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... Read More

Live webcast on Thursday, August 21 st at 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... Read More

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 6 th , at... Read More

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... Read More

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... Read More

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. Berman dove... Read More

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... Read More

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... Read More

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... Read More

Cash Burn of $4.0 million in Q1 remains in line with projected quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trial FDA decision on PMA application for the VenoValve expected in the second half of 2025 On track for enVVe IDE application submission in Q3 of 2025, pending GLP study results IRVINE, CA /... Read More

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 April 23-25, 2025 in London, England. As part of the Symposium, Dr. David Dexter, Sentara Hospital,... Read More

Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Tuesday, April 22 nd 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 that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in the Virtual... Read More

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) 52 nd Annual Symposium being held March 29-April 2, 2025 in Austin, TX. As part of the SCVS Symposium, Dr. Cassius... Read More

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... Read More

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... Read More

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" or the "Company"), a company setting new standards of care for the treatment of venous... Read More

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 continued to experience a median 75% reduction in pain at 24 months. Interim... Read More

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... Read More

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,... Read More

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 /... Read More

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 20 th 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... Read More

Continued progress toward submission of 5 th and final module of FDA premarket approval (PMA) application for VenoValve® in Q4 GLP study for enVVe® transcatheter-based replacement venous valve underway; On track to file IDE approval for pivotal trial mid-2025 Ended the quarter with $48.4 million cash and investments on hand sufficient to fund operations beyond expected regulatory approval of the VenoValve and start of the... Read More

First wave of implants successfully completed with updated delivery system performing very well Company 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 standards of care for the treatment of venous disease, today announced the successful start to its... Read More

IRVINE, CA / ACCESSWIRE / September 26, 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 pricing of an underwritten public offering led by existing institutional investors of 4,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at a public offering price of $3.50 per share.... Read More

IRVINE, CA / ACCESSWIRE / September 26, 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 that it is proposing to offer and sell, subject to market conditions, shares of its common stock (or pre-funded warrants in lieu thereof) in an underwritten public offering. enVVeno expects to grant the underwriter a... Read More

MedTech Marketing Leader with Significant New Product Launch Experience for Cardiovascular Devices Key Addition to Commercial Team as Company Begins Planning for the VenoValve Monetization Several Upcoming Company Milestones Planned for Q4 of 2024 Including: Completion of PMA Submission Seeking FDA Approval for the VenoValve Release of One Year Data from VenoValve U.S. Pivotal Study Beginning of GLP Pre-clinical Study for... Read More

VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA 4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDA Company on Track to File the 5 th and Final Module in Q4 2024 IRVINE, CA / ACCESSWIRE / August 14, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today... Read More

Ended the quarter with $39.1 million cash and investments on hand sufficient to fund operations, through the end of 2025, including potential PMA approval of VenoValve® Positive interim venous ulcer healing data showing significant improvement from the VenoValve pivotal trial presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting Company on track to file application seeking VenoValve FDA approval in Q4... Read More

Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Thursday, June 27 th at 4:00 PM ET IRVINE, CA / ACCESSWIRE / June 25, 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 that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in the Virtual... Read More

91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved 100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed 89% of Venous Ulcers with a Duration of More Than One Year Prior to VenoValve Surgery Have Fully Healed or Improved No Ulcer Recurrences Company on Track to File Application Seeking VenoValve FDA Approval in Q4... Read More

IRVINE, CA / ACCESSWIRE / June 17, 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 that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL. The... Read More

Ended the quarter with $42.9 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025 Positive 11-month topline efficacy data presented at the 46 th Annual Charing Cross Symposium Company on track to file PMA Application seeking VenoValve® FDA approval in Q4 2024 IRVINE, CA / ACCESSWIRE / May 8, 2024 / enVVeno Medical Corporation... Read More

Overall 8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit (rVCSS Improvement ≥ 3 Points) including: 9.29 Points for Patients at the Two-Year Milestone 8.08 Points for Patients at the One-Year Milestone 8.71 Points for Patients at the Six-Month Milestone 72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a... Read More

IRVINE, CA / ACCESSWIRE / April 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 that additional topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 Charing Cross International Symposium being held April 23 rd - 25 th in London, England. The presentation,... Read More

Appointment bolsters Company's transition from being a clinical stage to a commercial entity planning for the monetization of the VenoValve® PMA application seeking FDA approval for the VenoValve on track to be filed in Q4 of 2024 IRVINE, CA / ACCESSWIRE / April 9, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today... Read More

Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Thursday, March 21 st at 12:00 PM ET IRVINE, CA / ACCESSWIRE / March 15, 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 that it will present at the Virtual Investor Lunch Break: The enVVeno Opportunity event on... Read More

