Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
NVNO Catalyst Timeline
Dated clinical, regulatory and corporate events for enVVeno Medical Corporation
Past FDA Catalysts and PDUFA Decisions
How NVNO actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| - | Example Drug | Phase 3 data readout | Phase 3 |
Drug Pipeline Intelligence
No drug pipeline
enVVeno Medical Corporation is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.
Clinical Trial Results
Readouts, endpoints and source filings for every NVNO program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| VenoValve | Chronic Venous Insufficiency (CVI) | 2024-04-24 | average r VCSS improvement: 8.46; clinical improvement percentage: 94; clinical meaningful benefit percentage: 72; two year milestone r VCSS: 9.29; one year milestone r VCSS: 8.08; six month milestone r VCSS: 8.71; average follow up months clinical improvement: 11.04; average follow up months clinical meaningful benefit: 11.64Read More | Positive 11 Month Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical's VenoValve Pivotal Trial to be Presented Today at the 46 th Annual Charing Cross Symposium Overall 8.46 Average RevisRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Duhay FrancisDirector | Sell | -11 2,351 held | $11.21 | 09/11/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in NVNO
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| PERCEPTIVE ADVISORS LLC | 0 % | 564.00 K | 1.76 M |
NVNO Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How NVNO ranks across every disease it competes in
NVNO News
enVVeno Medical's First-in-Class enVVe System to Be Featured at The VEINS 2026 Innovation Summit as Company Advances Toward U.S. Pivotal Trial
enVVeno Medical Corporation will showcase its enVVe System at The VEINS 2026 Innovation Summit. This minimally invasive replacement venous valve aims to treat severe deep venous insufficiency, a condition affecting 3 million patients in the U.S. The company recently received FDA approval to initiate the pivotal TAVVE trial, with enrollment expected to start in Q4 2026.
Read more →enVVeno Medical CEO Rob Berman Goes Direct to Investors with New "WTF" Video Series
enVVeno Medical Corporation has launched a new video series, "WTF Rob Berman," aimed at providing investors with straightforward information about the company. Hosted by CEO Rob Berman, the series intends to cut through corporate jargon and deliver clear insights into the company's technology and clinical developments. The inaugural episode is now available, with more episodes planned to follow.
Read more →enVVeno Medical Presentation from H.C. Wainwright Conference Now Available On-Demand
enVVeno Medical Corporation has made its pre-recorded presentation from the H.C. Wainwright 28th Annual Global Investment Conference available for on-demand viewing. The presentation, led by CEO Robert Berman, covers the company's innovative enVVe® System and recent developments. Additionally, management will hold one-on-one meetings with investors during the conference scheduled for September 14-16, 2026.
Read more →enVVeno Medical Secures Transformational U.S. Patent for enVVe System, Strengthening Competitive Moat Ahead of Launch of Historic FDA Pivotal Trial
enVVeno Medical Corporation has secured a U.S. patent for its enVVe system, a non-surgical replacement venous valve aimed at treating deep venous insufficiency. This patent enhances the company's intellectual property and regulatory standing, following FDA IDE approval for a pivotal trial. The enVVe system is designed to offer a less invasive treatment option for patients with limited surgical candidacy.
Read more →enVVeno Medical to Present in the Webull Corporate Connect Webinar Series
enVVeno Medical Corporation will present at the Webull Corporate Connect Webinar Series on June 24, 2026. CEO Rob Berman will discuss the company's mission to improve treatment for deep venous disease, the FDA IDE approval for the enVVe System, and plans for a pivotal trial of a non-surgical venous valve. This presentation highlights the significant unmet needs in treating severe Deep Venous Insufficiency.
Read more →enVVeno Medical to Participate in the Virtual Investor Closing Bell Series
enVVeno Medical Corporation announced that CEO Robert Berman will participate in a Virtual Investor Closing Bell event on June 9, 2026. During the event, he will discuss the company's recent FDA IDE approval for the enVVe System, a non-surgical replacement venous valve. The event will include a live Q&A session, allowing audience interaction.
Read more →enVVeno Medical Discusses FDA IDE Approval in Virtual Investor “What This Means” Segment
enVVeno Medical Corporation has received FDA IDE approval for a pivotal study of its non-surgical replacement venous valve, marking a significant milestone. This approval positions the company to potentially offer the first effective treatment for approximately 3 million U.S. patients suffering from deep venous insufficiency (DVI). The enVVe system aims to enhance the standard of care with a transcatheter delivered device.
Read more →enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System
enVVeno Medical Corporation reported its first quarter 2026 financial results, ending with approximately $25 million in cash. The company received FDA IDE approval for its TAVVE pivotal study, which aims to evaluate the enVVe System for treating severe deep venous insufficiency. Patient enrollment is expected to begin later this year, positioning the company for significant advancements.
