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enVVeno Medical (NVNO)
NASDAQ:NVNO

enVVeno Medical (NVNO) AI Stock Analysis

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NVNO

enVVeno Medical

(NASDAQ:NVNO)

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Neutral 43 (OpenAI - 5.2)
Rating:43Neutral
Price Target:
$0.32
▼(-3.33% Downside)
The score is driven primarily by weak financial performance (no revenue, sizable losses, and continued cash burn), compounded by a bearish technical setup (price below all key moving averages and negative MACD). Negative corporate events (FDA setback and Nasdaq bid-price compliance risk) add further downside risk, while valuation support is limited due to negative earnings and no indicated dividend.
Positive Factors
Strong Equity Position
A strong equity position with minimal leverage indicates financial stability and reduced financial risk, providing a solid foundation for future growth initiatives.
Innovative Product Pipeline
The development of a non-surgical venous valve demonstrates innovation and potential for market expansion, addressing safety concerns and enhancing treatment options.
Strategic Partnerships
Strategic partnerships enhance product validation and distribution capabilities, supporting revenue growth and market penetration in the healthcare sector.
Negative Factors
Profitability Issues
Severe profitability issues with highly negative margins indicate operational challenges, requiring strategic shifts to achieve sustainable financial performance.
FDA Approval Setback
The FDA's non-approval of VenoValve poses a significant setback, impacting product commercialization timelines and necessitating additional development efforts.
Negative Cash Flow
Insufficient cash flow generation from operations limits financial flexibility and necessitates improvements to sustain long-term viability and investment capacity.

enVVeno Medical (NVNO) vs. SPDR S&P 500 ETF (SPY)

enVVeno Medical Business Overview & Revenue Model

Company DescriptionenVVeno Medical Corporation, a medical device company, focuses on the development of various bioprosthetic tissue-based solutions to enhance the standard of care in the treatment of venous diseases. The company's lead product is the VenoValve, a surgical implant being developed for the treatment of severe deep venous chronic venous insufficiency. Its VenoValve is implanted in the femoral vein and acts as a one-way valve to help restore proper blood flow in the leg. The company was formerly known as Hancock Jaffe Laboratories, Inc. and changed its name to enVVeno Medical Corporation in October 2021. enVVeno Medical Corporation was incorporated in 1999 and is based in Irvine, California.
How the Company Makes MoneyenVVeno Medical makes money by developing, manufacturing, and selling medical devices designed to treat venous diseases. The company's primary revenue stream comes from the sales of its proprietary products aimed at improving venous valve function, particularly for patients with chronic venous insufficiency. Key factors contributing to its earnings include product sales to healthcare providers, partnerships with medical institutions for clinical trials and product distribution, and potentially licensing or royalty agreements related to its patented technologies. The company's ability to generate revenue is closely tied to the successful commercialization of its products and the establishment of strategic partnerships within the healthcare industry.

enVVeno Medical Financial Statement Overview

Summary
enVVeno Medical faces significant financial challenges, marked by substantial losses and negative cash flows. The income statement shows severe profitability issues with highly negative margins. The balance sheet, however, indicates strong financial stability due to low leverage and high equity. Cash flow analysis reveals insufficient cash flow generation from operations, necessitating strategic initiatives for improvement.
Income Statement
enVVeno Medical's income statement reveals a challenging financial position. The company has only recently generated revenue in the TTM period, with a gross profit margin of 17.37%. However, net income remains significantly negative, resulting in a net profit margin of -2626.72%. The EBIT and EBITDA margins also indicate substantial losses, at -2866.26% and -2819.95% respectively. These figures highlight ongoing operational challenges and a need for strategic shifts to improve profitability.
Balance Sheet
The balance sheet of enVVeno Medical shows a strong equity position with a low debt-to-equity ratio of 0.03, indicating minimal leverage and financial risk. The equity ratio stands at 94.40%, underlining substantial equity financing. However, the company's return on equity is negative at -55.68%, reflecting the impact of net losses. Despite the robust equity standing, profitability remains a significant concern.
Cash Flow
The cash flow analysis for enVVeno Medical reflects negative operating and free cash flows, with a free cash flow growth rate of -2.73% from the previous year. The operating cash flow to net income ratio is 0.81 for the TTM period, indicating that cash flows are not sufficient to cover net losses. While financing activities have contributed positively, the company must improve cash flow generation from operations to sustain long-term viability.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-494.00K-528.00K-546.00K-525.00K-452.91K-383.97K
EBITDA-21.47M-21.29M-22.97M-24.14M-16.07M-8.75M
Net Income-21.96M-21.82M-23.52M-24.67M-16.53M-9.14M
Balance Sheet
Total Assets32.35M44.95M48.63M41.66M57.70M10.54M
Cash, Cash Equivalents and Short-Term Investments30.95M43.15M46.41M39.04M54.73M9.33M
Total Debt791.00K1.06M1.40M1.72M2.01M880.65K
Total Liabilities2.90M2.79M2.44M2.93M3.29M3.44M
Stockholders Equity29.45M42.16M46.20M38.73M54.40M7.10M
Cash Flow
Free Cash Flow-17.24M-16.88M-18.89M-15.73M-12.21M-7.86M
Operating Cash Flow-17.23M-16.84M-18.86M-15.62M-11.85M-7.68M
Investing Cash Flow618.00K1.33M-7.87M-34.55M-367.89K-180.29K
Financing Cash Flow241.00K13.64M25.79M0.0057.61M15.07M

