Orchestra BioMed approved to commence Virtue Trial, as per FDA green light
Orchestra BioMed's Virtue SAB Trial: A Step Forward in Cardiovascular Care
Orchestra BioMed, a biomedical company, is one step closer to bringing a new product to market with the Virtue Trial. This trial is significant as it compares the company's Virtue SAB to Boston Scientific's AGENT paclitaxel-coated balloon in a coronary indication.
The Virtue SAB program is currently targeting the initiation of the trial during the second half of 2025. Dr. Allen Jeremias, a prominent figure in the field, anticipates continued momentum for drug-coated balloons and is eager to see how Virtue SAB performs in a head-to-head trial against AGENT.
Virtue SAB delivers a proprietary extended-release formulation of sirolimus (SirolimusEFR) through micropores on a non-coated balloon. This design is intended to provide precise dosing and sustained drug delivery for treating arterial disease, including coronary In-Stent Restenosis (ISR).
The trial will assess Virtue SAB against current standards for ISR treatment, such as drug-coated balloons and drug-eluting stents. In a previous pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including a 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm.
Orchestra BioMed is currently completing late-stage clinical trials with Virtue SAB for in-stent restenosis of coronary arteries and aims to finish enrolling participants soon. The primary endpoint of the Virtue Trial is a non-inferiority comparison of Target Lesion Failure (TLF) at 12 months.
The Virtue Trial will randomize 740 patients across up to 75 centers in the U.S. The trial is a head-to-head comparison between Virtue SAB and AGENT Paclitaxel DCB in the treatment of coronary ISR. The "gold-standard" drug for preventing arterial restenosis is sirolimus, and Virtue SAB is designed to optimize both the arterial tissue uptake and retention of sirolimus.
The technology's potential advantages are highlighted by its four FDA Breakthrough Device Designations across Orchestra’s technology portfolio, including Virtue SAB. This regulatory recognition reflects the technology’s potential impact in cardiovascular care.
Prominent figures in the field, such as Dr. Dean J. Kereiakes, a prominent figure in interventional cardiology, believe Virtue SAB has the potential to set a new standard of care. The Virtue Trial is a landmark trial for Orchestra BioMed, potentially delivering a next-generation solution for atherosclerotic disease.
Orchestra BioMed Holdings, Inc. has received FDA approval for an amendment to its IDE to initiate a U.S. pivotal clinical trial for its Virtue SAB. The trial is designed to showcase the full potential of Virtue SAB in a clinical setting. With the Virtue Trial underway, Orchestra BioMed moves closer to bringing a new product to market and potentially revolutionizing cardiovascular care.
In the context of the ongoing Virtue Trial, the significance lies in how it compares Orchestra BioMed's Virtue SAB to AGENT paclitaxel-coated balloon, demonstrating the company's commitment to advancing medical-conditions like cardiovascular-health and health-and-wellness. The trial's focus on arterial disease, particularly coronary In-Stent Restenosis (ISR), highlights the potential of Virtue SAB's extended-release formulation of sirolimus (SirolimusEFR) to deliver improved treatment options in the field of science.
