enVVeno Medical (NVNO) AI Stock Analysis

• Market Cap: $6.56M
• Dividend Yield: N/A
• Average Volume (3M): 589.93K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.98
• Revenue Growth: N/A
• EPS Growth: 18.94%
• Country: US
• Employees: 37
• Sector: Healthcare
• Sector Strength: 45
• Industry: Medical - Devices
• EPS (TTM): N/A
• Shares Outstanding: 655,606
• 10 Day Avg. Volume: 395,892
• 30 Day Avg. Volume: 589,933
• PEG Ratio: <0.01
• Price to Book (P/B): 0.04
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -0.09
• Enterprise Value/Market Cap: -0.09
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: 1.19
• Enterprise Value/Ebitda: 0.03
• 1Y Price Target: N/A
• Price Target Upside: N/A
• Rating Consensus: N/A
• Number of Analyst Covering: 0
• EPS Forecast (FY): -35
• Revenue Forecast (FY): $7.00M

• Rating: 42 Neutral
• Price Target: $11.50 ▲(3094.44% Upside)
• Action: Reiterated Date: 01/31/26
• Date: Action: Reiterated 01/31/26

The score is primarily pressured by weak financial performance (no revenue, sizable losses, and ongoing cash burn) and a negative FDA-related setback. Technicals also reflect a weak longer-term trend with negative MACD. Low debt provides some balance-sheet support, but valuation support is limited given a negative P/E and no dividend yield.

Positive Factors

Low leverage

Minimal debt reduces near-term solvency risk and interest burden, preserving financial flexibility. For a device developer still in clinical stages, low leverage supports the ability to prioritize R&D and regulatory work without immediate refinancing pressure, aiding longer-term execution.

Cash runway

A reported $31.5M in cash provides a tangible runway into 2027, enabling planned clinical activities and regulatory alignment for next-generation programs. This reduces the immediacy of dilutive financing and allows the company to advance human testing and endpoint discussions with regulators.

Next-gen product ready for testing

Having a transcatheter enVVe program ready for human testing represents a structural product pivot toward less-invasive therapy, aligned with industry trends. If clinical data are positive, this could materially improve commercial feasibility versus the surgical VenoValve approach.

Negative Factors

No commercial revenue

The company is not generating sales and reports negative gross profit, indicating costs exceed any product-derived income. This structural lack of commercialization means prolonged dependence on external funding until product approvals and market adoption occur.

Significant cash burn

Sustained negative operating and free cash flow (~-$17.2M TTM) shows the business consumes capital to fund operations and trials. Persistent cash burn heightens reliance on external financing, increasing dilution risk and creating execution pressure to achieve regulatory milestones before runway lapses.

Regulatory setback

An unfavorable FDA PMA appeal decision is a material regulatory setback that delays commercialization and raises uncertainty on approval pathways. It forces resource reallocation, protocol redesign, and renewed regulator engagement, increasing time and cost to market and execution risk.

enVVeno Medical Business Overview & Revenue Model

Company Description

enVVeno Medical Corporation, a clinical-stage medical device company, focuses on the development of bioprosthetic tissue-based solutions to enhance the standard of care in the treatment of venous disease. The company's lead product is the VenoValve, a replacement venous valve for the treatment of venous chronic venous insufficiency. Its VenoValve implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. The company also develops enVVe, a non-surgical and transcatheter-based replacement venous valve system consisting of the enVVe valve, enVVe delivery system, and delivery system accessories. 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 Money

enVVeno 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

Operating fundamentals are very weak (TTM no revenue, negative gross profit, and large losses), and cash burn remains heavy (TTM operating and free cash flow around -$17.2M). The main offset is low leverage (minimal debt), which reduces near-term solvency risk, but the declining equity base and sharply negative ROE underscore ongoing dilution risk until commercialization improves.

