Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon.
It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy.
FDA IDE enables the company to initiate an updated design of its planned Virtue SAB in the Treatment of Coronary ISR Trial. The company plans to initiate a U.S. pivotal clinical trial comparing its next-generation Virtue SAB (sirolimus-angioinfusion balloon) to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for coronary indication, picking up approval last month.
Orchestra hopes to use the study results to support regulatory approval in the U.S.
More about Virtue SAB and the Orchestra BioMed IDE study
The company designed Virtue SAB to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR. It utilizes a non-coated microporous AngioInfusion balloon that protects the drug in transit. This delivers a large liquid dose, overcoming certain limitations of DCBs.
SirolimusEFR enables tissue uptake and extended release of the required therapeutic levels of sirolimus. With this, Virtue SAB has breakthrough device designation for treating coronary ISR. It also has a breakthrough designation for coronary small vessel disease and peripheral artery disease below-the-knee.
The Virtue Trial will evaluate Virtue SAB and Agent. It has a primary endpoint of a on-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. Orchestra BioMed expects to randomize 740 patients across up to 75 U.S. centers. It anticipates initiation in the second half of 2025.
The company believes its approach offers the “most direct path to regulatory approval,” Chair and CEO David Hochman says.
“We believe there is a multibillion-dollar U.S. market for coronary drug delivery balloons based on the significant unmet clinical need, market demand, and established reimbursement,” said Hochman. “We made a deliberate, strategic decision to pursue a head-to-head trial with the commercially available Agent paclitaxel-coated balloon, underscoring our confidence in Virtue SAB as a fundamentally differentiated solution for the treatment of atherosclerosis.”
