enVVeno Medical Corporation (NVNO): History, Ownership, Mission, How It Works & Makes Money

enVVeno Medical Corporation (NVNO) operates with a tiny market capitalization of just over $6.4 Million USD as of November 2025, but are they positioned to disrupt the treatment landscape for the estimated 2.5 million U.S. patients suffering from severe Chronic Venous Insufficiency (CVI)? This late clinical-stage medical device company is betting its future on first-in-class bioprosthetic solutions like the VenoValve, which analysts project could save the healthcare system $5.9 billion annually if approved, despite the recent unfavorable FDA appeal decision on November 13, 2025. You're looking at a classic high-risk, high-reward MedTech story, where a net loss of $4.5 million in Q3 2025 is defintely overshadowed by the potential of a breakthrough device. How does a company with $31.0 million in cash and investments navigate a complex regulatory path to turn a niche technology into a commercial success?

enVVeno Medical Corporation (NVNO) History

Given Company's Founding Timeline

You need to understand the roots of a company to grasp its current strategy, and enVVeno Medical Corporation's history is one of clear focus and a significant pivot. The company started its life under a different name, laying the groundwork for its current mission in deep venous disease treatment.

Year established

The entity was initially incorporated in 1999 under the name Hancock Jaffe Laboratories, Inc.

Original location

Operations began and remain based in Irvine, California, a hub for medical device innovation in the United States.

Founding team members

The original founders were Norman Jaffe and Robert Hancock, whose names formed the initial corporate identity.

Initial capital/funding

Early-stage funding details are typical of a private entity, but the company's total funding over six rounds was approximately $874K. A significant capitalization event occurred with its Initial Public Offering (IPO) in 2018, which raised approximately $8.4 million. Later, a Post-IPO round in October 2023 brought in another $28M.

Given Company's Evolution Milestones

The company's journey from a small lab to a late clinical-stage Nasdaq-listed firm is marked by key events, mostly centered on advancing its core bioprosthetic valve technology. Here's the quick math on their development.

Given Company's Transformative Moments

The most transformative period for enVVeno Medical Corporation has been the strategic shift to focus almost entirely on bioprosthetic (tissue-based) solutions for deep venous disease, specifically the VenoValve and the non-surgical enVVe system. This wasn't just a product decision; it was a market focus decision.

The October 2021 name change from Hancock Jaffe Laboratories, Inc. to enVVeno Medical Corporation was a clear signal of this singular focus. It moved the company from a general lab name to a brand tied directly to its innovative valve technology (VenoValve and enVVe), which is defintely a smart move for market recognition.

The regulatory and clinical milestones in 2025 are defining its near-term future. The company is actively engaged in a supervisory appeal with the FDA regarding a not-approvable PMA decision for the VenoValve, with a final decision expected by year-end 2025. A favorable decision would instantly pivot the company from a development stage entity to a commercial enterprise targeting an estimated 2.5 million potential patients annually in the U.S.

• Pivoting to Bioprosthetics: The commitment to tissue-based valves like VenoValve and enVVe, which mimic natural human valve function, defined its competitive edge against traditional stent-based solutions.
• The FDA Appeal: The ongoing supervisory appeal for VenoValve in 2025 is the single most critical event, determining whether the company can access the U.S. market for its lead product.
• Dual Product Strategy: Developing both the surgical VenoValve and the transcatheter (non-surgical) enVVe shows a commitment to capturing the entire severe Chronic Venous Insufficiency (CVI) market.

Their financial discipline is also a key factor; the net loss for Q3 2025 narrowed to $4.5 million, a 20% improvement from the prior year's Q3 net loss of $5.6 million, showing operating expenses are being managed tightly as they navigate the regulatory path. You can find more detail on their strategic direction in Mission Statement, Vision, & Core Values of enVVeno Medical Corporation (NVNO).

enVVeno Medical Corporation (NVNO) Ownership Structure

enVVeno Medical Corporation is a publicly traded company on the Nasdaq Capital Market (NasdaqCM), and its control is highly concentrated among insiders and institutional investors. The company's governance is heavily influenced by its largest shareholders, with insiders holding a significant majority of the outstanding shares as of late 2025.

This structure means that while retail investors can trade the stock, strategic decisions are defintely steered by a tight group of executives, directors, and a few large institutional funds.

enVVeno Medical Corporation's Current Status

enVVeno Medical Corporation (NVNO) is a late-stage clinical medical device company, trading publicly on the NasdaqCM. As of November 2025, the company has approximately 20.22 million shares outstanding and a market capitalization of roughly $6.48 million. The focus remains on advancing its bioprosthetic solutions, primarily the VenoValve for severe Chronic Venous Insufficiency (CVI), but its stock price has been under pressure due to a recent unfavorable FDA appeal decision regarding the VenoValve device.

