical Venous Valve Treatment: enVVeno's VenoValve Hits Regulatory Roadblock FDA cites insufficient efficacy data and safety concerns for VenoValve in treating chronic venous insufficiency. Device targeted 2.5-3.5M US patients with severe CVI. Company exploring resubmission options.

#NVNO enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)

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StockTitan

@stocktitan.net

8 months ago

Trump's CVI Diagnosis Could Make This Medical Device Company's FDA Decision More Significant enVVeno's VenoValve targets 2.5M US patients with chronic venous insufficiency. FDA decision expected H2'2025 could reshape CVI treatment landscape. Learn more.

#NVNO enVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company

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StockTitan

@stocktitan.net

8 months ago

enVVeno Medical Reveals Strong $35M Cash Position, Gears Up for Critical FDA Decision on VenoValve enVVeno reports $35.1M cash runway through Q3'2026, awaits FDA decision on VenoValve. Latest clinical progress and Trump CVI coverage boost visibility. Get details.

#NVNO enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

@stocktitan.net

8 months ago

Inside enVVeno Medical: CEO Shares Breakthrough Vision for Deep Venous Disease Treatment Revolution Watch enVVeno Medical CEO's exclusive deep dive into company strategy and groundbreaking venous disease treatments. Access full presentation now.

#NVNO enVVeno Medical Participates in the Virtual Investor "What’s Your Story" Summer Spotlight On-Demand Conference

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PRISM MarketView

@prismmarketview.bsky.social

9 months ago

Mid-day Movers Alert
Consumer products and healthcare stocks are taking center stage today, driving momentum in the markets. Investors are watching closely as key players gain traction in both sectors.
#BYRN #NVNO
prismmarketview.com/prism-mid-da...

PRISM MarketView

@prismmarketview.bsky.social

9 months ago

enVVeno Medical Shares Positive Interim Results from VenoValve Pivotal Study enVVeno Medical Corporation (NVNO), a medical device company focused on treating deep venous disease, reported encouraging two-year interim data from its pivota

#NVNO has announced positive interim results from its pivotal VenoValve® study, showcasing significant improvements for patients with chronic venous insufficiency. A promising step forward in vascular health innovation.
#enVVenoMedical
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StockTitan

@stocktitan.net

9 months ago

Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting enVVeno Medical (NVNO) reported positive interim 2-year data from its VenoValve pivotal trial, showing sustained clinical improvements in patients with severe deep venous CVI. Key findings include: 83.3% of subjects maintained clinically meaningful benefit with 3+ point improvement in rVCSS, 9.1 point average rVCSS improvement in responder cohort, and 74% median improvement in leg pain. The trial also demonstrated 60% complete healing of ulcers, with 100% valve patency rate among 30 subjects. The VenoValve, a potential first-in-class surgical replacement venous valve, targets approximately 2.5 million potential new U.S. patients annually. The company has submitted a PMA application to the FDA, with a decision expected in H2 2025.

#NVNO Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting

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StockTitan

@stocktitan.net

10 months ago

Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery enVVeno Medical (NASDAQ:NVNO) has published promising three-year data from its first-in-human VenoValve® trial in the Annals of Vascular Surgery. The VenoValve, a surgical replacement venous valve for severe deep venous CVI, demonstrated continued safety and effectiveness after three years of implantation. Key findings from the study of 11 subjects include:- 79% primary patency rate at three years- 7-point improvement in Venous Clinical Severity Score- 84% reduction in pain on the Visual Analog ScaleThe company estimates 2.5 million potential new U.S. patients annually could benefit from VenoValve. A PMA application has been submitted to the FDA, with a decision expected in H2 2025.

#NVNO Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

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StockTitan

@stocktitan.net

1 year ago

enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25 enVVeno Medical (NASDAQ:NVNO) has reported its Q4 and full-year 2024 financial results, highlighting progress towards VenoValve FDA approval expected in H2 2025. The company ended 2024 with $43.2 million in cash and investments, sufficient to fund operations through VenoValve approval and enVVe pivotal trial initiation.Key financial metrics include a Q4 cash burn of $5.2 million, with projected increases to $5-7 million per quarter in 2025. Net losses decreased 7% to $21.8 million in 2024 from $23.5 million in 2023.Clinical highlights for VenoValve show strong two-year follow-up data with 78% of subjects maintaining significant clinical benefits, including 75% pain reduction. The SAVVE trial demonstrated 85% of patients experiencing meaningful improvement at one year. For enVVe, the company is on track for IDE application submission by mid-2025, pending GLP study completion in Q1 2025.

#NVNO enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25

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StockTitan

@stocktitan.net

1 year ago

Can These 5 Growth Drivers Make enVVeno Medical the Next Big Thing in Venous Disease Treatment? CEO outlines key investment catalysts and strategic vision for 2025, highlighting growth opportunities in venous disease treatment technology

#NVNO enVVeno Medical Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference

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StockTitan

@stocktitan.net

1 year ago

VenoValve Clinical Trial Hits Home Run: 100% Patency Rate Stuns Medical Community Revolutionary venous disease treatment maintains 78% success rate and 75% pain reduction after 2 years, as enVVeno awaits important FDA verdict in 2025.

#NVNO Interim Two-Year Follow-Up Data from the VenoValve(R) U.S. Pivotal Trial to be Presented Today at the VESS 2025 Annual Winter Meeting

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StockTitan

@stocktitan.net

1 year ago

enVVeno Medical Completes Key Pre-Clinical Study for Revolutionary Venous Valve, Advances FDA Approval Path enVVeno Medical hits milestone in venous valve development with successful pre-clinical study completion, while advancing FDA approval for VenoValve targeting 2.5M patients.

#NVNO enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe

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StockTitan

@stocktitan.net

1 year ago

#NVNO enVVeno Medical Highlights Successful 2024 VEITH Symposium with Launch of Recap Website

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StockTitan

@stocktitan.net

1 year ago

#NVNO enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium

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Market Wire News

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1 year ago

BREAKING NEWS: ( NASDAQ: #NVNO ) enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

#StockMarket #News

StockTitan

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1 year ago

#NVNO enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

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Market Wire News

@marketwirenews.com

1 year ago

News; ( NASDAQ: #NVNO ) enVVeno Medical Provides Update on FDA Premarket Approval Application Status for VenoValve(R)

#StockMarket #News