Author: enVVeno Medical Corporation

  • enVVeno Medical Announces Reverse Stock Split

    enVVeno Medical Announces Reverse Stock Split

    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 Split will become effective at 12:01 a.m. Eastern time on January 20, 2026 and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on January 20, 2026 under the Company’s existing trading symbol “NVNO”. At such time, the Company’s common stock will also commence trading under a new CUSIP number 29415J205.

    “The Reverse Stock Split, which was approved by stockholders at the Company’s annual meeting on December 11, 2025, is an important first step in a multi-part plan for 2026 that we expect will create value for shareholders and reestablish our roadmap for enVVeno medical to become the preeminent company for treating deep venous disease,” commented Robert Berman, CEO of enVVeno Medical. “We have been busy working on our strategic plans for 2026, the details of which will become evident in the coming weeks, and regaining compliance with listing requirements for The Nasdaq Capital Market positions the Company to execute those plans.”

    At the effective time of the Reverse Stock Split, every thirty-five (35) shares of NVNO common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.00001 per share. This will reduce the Company’s outstanding common stock from approximately 22.9 million shares to approximately 655 thousand shares. The Company will not issue fractional shares as a result of the Reverse Stock Split and will instead pay cash for any fractional shares resulting from the reverse split. The shares and exercise prices, as applicable, underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly.

    The Company’s transfer agent, Equiniti Trust Company, LLC, will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as of the effective date, a letter of transmittal providing instructions for the exchange of shares. Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split, subject to such broker’s particular processes, and will not be required to take any action in connection with the Reverse Stock Split.

    Additional information regarding the Reverse Stock Split can be found in the Company’s definitive proxy statement (Form DEF 14A) and revised definitive proxy statement filed with the U.S. Securities and Exchange Commission on October 30, 2025 and December 2, 2025, respectively. Equiniti can be reached by phone at (877) 248-6417 (toll free) or (718) 921-8317.

    About enVVeno Medical Corporation
    enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.

    Cautionary Note on Forward-Looking Statements
    This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

    INVESTOR CONTACT:
    Jenene Thomas, JTC Team, LLC
    NVNO@jtcir.com
    (908) 824-0775

    MEDIA CONTACT:
    Glenn Silver, FINN Partners
    Glenn.Silver@finnpartners.com
    (973) 818-8198

    SOURCE: enVVeno Medical Corporation

    View the original press release on ACCESS Newswire

  • enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment

    enVVeno Medical (NASDAQ:NVNO) to Participate in a Live Virtual Investor CEO Connect Segment

    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 Medical will participate in a Live Virtual Investor CEO Connect segment on Wednesday, December 3, 2025 at 4:00 PM ET.

    As part of the event, Mr. Berman will provide a corporate overview and discuss the Company’s recent news and next steps. In addition to the moderated discussion, there will be a live question and answer session. Mr. Berman will answer as many questions as possible in the time allowed.

    A live video webcast of the presentation will be available on the Events page of the Company’s website (www.envveno.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days.

    About enVVeno Medical Corporation

    enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.

    Cautionary Note on Forward-Looking Statements

    This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

    ###

    INVESTOR CONTACT:

    Jenene Thomas, JTC Team, LLC
    NVNO@jtcir.com
    (908) 824-0775

    MEDIA CONTACT:
    Glenn Silver, FINN Partners
    Glenn.Silver@finnpartners.com
    (973) 818-8198

    SOURCE: enVVeno Medical Corporation

    View the original press release on ACCESS Newswire

  • enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve

    enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve

    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”) in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness.

    “Although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe, our next generation transcatheter based replacement venous valve,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “enVVe should have a different safety profile than an open surgical device and is ready for human testing. Assuming that we can reach alignment with the Agency on achieveble endpoints for enVVe, it makes sense to turn our attention and devote our resources to enVVe. We will continue to interact with the FDA on enVVe and will provide periodic updates on our progress.”

    The Company reported $31.5 million in cash and investments at the end of the third quarter. With its quarterly cash burn of $4 to $5 million a quarter, the Company has sufficient cash to fund operations into 2027.

    Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that there are approximately 2.5 million to 3.5 million patients with severe deep venous CV I in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S. has been estimated to exceed $20 billion a year.

