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© ACCESSWIRE
15.01.2026
NVNO
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enVVeno Medical Announces Reverse Stock Split
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IRVINE, CA / ACCESS Newswire / January 15, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced that the Company's Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1 for 35 (the "Reverse Stock Split"). The Reverse Stock S...
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26.11.2025
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enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment
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Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Wednesday, December 3rd at 4:00 PM ET IRVINE, CA / ACCESS Newswire / November 26, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), today announced that Robert Berman, Chief Executive Officer of enVVeno Medica...
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13.11.2025
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enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
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IRVINE, CA / ACCESS Newswire / November 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 it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") i...
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20.10.2025
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31.10.2025
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enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update
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- Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study- Cash burn of $4.2 million in Q3 remains in line with projected quarterly range- Ongoing engagement with FDA for supervisory appeal of the VenoValve PMA decision with feedback expected by the end of 202...
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20.10.2025
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26.09.2025
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enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor "What This Means" Segment
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Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / September 26, 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 Robert Berman, Chief Executive Officer of enVVeno Medi...
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15.09.2025
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enVVeno Medical Updates Regulatory Status of VenoValve(R)
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IRVINE, CA / ACCESS Newswire / September 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 file a request for supervisory appeal of the not-approvable letter from the Center for Devices...
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20.08.2025
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enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)
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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...
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15.08.2025
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enVVeno Medical to Present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech
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- 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 Con...
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06.08.2025
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Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency
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Clinical data and cost-effectiveness analysis demonstrates the VenoValve would provide both better health outcomes and lower costs compared to current standard of care treatmentsThe VenoValve could potentially save $5.9 billion annually in healthcare costs for the approximately 2.5 million U.S. patients with severe CVICompany to host live webcast w...
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04.08.2025
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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
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- 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 (Nasda...
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01.08.2025
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enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update
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- 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 2...
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22.07.2025
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enVVeno Medical Participates in the Virtual Investor "What’s Your Story" Summer Spotlight On-Demand Conference
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- 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 &qu...
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20.10.2025
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06.06.2025
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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
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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 baseline83% 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 impr...
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19.05.2025
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enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer
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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 tha...
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13.05.2025
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Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery
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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 benefitsCompany has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a...
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01.05.2025
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enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H24
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Cash Burn of $4.0 million in Q1 remains in line with projected quarterly rangeCash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trialFDA decision on PMA application for the VenoValve expected in the second half of 2025On track for enVVe IDE applica...
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23.04.2025
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VenoValve to be Featured During Presentation at the 47th Annual Charing Cross Symposium
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IRVINE, CA / ACCESS Newswire / April 23, 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 the VenoValve® will be featured during a presentation at the Annual Charing Cross Symposium being held...
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16.04.2025
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enVVeno Medical to Participate in a Live Virtual Investor Closing Bell Segment
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Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Tuesday, April 22nd at 4:00 PM ET IRVINE, CA / ACCESS Newswire / April 16, 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...
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31.03.2025
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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
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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 Sympo...
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28.02.2025
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enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25
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Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly rangeCash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trialPMA application for the VenoValve submitted, with FDA decision expected in the second half of 2...
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19.02.2025
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enVVeno Medical Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference
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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"...
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19.02.2025
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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
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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.IRVINE, CA / ACCESS Newswire / February 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" o...
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© ACCESSWIRE
07.02.2025
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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
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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.Subjects c...
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16.12.2024
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enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe
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Successful Completion of All Planned Implants in GLP StudyenVVe Delivery System Demonstrates Consistent PerformanceCompany 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"),...
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27.11.2024
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enVVeno Medical Highlights Successful 2024 VEITH Symposium with Launch of Recap Website
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Interviews with participating patients from the VenoValve® U.S. Pivotal TrialWebcast replay from with the presenting Primary InvestigatorsPresentation with data from the VenoValve U.S. Pivotal TrialAccess the Recap Website Here!IRVINE, CA / ACCESSWIRE / November 27, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the &...
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20.11.2024
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enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium
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85% Clinical Meaningful Benefit Responder Rate7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort75% Median Reduction in Pain (VAS)87% Median Ulcer Area Reduction97% Target Vein Patency RateImprovement in All Patient Reported Quality-of-Life IndicatorsCompany to Host Video Conference Call with VEITH Presenter...
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19.11.2024
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enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
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Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH SymposiumCompany 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) (&qu...
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31.10.2024
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enVVeno Medical Reports Third Quarter 2024 Financial Results and Confirms Guidance for Release of Definitive VenoValve Data in November and Completion of FDA Premarket Approval Application for VenoValve in Q4 of this Year
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Continued progress toward submission of 5th and final module of FDA premarket approval (PMA) application for VenoValve® in Q4GLP study for enVVe® transcatheter-based replacement venous valve underway; On track to file IDE approval for pivotal trial mid-2025Ended the quarter with $48.4 million cash and investments on hand sufficient to fun...
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© ACCESSWIRE
28.10.2024
NVNO
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enVVeno Medical Successfully Initiates 6-Month Pre-Clinical GLP Study Evaluating enVVe(R)
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First wave of implants successfully completed with updated delivery system performing very wellCompany on schedule to be in position to apply for approval for enVVe pivotal trial mid-2025 IRVINE, CA / ACCESSWIRE / October 28, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new sta...
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