In April, 2026, the first patient implant in the U.S. FDA Early Feasibility Study (“EFS”) for the GeminiOne Transcatheter Edge-to-Edge Repair (“TEER”) system has been successfully completed. The procedure was performed by Professor Saibal Kar, Director of Structural Heart Disease Interventions and Clinical Research at Los Robles Regional Medical Center (part of HCA Healthcare), and Clinical Professor of Medicine at the David Geffen School of Medicine at University of California, Los Angeles.