Orchestra BioMed announces first patient enrollments in Virtue SAB

Orchestra BioMed (OBIO) announced the first patient enrollments in the Virtue SAB in the Treatment of Coronary ISR Trial, the Company’s U.S. IDE pivotal trial comparing its highly differentiated Virtue Sirolimus AngioInfusion Balloon to the AGENT paclitaxel-coated balloon, currently the only drug-coated balloon FDA-approved for a coronary indication. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients at up to 75 centers in the United States with enrollment completion currently planned for mid-2027.