4 - enVVeno Medical Corp (0001661053) (Issuer)

4 - enVVeno Medical Corp (0001661053) (Issuer)

4 - enVVeno Medical Corp (0001661053) (Issuer)

4 - enVVeno Medical Corp (0001661053) (Issuer)

4 - enVVeno Medical Corp (0001661053) (Issuer)

8-K - enVVeno Medical Corp (0001661053) (Filer)

10-Q - enVVeno Medical Corp (0001661053) (Filer)

8-K - enVVeno Medical Corp (0001661053) (Filer)

EFFECT - enVVeno Medical Corp (0001661053) (Filer)

S-8 - enVVeno Medical Corp (0001661053) (Filer)

S-3/A - enVVeno Medical Corp (0001661053) (Filer)

S-3 - enVVeno Medical Corp (0001661053) (Filer)

10-K/A - enVVeno Medical Corp (0001661053) (Filer)

10-K - enVVeno Medical Corp (0001661053) (Filer)

DEF 14A - enVVeno Medical Corp (0001661053) (Filer)

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

Successful Completion of All Planned Implants in GLP StudyenVVe Delivery System Demonstrates Consistent PerformanceCompany Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results IRVINE, CA / ACCESSWIRE / December 16, 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 completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The successful completion of all planned implants in the GLP study, including both long-t

Interviews with participating patients from the VenoValve® U.S. Pivotal TrialWebcast replay from with the presenting Primary InvestigatorsPresentation with data from the VenoValve U.S. Pivotal TrialAccess the Recap Website Here!IRVINE, CA / ACCESSWIRE / November 27, 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 launch of a recap website which highlights the Company's participation at the recently held 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium. Materials accessible on the recap website include interviews with two patients and

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