enVVeno Medical Corporation

Sep 11, 2026

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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.

Jul 7, 2026

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.

Jun 22, 2026

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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.

Jun 2, 2026

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.

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.

May 7, 2026

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.

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.

Apr 29, 2026

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enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve First-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal Trial Clinical site activation an

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.

Mar 27, 2026

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.

Mar 27, 2026

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.

Feb 5, 2026

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.

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.

Nov 26, 2025

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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.

Nov 13, 2025

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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.

Oct 31, 2025

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.

Sep 26, 2025

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.

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.

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.

Aug 20, 2025

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enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve

enVVeno Medical Corporation has received a not-approvable letter from the FDA regarding its PMA application for VenoValve, a surgical replacement valve for chronic venous insufficiency. The FDA's decision was based on insufficient data demonstrating a favorable benefit-risk profile and safety concerns related to the surgical procedure. Despite disappointment, enVVeno remains committed to patients and is exploring options, including potential resubmission or appeals. The company also aims to apply lessons learned for its non-surgical alternative, enVVe, that is currently under development.

Aug 15, 2025

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

enVVeno Medical Corporation will present at the Webull Financial Corporate Connect Webinar Series from August 19-21, 2025. CEO Robert Berman will lead the presentation on August 21 at 2:00 PM ET. The company focuses on innovative treatments for deep venous disease, including their lead product, the VenoValve.

Aug 6, 2025

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

enVVeno Medical Corporation announced preliminary findings from a health economic study indicating that its VenoValve could be a cost-effective treatment for severe Chronic Venous Insufficiency (CVI). The study suggests the VenoValve may save $5.9 billion annually in healthcare costs for U.S. patients. A live webcast will discuss these findings, emphasizing the device's potential to improve patient outcomes while reducing costs.

Aug 4, 2025

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 Corporation participated in a virtual investor segment discussing the implications of President Trump's recent diagnosis of chronic venous insufficiency (CVI). The company's VenoValve is being developed as a treatment option for the estimated 2.5 million patients in the U.S. suffering from severe CVI. A pre-market authorization application for the VenoValve has been submitted to the FDA, with a decision expected in the second half of 2025.

Aug 1, 2025

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

enVVeno Medical Corporation reported its Q2 2025 financial results, highlighting a cash burn of $3.8 million and sufficient funds to operate through Q3 2026. The company is preparing for a phased launch of its VenoValve product, pending FDA approval expected in the second half of 2025. Additionally, the IDE submission for its enVVe product is on track for the same timeframe. Despite an increase in net losses, the company remains optimistic about its future milestones.

Jul 22, 2025

enVVeno Medical Participates in the Virtual Investor “What’s Your Story” Summer Spotlight On-Demand Conference

enVVeno Medical Corporation participated in the Virtual Investor 'What’s Your Story' Summer Spotlight On-Demand Conference. CEO Rob Berman discussed his commitment to the company and provided insights into its innovative products for treating deep venous disease. The on-demand video is available on the company's website and virtualinvestorco.com.

Jun 6, 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

Interim data from enVVeno Medical's VenoValve pivotal trial show significant clinical improvements after two years. 83% of participants experienced a meaningful benefit, with an average rVCSS improvement of 9.1 points. The trial also reported a median 74% reduction in leg pain and a 100% valve patency rate. A decision from the FDA on the VenoValve is expected in late 2025.

May 19, 2025

enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer

enVVeno Medical Corporation has appointed Jennifer Bright as Chief Financial Officer, effective May 19, 2025. Bright brings over 25 years of experience in financial leadership within the medical device and pharmaceutical industries. Her role will be crucial in guiding the company's transition to a commercial entity and enhancing its financial infrastructure, particularly for the VenoValve and enVVe devices aimed at treating deep venous disease.

Three-Year VenoValve® First-in-Human Trial Data Published in the Annals of Vascular Surgery

The three-year results from the first-in-human trial of VenoValve show promising safety and effectiveness, with a 79% patency rate and significant symptom relief in patients. The findings have been published in the Annals of Vascular Surgery. enVVeno Medical Corporation has submitted a PMA application to the FDA, with a decision expected in late 2025.

enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H25

enVVeno Medical Corporation reported its first quarter 2025 financial results, highlighting a cash position of $38.9 million and a consistent cash burn of $4.0 million. The company anticipates an FDA decision on its VenoValve PMA application in the second half of 2025 and is on track to submit its enVVe IDE application in Q3 2025. Despite net losses, the company remains optimistic about transitioning to a commercial enterprise in 2025.

