Orchestra BioMed Holdings has announced the first patient enrolments in the Virtue SAB in the Treatment of Coronary ISR Trial, the Company’s U.S. IDE pivotal trial comparing its highly differentiated Virtue Sirolimus AngioInfusion 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.
“Virtue SAB and SirolimusEFR were specifically designed to optimize the dose, delivery, uptake and extended release of sirolimus without the limitations of a drug coating on the balloon surface. A substantial body of clinical evidence from drug-eluting stent studies has established sirolimus and its analogs as the gold-standard drug for promoting vessel healing and preventing restenosis following interventional procedures,” said Jarrod D. Frizzell, MD, MS, FACC, FSCAI, Director of Complex Coronary Therapeutics, Interventional Cardiology, The Christ Hospital Health Network.
Frizzell added: “The Virtue Trial will allow us to evaluate the performance of this fundamentally different approach to delivering sirolimus, which has shown promising results in a prior pilot clinical study in coronary ISR treatment, in direct comparison to the AGENT paclitaxel-coated balloon.”
Additionally, Dr. Jeremias commented: “Drug coated balloons offer a promising alternative to drug-eluting stents for the treatment of coronary indications such as coronary ISR. Virtue SAB and SirolimusEFR are designed to go beyond DCBs with the goal of optimizing drug dosing, tissue uptake and extended drug bioavailability at the site of treatment. Our team at St. Francis is excited to play a leadership role in the Virtue Trial which will evaluate this differentiated, non-coated drug-delivery system head-to-head versus the current market leading DCB.”
Virtue SAB is designed to deliver a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon that protects the drug in transit and helps overcome certain limitations of DCBs. SirolimusEFR is designed to enable enhanced tissue uptake and extended release of therapeutic levels of sirolimus through the critical healing period, exceeding previously published target tissue concentrations of proven drug-eluting stents. In the multi-center SABRE pilot study, Virtue SAB demonstrated promising clinical results for the treatment of single-layer coronary ISR:
- 12-month target lesion failure of 2.8%
- Zero target lesion revascularizations from 12-month follow-up through 36-month follow-up; and
- 6-month late lumen loss of 0.12mm.
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. Orchestra BioMed estimates the total global market opportunity for drug-eluting balloons to be over 10 billion USD annually.
The Virtue Trial is a prospective, multi-centre, randomised trial comparing clinical outcomes of Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR. Data from the Virtue Trial is expected to be used to support regulatory approval in the U.S. The primary endpoint 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 revascularisation at 12 months. The trial is expected to randomise 740 patients across up to 75 centres in the U.S.
Darren R. Sherman, President and Chief Operating Officer of Orchestra BioMed stated: “We believe the future of arterial disease treatment will be driven by optimised delivery and extended tissue release of therapeutic doses of sirolimus, the proven antiproliferative drug with well-established safety and effectiveness.
“Balloon surface-coating drug delivery has challenges and limitations, including dosing constraints, drug-loss that requires rapid device navigation, and the release of large embolic particulates. We designed Virtue SAB and its key enabling technology, our proprietary SirolimusEFR, to overcome these limitations and realise the full potential of arterial drug delivery during angioplasty. With the launch of the Virtue Trial, we’re taking a major step toward realising our vision of improving patient outcomes.”
