enVVeno Medical Corp

enVVeno Medical Corp. is a development stage medical device company, which develops tissue based solutions that are designed to be life sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease. Its products include The Bioprosthetic Heart Valve, The CoreoGraft, and The Venous Valve. The company was founded by Norman Jaffe on December 22, 1999 and is headquartered in Irvine, CA.

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enVVeno Medical Corp. is a development stage medical device company, which develops tissue based solutions that are designed to be life sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease. Its products include VenoValve and enVVe. The company was founded by Norman Jaffe on December 22, 1999 and is headquartered in Irvine, CA.

Successful Completion of All Planned Implants in GLP Study enVVe Delivery System Demonstrates Consistent Performance Company 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-term and short-term subjects, completes a critical phase of the study.

enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe

Interviews with participating patients from the VenoValve® U.S. Pivotal Trial Webcast replay from with the presenting Primary Investigators Presentation with data from the VenoValve U.S. Pivotal Trial Access 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.

enVVeno Medical Highlights Successful 2024 VEITH Symposium with Launch of Recap Website

The FDA's approval of VenoValve's PMA has the potential to significantly expand NVNO's portfolio of bioprosthetic solutions.

NVNO Completes Application for VenoValve's PMA, Shares Likely to Gain

85% Clinical Meaningful Benefit Responder Rate 7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort 75% Median Reduction in Pain (VAS) 87% Median Ulcer Area Reduction 97% Target Vein Patency Rate Improvement in All Patient Reported Quality-of-Life Indicators Company 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 Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S. Among the data being presented at VEITH are: Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).

enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium

Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium Company 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 have been submitted, reviewed and approved by the FDA.

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

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