enVVeno Medical

NVNO

Market cap $15M

Overview Fund Activity

0.7814 USD

-0.0046

0.59%

At close Updated Sep 12, 4:00 PM EDT

Pre-market

After hours

0.7762

-0.0052

0.67%

1 day

-0.59%

5 days

0.18%

1 month

-82.94%

3 months

-82.2%

6 months

-72.77%

Year to date

-74.55%

1 year

-85.12%

5 years

-93.35%

10 years

-99.4%

About: enVVeno Medical Corp is a late clinical-stage medical device company focused on advancing bioprosthetic (tissue-based) solutions to improve the standard of care for treating venous disease. The company's product, VenoValve, is a surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study. The company is also developing a second product called enVVe, which is a non-surgical, transcatheter-based replacement venous valve. Both the products are designed to act as one-way valves to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location, the United States.

Employees: 37

Healthcare Medical Devices

0

Funds holding %

of 7,462 funds

–

Analysts bullish %

Fund manager confidence

Based on 2025 Q2 regulatory disclosures by fund managers ($100M+ AUM)

11,989% more call options, than puts

Call options by funds: $1.09M | Put options by funds: $9K

120% more first-time investments, than exits

New positions opened: 11 | Existing positions closed: 5

112% more capital invested

Capital invested by funds: $9.57M [Q1] → $20.3M (+$10.7M) [Q2]

50% more repeat investments, than reductions

Existing positions increased: 9 | Existing positions reduced: 6

20% more funds holding

Funds holding: 30 [Q1] → 36 (+6) [Q2]

8.22% more ownership

Funds ownership: 20.75% [Q1] → 28.97% (+8.22%) [Q2]

See Fund Rankings

Financial journalist opinion

Based on 3 articles about NVNO published over the past 30 days

Zacks Investment Research

NVNO's Shares Decline on Unfavorable FDA Review Outcome for VenoValve

enVVeno Medical shares plunge after the FDA rejects its VenoValve PMA, citing insufficient trial data and safety concerns tied to the surgical procedure.

NVNO's Shares Decline on Unfavorable FDA Review Outcome for VenoValve

enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)

IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form.

enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)

enVVeno Medical to Present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech

- Live webcast on Thursday, August 21stat 2:00 PM ET IRVINE, CA / ACCESS Newswire / August 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech being held virtually August 19-21, 2025. Details for the presentation are as follows: Date and Time: Thursday, August 21, 2025 at 2:00 PM ET Presenter: Robert Berman, enVVeno Medical's Chief Executive Officer Registration Link: HERE About Webull Financial Webull Financial is a leading online brokerage platform committed to empowering self-directed investors with innovative tools and cutting-edge technology.

enVVeno Medical to Present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech

Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency

Clinical data and cost-effectiveness analysis demonstrates the VenoValve would provide both better health outcomes and lower costs compared to current standard of care treatments The VenoValve could potentially save $5.9 billion annually in healthcare costs for the approximately 2.5 million U.S. patients with severe CVI Company to host live webcast with lead author of the cost-analysis manuscript, today, August 6th, at 12:00 PM ET; Access the Webcast Here IRVINE, CA / ACCESS Newswire / August 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announcedpreliminary findings from a VenoValve health economic study, which indicate that the VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The Company announced it will host a live webcast to discuss the cost-effectiveness analysis results today, Wednesday, August 6th at 12:00 PM ET (details below).

Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency

enVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company

- enVVeno is developing the VenoValve as a potential treatment option for the approximately 2.5 million patients in the U.S. suffering from severe deep Chronic Venous Insufficiency - FDA decision expected in 2H'2025 - Access the "What This Means" segment here IRVINE, CA / ACCESS Newswire / August 4, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it participated in a Virtual Investor "What This Means" segment entitled, "enVVeno Medical - Making Veins Work Again - How President Trump's CVI Diagnosis is Raising Awareness." Rob Berman, CEO and Dr. Marc Glickman, CMO of enVVeno Medical discussed the progressive nature of chronic veinous insufficiency and whether President Trump may one day be a candidate for the VenoValve® following U.S. Food and Drug Administration (FDA) approval.

enVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company

enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update

- Cash burn of $3.8 million in Q2 remains in line with projected quarterly range - Cash and investments are sufficient to fund operations through Q3'2026 at current cash burn rate - Commercial readiness activities underway for a phased launch of VenoValve® subject to FDA decision expected in 2H'2025 - IDE submission for enVVe® on track for 2H'2025 IRVINE, CA / ACCESS Newswire / August 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the second quarter 2025. "As the recent headlines around CVI confirmed, CVI is a pervasive and a progressive disease that is especially debilitating once it becomes severe.

enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update

enVVeno Medical Participates in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference

- Video webcast now available on-demand IRVINE, CA / ACCESS Newswire / July 22, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Rob Berman, CEO of enVVeno, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. As part of the segment, Mr.

enVVeno Medical Participates in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference

Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting

Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here IRVINE, CA / ACCESS Newswire / June 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below).

Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting

enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer

IRVINE, CA / ACCESS Newswire / May 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, announced the appointment of Jennifer Bright as Chief Financial Officer, effective today, May 19, 2025. Ms. Bright brings more than 25 years of financial and strategic leadership experience built across several commercial-stage medical device and pharmaceutical companies including Biolase, Spectrum Pharmaceuticals, Apria Healthcare, Smile Brands, and Teleflex Medical, as well as technical accounting and auditing experience at PricewaterhouseCoopers LLP.

enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer

Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025 IRVINE, CA / ACCESS Newswire / May 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that its manuscript titled, " Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux 1," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6).

Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

See News Rankings

Charts implemented using Lightweight Charts™