Income Statement

TTM (Trailing-Twelve-Months) results show no revenue and a negative gross profit, indicating the business is not yet generating commercial sales and is absorbing production/operating costs. Losses remain large (TTM net loss of ~$22.0M; EBIT loss of ~$23.6M), with profitability still deeply negative and little evidence of operating leverage. A modest improvement versus 2022–2023 is visible in net loss, but the company remains far from break-even.

Balance Sheet

Leverage is low, with minimal debt (TTM total debt ~$0.8M) and a very low debt-to-equity ratio (~0.03), which reduces near-term solvency risk. However, the equity base has trended down meaningfully from 2021 to TTM (roughly $54.4M to $29.4M), reflecting sustained losses and/or financing dynamics. Returns on equity remain sharply negative (TTM ~-0.61), highlighting ongoing value dilution until profitability improves.

Cash Flow

Cash burn remains significant, with TTM operating cash flow of about -$17.2M and free cash flow of about -$17.2M, indicating the business is still funding operations through external capital rather than internally generated cash. Cash burn improved versus 2023 (free cash flow growth positive), but the company is still consistently free-cash-flow negative. Free cash flow roughly matches net loss (around 1.0x), suggesting losses are largely translating into cash outflow rather than being offset by non-cash items.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
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 Assets	32.35M	44.95M	48.63M	41.66M	57.70M	10.54M
Cash, Cash Equivalents and Short-Term Investments	30.95M	43.15M	46.41M	39.04M	54.73M	9.33M
Total Debt	791.00K	1.06M	1.40M	1.72M	2.01M	880.65K
Total Liabilities	2.90M	2.79M	2.44M	2.93M	3.29M	3.44M
Stockholders Equity	29.45M	42.16M	46.20M	38.73M	54.40M	7.10M
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 Flow	618.00K	1.33M	-7.87M	-34.55M	-367.89K	-180.29K
Financing Cash Flow	241.00K	13.64M	25.79M	0.00	57.61M	15.07M

enVVeno Medical Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 0.36
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: 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 10.16, below the 50-day MA of 11.07, and below the 200-day MA of 63.53, indicating a bearish trend. The MACD of -0.19 indicates Negative momentum. The RSI at 46.34 is Neutral, neither overbought nor oversold. The STOCH value of 39.22 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NVNO.

enVVeno Medical Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
PAVM	49 Neutral	$15.09M	-0.59	20.03%	―	-99.28%	-46.17%
TNON	49 Neutral	$9.68M	-0.32	-197.26%	―	-2.47%	91.23%
CTSO	44 Neutral	$47.26M	-3.96	-96.15%	―	-8.97%	47.29%
NVNO	42 Neutral	$6.56M	-0.25	-57.19%	―	―	18.94%
COCH	42 Neutral	$55.68M	-0.54	―	―	-25.18%	-9.71%
SINT	40 Underperform	$11.13M	-0.42	-204.04%	―	-60.89%	94.49%

enVVeno Medical Corporate Events

enVVeno Medical Executes One-for-35 Reverse Stock Split

On January 20, 2026, enVVeno Medical Corporation implemented a one-for-35 reverse stock split of its common stock, combining every 35 issued and outstanding shares into one share without changing the par value, and rounding any fractional shares up to the nearest whole share. The move, approved by both the board and stockholders, reduced the number of shares outstanding from 22,946,223 to 655,606, triggered proportional adjustments to outstanding options and warrants, and led the stock to begin trading on a split-adjusted basis the same day, significantly consolidating the company’s equity base while leaving its authorized share count unchanged.

The most recent analyst rating on (NVNO) stock is a Sell with a $0.32 price target. To see the full list of analyst forecasts on enVVeno Medical stock, see the NVNO Stock Forecast page.

enVVeno Medical Holds Annual Stockholders Meeting

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.

enVVeno Medical Amends Quorum Requirement for Meetings

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.

enVVeno Medical Faces FDA Setback on VenoValve

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.