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 2024IRVINE, 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 announced that Andrew Cormack has been hired as the Company's Chief Commercial Officer. Mr. Cormack, who joined enVVeno Medical on April 8, comes to enVVeno following a career at both start-up and large medical device companies including WallabyPhenox, Medtronic, Covidien,

IRVINE, CA / ACCESSWIRE / August 16, 2022 / 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 appointment of Kevin Belteau as Vice President of Clinical Operations. Mr. Belteau joins enVVeno Medical following a twenty-three-year career in clinical operations at Medtronic.Mr. Belteau joined Medtronic as a field engineer upon graduation from college and has progressed through various clinical operations roles over the course of his tenure there. Most recently he managed his own team of clinical operations professionals and has been directly involved is more than 75 clinical st

85% Clinical Meaningful Benefit Responder Rate7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort75% Median Reduction in Pain (VAS)87% Median Ulcer Area Reduction97% Target Vein Patency RateImprovement in All Patient Reported Quality-of-Life IndicatorsCompany to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st A

Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH SymposiumCompany to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th 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 treatment of venous disease, today announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application

Continued progress toward submission of 5th and final module of FDA premarket approval (PMA) application for VenoValve® in Q4GLP study for enVVe® transcatheter-based replacement venous valve underway; On track to file IDE approval for pivotal trial mid-2025Ended 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 enVVe pivotal trial IRVINE, CA / ACCESSWIRE / October 31, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reported financial results for the third quarter 2024."We

First wave of implants successfully completed with updated delivery system performing very wellCompany 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 six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The first wave of implants, for the long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December. The GLP study is a

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 sto

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

MedTech Marketing Leader with Significant New Product Launch Experience for Cardiovascular DevicesKey Addition to Commercial Team as Company Begins Planning for the VenoValve MonetizationSeveral Upcoming Company Milestones Planned for Q4 of 2024 Including:Completion of PMA Submission Seeking FDA Approval for the VenoValveRelease of One Year Data from VenoValve U.S. Pivotal StudyBeginning of GLP Pre-clinical Study for enVVe in Preparation for enVVe Pivotal Trial IRVINE, CA / ACCESSWIRE / September 3, 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 Sandy Prietto has

VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDACompany on Track to File the 5th 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 provided an update on the U.S. Food and Drug Administration (FDA) premarket approval (PMA) application status for its lead product, a surgical replacement venous valve called the VenoValve. Four (4) out of five (5) modules that comprise the VenoValve PMA application have now bee

- 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 2024- Continued progress toward launch of GLP study for enVVe® transcatheter-based replacement venous valveIRVINE, CA / ACCESSWIRE / August 1, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the

Live video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Thursday, June 27th 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 Investor Closing Bell Series on Thursday, June 27, 2024 at 4:00 PM ET. As part of the event, Mr. Berman will discuss the Company's recently reported positive interim venous ulcer healing data showing significant improvement from the Company's SAVVE U.S. pivotal trial for the

SRPT: 45% | Sarepeta Therapeutics shares are trading higher after the company announced FDA approval of an expansion to the labeled indication for ELEVIDYS to include individuals with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene who are at least 4 years of age. Also, multiple firms raised their respective price targets on the stock. CLOV: 13% | Clover Health shares are trading higher following the purchase of 877,567 shares by a company director. NVNO: 16% | EnVVeno Medical shares are trading higher after the company reported interim venous ulcer healing data from the SAVVE U.E. pivotal trial for VenoValve, which will be presented at the Society for Vascular Surger

 91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed89% of Venous Ulcers with a Duration of More Than One Year Prior to VenoValve Surgery Have Fully Healed or ImprovedNo Ulcer RecurrencesCompany on Track to File Application Seeking VenoValve FDA Approval in Q4 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

enVVeno Medical (NASDAQ:NVNO) reported quarterly losses of $(0.31) per share which beat the analyst consensus estimate of $(0.40) by 22.5 percent. This is a 45.61 percent increase over losses of $(0.57) per share from the same period last year.

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 BenefitCompany on Track to File Application Seeking VenoValve FDA Approval in Q4 2024

enVVeno Medical (NASDAQ:NVNO) reported its Q4 earnings results on Thursday, February 29, 2024 at 04:15 PM. Here's what investors need to know about the announcement. Earnings enVVeno Medical beat estimated earnings by 30.0%, reporting an EPS of $-0.32 versus an estimate of $-0.46. Revenue was down $0 from the same period last year. Past Earnings Performance Last quarter the company missed on EPS by $0.06 which was followed by a 1.0% drop in the share price the next day. ** Listen to the earnings announcement yourself by clicking here. ** To track all earnings releases for enVVeno Medical visit their earnings calendar here. This article was generated by Benzinga's automated content engine a

enVVeno Medical (NASDAQ:NVNO) reported quarterly losses of $(0.32) per share which beat the analyst consensus estimate of $(0.46) by 30.43 percent. This is a 41.82 percent increase over losses of $(0.55) per share from the same period last year.

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