enVVeno Medical Corporation - Common Stock (NVNO)

IRVINE, CA / ACCESS Newswire / March 31, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced its abstract has been accepted for presentation at the Society for Clinical Vascular Surgery (SCVS) 52nd Annual Symposium being held March 29-April 2, 2025 in Austin, TX.

Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range

On-demand video webcast now available here

One-year follow-up data demonstrates sustained improvements across venous specific quality-of-life (QoL) indicators.

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.

Successful Completion of All Planned Implants in GLP Study

Interviews with participating patients from the VenoValve® U.S. Pivotal Trial

85% Clinical Meaningful Benefit Responder Rate

Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium

Continued progress toward submission of 5th and final module of FDA premarket approval (PMA) application for VenoValve® in Q4

First wave of implants successfully completed with updated delivery system performing very well

enVVeno Medical (NASDAQ: NVNO), a late-clinical stage medical device company setting new standards of care for the treatment of venous diseases, recently announced the pricing of an underwritten public offering. Led by existing institutional investors, the offering involved the issuance and sale of 4,285,715 shares of the company’s common stock (or pre-funded warrants in lieu thereof) at a public offering price of $3.50 per unit. enVVeno expected to receive aggregate gross proceeds from the offering of about $15.0 million. The offering was anticipated to close on or about September 30, 2024, subject to customary closing conditions.

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. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The purchase price of each pre-funded warrant sold in the offering will be equal to the price at which a share of common stock is sold in the offering, minus $0.0001, and the exercise price of each pre-funded warrant will equal $0.0001 per share. In connection with the offering, enVVeno has granted the underwriter a 30-day option to purchase up to an additional 642,857 shares of common stock from the Company at the public offering price, less underwriting discounts and commissions.

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 30-day option to purchase up to an additional 15% of the number of shares of common stock and pre-funded warrants to be offered in this public offering on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

MedTech Marketing Leader with Significant New Product Launch Experience for Cardiovascular Devices

VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA

- 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®

Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Thursday, June 27th at 4:00 PM ET

91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved

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 presentation, entitled "The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux," will be made on Friday, June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.

- 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 46th Annual Charing Cross Symposium- Company on track to file PMA Application seeking VenoValve® FDA approval in Q4 2024

Appointment bolsters Company's transition from being a clinical stage to a commercial entity planning for the monetization of the VenoValve®

Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Thursday, March 21st at 12:00 PM ET

IRVINE, CA / ACCESSWIRE / April 24, 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 presentation of positive topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 Charing Cross International Symposium in London, UK.

97% of VenoValve Study Patients Showing Clinical Improvement at Six Months (as Measured by the Revised Venous Clinical Severity Score (rVCSS))