Orchestra BioMed Starts U.S. Virtue Coronary Balloon Trial as Terumo Reworks Deal With $30M Support

Overview

• Orchestra BioMed reported first patient enrollments in its FDA IDE trial of the Virtue Sirolimus AngioInfusion Balloon for coronary in-stent restenosis.
• The randomized study compares Virtue to Boston Scientific’s Agent paclitaxel-coated balloon, currently the only FDA‑approved coronary drug-coated balloon.
• Initial procedures took place at The Christ Hospital Heart & Vascular Institute in Cincinnati and St. Francis Hospital & Heart Center in Roslyn, New York.
• Enrollment is planned for up to 740 patients across as many as 75 U.S. sites, with company projections targeting completion around mid‑2027.
• Terumo terminated a prior distribution pact in favor of a right of first refusal, paying $10 million upfront plus a $20 million preferred equity investment, with the ROFR expiring 90 days after Virtue trial primary endpoint data disclosure and the transactions expected to close by Nov. 7, 2025.