enVVeno Medical Corporation is a medical device firm dedicated to advancing innovative bioprosthetic, tissue-engineered solutions to elevate the treatment standard for venous diseases. The company’s primary focus includes its pioneering VenoValve, a surgical implant developed to address severe deep venous chronic venous insufficiency by acting as a one-way valve to help restore appropriate blood flow within the leg. Although the VenoValve recently received an unfavorable supervisory appeal decision from the U.S. Food and Drug Administration regarding its Premarket Approval application, enVVeno is now strategically shifting its resources toward its next-generation, non-surgical transcatheter-based replacement venous valve, enVVe. The enVVe program is progressing, with an Investigational Device Exemption application anticipated by mid-2025 for a pivotal clinical trial. Incorporated in 1999 and previously known as Hancock Jaffe Laboratories, Inc. until its name change in October 2021, enVVeno Medical Corporation maintains its operations in Irvine, California.