97% of VenoValve Study Patients Showing Clinical Improvement at Six Months (as Measured by the Revised Venous Clinical Severity Score (rVCSS)) 74% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at Six Months (Improvement in rVCSS of 3 or More Points) Average rVCSS Improvement Per Patient is 8 Points, More Than Two and a Half Times the Amount Needed to Show the VenoValve's Clinically Meaningful... Read More

$46.4 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025 Topline efficacy data for VenoValve® U.S. pivotal trial to be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024 Continued progress toward launch of GLP study for enVVe® transcatheter-based replacement venous valve IRVINE, CA / ACCESSWIRE /... Read More

IRVINE, CA / ACCESSWIRE / February 20, 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 that topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 American Venous Forum (AVF) Annual Meeting being held March 3-6, 2024 in Tampa, Florida. The presentation will be made on... Read More

Interviews with patients from the VenoValve® pivotal study Materials now available on the Company's website IRVINE, CA / ACCESSWIRE / December 14, 2023 / e nVVeno Medical Corporatio n (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that it has posted Company highlights and materials from the recently held 50 th Annual VEITH Symposium on... Read More

No Deaths or Pulmonary Embolisms Occurring During the 30 Day MAE Period Expected Overall Device-Related Material Adverse Event Rate of 8% for the Fully Enrolled 75 Patient Study Six (6) DVT Related MAEs IRVINE, CA / ACCESSWIRE / November 16, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that positive... Read More

$51.4 million cash on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025 Achieved full enrollment for VenoValve® U.S. pivotal trial Expedited development plan for the enVVe® transcatheter-based replacement venous valve IRVINE, CA / ACCESSWIRE / October 26, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new... Read More

Live moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Wednesday, October 25 th at 12:00 PM ET IRVINE, CA / ACCESSWIRE / October 12, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical, will participate at the... Read More

18 VenoValve patients enrolled over the final two months of the study Surge in VenoValve demand exceeded the enrollment limit Topline safety and efficacy readout and PMA eligibility now expected to occur in Q4 2023, Q2 2024, and Q3 2024, respectively IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of... Read More

enVVe development cycle to be reduced by 6 months Application for enVVe pivotal trial now expected to be ready by end of 2024 IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced a plan to expedite the development of enVVe ® , its transcatheter based replacement venous... Read More

Up to an additional $34 million of capital may become available from milestone-driven warrants in Q2, 2024 upon the release of initial topline efficacy data from the VenoValve pivotal trial Up to an additional $41 million of capital may become available from milestone-driven warrants upon expected FDA pre-market approval of the VenoValve IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO)... Read More

Ended the quarter with $29.8 million in cash and investments with quarterly burn of $4.4 million - in line with Company guidance Cash on hand sufficient to fund its current operations past the release of topline safety and efficacy data from the SAVVE® study and through the end of 2024 IRVINE, CA / ACCESSWIRE / July 31, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new... Read More

IRVINE, CA / ACCESSWIRE / July 14, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reminded investors that it will host a virtual KOL event on Tuesday, July 18, 2023, at 3:00 PM ET. To register for the event, please click here . The KOL event will feature two principal investigators from the Company's ongoing... Read More

57 patients enrolled to date in the SAVVE® study Full SAVVE enrollment expected by year-end July 13 - Company to participate in investor event to further discuss enrollment July 18 - KOL event with two SAVVE study Principal Investigators IRVINE, CA / ACCESSWIRE / July 5, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease,... Read More

Ended the quarter with $34.2 million in cash and investments with quarterly burn of $4.9 million - in line with Company projections Cash expected to support operations through the end of 2024, including release of SAVVE topline data and TAVVE first-in-human study data IRVINE, CA / ACCESSWIRE / May 1, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the... Read More

Achieved more than half of enrollment in U.S. SAVVE pivotal trial of VenoValve® in 2022 Multiple near-term milestones expected across VenoValve® and enVVe™ clinical programs Ended the year with $39.1 million in cash and investments including $3.6 million burn for Q4 Cash expected to support operations through the end of 2024, including release of SAVVE topline data and TAVVE first-in-human study data IRVINE, CA / ACCESSWIRE... Read More

Live video webcast presentation on Wednesday, March 8 th at 9:10 AM ET IRVINE, CA / ACCESSWIRE / February 8, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that Robert Berman, CEO of enVVeno Medical , will present at Cowen's 43 rd Annual Health Care Conference on Wednesday, March 8, 2023 at 9:10 AM ET.... Read More

Dr. Alavi is a highly accomplished medical device executive with proven track record of successfully leading R&D, Quality Assurance, Regulatory Affairs, and Manufacturing organizations across a number of companies within the cardiac and vascular space IRVINE, CA / ACCESSWIRE / January 18, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment... Read More