enVVeno Medical (NVNO)
NASDAQ:NVNO
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enVVeno Medical
(NASDAQ:NVNO)
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Rating:46Neutral
Price Target:
$11.00
▲(2955.56% Upside)
Action:Reiterated
Date:05/09/26
The score is held down primarily by weak financial performance (no revenue, sustained losses, and material cash burn) and bearish technicals (below major moving averages with negative MACD and weak RSI). A positive offset is the FDA IDE approval and stated cash runway into Q3 2027, but it does not outweigh current fundamentals and price trend.
Positive Factors
Regulatory Milestone (IDE Approval)
IDE approval creates a durable regulatory pathway to generate pivotal clinical data in the U.S. The two-stage TAVVE trial (10-patient safety cohort then 220-patient randomized phase) de-risks long-term commercialization prospects and enables a potential PMA route for an unmet-market therapy.
Negative Factors
Pre-revenue Status
Being pre-revenue is a foundational limitation: the business lacks recurring commercial cash flows and remains fully dependent on successful trials and future approvals to monetize the technology. This structural dependency extends funding risk and execution uncertainty over multiple quarters.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory Milestone (IDE Approval)
IDE approval creates a durable regulatory pathway to generate pivotal clinical data in the U.S. The two-stage TAVVE trial (10-patient safety cohort then 220-patient randomized phase) de-risks long-term commercialization prospects and enables a potential PMA route for an unmet-market therapy.
Read all positive factors
enVVeno Medical (NVNO) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$6.68M
Dividend YieldN/A
Average Volume (3M)589.93K
Price to Earnings (P/E)―
Beta (1Y)1.76
Revenue GrowthN/A
EPS Growth27.91%
CountryUS
Employees37
SectorHealthcare
Sector Strength45
IndustryMedical - Devices
Share Statistics
EPS (TTM)-1147.01
Shares Outstanding667,669
10 Day Avg. Volume395,892
30 Day Avg. Volume589,933
Financial Highlights & Ratios
PEG Ratio<0.01
Price to Book (P/B)0.25
Price to Sales (P/S)0.00
P/FCF Ratio-0.43
Enterprise Value/Market Cap-0.27
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit3.72
Enterprise Value/Ebitda0.10
Forecast
1Y Price TargetN/A
Price Target UpsideN/A
Rating ConsensusN/A
Number of Analyst Covering0
EPS Forecast (FY)-35
Revenue Forecast (FY)$7.00M
enVVeno Medical Business Overview & Revenue Model
Company Description
enVVeno Medical Corporation, based in Irvine, California, is a medical device firm founded in 1999 that is currently in its clinical development phase. The company's primary objective is to pioneer advanced bioprosthetic, tissue-engineered solutio...
How the Company Makes Money
As a clinical-stage medical device company, enVVeno Medical’s ability to generate recurring commercial revenue is dependent on obtaining regulatory approvals and successfully commercializing VenoValve; specific, current product sales revenue detai...
enVVeno Medical Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
55
Neutral
Cash Flow
18
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -491.00K | 0.00 | -528.00K | -546.00K | -525.00K | -452.91K |
| EBITDA | -18.33M | -18.98M | -21.29M | -22.97M | -24.14M | -16.07M |
| Net Income | -18.82M | -19.47M | -21.82M | -23.52M | -24.67M | -16.53M |
Balance Sheet | ||||||
| Total Assets | 26.10M | 29.56M | 44.95M | 48.63M | 41.66M | 57.70M |
| Cash, Cash Equivalents and Short-Term Investments | 24.93M | 28.21M | 43.15M | 46.41M | 39.04M | 54.73M |
| Total Debt | 603.00K | 700.00K | 1.06M | 1.40M | 1.72M | 2.01M |
| Total Liabilities | 2.35M | 2.43M | 2.79M | 2.44M | 2.93M | 3.29M |
| Stockholders Equity | 23.75M | 27.13M | 42.16M | 46.20M | 38.73M | 54.40M |
Cash Flow | ||||||
| Free Cash Flow | -14.79M | -15.57M | -16.88M | -18.89M | -15.73M | -12.21M |
| Operating Cash Flow | -14.79M | -15.57M | -16.84M | -18.86M | -15.62M | -11.85M |
| Investing Cash Flow | 13.43M | 15.86M | 1.33M | -7.87M | -34.55M | -367.89K |
| Financing Cash Flow | 1.02M | 1.02M | 13.64M | 25.79M | 0.00 | 57.61M |
enVVeno Medical Technical Analysis
Negative
0.36
Price Trends
10.81
Negative
10.70
Negative
15.55
Negative
Market Momentum
-0.16
Positive
43.66
Neutral
42.00
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NVNO, the sentiment is Negative. The current price of 0.36 is below the 20-day moving average (MA) of 10.58, below the 50-day MA of 10.81, and below the 200-day MA of 15.55, indicating a bearish trend. The MACD of -0.16 indicates Positive momentum. The RSI at 43.66 is Neutral, neither overbought nor oversold. The STOCH value of 42.00 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NVNO.
enVVeno Medical Risk Analysis
enVVeno Medical disclosed 36 risk factors in its most recent earnings report. enVVeno Medical reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 1 New Risks
1.
The Company received a not-approvable letter from the FDA. Q4, 2025
enVVeno Medical Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
47 Neutral | $48.74M | -1.89 | 239.44% | ― | 10.38% | 20.70% | |
46 Neutral | $6.68M | >-0.01 | -57.19% | ― | ― | 27.91% | |
46 Neutral | $27.54M | -2.32 | -165.13% | ― | 7.72% | 34.39% | |
45 Neutral | $36.94M | -0.44 | -49.65% | ― | -95.74% | -118.94% | |
42 Neutral | $4.15M | -0.32 | -268.55% | ― | 39.98% | 90.08% | |
41 Neutral | $9.11M | -0.48 | -204.04% | ― | -59.95% | 56.67% |
* Healthcare Sector Average
NVNO
enVVeno Medical
10.00
-134.55
-93.08%
SINT
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2.11
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COCH
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TNON
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enVVeno Medical Corporate Events
Business Operations and StrategyFinancial DisclosuresProduct-Related Announcements
enVVeno Medical Wins FDA IDE for TAVVE Trial
Positive
Apr 29, 2026
On April 29, 2026, enVVeno Medical announced that the U.S. Food and Drug Administration granted its first-ever Investigational Device Exemption approval for a U.S. pivotal study of a non-surgical replacement venous valve, clearing the company to b...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.