    About enVVeno Medical Corporation
    enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is developing surgical and non-surgical replacement venous valves for the treatment of deep venous CVI.

    Cautionary Note on Forward-Looking Statements
    This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

    INVESTOR CONTACT:
    Jenene Thomas, JTC Team, LLC
    NVNO@jtcir.com
    (908) 824-0775

    MEDIA CONTACT:
    Glenn Silver, FINN Partners
    Glenn.Silver@finnpartners.com
    (973) 818-8198

    SOURCE: enVVeno Medical Corporation

    View the original press release on ACCESS Newswire

  • enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update

    – 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 2025

    IRVINE, CA / ACCESS Newswire / October 31, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno Medical” or the “Company”), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the third quarter 2025.

    Summary of Financial Results for the Third Quarter 2025

    The Company ended the quarter with $31.0 million in cash and investments. With the VenoValve commercializations costs and enVVe IDE expenses currently on hold pending resolution with the FDA, this capital has the potential to fund the Company through the second quarter of 2027. The Company expects its cash burn rate to increase from current levels in the event the Company proceeds to commercialization of the VenoValve and the IDE study with enVVe.

    Cash burn for the quarter was $4.2 million, consistent with the Company’s projected cash burn rate of approximately $4-5 million per quarter.

    The Company reported net losses of $4.5 million and $5.6 million for the three months ended September 30, 2025 and 2024, respectively, representing a decrease in net loss of $1.1 million, or 20%, due to a decrease in operating expenses of $1.3 million, partially offset by a decrease in other income of $0.2 million.

    “We are well capitalized and should have sufficient capital to cover the period of our ongoing discussions with the FDA seeking a potential commercial path forward for the VenoValve and clarity for the enVVe IDE study,” commented Robert Berman, CEO of enVVeno Medical. “Our recent in-person appeal meeting with the FDA provided a focused setting to address the concerns outlined in the not-approvable letter, including safety concerns raised by the FDA, proposed mitigations, the VenoValve’s effectiveness, and also provided the opportunity for the Agency to hear directly from one of our primary investigators and a patient from the VenoValve study. We look forward to our continued interactions with the FDA and remain committed to the 2.5 million patients suffering from severe deep chronic venous insufficiency.”

    Clinical Program Progress

    VenoValve®: Novel, First-In-Class Surgical Replacement Venous Valve

    • Filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI)

    • Completed the in-person appeal meeting with the FDA. Participants included a patient as well as one of the primary investigators from VenoValve U.S. pivotal study

    • Decision from this stage of the appeal expected before year end 2025

    enVVe®: Novel, First-In-Class Non-Surgical Transcatheter-Based Replacement Venous Valve

    • Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study

    • Successfully completed other testing necessary for IDE filing and awaiting the final consolidated study report

    • Targeting IDE filing for enVVe pivotal trial following clarity gained from VenoValve appeal process

    About enVVeno Medical Corporation

    enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company’s lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs.

    Cautionary Note on Forward-Looking Statements

    This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

    ###

    INVESTOR CONTACT:

    Jenene Thomas, JTC Team, LLC
    NVNO@jtcir.com
    (908) 824-0775

    MEDIA CONTACT:
    Glenn Silver, FINN Partners
    Glenn.Silver@finnpartners.com
    (973) 818-8198

    SOURCE: enVVeno Medical Corporation

    View the original press release on ACCESS Newswire

  • enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor “What This Means” Segment

    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 Medical participated in a Virtual Investor “What This Means” segment.

    As part of the segment, Mr. Berman discussed the Company’s recent news announcing it filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).

    The Virtual Investor “What This Means” segment featuring enVVeno Medical is now available here.

    About enVVeno Medical Corporation

    enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company’s lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of severe deep Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The Company is currently performing the final testing necessary to seek IDE approval from the FDA to begin the U.S. pivotal trial for enVVe.

    INVESTOR CONTACT:
    Jenene Thomas, JTC Team, LLC
    NVNO@jtcir.com
    (908) 824-0775

    MEDIA CONTACT:
    Glenn Silver, FINN Partners
    Glenn.Silver@finnpartners.com
    (973) 818-8198

    SOURCE: enVVeno Medical Corporation

    View the original press release on ACCESS Newswire