enVVeno MedicalNVNO
NVNO
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
0
Funds holding %
of 7,398 funds
–
Analysts bullish %
Fund manager confidence
Based on 2024 Q4 regulatory filings by fund managers ($100M+ AUM)
528% more call options, than puts
Call options by funds: $289K | Put options by funds: $46K
100% more repeat investments, than reductions
Existing positions increased: 10 | Existing positions reduced: 5
9% less first-time investments, than exits
New positions opened: 10 | Existing positions closed: 11
3% less funds holding
Funds holding: 36 [Q3] → 35 (-1) [Q4]
14.78% less ownership
Funds ownership: 39.09% [Q3] → 24.31% (-14.78%) [Q4]
26% less capital invested
Capital invested by funds: $17.5M [Q3] → $12.9M (-$4.62M) [Q4]
Research analyst outlook
We haven’t received any recent analyst ratings for NVNO.
Financial journalist opinion
Neutral
Accesswire
2 days ago
The Impact of the VenoValve(R) on Patients with Primary and Secondary Chronic Venous Insufficiency (CVI) to be Presented at the Society for Clinical Vascular Surgery 52nd Annual Symposium
IRVINE, CA / ACCESS Newswire / March 31, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced its abstract has been accepted for presentation at the Society for Clinical Vascular Surgery (SCVS) 52nd Annual Symposium being held March 29-April 2, 2025 in Austin, TX. As part of the SCVS Symposium, Dr. Cassius Iyad Ochoa Chaar, Associate Professor of Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the VenoValve U.S. pivotal trial, will present the abstract titled, " Impact of the VenoValve on Patients with Primary and Thrombotic Deep Venous Reflux " on Wednesday, April 2, 2025 beginning at 8:20 AM CT.
Neutral
Accesswire
1 month ago
enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25
Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025 On track for enVVe IDE application submission by mid-2025, pending GLP study results IRVINE, CA / ACCESS Newswire / February 28, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2024. "Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical," commented Robert Berman, CEO of enVVeno Medical.
Neutral
Accesswire
1 month ago
enVVeno Medical Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference
On-demand video webcast now available here IRVINE, CA / ACCESS Newswire / February 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it participated in the Virtual Investor "Top 5 for ‘25" On-Demand Conference . As part of the event, Robert Berman, Chief Executive Officer of enVVeno, presented the top five reasons of why he believes the investment community and industry colleagues should pay attention to the Company in 2025.
Neutral
Accesswire
1 month ago
One-Year Data from the VenoValve(R) U.S. Pivotal Trial Highlighting Impact on Patients' Quality of Life (QOL) to be Presented Today at the 37th Annual Meeting of the American Venous Forum
One-year follow-up data demonstrates sustained improvements across venous specific quality-of-life (QoL) indicators. PMA application for the VenoValve submitted in November 2024, with an FDA decision expected in the second half of 2025.
Neutral
Accesswire
1 month ago
Interim Two-Year Follow-Up Data from the VenoValve(R) U.S. Pivotal Trial to be Presented Today at the VESS 2025 Annual Winter Meeting
Two-year follow-up data from 34 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit, from 12 months to 24 months. 78% of subjects maintained a clinically meaningful benefit of more than 3 points in rVCSS at 24 months, with an average improvement of 8.2 points among the responder cohort.
Neutral
Accesswire
3 months ago
enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe
Successful Completion of All Planned Implants in GLP Study enVVe Delivery System Demonstrates Consistent Performance Company Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results IRVINE, CA / ACCESSWIRE / December 16, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the successful completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The successful completion of all planned implants in the GLP study, including both long-term and short-term subjects, completes a critical phase of the study.
Neutral
Accesswire
4 months ago
enVVeno Medical Highlights Successful 2024 VEITH Symposium with Launch of Recap Website
Interviews with participating patients from the VenoValve® U.S. Pivotal Trial Webcast replay from with the presenting Primary Investigators Presentation with data from the VenoValve U.S. Pivotal Trial Access the Recap Website Here! IRVINE, CA / ACCESSWIRE / November 27, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the launch of a recap website which highlights the Company's participation at the recently held 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium.
Positive
Zacks Investment Research
4 months ago
NVNO Completes Application for VenoValve's PMA, Shares Likely to Gain
The FDA's approval of VenoValve's PMA has the potential to significantly expand NVNO's portfolio of bioprosthetic solutions.
Neutral
Accesswire
4 months ago
enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium
85% Clinical Meaningful Benefit Responder Rate 7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort 75% Median Reduction in Pain (VAS) 87% Median Ulcer Area Reduction 97% Target Vein Patency Rate Improvement in All Patient Reported Quality-of-Life Indicators Company to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S. Among the data being presented at VEITH are: Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).
Neutral
Accesswire
4 months ago
enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 19, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA.
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