enVVeno Medical Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.33
Price Trends
50DMA
0.41
Negative
100DMA
0.63
Negative
200DMA
2.20
Negative
Market Momentum
MACD
-0.02
Negative
RSI
41.81
Neutral
STOCH
40.16
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 0.33 is below the 20-day moving average (MA) of 0.34, below the 50-day MA of 0.41, and below the 200-day MA of 2.20, indicating a bearish trend. The MACD of -0.02 indicates Negative momentum. The RSI at 41.81 is Neutral, neither overbought nor oversold. The STOCH value of 40.16 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 35 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 0 New Risks

enVVeno Medical Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
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%
49
Neutral
$10.59M-0.35-197.26%-2.47%91.23%
45
Neutral
$8.64M-0.4820.03%-99.28%-46.16%
44
Neutral
$44.04M-3.84-96.15%-8.97%47.29%
43
Neutral
$6.79M-0.30-57.19%18.94%
42
Neutral
$20.60M-0.51-25.18%-9.71%
40
Underperform
$14.75M-0.55-204.04%-60.89%94.49%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
NVNO
enVVeno Medical
0.33
-2.84
-89.46%
SINT
Sintx Technologies
3.79
0.45
13.32%
CTSO
Cytosorbents
0.73
-0.35
-32.41%
PAVM
PAVmed
8.29
-11.18
-57.42%
COCH
Envoy Medical
0.69
-0.73
-51.76%
TNON
Tenon Medical, Inc.
0.96
-0.73
-43.20%

enVVeno Medical Corporate Events

Executive/Board ChangesShareholder MeetingsStock Split
enVVeno Medical Holds Annual Stockholders Meeting
Neutral
Dec 12, 2025

On December 11, 2025, enVVeno Medical Corporation held its Annual Meeting of Stockholders, where 54.70% of the voting power was represented. During the meeting, Matthew M. Jenusaitis and Robert A. Berman were elected as Class II directors, the compensation of named executive officers was approved on a non-binding basis, and CBIZ CPAs P.C. was ratified as the public accounting firm for 2025. However, the 2025 Equity Incentive Plan was not adopted, and the 2016 Omnibus Incentive Plan remains in effect. Additionally, the Board was granted authority to effectuate a reverse stock split at a ratio between one-for-five and one-for-thirty-five at their discretion.

Shareholder Meetings
enVVeno Medical Amends Quorum Requirement for Meetings
Neutral
Nov 20, 2025

On November 17, 2025, enVVeno Medical Corporation’s Board of Directors approved an amendment to the company’s bylaws, specifically modifying the quorum requirement for stockholder meetings. The new amendment stipulates that a quorum is constituted by the presence, in person or by proxy, of holders of thirty-three and one-third percent of the voting power of outstanding shares, effective immediately upon approval.

Business Operations and StrategyLegal ProceedingsProduct-Related Announcements
enVVeno Medical Faces FDA Setback on VenoValve
Negative
Nov 14, 2025

On November 13, 2025, enVVeno Medical Corporation announced that it received an unfavorable decision from the FDA regarding its appeal for the Premarket Approval of VenoValve®, a surgical replacement venous valve for severe deep chronic venous insufficiency. Despite the setback, the company gained valuable insights for its next-generation transcatheter-based valve, enVVe, which is ready for human testing. The company plans to focus resources on enVVe, aiming to align with the FDA on achievable endpoints. enVVeno reported having $31.5 million in cash and investments, sufficient to fund operations into 2027.

Business Operations and StrategyPrivate Placements and Financing
enVVeno Medical Launches $50M Equity Offering Program
Neutral
Oct 30, 2025

On October 30, 2025, enVVeno Medical Corporation entered into an At-the-Market Offering Agreement with Ladenburg Thalmann & Co. Inc. to establish an equity program allowing the sale of up to $50 million in common stock. This agreement enables enVVeno to sell shares at market prices through ordinary brokers’ transactions on the NASDAQ Capital Market, with the agent receiving a 3% commission on sales. The company retains the flexibility to suspend or terminate the agreement at any time, impacting its financial strategy and market positioning.

Delistings and Listing ChangesRegulatory Filings and Compliance
enVVeno Medical Faces Nasdaq Delisting Notice
Negative
Oct 10, 2025

On October 7, 2025, enVVeno Medical Corporation was notified by Nasdaq that its common stock had fallen below the $1.00 per share minimum bid price requirement for 30 consecutive business days, putting it out of compliance with Nasdaq’s listing rules. The company has until April 6, 2026, to regain compliance by ensuring its stock closes at or above $1.00 for at least 10 consecutive trading days. Failure to comply could lead to delisting, though the company may qualify for an additional compliance period and has the right to appeal any delisting decision.

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.Date of analysis: Dec 30, 2025