Apr 23, 2025

VenoValve to be Featured During Presentation at the 47th Annual Charing Cross Symposium

enVVeno Medical Corporation announced that its VenoValve will be presented at the Annual Charing Cross Symposium in London. Dr. David Dexter will discuss the progress and future prospects of invasive correction for deep venous reflux. The VenoValve aims to address severe Chronic Venous Insufficiency (CVI), with an estimated 2.5 million potential candidates in the U.S. The FDA decision on its pre-market authorization application is expected in late 2025.

Apr 16, 2025

enVVeno Medical to Participate in a Live Virtual Investor Closing Bell Segment

enVVeno Medical Corporation announced that CEO Robert Berman will participate in a Virtual Investor Closing Bell segment on April 22, 2025. During the event, he will provide an overview of the company's innovative venous valve technologies, including the VenoValve and enVVe, and will engage in a live Q&A session. This event highlights the company's focus on improving treatment standards for venous disease.

Mar 31, 2025

The Impact of the VenoValve® on Patients with Primary and Secondary Chronic Venous Insufficiency (CVI) to be Presented at the Society for Clinical Vascular Surgery 52nd Annual Symposium

enVVeno Medical Corporation's VenoValve has been accepted for presentation at the SCVS 52nd Annual Symposium. Dr. Cassius Iyad Ochoa Chaar will discuss its impact on patients with chronic venous insufficiency. The VenoValve is a first-in-class surgical solution aimed at treating severe cases of CVI, with a PMA application submitted to the FDA.

enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25

enVVeno Medical Corporation reported its fourth quarter and year-end 2024 financial results, highlighting the submission of the PMA application for its VenoValve, with FDA approval expected in the second half of 2025. The company also noted sustained clinical improvements in pivotal trials and a strong financial position with $43.2 million in cash. However, it reported net losses of $21.8 million and anticipates an increase in cash burn in 2025.

Feb 19, 2025

enVVeno Medical Participates in the Virtual Investor “Top 5 for ’25” On-Demand Conference

enVVeno Medical Corporation announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. CEO Robert Berman presented compelling reasons for investors to consider the company in 2025. The on-demand video of the presentation is available for viewing on the company's website. enVVeno focuses on innovative treatments for venous disease, including the VenoValve and enVVe.

Feb 19, 2025

One-Year Data from the VenoValve® 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

enVVeno Medical Corporation presented one-year follow-up data from the VenoValve U.S. pivotal trial, showing significant improvements in quality of life for patients with chronic venous insufficiency. The VenoValve aims to be the first FDA-approved treatment for this condition, with a PMA application submitted and a decision expected in late 2025. The data presentation took place at the 37th Annual Meeting of the American Venous Forum.

Feb 7, 2025

Interim Two-Year Follow-Up Data from the VenoValve® U.S. Pivotal Trial to be Presented Today at the VESS 2025 Annual Winter Meeting

The VenoValve pivotal trial's two-year follow-up data shows significant clinical improvement in patients, with 78% maintaining a meaningful benefit and a median 75% reduction in pain. The data will be presented at the VESS 2025 Annual Winter Meeting. The FDA's decision on the PMA application for VenoValve is expected in late 2025.

Dec 16, 2024

enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe

enVVeno Medical Corporation has successfully completed the final wave of implants in its pre-clinical GLP study for the enVVe transcatheter-delivered replacement venous valve. This milestone positions the company to submit its IDE application to the FDA by mid-2025, pending the study results. The enVVe system has shown consistent performance, indicating readiness for the pivotal trial.

Nov 27, 2024

enVVeno Medical Highlights Successful 2024 VEITH Symposium with Launch of Recap Website

enVVeno Medical Corporation announced the launch of a recap website highlighting its participation at the VEITH Symposium. The site features interviews with patients and primary investigators from the VenoValve U.S. Pivotal Trial, showcasing compelling data. The VenoValve is positioned as a potential first-in-class treatment for severe chronic venous insufficiency, addressing a significant healthcare need.

enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium

enVVeno Medical Corporation presented one-year data from the VenoValve U.S. pivotal trial at the VEITH Symposium. The results showed an 85% responder rate for clinically meaningful benefits and a 97% target vein patency rate. The data supports their application for pre-market authorization from the FDA. The company is optimistic about the VenoValve's potential to address severe chronic venous insufficiency.

