OpSens Inc. announced the successful completion of the first cases in a clinical study, named SAFE-TAVI, studying SavvyWire(TM) left ventricular rapid pacing in transcatheter aortic valve replacement procedures, or TAVR, in Europe. Dr. Regueiro from Hospital Clínic de Barcelona, Spain, conducted the procedures as one of the primary investigators of the study. This study is part of the OpSens pre-CE mark clinical strategy that will lead to the commercialization of SavvyWire in Europe. OpSens' SavvyWire has previously received Health Canada and U.S. FDA clearance. Using SavvyWire for left ventricular pacing can eliminate the need for venous access, reduce procedure time, and avoid potential complications associated with right ventricular pacing. Dr. Josep Rodés-Cabau, from the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec or "IUCPQ"), is the global principal investigator of the SAFE-TAVI study that will enroll 120 patients with, among other conditions, severe aortic valve stenosis requiring a TAVR procedure in which left ventricular rapid pacing is considered necessary. The SAFE-TAVI study is planned to be conducted at up to nine hospitals: in eight renowned centers across Spain and in Canada, at the IUCPQ. As the global principal investigator of the SAFE-TAVI study, Dr. Rodés-Cabau will oversee and
coordinate the principal investigators in their respective Spanish hospitals.