Orchestra BioMed Announces First Patient Enrollments In Virtue SAB In Treatment Of Coronary ISR Trial

Author: Benzinga Newsdesk | October 27, 2025 08:04am

• Orchestra BioMed's Virtue® Sirolimus AngioInfusionTM Balloon ("Virtue SAB") is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus ("SirolimusEFRTM")
• The Virtue Trial is the first U.S. investigational device exemption ("IDE") head-to-head randomized coronary pivotal trial evaluating a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™)
• Coronary in-stent restenosis ("ISR"), the clinical focus of the Virtue Trial, is a difficult-to-treat and serious complication of coronary stenting that increases the risk of life-threatening heart problems, affecting an estimated 100,000 patients in the U.S. annually
• Virtue SAB has FDA Breakthrough Device Designation for the treatment of coronary ISR, as well as for coronary small vessel disease and below-the-knee peripheral artery disease

NEW HOPE, Pa., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO, "Orchestra BioMed" or the "Company"))), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced the first patient enrollments in the Virtue SAB in the Treatment of Coronary ISR Trial ("Virtue Trial"), the Company's U.S. IDE pivotal trial comparing its highly differentiated Virtue® Sirolimus AngioInfusionTM Balloon ("Virtue SAB") to the AGENT paclitaxel-coated balloon, currently the only drug-coated balloon ("DCB") FDA-approved for a coronary indication. The initial cases were successfully completed by the teams at The Christ Hospital Heart & Vascular Institute in Cincinnati, OH, and St. Francis Hospital & Heart Center in Roslyn, NY, marking the initiation of the Virtue Trial. Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart & Vascular Institute and Medical Director of The Christ Hospital Research Institute and Allen Jeremias M.D., Director of Interventional Cardiology Research and Associate Director, Cardiac Catheterization Laboratory, St. Francis Hospital & Heart Center are co-principial investigators of the Virtue Trial. 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.

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