Nov 19, 2024

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enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

enVVeno Medical Corporation has submitted its PMA application to the FDA for the VenoValve, aimed at treating severe chronic venous insufficiency (CVI). Four of the five modules have been approved, with the final module containing clinical data from the SAVVE trial. The company anticipates a decision from the FDA in the latter half of 2025. The VenoValve has been designated as a breakthrough device, highlighting its potential impact on patient care.

Oct 31, 2024

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

enVVeno Medical Corporation reported its third quarter 2024 financial results, highlighting progress in its FDA premarket approval application for the VenoValve. The company is set to release definitive data at the VEITHsymposium in November. Despite a cash position of $48.4 million, the company reported a 12% increase in net losses compared to the previous year.

Oct 28, 2024

enVVeno Medical Successfully Initiates 6-Month Pre-Clinical GLP Study Evaluating enVVe®

enVVeno Medical Corporation has successfully initiated a six-month pre-clinical GLP study for its transcatheter-delivered replacement venous valve, enVVe. The first wave of implants has been completed, and the company is on schedule to seek IDE approval from the FDA by mid-2025. The enVVe valve aims to address severe Chronic Venous Insufficiency, a condition affecting millions.

enVVeno Medical Corporation Announces Pricing of $15.0 Million Public Offering

enVVeno Medical Corporation has announced the pricing of a public offering of 4,285,715 shares at $3.50 per share, aiming to raise approximately $15 million. The offering is led by institutional investors and is expected to close around September 30, 2024. Proceeds will primarily fund the development of the company's lead products, VenoValve and enVVe.

Sep 26, 2024

enVVeno Medical Corporation Announces Proposed Public Offering

enVVeno Medical Corporation has announced a proposed public offering of its common stock, subject to market conditions. The company plans to use the proceeds to further develop its lead products, VenoValve and enVVe, while also addressing general corporate needs. The offering includes a 30-day option for underwriters to purchase additional shares. The company is currently conducting pivotal trials for its products.

Sep 3, 2024

enVVeno Medical Adds Sandy Prietto to its Executive Team as Vice President of Marketing

enVVeno Medical Corporation has appointed Sandy Prietto as Vice President of Marketing. Prietto, who has extensive experience in medical device marketing, will lead efforts for the VenoValve's commercial launch. The company is also planning several key milestones for 2024, including the completion of a PMA submission for FDA approval and the release of pivotal study data.

Aug 14, 2024

enVVeno Medical Provides Update on FDA Premarket Approval Application Status for VenoValve®

enVVeno Medical Corporation has provided an update on its FDA premarket approval application for the VenoValve, a surgical valve for treating severe Chronic Venous Insufficiency (CVI). Four out of the five required modules have been approved, with the final module expected to be submitted in Q4 2024. The VenoValve aims to address a significant medical need, as there are currently no effective treatments for severe CVI.

Aug 1, 2024

enVVeno Medical Reports Second Quarter 2024 Financial Results and Provides Corporate Update

enVVeno Medical Corporation reported strong financial results for Q2 2024, ending with $39.1 million in cash. The company highlighted positive interim data from the VenoValve pivotal trial, showing significant improvements in venous ulcer healing. They are on track to file for FDA approval of VenoValve in Q4 2024 and are progressing towards launching a GLP study for the enVVe valve.

Positive Interim Venous Ulcer Healing Data Showing Significant Improvement from the enVVeno Medical VenoValve® Pivotal Trial to be Presented Today at the Society for Vascular Surgery 2024 Vascular Annual Meeting

enVVeno Medical Corporation announced positive interim results from the SAVVE trial for its VenoValve device, showing significant healing in venous ulcer patients. At one year, 91% of patients had healed or improved ulcers, with a 100% healing rate for those treated within a year of ulcer onset. The company plans to file for FDA approval by Q4 2024.

Jun 17, 2024

New Interim Venous Ulcer Healing Data from the enVVeno Medical VenoValve® Pivotal Trial to be Presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024

enVVeno Medical Corporation announced that new interim data from its VenoValve pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting. The data will cover healing rates for venous ulcers after one year of treatment. The presentation aims to demonstrate the VenoValve's effectiveness in treating patients with severe Chronic Venous Insufficiency, a condition with limited treatment options.

