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Envveno Medical Corporation SEC Filings

NVNO NASDAQ

Welcome to our dedicated page for Envveno Medical Corporation SEC filings (Ticker: NVNO), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

Tracking the FDA journey of a novel venous valve is challenging—especially when enVVeno Medical Corporation’s pivotal trial data, PMA module responses, and financing details are scattered across dense SEC filings. If you have ever asked, “Where can I find the latest enVVeno Medical insider trading Form 4 transactions or the newest 8-K material events explained?� this page solves that problem.

Stock Titan’s AI reads every submission the moment it hits EDGAR, then serves plain-English answers. Need the enVVeno Medical quarterly earnings report 10-Q filing without wading through accounting jargon? Our summaries highlight cash burn, R&D spend, and trial milestones. Wondering whether management is buying shares? AGÕæÈ˹ٷ½-time alerts surface enVVeno Medical Form 4 insider transactions alongside context so you can gauge executive conviction.

All core documents are here and continuously updated:

  • 10-K annual report—get the enVVeno Medical annual report 10-K simplified to understand long-term strategy and regulatory timelines.
  • 10-Q quarterly updates—compare enrollment progress with last quarter in seconds.
  • 8-K releases—see FDA feedback or financing announcements the moment they post.
  • DEF 14A proxy—explore enVVeno Medical proxy statement executive compensation details.
  • Form 4—track enVVeno Medical executive stock transactions Form 4 in real time.

From “understanding enVVeno Medical SEC documents with AI� to detailed enVVeno Medical earnings report filing analysis, our platform turns complex disclosures into actionable insight so you can focus on decisions—not document hunts.

Rhea-AI Summary

enVVeno Medical (NVNO) remains pre-revenue but is progressing its venous-valve pipeline while absorbing higher operating costs. In Q2-25 the company reported a net loss of $6.7 m (-0.33/sh), 35 % wider than Q2-24, driven by a 58 % jump in SG&A to $4.2 m (severance, stock comp and a $0.6 m reserve for prepaid clinical costs). R&D spend held essentially flat at $2.9 m.

Cash, cash equivalents and short-term Treasuries fell to $35.1 m from $43.2 m at YE-24; operating cash burn was $7.7 m for the first half. Working capital totals $32.6 m and management believes liquidity is adequate for �12 months, but it forecasts quarterly burn to rise to $5-7 m as trials advance.

  • Pipeline: VenoValve PMA filing completed Nov-24 and is under FDA breakthrough-priority review; decision expected 2H-25.
  • Interim two-year data (n=42) show 83 % of pivotal-trial patients retain â‰�3-point rVCSS improvement, 74 % median pain reduction and 100 % valve patency (n=30).
  • enVVe transcatheter valve finished GLP study; IDE submission targeted Q3-25.
  • 19.2 m shares outstanding after exercising 1.7 m pre-funded warrants.

Key takeaways: Clinical results and regulatory momentum are constructive, but losses, cash draw and the absence of revenue keep financing risk on the table.

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FAQ

What is the current stock price of Envveno Medical Corporation (NVNO)?

The current stock price of Envveno Medical Corporation (NVNO) is $4.84 as of August 4, 2025.

What is the market cap of Envveno Medical Corporation (NVNO)?

The market cap of Envveno Medical Corporation (NVNO) is approximately 85.4M.

What is the primary focus of enVVeno Medical Corporation?

enVVeno Medical Corporation specializes in developing innovative bioprosthetic solutions to treat venous disease, particularly severe chronic venous insufficiency (CVI). Their approach focuses on replacing dysfunctional venous valves with novel surgical and transcatheter-based devices.

What are the company’s lead products?

The company’s lead products are the VenoValve, a surgical replacement venous valve, and enVVe, a non-surgical, transcatheter-based venous valve. Both are engineered to restore one-way blood flow and improve clinical outcomes for patients with deep venous CVI.

How does enVVeno generate value through its product development?

enVVeno enhances value through diligent clinical trials, regulatory approvals, and robust data collection that demonstrates the efficacy and safety of its devices. This rigorous approach supports its strategy to address a significant unmet need in venous disease treatment.

What is the current regulatory status of enVVeno's products?

The VenoValve is under a modular PMA application process with the FDA, with several modules already approved. enVVe is progressing through pre-clinical GLP studies as a precursor to filing for IDE approval to initiate its pivotal trial.

How do the VenoValve and enVVe devices function?

Both devices are designed to replicate the one-way mechanism of venous valves, ensuring proper blood flow from the lower extremities back to the heart and lungs. The VenoValve is implanted surgically, while enVVe is designed for a less invasive, catheter-based delivery.

What differentiates enVVeno Medical from its competitors?

enVVeno Medical differentiates itself through its specialized focus on bioprosthetic solutions for venous disease, a robust clinical development pathway, and a strategic modular approach to the FDA approval process. This combination of focused innovation and regulatory rigor positions the company uniquely in the medical device landscape.
Envveno Medical Corporation

NASDAQ:NVNO

NVNO Rankings

NVNO Stock Data

85.40M
17.35M
0.92%
21.34%
2.64%
Medical Devices
Surgical & Medical Instruments & Apparatus
United States
IRVINE