NVNO Apr 29, 2026NVNOFDA Updates
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.
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NVNO Mar 27, 2026NVNOFDA Updates
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.
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NVNO Feb 5, 2026NVNOGeneral
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.
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NVNO Jan 16, 2026NVNOGeneral
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.
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NVNO Nov 13, 2025NVNOFDA Updates
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.
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NVNO Aug 20, 2025NVNOFDA Updates
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.
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NVNO Apr 24, 2024NVNOConferences/Events
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.
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NVNO Mar 6, 2024NVNOConferences/Events
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.
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NVNO Nov 16, 2023NVNOConferences/Events
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.
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NVNO Sep 22, 2021NVNOGeneral
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
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NVNO Feb 9, 2021NVNOGeneral
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
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NVNO Dec 21, 2020NVNOGeneral
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
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NVNO Jul 17, 2020NVNOGeneral
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
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NVNO Jun 7, 2019NVNOGeneral
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
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NVNO Apr 30, 2019NVNOGeneral
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
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NVNO Mar 13, 2019NVNOGeneral
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,
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NVNO Oct 2, 2018NVNOGeneral
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
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NVNO Jul 13, 2018NVNOGeneral
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
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NVNO Jun 12, 2018NVNOGeneral
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
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NVNO May 31, 2018NVNOGeneral
Hancock Jaffe Laboratories, Inc. Announces Pricing of Initial Public Offering Irvine, Calif.
Jaffe Laboratories, Inc. Announces Pricing of Initial Public Offering
Calif., May 31, 2018 - Hancock Jaffe Laboratories, Inc. ("HJLI"), a company specializing in bioprosthetic
medical devices to establish improved standards of care for treating cardiac and vascular diseases, to
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