Federally-approved trial for Virtue to commence by Orchestra BioMed
Orchestra BioMed Advances Virtue Sirolimus AngioInfusion Balloon Trial
Orchestra BioMed, a leading biomedical company, is making significant strides in the development of its Virtue Sirolimus AngioInfusion Balloon (SAB). The company has secured over $111 million in funding through various equity offerings and strategic transactions, with a substantial portion allocated for the Virtue SAB trial and another key study, the BACKBEAT study.
The Virtue SAB trial is a landmark event for Orchestra BioMed, aiming to deliver a next-generation solution for atherosclerotic disease. This prospective, multi-center, randomized trial will compare the clinical outcomes of Virtue SAB to AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary in-stent restenosis (ISR).
Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon. It stands out as the only device with a completely different mechanism of action among DCBs, according to cardiologist Allen Jeremias, MD, MSc.
The primary endpoint of the Virtue Trial is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, nonfatal target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 12 months.
The Virtue Trial will randomize 740 patients across up to 75 centers in the U.S. and will showcase the full potential of Virtue SAB, with the potential for optimal clinical outcomes with robust sirolimus delivery.
Mr. Hochman, Chairman and CEO of Orchestra BioMed, stated that the company believes there is a multibillion-dollar U.S. market for coronary drug delivery balloons. He also mentioned that Orchestra BioMed made a strategic decision to pursue a head-to-head trial with the commercially available AGENT paclitaxel-coated balloon.
The Virtue Trial will compare Orchestra BioMed's Sirolimus-AngioInfusion Balloon, Virtue SAB, to Boston Scientific's AGENT paclitaxel-coated balloon, currently the only FDA-approved DCB for a coronary indication. However, as of now, no direct recent clinical trial results or head-to-head efficacy data have been disclosed in the public domain comparing Virtue SAB to AGENT specifically for coronary ISR.
The latest updates on the Virtue SAB trial indicate that Orchestra BioMed is actively advancing the study with robust financial backing and enrollment progress. Further clinical results and head-to-head comparisons are awaited to establish comparative safety and efficacy profiles.
[1] Orchestra BioMed Press Release. (2025, August). Orchestra BioMed Announces $111 Million in Funding to Advance Clinical Development of Virtue Sirolimus AngioInfusion Balloon and Related Programs. [2] BTIG Research. (2025, July). BTIG Downgrades Orchestra BioMed to Neutral. [3] Orchestra BioMed Press Release. (2025, June). Orchestra BioMed Announces FDA Approval of Amendment to its Investigational Device Exemption (IDE) to Initiate a U.S. Pivotal Clinical Trial for its Virtue Sirolimus AngioInfusion Balloon. [4] Ligand Pharmaceuticals Press Release. (2025, May). Ligand Pharmaceuticals and Orchestra BioMed Announce Strategic Collaboration Agreement.
- In the field of health-and-wellness and medical-conditions, Orchestra BioMed's Virtue Sirolimus AngioInfusion Balloon trial, aiming to improve cardiovascular health, seeks to compare its effectiveness with AGENT Paclitaxel Drug-Coated Balloon in addressing coronary in-stent restenosis, particularly in the context of cardiovascular health.
- The results of this Virtue Sirolimus AngioInfusion Balloon trial could provide significant insights into the science of cardiovascular health, potentially influencing future treatments and enhancing our understanding of medical-conditions and health-and-wellness.