The company reported ending the third quarter of 2025 with $31.0 million in cash and investments, which management projects can fund operations through Q2 2027, excluding potential commercialization costs. This cash runway is a key metric, but still, the regulatory setback introduces near-term risk to the commercialization timeline and the overall valuation.

enVVeno Medical Corporation's Ownership Breakdown

The ownership structure is unusual for a small-cap public company, showing a high level of insider concentration. This suggests that the company's trajectory is largely in the hands of its founders and key stakeholders, which can be a double-edged sword: alignment of interests but lower public float liquidity.

Here's the quick math: with insiders controlling over half the stock, they have the votes to approve most major corporate actions without needing institutional or retail support. This is a crucial factor for any investor to consider. For a deeper dive into the company's long-term vision, you should check out the Mission Statement, Vision, & Core Values of enVVeno Medical Corporation (NVNO).

enVVeno Medical Corporation's Leadership

The organization is led by an experienced team with deep backgrounds in the medical device and life sciences sectors. The management team has an average tenure of 2.3 years, which shows a relatively stable core group for a clinical-stage company.

• Robert Berman: Chief Executive Officer and Director. He has served since April 2018, leading the transition from a private cardiac-focused company to a public entity centered on venous disease.
• Jennifer Bright: Chief Financial Officer. Ms. Bright joined in May 2025, bringing over 25 years of financial and strategic leadership from companies like Biolase and Teleflex Medical.
• Marc Glickman, M.D.: Senior Vice President and Chief Medical Officer. He provides the critical clinical and medical expertise for the product pipeline.
• Hamed Alavi, Ph. D.: Senior Vice President and Chief Technology Officer. Dr. Alavi oversees the development of the innovative medical device technologies.
• Andrew Cormack: Chief Commercial Officer. He is tasked with building the commercial strategy for the VenoValve and future products, subject to regulatory approval.

The board of directors is also experienced, with an average tenure of 7.1 years, which provides continuity and institutional knowledge, especially vital during the ongoing regulatory challenges.

enVVeno Medical Corporation (NVNO) Mission and Values

enVVeno Medical Corporation's purpose extends beyond standard medical device sales; it's centered on fundamentally changing the treatment paradigm for severe deep chronic venous insufficiency (CVI) by pioneering bioprosthetic valve technology. This mission is defintely a high-stakes one, given the approximately 2.5 million U.S. patients suffering from this debilitating condition annually.

The company's cultural DNA is built on scientific rigor and a patient-first approach, which is necessary when you are dealing with complex, first-in-category medical devices like the VenoValve and enVVe. Honestly, their mission is a direct map to their product pipeline and their regulatory battles with the FDA, which is a sign of a focused, mission-driven organization.

enVVeno Medical Corporation's Core Purpose

The company's core purpose is to establish itself as the world-wide leader in treatments for severe, deep venous disease, setting a new standard of care. This focus is what drives their cash burn, which was a manageable $4.2 million in the third quarter of 2025, as they push toward regulatory milestones.

Official mission statement

The official mission statement is a commitment to transforming the management of chronic venous insufficiency (CVI) by developing first-in-class, innovative bioprosthetic (tissue-based) solutions. This is a big goal, so the focus is on restoring the one-way valve function of the venous system to propel blood effectively from the lower extremities back to the heart.

• Bring first-in-category, effective treatments to patients with severe CVI.
• Advance medical technology through innovative venous disease solutions.
• Reconstruct the one-way valve function of the venous system.

Here's the quick math on the potential impact: a health economic study suggests the VenoValve alone could potentially save the U.S. healthcare system up to $5.9 billion annually, which is a massive financial and humanitarian win.

Vision statement

enVVeno Medical Corporation's vision is to be recognized as the global leader in treating deep venous disease, fundamentally improving patient outcomes and lowering overall healthcare costs through minimally invasive treatments. They are positioning themselves to lead the ongoing national dialogue about CVI, especially following recent high-profile public awareness events.

• Set new standards of care for deep venous disease treatment.
• Reduce patient recovery time and lower overall healthcare costs.
• Transition from a development-stage company to a commercial enterprise in 2025.