May 8, 2024

enVVeno Medical Reports First Quarter 2024 Financial Results and Provides Corporate Update

enVVeno Medical Corporation reported its Q1 2024 financial results, highlighting a strong cash position of $42.9 million. The company presented positive efficacy data for its VenoValve at the 46th Annual Charing Cross Symposium and is preparing to file a PMA application for FDA approval by Q4 2024. Despite a decrease in net losses, the company still reported a cash burn of $3.5 million for the quarter.

Positive 11 Month Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical’s VenoValve® Pivotal Trial to be Presented Today at the 46th Annual Charing Cross Symposium

enVVeno Medical Corporation presented positive topline efficacy data from its VenoValve pivotal trial at the 2024 Charing Cross International Symposium. The data indicates an average improvement of 8.46 points in the Revised Venous Clinical Severity Score (rVCSS) among patients, with 94% showing clinical improvement. The company aims to file for FDA approval in Q4 2024, having collected promising data over an 11-month follow-up period.

Apr 24, 2024

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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 Revis

enVVeno Medical Corporation announced positive topline efficacy data from its VenoValve pivotal trial, to be presented at the 46th Annual Charing Cross Symposium. Key findings include an average Revised Venous Clinical Severity Score (rVCSS) improvement of 8.46 points across patients, indicating significant clinical benefits. Furthermore, 94% of study participants demonstrated clinical improvement at an average follow-up of 11.04 months. The company is on track to file an application for VenoValve FDA approval in the fourth quarter of 2024.

Apr 16, 2024

New Topline Efficacy Data from the enVVeno Medical VenoValve® Pivotal Trial to be Presented at the 46th Annual Charing Cross Symposium on April 24, 2024

enVVeno Medical Corporation announced that new topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 Charing Cross International Symposium. The data will focus on the clinical outcomes of patients with Chronic Venous Insufficiency (CVI) after VenoValve implantation. The presentation aims to highlight the device's potential benefits compared to existing treatments.

Apr 9, 2024

enVVeno Medical Appoints Andrew Cormack as Its Chief Commercial Officer

enVVeno Medical Corporation has appointed Andrew Cormack as Chief Commercial Officer to lead the commercialization of the VenoValve. The company is preparing to file a PMA application for the VenoValve with the FDA in Q4 2024, following promising initial data from the SAVVE study. Cormack's extensive experience in product launches is expected to enhance the company's market strategy.

Mar 15, 2024

enVVeno Medical to Participate in the Virtual Investor Lunch Break: The enVVeno Opportunity

enVVeno Medical Corporation will participate in the Virtual Investor Lunch Break on March 21, 2024. CEO Robert Berman will present a corporate overview and discuss the company's innovative solutions for venous disease treatment. The event will be accessible via a live video webcast, with a replay available for 90 days.

Mar 6, 2024

Positive Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical’s VenoValve® Pivotal Trial to be Presented Today at the VENOUS2024 American Venous Forum Annual Meeting

enVVeno Medical Corporation presented positive topline data from its VenoValve pivotal trial at the 2024 American Venous Forum Annual Meeting. The results indicate that 97% of patients showed clinical improvement, with 74% achieving a significant benefit. The company plans to file for FDA approval in Q4 2024 after collecting additional data.

Mar 6, 2024

Positive Topline Efficacy Data Showing Significant Clinical Improvement from enVVeno Medical's VenoValve Pivotal Trial to be Presented Today at the VENOUS2024 American Venous Forum Annual Meeting 97% of VenoValve Study P

enVVeno Medical Corporation announced significant clinical improvement results from their VenoValve pivotal trial, which will be presented at the VENOUS2024 American Venous Forum. A remarkable 97% of patients experienced clinical improvement, with an average increase in the revised Venous Clinical Severity Score (rVCSS) of 8 points. The data suggests that many patients have progressed from severe Chronic Venous Insufficiency (CVI) to a milder form or have even resolved their symptoms. The company plans to file for FDA approval in Q4 2024 after gathering additional data.

Feb 29, 2024

enVVeno Medical Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update

enVVeno Medical Corporation reported its fourth quarter and year-end 2023 financial results, highlighting a strong cash position of $46.4 million. The company is set to present topline efficacy data for its VenoValve in March 2024 and is progressing towards launching a GLP study for its enVVe valve. Despite a net loss of $23.5 million, the company is optimistic about upcoming milestones.

