Robert Berman: enVVe System Pivotal Trial to Start in 2026
Robert Berman, CEO, stated, "2025 represented a significant inflection point for the Company. Following the FDA's decision regarding the VenoValve, we made the strategic determination to accelerate development of the enVVe System, a less invasive, transcatheter-based approach designed to address prior regulatory considerations while broadening the potential physician adoption base. With pre-clinical development complete and active discussions underway with the FDA, we are now focused on initiating our pivotal trial in 2026 and believe the enVVe System represents a transformative opportunity to address a large and underserved patient population suffering from severe chronic venous insufficiency."
