Core Insights - Orchestra BioMed has initiated the first patient enrollments in the Virtue Trial, a pivotal U.S. IDE trial comparing its Virtue® Sirolimus AngioInfusion Balloon (Virtue SAB) to the AGENT paclitaxel-coated balloon, the only FDA-approved drug-coated balloon for coronary indications [1][5] - The Virtue Trial aims to enroll 740 patients across up to 75 centers in the U.S., with completion expected by mid-2027 [1][5] - Virtue SAB is designed to optimize the delivery and extended release of sirolimus, addressing limitations of traditional drug-coated balloons [2][8] Company Overview - Orchestra BioMed is focused on accelerating high-impact biomedical technologies through strategic partnerships with leading global medical device companies [9] - The company’s flagship products include the Virtue SAB and Atrioventricular Interval Modulation (AVIM) Therapy, both of which are undergoing pivotal clinical trials and represent significant market opportunities [9] - Virtue SAB has received FDA Breakthrough Device Designation for treating coronary in-stent restenosis (ISR), coronary small vessel disease, and below-the-knee peripheral artery disease [3][9] Product Details - Virtue SAB is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (SirolimusEFR) [3][8] - The device aims to enhance tissue uptake and drug bioavailability, surpassing previously published target tissue concentrations of drug-eluting stents [2][8] - Clinical data from the SABRE pilot study indicated promising results for Virtue SAB in treating single-layer coronary ISR [8] Market Context - The global market opportunity for drug-eluting balloons is estimated to exceed $10 billion annually [5] - Coronary ISR affects approximately 100,000 patients in the U.S. each year, representing a significant clinical challenge [3][7] - The Virtue Trial's primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) at 12 months, which includes cardiac death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization [5]

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]