Feb 20, 2024

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Topline Efficacy Data from the enVVeno Medical VenoValve® Pivotal Trial to be Presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024

enVVeno Medical Corporation announced that topline efficacy data from its VenoValve U.S. pivotal trial will be presented at the 2024 American Venous Forum Annual Meeting. The data will assess clinical improvements in patients with severe Chronic Venous Insufficiency, using the revised Venous Clinical Severity Scores. The presentation is scheduled for March 6, 2024, by Dr. Cassius Iyad Ochoa Chaar.

Dec 14, 2023

enVVeno Medical Posts Company Highlights and Materials from 2023 VEITH Symposium

enVVeno Medical Corporation has released highlights from the 50th Annual VEITH Symposium, including patient interviews from the VenoValve pivotal study. The company aims to provide valuable insights to investors unable to attend the event. The VenoValve is currently being evaluated in a pivotal study, with plans for a new product, enVVe, expected to enter trials in late 2024.

Nov 16, 2023

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enVVeno Medical Presents Positive Preliminary Device Related Material Adverse Event (MAE) Data from the VenoValve Pivotal Trial at the 50th Annual VEITH Symposium

enVVeno Medical Corporation presented positive preliminary data from the VenoValve pivotal trial at the VEITH Symposium. The study, involving 75 patients, reported an 8% device-related Material Adverse Event (MAE) rate, with no deaths or pulmonary embolisms. However, there were six cases of deep vein thrombosis (DVT), with some MAEs pending further review. The company plans to file for pre-market approval with the FDA in Q4 of 2024.

Nov 16, 2023

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enVVeno Medical Presents Positive Preliminary Device Related Material Adverse Event (MAE) Data from the VenoValve Pivotal Trial at the 50 th Annual VEITH Symposium - No Deaths or Pulmonary Embolisms Occurring During the

enVVeno Medical Corporation presented positive preliminary safety data for its VenoValve at the 50th Annual VEITH Symposium. The data showed no deaths or pulmonary embolisms and an 8% overall device-related material adverse event rate in a study involving 75 patients. However, there were six reported cases of deep vein thrombosis among the participants. The company aims for FDA approval for the VenoValve by the end of 2024, while also developing a non-surgical replacement valve.

Oct 26, 2023

enVVeno Medical Reports Third Quarter 2023 Financial Results and Provides Corporate Update

enVVeno Medical Corporation reported its third quarter 2023 financial results, highlighting a strong cash position of $51.4 million. The company achieved full enrollment in the VenoValve U.S. pivotal trial and plans to expedite the development of its enVVe transcatheter valve. Despite a decrease in net losses, the company anticipates an increase in cash burn as it approaches commercialization.

Oct 12, 2023

enVVeno Medical to Participate at the Virtual Investor Ask the CEO Conference

enVVeno Medical Corporation announced that CEO Robert Berman will participate in the Virtual Investor Ask the CEO Conference on October 25, 2023. This event allows investors to engage directly with management and ask questions. The company recently achieved full enrollment in its VenoValve pivotal trial and raised $28 million in capital, signaling a strong growth trajectory.

enVVeno Medical Achieves Full Enrollment for VenoValve U.S. Pivotal Trial

enVVeno Medical Corporation has successfully completed full enrollment in its U.S. pivotal trial for the VenoValve, achieving this milestone ahead of schedule. The trial, known as SAVVE, has seen a surge in patient demand, with initial safety data expected in Q4 2023 and efficacy data in Q2 2024. The company aims to file for FDA approval by Q3 2024.

Oct 6, 2023

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enVVeno Medical Announces New Expedited Development Plan for the enVVe® Transcatheter Based Replacement Venous Valve

enVVeno Medical Corporation announced an expedited development plan for its enVVe transcatheter-based replacement venous valve, reducing the development cycle by six months. The company plans to start a pre-clinical GLP study in early 2024 and aims to seek an Investigational Device Exemption by the end of 2024. This valve is designed to treat severe Chronic Venous Insufficiency with a minimally invasive procedure.