The company's core values-Innovation and Scientific Excellence, Patient-Centric Approach, Ethical Integrity and Transparency, Collaborative Innovation, and Sustainable Development-are the bedrock of this vision.

enVVeno Medical Corporation slogan/tagline

While an official, concise slogan isn't always public, the company has used a phrase that perfectly encapsulates their product function and patient benefit: Mission Statement, Vision, & Core Values of enVVeno Medical Corporation (NVNO).

• Making Veins Work Again.

The company had a net loss of $4.5 million in Q3 2025, but this is a 20% decrease from the prior year, showing their commitment to efficient operations while pursuing their mission.

enVVeno Medical Corporation (NVNO) How It Works

enVVeno Medical Corporation is a late clinical-stage medical device company that creates first-in-class, bioprosthetic (tissue-based) solutions to fix faulty valves in the deep venous system, aiming to treat severe deep venous Chronic Venous Insufficiency (CVI). The company's value creation is currently rooted in advancing its two key valve replacement systems through the rigorous U.S. Food and Drug Administration (FDA) regulatory process, not through product sales yet.

Given Company's Product/Service Portfolio

Given Company's Operational Framework

The company operates as a research and development (R&D) enterprise, so its primary process is clinical and regulatory advancement, not manufacturing or sales. They make money by raising capital to fund R&D, not from product revenue.

Here's the quick math on their runway: enVVeno Medical ended the third quarter of 2025 with $31.0 million in cash and investments. With a quarterly cash burn of about $4.2 million in Q3 2025, this capital is projected to fund operations through the second quarter of 2027, excluding the costs of VenoValve commercialization and the enVVe pivotal trial.

The core operational process is a linear, high-stakes path:

• Bioprosthetic Valve Development: Design and test tissue-based valves to mimic the function of healthy human venous valves.
• Clinical Trials and Data Generation: Run pivotal U.S. trials, like the SAVVE study for VenoValve, to collect safety and effectiveness data.
• Regulatory Submission and Clearance: Submit a Pre-Market Approval (PMA) application to the FDA for VenoValve, or an Investigational Device Exemption (IDE) for enVVe to start its pivotal trial.
• Pre-Commercialization (Currently on Hold): Develop a commercialization plan, including hiring a sales team and establishing distribution, which is on hold following the unfavorable FDA appeal decision on VenoValve in November 2025.

The current reality is that the unfavorable FDA appeal decision on VenoValve, received on November 13, 2025, means the company must now focus its resources on charting a new regulatory path for VenoValve and getting clarity for the enVVe IDE submission, which was on track for the second half of 2025.

For more background, you can check: Exploring enVVeno Medical Corporation (NVNO) Investor Profile: Who's Buying and Why?

Given Company's Strategic Advantages

enVVeno Medical's market success hinges on its ability to be a first-mover in a massive, underserved market. This is defintely a high-risk, high-reward profile.

• First-in-Class Technology: VenoValve is a novel surgical solution for deep venous CVI, a condition with an estimated U.S. patient population of 2.5 million new candidates annually. No other FDA-approved surgical replacement venous valve exists for this patient group.
• Dual-Approach Strategy: The company is developing both a surgical option (VenoValve) and a non-surgical, catheter-based option (enVVe), which could capture a broader spectrum of the severe CVI market.
• Strong Intellectual Property (IP) Portfolio: The company protects its innovation with a robust IP strategy, including seven issued patents and four pending patent filings, which creates a significant barrier to entry for competitors.
• Large Addressable Market: The severe deep venous CVI market represents an estimated annual opportunity of $2.5 billion, providing a huge incentive for successful commercialization.

enVVeno Medical Corporation (NVNO) How It Makes Money

enVVeno Medical Corporation is a late clinical-stage medical device company, meaning it currently generates zero revenue from product sales; its entire income stream is derived from non-core sources like interest on its cash reserves. The business model is purely capital-intensive research and development (R&D), with the goal of transitioning to a commercial enterprise by selling its innovative bioprosthetic venous valves, VenoValve and enVVe, following regulatory approval.

enVVeno Medical Corporation's Revenue Breakdown

As a pre-commercial entity, enVVeno Medical Corporation's revenue is not from selling its core products, VenoValve or enVVe, which are still awaiting regulatory clarity. For the third quarter of the 2025 fiscal year (Q3 2025), the company reported a minimal total revenue of approximately $383,000, which is entirely comprised of non-operating income, primarily interest earned on its cash and investments.

The 'Non-Core Income' stream, which is 100% of their current revenue, is on a decreasing trend. This is evident from the Q3 2025 results, where a decrease in net loss was partially offset by a $0.2 million reduction in other income compared to the prior year period. This is a defintely important detail: as interest rates fluctuate, so does this non-core revenue stream.