Read more →enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve
enVVeno Medical Corporation has received the first FDA Investigational Device Exemption (IDE) approval for its enVVe system, a non-surgical replacement venous valve. This pivotal study will target approximately 3 million U.S. patients suffering from severe Chronic Venous Insufficiency (CVI). The company plans to initiate patient enrollment later this year, with the potential for significant market impact.
Read more →enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve enVVe system to be evaluated in TAVVE U.S. Pivotal Trial
enVVeno Medical Corporation has received FDA IDE approval for its enVVe system, marking a significant milestone as it prepares to conduct a pivotal study for a non-surgical replacement venous valve to treat severe chronic venous insufficiency. The study, known as the TAVVE study, aims to enroll patients across up to 40 clinical sites in the U.S., initiating with a 10-patient safety cohort later this year. The company aims to address the severe clinical need faced by approximately 3 million U.S. patients suffering from debilitating venous conditions. This breakthrough could potentially offer the first effective treatment option for these patients, who currently have no effective therapies available.
Read more →enVVeno Medical Reports Full Year 2025 Financial Results and Highlights Strategic Advancement of enVVe® System
enVVeno Medical Corporation reported its financial results for 2025, highlighting the completion of pre-clinical studies for the enVVe System and plans to initiate a pivotal trial in 2026. The company aims to address chronic venous insufficiency, a condition affecting millions in the U.S. Despite a net loss, their financial position supports ongoing development efforts.
Read more →enVVeno Medical Reports Full Year 2025 Financial Results and Highlights Strategic Advancement of enVVe(R) System
enVVeno Medical Corporation reported its financial results for 2025, highlighting the completion of pre-clinical studies for the enVVe System. The company plans to initiate a pivotal trial in 2026, aiming to address chronic venous insufficiency. Despite a net loss, enVVeno's financial position is expected to support operations into mid-2027.
Read more →enVVeno Medical Regains Compliance with Nasdaq Minimum Bid Price Requirement
enVVeno Medical Corporation has regained compliance with Nasdaq's minimum bid price requirement after maintaining a closing bid price of at least $1.00 for 10 consecutive business days. The company reported a cash and investments balance of approximately $28 million as of December 31, 2025. This compliance is expected to support their strategic plans for 2026.
Read more →enVVeno Medical Announces Reverse Stock Split
enVVeno Medical Corporation has announced a reverse stock split at a ratio of 1 for 35, effective January 20, 2026. This decision, approved by stockholders, is part of a broader strategy to enhance shareholder value and ensure compliance with Nasdaq listing requirements. The company will reduce its outstanding shares significantly and adjust equity awards accordingly.
Read more →enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment
enVVeno Medical Corporation announced that CEO Robert Berman will participate in a Live Virtual Investor CEO Connect segment on December 3, 2025. During the event, he will provide an overview of the company and discuss recent developments. A live Q&A session will follow, allowing investors to engage directly.
Read more →enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
enVVeno Medical Corporation has received an unfavorable decision from the FDA regarding its VenoValve after a supervisory appeal upheld a previous not-approvable letter. The FDA determined that VenoValve did not provide reasonable assurance of safety and effectiveness. CEO Robert Berman indicated that the company will shift focus to enVVe, their next-generation transcatheter valve, which is expected to have a different safety profile and is ready for human testing. enVVeno also has sufficient cash reserves to sustain operations until 2027.
Read more →enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update
enVVeno Medical Corporation reported its third quarter 2025 financial results, highlighting sufficient cash reserves to support operations until mid-2027. The company is actively engaging with the FDA regarding its VenoValve PMA appeal, with feedback expected by the end of 2025. Despite a cash burn of $4.2 million this quarter, the company has seen a reduction in net losses compared to the previous year.
Read more →enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor “What This Means” Segment
enVVeno Medical Corporation recently participated in a Virtual Investor segment where CEO Robert Berman discussed the company's request for a supervisory appeal regarding a not-approvable letter from the FDA. This letter was related to their Premarket Approval application for the VenoValve, a device aimed at treating severe chronic venous insufficiency. The company continues to develop its products, including the enVVe valve, which is in the final testing phase for IDE approval.
Read more →enVVeno Medical Updates Regulatory Status of VenoValve®
enVVeno Medical Corporation announced plans to appeal the FDA's not-approvable letter regarding its VenoValve device for treating severe chronic venous insufficiency. The company has established a collaborative relationship with the FDA and is optimistic about the appeal process, which is required to be filed by September 18, 2025. The appeal aims to address concerns raised during the PMA review.
Read more →enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve®
enVVeno Medical Corporation received a not-approvable letter from the FDA regarding its VenoValve PMA application. The FDA's review highlighted insufficient data to establish a favorable benefit-risk profile and raised safety concerns related to the surgical procedure. The company plans to review FDA feedback and explore options for resubmission or appeal.
Read more →