Orchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon

Core Viewpoint - Orchestra BioMed has received FDA approval for an Investigational Device Exemption amendment to initiate the Virtue Trial, which will compare its Sirolimus-AngioInfusion Balloon (Virtue SAB) against the Boston Scientific AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis (ISR) [1][5][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [9][10] - The company is developing the Virtue SAB for atherosclerotic artery disease, which is a leading cause of mortality worldwide [10] Product Differentiation - Virtue SAB utilizes a proprietary extended-release formulation of sirolimus (SirolimusEFR™) delivered through a non-coated microporous AngioInfusion™ Balloon, designed to overcome limitations of traditional drug-coated balloons (DCBs) [2][4][8] - The device has been granted multiple FDA Breakthrough Device Designations for various indications, including coronary ISR and small vessel disease [5][8] Clinical Trial Details - The Virtue Trial will be the first U.S. head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon for coronary ISR [5] - The trial aims to enroll 740 patients across up to 75 centers in the U.S., with a primary endpoint of non-inferiority in Target Lesion Failure (TLF) at 12 months [6][5] Market Potential - The U.S. market for coronary drug delivery balloons is estimated to be multibillion-dollar, driven by significant unmet clinical needs and established reimbursement [6] - The company believes that the superior safety and efficacy of sirolimus over paclitaxel will be demonstrated through the performance of Virtue SAB in clinical settings [6]