Oct 6, 2023

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enVVeno Medical Announces Private Placement of $28 Million

enVVeno Medical Corporation has announced a private placement of approximately $28 million with institutional investors to support its operations and reduce capital risk through 2025. The funding is expected to facilitate significant milestones, including the release of efficacy data from the VenoValve pivotal trial and preparations for commercialization. Additional capital may be available through milestone-driven warrants linked to upcoming trial results and FDA approval.

enVVeno Medical Reports Second Quarter 2023 Financial Results and Provides Corporate Update

enVVeno Medical Corporation reported its second quarter 2023 financial results, highlighting a cash balance of $29.8 million and a cash burn of $4.4 million. The company remains on track to complete enrollment in the SAVVE pivotal study by the end of 2023, with positive feedback on its VenoValve. Despite a decrease in net losses, the company continues to face significant operational expenses.

Jul 14, 2023

enVVeno Medical to Host Virtual KOL Event on July 18, 2023

enVVeno Medical Corporation will host a virtual Key Opinion Leader (KOL) event on July 18, 2023, featuring discussions on their VenoValve technology. The event will include insights from principal investigators involved in the ongoing SAVVE study and address the need for replacement venous valve technology. A live Q&A session will follow the presentations.

Sep 22, 2021

Hancock Jaffe Announces Corporate Rebranding to Reflect Prioritization of its Development Pipeline on Venous Disease Programs - Hancock Jaffe changing name to enVVeno Medical Corporation and ticker symbol to NASDAQ: NVNO

Jaffe Announces Corporate Rebranding to Reflect Prioritization of its Development Pipeline on Venous Disease Programs Hancock Jaffe changing name to enVVeno Medical Corporation and ticker symbol to NASDAQ: NVNO, effective October 1, 2021 - Development strategy to focus on venou

Feb 9, 2021

Hancock Jaffe Laboratories Announces Pricing of Upsized $36 Million Offering

Jaffe Laboratories Announces Pricing of Upsized California, February 9, 2021 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced the pricing of its upsized underwritten public offering of un

Dec 21, 2020

Hancock Jaffe Deemed Compliant With All Nasdaq Continued Listing Requirements Company Regains Compliance with Nasdaq Minimum Bid Requirement

Jaffe Deemed Compliant With All Nasdaq Continued Listing Requirements Regains Compliance with Nasdaq Minimum Bid Requirement California, December 21, 2020 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health

Jul 17, 2020

Hancock Jaffe Laboratories Announces Pricing of $5.6 Million Offering

Jaffe Laboratories Announces Pricing of $5.6 Million Offering California., July 17, 2020 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced the pricing of a $5.6 million offering, which con

Jun 7, 2019

Hancock Jaffe Reports Early Positive Results from First-In-Human VenoValve Study Reflux Significantly Reduced in Four out of Five Patients

Hancock Jaffe Reports Early Positive Results from First-In-Human VenoValve Study Reflux Significantly Reduced in Four out of Five Patients IRVINE, California., June 7, 2019 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a developer of medical devices that restore

Apr 30, 2019

Hancock Jaffe Mourns the Loss of Director Marc Robins

Jaffe Mourns the Loss of Director Marc Robins California., April 30, 2019 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announces the passing of its director, Marc Robins. Mr. Robins passed awa

Mar 13, 2019

Hancock Jaffe Completes $2.7 Million Private Placement of Common Stock Company Strengthens Financial Position Ahead of Key Milestones Irvine, California

Jaffe Completes $2.7 Million Private Placement of Common Stock Strengthens Financial Position Ahead of Key Milestones California - March 13, 2019 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health,

Oct 2, 2018

HANCOCK JAFFE APPOINTS THREE NEW INDEPENDENT DIRECTORS Accomplished medical device professionals and nationally recognized fund manager and analyst bring key experience to the leadership of cardiac and vascular device co

JAFFE APPOINTS THREE NEW INDEPENDENT DIRECTORS medical device professionals and nationally recognized fund manager and analyst bring key experience to the leadership of cardiac and vascular device company IMMEDIATE RELEASE - Irvine, Calif., October 2, 2018 - Hancock Jaffe Labo

Jul 13, 2018

Hancock Jaffe Appoints Bob Rankin as Chief Financial Officer Irvine, Calif.

Jaffe Appoints Bob Rankin as Chief Financial Officer Calif., July 13, 2018 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, today

Jun 12, 2018

Hancock Jaffe Laboratories, Inc. Announces Full Exercise of $1,125,000 Underwriter's Over Allotment Irvine, Calif.

Jaffe Laboratories, Inc. Announces Full Exercise of $1,125,000 Underwriter's Over Allotment Calif., June 12, 2018 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treati

May 31, 2018