Business Economics

The core economic reality for enVVeno Medical Corporation right now is that it is a net consumer of capital, not a generator of it. The entire business is a multi-year investment in clinical trials and regulatory approval, which, if successful, promises a high-margin medical device revenue stream.

• Cost Structure: The vast majority of costs are R&D and general administrative expenses, not Cost of Goods Sold (COGS). The Q3 2025 net loss was $4.5 million, funded entirely by its cash reserves.
• Cash Burn Rate: The company's quarterly cash burn for Q3 2025 was $4.2 million, which is in line with their projected quarterly range. This burn rate is the true cost of their current operations.
• Future Revenue Model: The long-term plan is a razor-and-blade model variation, where the 'razor' is the VenoValve or enVVe device, sold at a high price point to hospitals and surgical centers. The target market is large: an estimated 2.5 million potential new patients each year in the U.S. for the VenoValve procedure.
• Pricing Strategy: While commercial pricing is not public, first-in-class, life-changing surgical devices like the VenoValve typically command premium prices, potentially in the tens of thousands of dollars per unit, justified by the cost-effectiveness of treating severe deep Chronic Venous Insufficiency (CVI).

enVVeno Medical Corporation's Financial Performance

As of November 2025, the company's financial health is measured by its cash runway and its progress on regulatory milestones, not profitability. The unfavorable appeal decision from the U.S. Food & Drug Administration (FDA) for the VenoValve on November 13, 2025, is a major near-term risk that directly impacts the timeline for a commercial revenue stream.

• Cash Position: enVVeno Medical Corporation ended Q3 2025 with a strong cash and investments balance of $31.0 million. This capital is projected to fund current operations through the second quarter of 2027, excluding the costs associated with VenoValve commercialization or the enVVe pivotal study.
• Net Loss: The net loss for Q3 2025 was $4.5 million, a 20% improvement from the $5.6 million net loss reported in Q3 2024, driven by a reduction in operating expenses.
• Earnings Per Share (EPS): The Q3 2025 reported EPS was a loss of -$0.23, which beat the analyst consensus estimate of -$0.30. Here's the quick math: the lower-than-expected loss is mainly due to cost control, not revenue growth.

The current financial picture is a classic biotech/med-tech profile: deep losses, no product revenue, and a finite cash runway, all hinging on a binary regulatory outcome. Breaking Down enVVeno Medical Corporation (NVNO) Financial Health: Key Insights for Investors

enVVeno Medical Corporation (NVNO) Market Position & Future Outlook

enVVeno Medical Corporation's market position as of late 2025 is defined by a critical pivot: transitioning from its initial surgical device, VenoValve, to the next-generation, non-surgical enVVe program, following the FDA's upheld rejection of the VenoValve Pre-Market Approval (PMA) application in November 2025. The future outlook hinges entirely on the success of the enVVe transcatheter venous valve, which targets a significant, underserved patient population with severe deep Chronic Venous Insufficiency (CVI).

Competitive Landscape

The company operates in the broad, highly competitive vascular device market, but its focus on a first-in-class deep venous valve replacement for CVI creates a specialized niche. While enVVeno Medical Corporation has no commercial revenue, its competitive standing is measured by the potential of its technology against established players who dominate the overall vascular intervention space.

Opportunities & Challenges

The company's near-term trajectory is a high-stakes race against time and capital, now fully focused on a single, non-surgical technology. The pivot to enVVe is the clear strategic move, but it restarts the regulatory clock. Mission Statement, Vision, & Core Values of enVVeno Medical Corporation (NVNO).

Industry Position

enVVeno Medical Corporation is positioned as a high-risk, high-reward micro-cap medical device developer. Honestly, the company holds a unique position, not as a market share leader, but as a potential innovator in a therapeutic white space.

• Niche Focus: The company is one of the few focused on developing a dedicated, first-in-class replacement valve for deep venous CVI caused by valve failure, a problem affecting millions.
• Post-Rejection Pivot: The strategic shift to the enVVe transcatheter program is critical. This non-surgical approach aligns better with current trends in minimally invasive vascular procedures.
• Capital Cushion: The company's cash runway through Q2 2027 gives management a defintely needed window to execute the enVVe Investigational Device Exemption (IDE) submission and initial clinical steps.

What this estimate hides is that the company's valuation is highly sensitive to regulatory news; the stock price dropped significantly after the November 2025 FDA decision. So, the next key action is for management to secure the IDE approval for enVVe, which will dictate all future market strategy.